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CHAPTER 117
MAINE PHARMACY ACT
SUBCHAPTER 1
TITLE AND DEFINITIONS
§13701. Short title
This chapter shall be known and may be cited as the "Maine Pharmacy Act." [PL 1987, c. 710,
§5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13702. Definitions
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 716, §1 (AMD). PL 1997, c. 117, §9 (AMD). PL 1997,
c. 245, §§3,4 (AMD). RR 1999, c. 1, §46 (COR). PL 1999, c. 42, §§1,2 (AMD). PL 1999, c.
130, §§1-5 (AMD). PL 2005, c. 430, §6 (AMD). PL 2005, c. 430, §10 (AFF). PL 2007, c. 402,
Pt. DD, §1 (RP).
§13702-A. Definitions
As used in this chapter, unless the context otherwise indicates, the following terms have the
following meanings. [PL 2007, c. 402, Pt. DD, §2 (NEW).]
1. Automated pharmacy systems. "Automated pharmacy systems" means mechanical systems
that perform operations or activities, other than compounding, relative to the storage, packaging,
labeling, dispensing or distribution of medications, and systems that collect, control and maintain all
transactional information.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
1-A. Biological product. "Biological product" has the same meaning as in 42 United States Code,
Section 262.
[PL 2019, c. 34, §1 (NEW).]
2. Board. "Board" means the Maine Board of Pharmacy.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
2-A. Collaborative drug therapy management. "Collaborative drug therapy management"
means the initiating, administering, monitoring, modifying and discontinuing of a patient's drug therapy
by a pharmacist as authorized by a practitioner in accordance with a collaborative practice agreement.
"Collaborative drug therapy management" includes collecting and reviewing patient histories;
obtaining and checking vital signs, including pulse, temperature, blood pressure and respiration; and,
under the supervision of, or in direct consultation with, a practitioner, ordering and evaluating the
results of laboratory tests directly related to drug therapy when performed in accordance with approved
protocols applicable to the practice setting and when the evaluation does not include a diagnostic
component.
[PL 2021, c. 271, §1 (AMD).]
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2-B. Collaborative practice agreement. "Collaborative practice agreement" means a written and
signed agreement between one or more pharmacists with training and experience relevant to the scope
of the collaborative practice and a practitioner that supervises or provides direct consultation to the
pharmacist or pharmacists engaging in collaborative drug therapy management that:
A. Defines the collaborative practice, which must be within the scope of the supervising
practitioner's practice, in which the pharmacist or pharmacists may engage; [PL 2013, c. 308, §1
(NEW).]
B. States the beginning and ending dates of the period of time during which the agreement is in
effect; and [PL 2013, c. 308, §1 (NEW).]
C. Includes individually developed guidelines for the prescriptive practice of the participating
pharmacist or pharmacists. [PL 2013, c. 308, §1 (NEW).]
[PL 2013, c. 308, §1 (NEW).]
3. Commissioner. "Commissioner" means the Commissioner of Professional and Financial
Regulation.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
4. Compounding. "Compounding" means the preparation, mixing, assembling, packaging or
labeling of a drug or device by a pharmacist:
A. For the pharmacist's patient for dispensing as the result of a practitioner's prescription drug
order; [PL 2021, c. 289, §2 (NEW).]
B. For the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale
or dispensing; [PL 2021, c. 289, §2 (NEW).]
C. In anticipation of prescription drug orders to be received by the pharmacist based on routine,
regularly observed prescribing patterns for the pharmacist's patient; or [PL 2021, c. 289, §2
(NEW).]
D. For nonpatient-specific drugs for distribution to licensed veterinarians for veterinarian office
use for nonfood-producing animals, as that term is defined in board rule. [PL 2021, c. 289, §2
(NEW).]
[PL 2021, c. 289, §2 (AMD).]
5. Dangerous substance. "Dangerous substance" means a substance described in section 13731,
subsection 2.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
6. Deliver or delivery. "Deliver" or "delivery" means the actual, constructive or attempted transfer
of a drug or device from one person to another, whether or not for a consideration.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
7. Department. "Department" means the Department of Professional and Financial Regulation.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
8. Device. "Device" means an instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent or other similar or related article, including any component part or accessory, that is
required under federal or state law to be prescribed by a practitioner and dispensed by a pharmacist.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
9. Dispense or dispensing. "Dispense" or "dispensing" means the preparation and delivery of a
prescription drug in a suitable container appropriately labeled for subsequent administration to or use
by a patient or other individual entitled to receive the prescription drug pursuant to a lawful order of a
practitioner.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
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10. Distribute. "Distribute" means the delivery of a drug other than by administering or
dispensing.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
11. Drug. "Drug" means:
A. Articles recognized as drugs in the official United States Pharmacopeia and National Formulary,
other drug compendiums or any supplement to any of them; [PL 2007, c. 402, Pt. DD, §2
(NEW).]
B. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease
in humans or other animals; [PL 2007, c. 402, Pt. DD, §2 (NEW).]
C. Articles, other than food, intended to affect the structure or any function of the body of humans
or other animals; and [PL 2007, c. 402, Pt. DD, §2 (NEW).]
D. Articles intended for use as a component of any articles specified in paragraphs A to C. [PL
2007, c. 402, Pt. DD, §2 (NEW).]
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
12. Electronic transmission. "Electronic transmission" means transmission of information in
electronic form or the transmission of the exact visual image of a document by way of electronic
equipment.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
12-A. Eligible product developer. "Eligible product developer" means a person that seeks to
develop an application for the approval of a drug under the Federal Food, Drug, and Cosmetic Act,
Section 505(b) or 505(j) or the licensing of a biological product under the federal Public Health Service
Act, Section 351.
[PL 2017, c. 434, §1 (NEW).]
13. Free clinic. "Free clinic" means an incorporated nonprofit health facility that provides health
care to people at no charge.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
14. Generic and therapeutically equivalent drug. "Generic" and "therapeutically equivalent
drug" means any drug that has identical amounts of the same active ingredients in the same dosage
form and in the same concentration that, when administered in the same amounts, will produce or can
be expected to have the same therapeutic effect as the drug prescribed.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
14-A. Interchangeable biological product. "Interchangeable biological product" means a
biological product that the federal Food and Drug Administration has:
A. Licensed and determined meets the standards for interchangeability pursuant to 42 United States
Code, Section 262(k)(4); or [PL 2019, c. 34, §2 (NEW).]
B. Determined is therapeutically equivalent as set forth in the most recent edition of or supplement
to the federal Food and Drug Administration's "Approved Drug Products with Therapeutic
Equivalence Evaluations" or a successor publication. [PL 2019, c. 34, §2 (NEW).]
[PL 2019, c. 34, §2 (NEW).]
15. Labeling. "Labeling" means the process of preparing and affixing a label to the outside of any
drug container, exclusive of the labeling by a manufacturer, packer or distributor of a nonprescription
drug or commercially packaged legend drug or device. Any such label must include all information
required by federal law or regulation and state law or rule.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
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16. Mail order contact lens supplier. "Mail order contact lens supplier" means a person or entity,
other than an optometrist or physician licensed in this State, that fills contact lens prescriptions by mail
or carrier for a patient who resides in this State.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
17. Mail order prescription pharmacy. "Mail order prescription pharmacy" means an entity that
dispenses prescription medications by mail or carrier from a facility not located in this State to a patient
who resides in this State.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
18. Manufacture. "Manufacture" means the production, preparation, propagation, compounding,
conversion or processing of a device or drug, either directly or indirectly, by extraction from substances
of natural origin or independently by means of chemical synthesis or by a combination of extraction
and chemical synthesis and includes any packaging or repacking of the substances or labeling or
relabeling of its container, except that manufacture does not include the preparation or compounding
of a drug by an individual for personal use or the preparation, compounding, packaging or labeling of
a drug:
A. By a pharmacist or practitioner incidental to administering or dispensing a drug in the course
of professional practice; or [PL 2007, c. 402, Pt. DD, §2 (NEW).]
B. By a practitioner or by authorization under the practitioner's supervision for the purpose of or
incidental to research, teaching or chemical analysis and not for sale. [PL 2007, c. 402, Pt. DD,
§2 (NEW).]
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
19. Manufacturer. "Manufacturer" means a person engaged in the manufacture of prescription
drugs.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
20. Nonprescription drugs. "Nonprescription drugs" means nonnarcotic drugs that may be sold
without a prescription and that are prepackaged for use by the consumer and labeled in accordance with
the requirements of the laws and rules of this State and the Federal Government.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
20-A. Opioid medication. "Opioid medication" means a controlled substance containing an
opioid included in schedule II of 21 United States Code, Section 812 or 21 Code of Federal Regulations,
Part 1308.
[PL 2015, c. 488, §28 (NEW).]
21. Person. "Person" means an individual, corporation, partnership, association or any other legal
entity.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
22. Pharmacist. "Pharmacist" means an individual provider of health care services licensed by
this State to engage in the practice of pharmacy.
A. "Chain pharmacist" means an individual who is engaged in the practice of pharmacy within a
chain; that is, where there is a corporate grouping of 4 or more pharmacies. [PL 2007, c. 402, Pt.
DD, §2 (NEW).]
B. "Hospital pharmacist" means an individual who is engaged in the practice of pharmacy in a
hospital setting. [PL 2007, c. 402, Pt. DD, §2 (NEW).]
C. "Independent pharmacist" means an individual who is engaged in the practice of pharmacy in
an independent pharmacy; that is, where there are fewer than 4 pharmacies under the same
ownership. [PL 2007, c. 402, Pt. DD, §2 (NEW).]
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D. "Qualified assistant pharmacist" means an individual licensed by this State as a qualified
assistant apothecary, qualified assistant or assistant pharmacist, provided that the license is in full
force and effect, except for the right to serve as a pharmacist in charge. [PL 2007, c. 402, Pt. DD,
§2 (NEW).]
[PL 2021, c. 146, §1 (AMD).]
23. Pharmacist in charge. "Pharmacist in charge" means a pharmacist who accepts responsibility
for the operation of a licensed pharmacy in conformance with applicable laws.
[PL 2021, c. 289, §3 (AMD).]
24. Pharmacy. "Pharmacy" means:
A. Any pharmacy or drug outlet located in a retail store, mail order business, free clinic or rural
health center with facilities located in this State that is engaged in dispensing, delivering or
distributing prescription drugs; or [PL 2007, c. 402, Pt. DD, §2 (NEW).]
B. Any mail order prescription company, or wholesaler, with facilities located in this State or doing
business in this State that is engaged in dispensing, delivering or distributing prescription drugs.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
24-A. Pharmacy intern. "Pharmacy intern" means a person who:
A. Is either enrolled in or a graduate of a school or college of pharmacy; and [PL 2011, c. 496,
§1 (NEW).]
B. Is licensed with the board and is authorized to engage in the practice of pharmacy while under
the direct supervision of a licensed pharmacist. [PL 2011, c. 496, §1 (NEW).]
[PL 2011, c. 496, §1 (NEW).]
25. Pharmacy technician. "Pharmacy technician" means a person employed by a pharmacy who
works in a supportive role to, and under the direct supervision of, a licensed pharmacist.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
26. Physician. "Physician" means an allopathic physician or osteopathic physician.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
27. Poison. "Poison" means an agent that when ingested, inhaled or otherwise absorbed by a living
organism is capable of producing a deleterious response seriously injuring function or producing death.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
28. Practice of pharmacy. "Practice of pharmacy" means the provision of health care services
that include the interpretation and evaluation of prescription drug orders; the compounding, dispensing
and labeling of drugs and devices, except labeling by a manufacturer, packer or distributor of
nonprescription drugs and commercially packaged legend drugs and devices; the participation in drug
selection and drug utilization reviews; the proper and safe storage of drugs and devices and the
maintenance of proper records for these drugs and devices; the administration of vaccines licensed by
the United States Food and Drug Administration that are recommended by the United States Centers
for Disease Control and Prevention Advisory Committee on Immunization Practices, or successor
organization, for administration to adults; the administration to adults by intramuscular and
subcutaneous injection of drugs approved by the United States Food and Drug Administration; the
performance of collaborative drug therapy management; the responsibility for advising, when
necessary or regulated, of therapeutic values, content, hazards and use of drugs and devices; the
ordering and dispensing of over-the-counter nicotine replacement products approved by the United
States Food and Drug Administration; the prescribing, dispensing and administering of an HIV
prevention drug, as defined in section 13786‑E, subsection 1, paragraph B, pursuant to a standing order
or collaborative practice agreement or to protocols developed by the board; and the offering or
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performing of those acts, services, operations or transactions necessary in the conduct, operation,
management and control of a pharmacy.
[PL 2021, c. 146, §2 (AMD); PL 2021, c. 265, §5 (AMD); PL 2021, c. 271, §2 (AMD).]
29. Practitioner. "Practitioner" means an individual who is licensed, registered or otherwise
authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional
practice.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
30. Prescription drug or legend drug. "Prescription drug" or "legend drug" means a drug that:
A. Under federal law is required, prior to being dispensed or delivered, to be labeled with either of
the following statements:
(1) "Caution: Federal law prohibits dispensing without prescription."; or
(2) "Caution: Federal law restricts this drug to use by or on the order of a licensed
veterinarian."; or [PL 2007, c. 402, Pt. DD, §2 (NEW).]
B. Is required by an applicable federal or state law or rule to be dispensed on prescription only or
is restricted to use by practitioners only. [PL 2007, c. 402, Pt. DD, §2 (NEW).]
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
31. Prescription drug order. "Prescription drug order" means a lawful written or oral order of a
practitioner for a drug or device. Written orders may be issued on a prescription form or by electronic
transmission.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
31-A. Proper name. "Proper name," as it relates to a biological product, means the nonproprietary
name for a biological product designated by the federal Food and Drug Administration for use on each
package of the product.
[PL 2019, c. 34, §3 (NEW).]
32. Rural health center. "Rural health center" means an incorporated nonprofit health facility
that provides comprehensive primary health care to citizens in rural areas.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
33. Targeted methamphetamine precursor. "Targeted methamphetamine precursor" means any
product containing any amount of ephedrine, pseudoephedrine or phenylpropanolamine or their salts,
isomers or salts of isomers, either alone or in combination with other ingredients:
A. In dry or solid nonliquid form; or [PL 2007, c. 402, Pt. DD, §2 (NEW).]
B. In liquid, liquid-filled capsule or glycerin matrix form if designation as a targeted
methamphetamine precursor has been completed by rule adopted pursuant to section 13795,
subsection 5, paragraph A. [PL 2007, c. 402, Pt. DD, §2 (NEW).]
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
34. Wholesaler. "Wholesaler" means a person who buys prescription drugs for resale and
distribution to persons other than consumers.
[PL 2007, c. 402, Pt. DD, §2 (NEW).]
SECTION HISTORY
PL 2007, c. 402, Pt. DD, §2 (NEW). PL 2009, c. 308, §1 (AMD). PL 2011, c. 496, §1 (AMD).
PL 2011, c. 577, §1 (AMD). PL 2013, c. 308, §§1, 2 (AMD). PL 2015, c. 488, §28 (AMD). PL
2017, c. 185, §1 (AMD). PL 2017, c. 434, §1 (AMD). PL 2019, c. 34, §§1-3 (AMD). PL 2021,
c. 146, §§1, 2 (AMD). PL 2021, c. 265, §5 (AMD). PL 2021, c. 271, §§1, 2 (AMD). PL 2021,
c. 289, §§2, 3 (AMD).
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SUBCHAPTER 2
MAINE BOARD OF PHARMACY
§13711. Establishment
There is established, within the department, in accordance with Title 5, chapter 379, the Maine
Board of Pharmacy. The board has all of the duties, powers and authority specifically granted by and
necessary to the enforcement of this Act. [PL 1997, c. 245, §6 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1997, c. 245, §6 (AMD).
§13712. Membership
The board consists of 7 members, two of whom must be public members as defined in Title 5,
section 12004‑A and the remainder of whom must be licensed pharmacists who possess the
qualifications specified in section 13713. At the time of the appointment, at least one of the licensed
pharmacists must be a hospital pharmacist, at least one must be a chain pharmacist and at least one
must be an independent pharmacist. [PL 2007, c. 402, Pt. DD, §3 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2007, c. 402, Pt. DD, §3 (AMD).
§13713. Qualifications
1. Public members. The public members of the board must be residents of this State who are at
least 21 years of age and shall not be, nor ever have been, members of the profession of pharmacy, the
spouse of a member of the profession of pharmacy, a person who has ever had any material financial
interest in providing pharmacy services or a person who has engaged in any activity directly related to
the practice of pharmacy.
[PL 1987, c. 710, §5 (NEW).]
2. Licensed pharmacists. The licensed pharmacist members of the board shall, at the time of their
appointment:
A. Be residents of this State; [PL 1987, c. 710, §5 (NEW).]
B. Be licensed and in good standing to engage in the practice of pharmacy in this State; [PL 1987,
c. 710, §5 (NEW).]
C. Be engaged in the practice of pharmacy in this State; and [PL 1987, c. 710, §5 (NEW).]
D. Have 5 years of experience in the practice of pharmacy in this State after licensure. [PL 1987,
c. 710, §5 (NEW).]
[PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13714. Appointment
The Governor shall appoint the members of the board. Prior to appointing any pharmacist as a
member of the board, the Governor may solicit recommendations of candidates from the Maine
Pharmacy Association and other pharmaceutical organizations as appropriate. [PL 1987, c. 710, §5
(NEW).]
SECTION HISTORY
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PL 1987, c. 710, §5 (NEW).
§13715. Terms of office
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 600, §A268 (RP).
§13715-A. Terms of office
1. Length. Members of the board are appointed for terms of 3 years. Appointments of members
must comply with Title 10, section 8009.
[PL 2007, c. 402, Pt. DD, §4 (AMD).]
2. Grounds for removal. The Governor may remove a member of the board for cause.
[PL 1993, c. 600, Pt. A, §269 (NEW).]
SECTION HISTORY
PL 1993, c. 600, §A269 (NEW). PL 2007, c. 402, Pt. DD, §4 (AMD).
§13716. Organization
1. Officers. The board shall elect from its members a president and other officers as it considers
appropriate and necessary to conduct its business.
[PL 2007, c. 402, Pt. DD, §5 (AMD).]
2. Terms of office. Officers elected by the board serve terms of one year commencing with the
day of their elections.
[PL 2007, c. 402, Pt. DD, §5 (AMD).]
3. Executive director.
[PL 1995, c. 397, §108 (RP).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1995, c. 397, §108 (AMD). PL 2007, c. 402, Pt. DD, §5 (AMD).
§13717. Compensation
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1995, c. 397, §109 (RP).
§13718. Meetings
1. Number. The board shall meet at least once a year to transact its business, which includes the
election of officers and the reorganization of the board. The board shall meet at additional times as it
may determine. Additional meetings may be called by the president or by 2/3 of the members of the
board.
[PL 2007, c. 402, Pt. DD, §6 (AMD).]
2. Place.
[PL 2007, c. 402, Pt. DD, §6 (RP).]
3. Notice.
[PL 2007, c. 402, Pt. DD, §6 (RP).]
4. Quorum.
[PL 2013, c. 246, Pt. B, §24 (RP).]
5. Open meeting.
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[PL 2007, c. 402, Pt. DD, §6 (RP).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2007, c. 402, Pt. DD, §6 (AMD). PL 2013, c. 246, Pt. B, §24
(AMD).
§13719. Employees
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1995, c. 397, §110 (RP).
§13720. Rules
The board shall make, adopt, amend and repeal such rules as may, from time to time, be determined
necessary by the board for the proper administration and enforcement of this Act. These rules shall be
promulgated in accordance with the Maine Administrative Procedure Act, Title 5, chapter 375. [PL
1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13721. Licensure and discipline
1. Responsibility. The board's responsibility for the control and regulation of the practice of
pharmacy in this State includes, but is not limited to, the following actions:
A. The licensing by examination or by endorsement of applicants who are qualified to engage in
the practice of pharmacy under this Act; [PL 2021, c. 289, §4 (AMD).]
B. The renewal of licenses to engage in the practice of pharmacy; [PL 1987, c. 710, §5 (NEW).]
C. The determination and issuance of standards for recognition and approval of degree programs
of schools and colleges of pharmacy whose graduates shall be eligible for licensure in this State
and the specification and enforcement of requirements for practical training, including internship;
[PL 1987, c. 710, §5 (NEW).]
D. The inspection during business hours of all pharmacies, dispensaries, stores, hospital
pharmacies, extended care facilities, boarding homes, nursing homes, substance use disorder
treatment centers, penal institutions, family planning centers or other drug outlets in which drugs
or medicines are manufactured, stored, distributed, compounded, dispensed or retailed in this State;
[PL 2017, c. 407, Pt. A, §145 (AMD).]
E. The licensing of any pharmacy as set out in section 13751 and any manufacturer or wholesaler
whose products are distributed in this State; [PL 2007, c. 402, Pt. DD, §7 (AMD).]
F. The enforcement of those provisions of this Act relating to the conduct or competence of
pharmacists practicing in this State and the processing of complaints which could lead to the
suspension, revocation or restriction of licenses to engage in the practice of pharmacy; [PL 1987,
c. 710, §5 (NEW).]
G. The licensing of pharmacy interns and adoption of rules governing the training, qualification
and employment of pharmacy interns and pharmacy students; and [PL 2011, c. 496, §2 (AMD).]
H. The licensing of pharmacy technicians, including the fee as set under section 13724, and
adoption of rules governing the training, qualification and employment of pharmacy technicians.
[PL 2007, c. 402, Pt. DD, §8 (AMD).]
[PL 2021, c. 289, §4 (AMD).]
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2. Reciprocal inspections. The board may enter into reciprocal inspection agreements with any
state in which a mail order prescription facility selling drugs to Maine citizens is located.
[PL 1997, c. 245, §8 (AMD).]
3. Pharmacist health program. The board may establish protocols for the operation of a
professional review committee as defined in Title 24, section 2502, subsection 4‑A. The protocols must
include the committee's reporting information the board considers appropriate regarding reports
received, contracts or investigations made and the disposition of each report, as long as the committee
is not required to disclose any personally identifiable information. The protocols may not prohibit an
impaired pharmacist or pharmacy technician from seeking alternative forms of treatment.
The board has the power to contract with other agencies, individuals, firms or associations for the
conduct and operation of a pharmacist health program operated by a professional review committee as
that term is defined in Title 24, section 2502, subsection 4‑A.
[PL 2007, c. 288, §2 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1997, c. 245, §§7,8 (AMD). PL 2005, c. 262, §B1 (AMD). PL
2007, c. 288, §2 (AMD). PL 2007, c. 402, Pt. DD, §§7, 8 (AMD). PL 2011, c. 496, §2 (AMD).
PL 2017, c. 407, Pt. A, §145 (AMD). PL 2021, c. 289, §4 (AMD).
§13722. Medications, drugs, devices and other materials
1. Responsibility. The board has the following responsibilities in regard to medications, drugs,
devices and other materials used in this State in the diagnosis, mitigation and treatment or prevention
of injury, illness and disease. The board shall:
A. Promulgate rules concerning the sale and dispensing of medications, drugs, devices and other
materials, including the right to seize any such drugs, devices and other materials found to be
detrimental to the public health and welfare by the board after appropriate hearing as required under
the Maine Administrative Procedure Act, Title 5, chapter 375; [PL 1987, c. 710, §5 (NEW).]
B. Establish the specifications of minimum professional and technical equipment, environment,
supplies and procedure for the compounding, dispensing or administering of medications, drugs,
devices and other materials within the practice of pharmacy; [PL 2021, c. 146, §3 (AMD).]
B-1. Establish standards for the use, maintenance and supervision of automated pharmacy systems;
[PL 2021, c. 289, §5 (AMD).]
B-2. Establish the terms and conditions for compounding drugs for veterinarian office use by rule,
including, at a minimum:
(1) Requirements and specifications of minimum professional and technical equipment,
environments, supplies and procedures and quality assurance requirements;
(2) Labeling requirements;
(3) Limits on the supply for administration to the veterinarian's patient and the supply for
dispensing to the veterinarian's client;
(4) Record-keeping requirements; and
(5) Procedures for notifications regarding defective drug products and adverse events.
Compounding drugs for veterinarian office use is not permitted until rules are adopted by the board
pursuant to this paragraph. Rules adopted pursuant to this paragraph are routine technical rules as
defined in Title 5, chapter 375, subchapter 2‑A; [PL 2021, c. 289, §6 (NEW).]
C. Assure that standards for purity and quality of medications, drugs, devices and other materials
within the practice of pharmacy are met; [PL 1987, c. 710, §5 (NEW).]
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D. Issue and renew licenses for purposes of ascertaining those persons engaged in the manufacture
and distribution of drugs; [PL 2007, c. 402, Pt. DD, §9 (AMD).]
E. Promulgate rules concerning the sale and the dispensing of any exempt narcotic preparation.
An "exempt narcotic preparation" means any medicinal preparation that contains in 30 milliliters
or, if a solid or semisolid preparation, in 30 grams:
(1) Not more than 130 milligrams of opium;
(2) Not more than 15 milligrams of morphine or any of its salts;
(3) Not more than 65 milligrams of codeine or any of its salts;
(4) Not more than 30 milligrams of dihydrocodeine or any of its salts; or
(5) Not more than one of the drugs named in subparagraphs (1) to (4).
A record shall be kept of the sale of exempt narcotic preparations. The record must contain the date
of sale, signature and address of the purchaser, name of the preparation, purpose for which
purchased and signature of the person making the sale; and [PL 1987, c. 710, §5 (NEW).]
F. After notice and hearing, designate as potent medicinal substances any compounds of barbituric
acid, amphetamines or any other central nervous system stimulants or depressants, psychic
energizers or any other drugs having a tendency to depress or stimulate which are likely to be
injurious to health if improperly used. [PL 1987, c. 710, §5 (NEW).]
[PL 2021, c. 146, §3 (AMD); PL 2021, c. 289, §§5, 6 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1999, c. 130, §6 (AMD). PL 2007, c. 402, Pt. DD, §9 (AMD).
PL 2021, c. 146, §3 (AMD). PL 2021, c. 289, §§5, 6 (AMD).
§13723. Other duties, powers and authority
The board has such other duties, powers and authority as may be necessary to enforce this Act and
the board may adopt rules pursuant to this Act, which include, but are not limited to, the following.
[PL 1987, c. 710, §5 (NEW).]
1. Professional associations. The board may join professional organizations and associations
organized exclusively to promote the improvement of the standards of the practice of pharmacy for the
protection of the health and welfare of the public and whose activities assist and facilitate the work of
the board.
[PL 1987, c. 710, §5 (NEW).]
2. Bond. In addition to any statutory requirements, the board may require such surety bonds as it
considers necessary to guarantee the performance and discharge of the duties of any officer or employee
receiving and disbursing funds.
[PL 2007, c. 402, Pt. DD, §10 (AMD).]
3. Seal.
[PL 2007, c. 402, Pt. DD, §10 (RP).]
4. Reports.
[PL 2007, c. 402, Pt. DD, §10 (RP).]
5. Fees.
[PL 2005, c. 262, Pt. B, §2 (RP).]
6. Grants. The board may receive and expend funds, in addition to its annual allocation, from
parties other than the State, as long as:
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A. The funds are awarded for the pursuit of a specific objective that the board is authorized to
accomplish by this Act or that the board is qualified to accomplish by reason of its jurisdiction or
professional expertise; [PL 2007, c. 402, Pt. DD, §10 (AMD).]
B. The funds are expended for the pursuit of the objective for which they are awarded; [PL 1987,
c. 710, §5 (NEW).]
C. Activities connected with or occasioned by the expenditures of the funds do not interfere with
or impair the performance of the board's duties and responsibilities and do not conflict with the
exercise of the board's powers as specified by this Act; [PL 1987, c. 710, §5 (NEW).]
D. The funds are kept in a separate, special state account; and [PL 1987, c. 710, §5 (NEW).]
E. Periodic reports are made to the commissioner concerning the board's receipt and expenditure
of the funds. [PL 1987, c. 710, §5 (NEW).]
[PL 2007, c. 402, Pt. DD, §10 (AMD).]
7. Investigatory powers. The board shall notify the Department of the Attorney General upon
receipt of a complaint. Upon receipt of the notifications, the Attorney General shall notify the
department within a timely period if the alleged violation requires criminal investigation. If a case does
not require criminal investigation, the board or its authorized representatives may investigate and gather
evidence concerning alleged violations of this Act or of the rules of the board. The board or an
authorized representative pursuant to paragraph A may remove from any premises authorized for
inspection pursuant to section 13721, subsection 1, paragraph D certain original records relating to
scheduled drugs or controlled substances, including, but not limited to, prescription records, shipping
and delivery records, patient profiles, inventories and other drug records for the purposes of analysis,
duplication and furthering the investigation. A signed inventory receipt of any records being removed
must be furnished to the premises by the board or an authorized representative. When a means of
producing legible photocopies is readily available at the site of the records being removed, an
authorized representative removing the records shall leave photocopies of the records as part of an
inventory receipt in accordance with this subsection. Except when photocopies are left as part of an
inventory receipt, the board or an authorized representative removing records from the premises shall,
within 48 hours from the time of removal, provide to a representative of the premises photocopies of
any removed records, together with a certificate identifying the agency in possession of the records, or
return the original records. Inventory receipts and photocopies of any removed records provided by
the board or an authorized representative are admissible as evidence if offered by any representative of
the premises to prove compliance with any rule of the board or requirement of law.
A. Prescriptions, orders and records required by this chapter and stocks of prescription and legend
drugs are open only to the board, the board's authorized representatives, federal and state law
enforcement officers whose duty it is to enforce the laws of this State or of the United States relating
to scheduled drugs or controlled substances or to enforce conditions of probation or other
supervision imposed by a court relating to scheduled drugs or controlled substances and other law
enforcement officers authorized by the board, the Attorney General or the district attorney for the
purposes of inspecting, investigating and gathering evidence of violations of law or any rule of the
board. A person having knowledge by virtue of the person's office of any such prescription, order
or record may not divulge that knowledge, except before a licensing board or representative or in
connection with a prosecution or proceeding in court. [PL 2009, c. 415, Pt. A, §19 (RPR).]
B. The Bureau of Health, the board, their officers, agents, inspectors and representatives, all peace
officers within the State and all prosecuting attorneys shall enforce all provisions of this chapter,
except those specifically delegated, and shall cooperate with all agencies charged with the
enforcement of the laws of the United States, of this State and of all other states relating to
prescription or legend drugs or their equivalent. [PL 1991, c. 274, §2 (AMD).]
C. [PL 1995, c. 621, §4 (RP).]
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[PL 2009, c. 415, Pt. A, §19 (AMD).]
8. Embargo. The board may embargo certain drugs or devices as follows.
A. Notwithstanding anything in this Act to the contrary, if a duly authorized representative of the
board finds or has probable cause to believe that any drug or device is adulterated or misbranded
within the meaning of the United States Food and Drug Act, the board representative shall affix to
the drug or device a tag or other appropriate marking giving notice that the article is or is suspected
of being adulterated or misbranded and has been detained or embargoed, and warning all persons
not to remove or dispose of the article by sale or otherwise until provision for removal or disposal
is given by the board, its representative or the court. No person may remove or dispose of the
embargoed drug or device by sale or otherwise without the permission of the board or its
representative or, after summary proceedings have been instituted, without permission from the
court. [PL 2007, c. 402, Pt. DD, §10 (AMD).]
B. When a drug or device detained or embargoed under paragraph A has been declared by a
representative of the board to be adulterated or misbranded, the board shall, as soon as practical,
report the declaration to the Attorney General's office, along with sufficient information to permit
the Attorney General to bring a petition for an injunction to the judge of the court in whose
jurisdiction the article is detained or embargoed. If the judge determines that the drug or device so
detained or embargoed is not adulterated or misbranded, the board shall direct the immediate
removal of the tag or other marking. [PL 1987, c. 710, §5 (NEW).]
C. If the court finds the detained or embargoed drug or device is adulterated or misbranded, that
drug or device, after entry of the decree, shall be destroyed at the expense of the owner under the
supervision of the board representative and all court costs and fees, storage and other proper
expense shall be borne by the owner of the drug or device. When the adulteration or misbranding
may be corrected by proper labeling or processing of the drug or device, the court, after entry of
the decree and after the costs, fees and expenses have been paid and a good and sufficient bond has
been posted, may direct that the drug or device be delivered to the owner for labeling or processing
under the supervision of a board representative. The expense of the supervision shall be paid by the
owner. The bond shall be returned to the owner of the drug or device on representation to the court
by the board that the drug or device is no longer in violation of the embargo and the expense of
supervision has been paid. [PL 1987, c. 710, §5 (NEW).]
[PL 2007, c. 402, Pt. DD, §10 (AMD).]
9. Budget.
[PL 1995, c. 397, §111 (RP).]
10. Procedure. Except as otherwise provided, the board shall exercise all of its duties, powers
and authority in accordance with the Maine Administrative Procedure Act, Title 5, chapter 375.
[PL 1987, c. 710, §5 (NEW).]
11. Exemption. The board may exempt a free clinic from all fees, in whole or in part, set under
this chapter.
[PL 2007, c. 402, Pt. DD, §10 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1991, c. 274, §2 (AMD). PL 1995, c. 251, §1 (AMD). PL 1995,
c. 397, §111 (AMD). PL 1995, c. 499, §4 (AMD). PL 1995, c. 499, §5 (AFF). PL 1995, c. 621,
§4 (AMD). PL 1997, c. 245, §§9,10 (AMD). PL 1999, c. 42, §3 (AMD). PL 2005, c. 262, §B2
(AMD). PL 2007, c. 344, §10 (AMD). PL 2007, c. 402, Pt. DD, §10 (AMD). PL 2009, c. 415,
Pt. A, §19 (AMD).
§13724. Fees
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The Director of the Office of Professional and Occupational Regulation may establish by rule fees
for purposes authorized under this chapter in amounts that are reasonable and necessary for their
respective purposes in accordance with this section. Rules adopted pursuant to this section are routine
technical rules as defined in Title 5, chapter 375, subchapter 2‑A. [PL 2019, c. 536, §3 (NEW).]
1. General fees. Except as provided in subsection 2, the fee for any one purpose may not exceed
$325.
[PL 2019, c. 536, §3 (NEW).]
2. Manufacturer of an opioid medication fee. The fee for a manufacturer of an opioid medication
is $55,000. This subsection does not apply to a manufacturer of an opioid medication if all of that
manufacturer's opioid medications are approved by the United States Food and Drug Administration
for use only in veterinary medicine.
[PL 2019, c. 536, §3 (NEW).]
SECTION HISTORY
PL 2005, c. 262, §B3 (NEW). PL 2007, c. 402, Pt. DD, §11 (AMD). PL 2011, c. 286, Pt. B, §5
(REV). PL 2019, c. 536, §3 (RPR).
§13725. Insulin Safety Net Program
(CONTAINS TEXT WITH VARYING EFFECTIVE DATES)
(WHOLE SECTION TEXT EFFECTIVE UNTIL 1/01/27)
(WHOLE SECTION TEXT REPEALED 1/01/27)
1. Definitions. As used in this section, unless the context otherwise indicates, the following terms
have the following meanings.
A. "Eligible individual" means an individual who has been determined to qualify for assistance
under the program pursuant to subsection 3 or 4. [PL 2021, c. 303, §1 (NEW).]
B. "Insulin" has the same meaning as in section 13786‑D, subsection 1, paragraph A, except for
an insulin product that has a wholesale acquisition cost of $8 or less per milliliter or applicable
National Council for Prescription Drug Plan billing unit, for the entire assessment time period,
adjusted annually based on the Consumer Price Index Annual Average, for All Urban Consumers,
CPI-U: U.S. City Averages, All Items reported by the United States Department of Labor, Bureau
of Labor Statistics. [PL 2021, c. 303, §1 (NEW).]
C. "Manufacturer" means a manufacturer engaged in the manufacturing of insulin that is self-
administered on an outpatient basis, except for a manufacturer with an annual gross revenue of
$2,000,000 or less from insulin sales in this State. [PL 2021, c. 303, §1 (NEW).]
D. "Urgent need of insulin" means having readily available for use less than a 7-day supply of
insulin and in need of insulin in order to avoid the likelihood of suffering significant health
consequences. [PL 2021, c. 303, §1 (NEW).]
[PL 2021, c. 303, §1 (NEW).]
2. Insulin Safety Net Program established. The board shall establish the Insulin Safety Net
Program, referred to in this section as "the program," in accordance with the requirements of this
section. Under the program, by March 1, 2022, each manufacturer shall establish procedures to make
insulin available in accordance with this section and as required under subsections 3 and 4 to
pharmacies for dispensing to eligible individuals who are in urgent need of insulin or who need access
to an affordable insulin supply.
[PL 2021, c. 303, §1 (NEW).]
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3. Urgent need safety net. A pharmacy shall dispense a 30-day supply of insulin, as permitted
under section 13786‑D, to an eligible individual in urgent need of insulin in accordance with this
subsection.
A. To be eligible, an individual must demonstrate on an application form developed by the board
that the individual:
(1) Is a resident of this State;
(2) Is not enrolled in MaineCare or any other health coverage or prescription drug coverage
that limits the total amount of cost-sharing that the enrollee is required to pay for a 30-day
supply of insulin, including copayments, deductibles or coinsurance, to $75 or less, regardless
of the type or amount of insulin prescribed;
(3) Has not received an urgent-need supply of insulin through the program within the previous
12 months; and
(4) Has an urgent need of insulin. [PL 2021, c. 303, §1 (NEW).]
B. The board shall make the application form accessible through the board's publicly accessible
website and make the form available to pharmacies and health care providers who prescribe or
dispense insulin, hospital emergency departments, urgent care clinics and community health
clinics. [PL 2021, c. 303, §1 (NEW).]
C. In addition to a completed, signed and dated application, an individual shall also present to a
pharmacy a valid insulin prescription and identification indicating residency in the form of a valid
Maine identification card, driver's license or permit. If the individual in urgent need of insulin is
under the age of 18, the individual's parent or legal guardian shall provide the pharmacy with proof
of residency. Upon receipt of the information required by this paragraph, the pharmacist shall
dispense the prescribed insulin in an amount that will provide the individual a 30-day supply. If an
individual does not have a valid prescription, a pharmacist may dispense an emergency refill of
insulin pursuant to section 13786‑D. [PL 2021, c. 303, §1 (NEW).]
D. The pharmacy shall notify the health care practitioner who issued the prescription order
presented under paragraph C no later than 72 hours after the insulin is dispensed. [PL 2021, c.
303, §1 (NEW).]
E. The pharmacy may submit to the manufacturer of the dispensed insulin product or to the
manufacturer's vendor a claim for payment for insulin dispensed under paragraph C that is in
accordance with the standards developed by a national council for prescription drug programs for
electronic claims processing, unless the manufacturer agrees to send to the pharmacy a replacement
supply of the same insulin as dispensed in the amount dispensed. If the pharmacy submits an
electronic claim to the manufacturer or the manufacturer's vendor, the manufacturer or vendor shall
reimburse the pharmacy in an amount that covers the pharmacy's acquisition cost. [PL 2021, c.
303, §1 (NEW).]
F. The pharmacy may collect an insulin copayment from the eligible individual to cover the
pharmacy's costs of processing and dispensing in an amount not to exceed $35 for the 30-day supply
of insulin dispensed under paragraph C. [PL 2021, c. 303, §1 (NEW).]
G. The pharmacy shall provide each eligible individual an information sheet provided by the board
with contact information for the Health Insurance Consumer Assistance Program established in
Title 24‑A, chapter 56‑A, subchapter 2‑A, including the program's publicly accessible website, toll-
free telephone number and e-mail address, so that the individual may access additional information
and assistance related to ongoing insulin coverage options, including assistance in: applying for
MaineCare; applying for a qualified health plan offered through the federally facilitated
marketplace, subject to open and special enrollment periods; accessing information on providers
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who participate in prescription drug discount programs, including providers who are authorized to
participate in the federal program under section 340b of the federal Public Health Service Act,
United States Code, Title 42, section 256b; and accessing insulin manufacturers' patient assistance
programs and other assistance programs through nonprofit organizations. [PL 2021, c. 303, §1
(NEW).]
H. The pharmacy shall retain a copy of the application form submitted by the individual under
paragraph A to the pharmacy for reporting and compliance purposes. [PL 2021, c. 303, §1
(NEW).]
[PL 2021, c. 303, §1 (NEW).]
4. Manufacturer's patient assistance. A manufacturer shall establish a patient assistance
program to provide access to insulin to any eligible individual who meets the requirements of this
subsection and who demonstrates a continued need for insulin. Each manufacturer's patient assistance
program must meet the requirements of this subsection.
A. Each manufacturer shall provide the Health Insurance Consumer Assistance Program
established in Title 24‑A, chapter 56‑A, subchapter 2‑A information regarding the manufacturer's
patient assistance program, including contact information for individuals to call for assistance in
accessing the patient assistance program. [PL 2021, c. 303, §1 (NEW).]
B. To be eligible to participate in a manufacturer's patient assistance program, an individual must:
(1) Be a Maine resident with a valid identification card that indicates Maine residency in the
form of a Maine identification card or driver's license or permit. If the individual is under the
age of 18, the individual's parent or legal guardian shall provide proof of residency;
(2) Have a family income that is equal to or less than 400 percent of the federal poverty
guidelines; and
(3) Not be enrolled in MaineCare or eligible to receive health care coverage through a federally
funded program or to receive prescription drug benefits through the United States Department
of Veterans Affairs or not be enrolled in prescription drug coverage through an individual or
group health plan that limits the total amount of cost-sharing that an enrollee is required to pay
for a 30-day supply of insulin, including copayments, deductibles or coinsurance, to $75 or
less, regardless of the type or amount of insulin needed.
Notwithstanding the requirement in this paragraph, an individual who is enrolled in Medicare Part
D is eligible for a manufacturer's patient assistance program if the individual has spent $1,000 on
prescription drugs in the current calendar year and meets the eligibility requirements in
subparagraphs (1) and (2). [PL 2021, c. 303, §1 (NEW).]
C. An individual who is interested in participating in a manufacturer's patient assistance program
may apply directly to the manufacturer or through the individual's health care practitioner, if the
practitioner participates in the manufacturer's patient assistance program. [PL 2021, c. 303, §1
(NEW).]
D. Upon receipt of an application for the manufacturer's patient assistance program, the
manufacturer shall process the application and determine eligibility. The manufacturer shall notify
the applicant of the determination within 10 business days of receipt of the application. If necessary,
the manufacturer may request additional information from the applicant. If additional information
is needed, the manufacturer shall notify the applicant within 5 business days of receipt of the
application as to what information is being requested. Within 3 business days of receipt of the
requested information, the manufacturer shall determine eligibility and notify the applicant of the
determination. If the individual has been determined to be not eligible, the manufacturer shall
include the reasons for denying eligibility in the notification. The individual may seek an appeal
of the determination in accordance with this section. If the individual is determined to be eligible,
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the manufacturer shall provide the individual with an eligibility statement or other indication that
the individual has been determined eligible for the manufacturer's patient assistance program. An
individual's eligibility is valid for 12 months and is renewable upon a redetermination of eligibility.
[PL 2021, c. 303, §1 (NEW).]
E. If the eligible individual has prescription drug coverage through an individual or group health
plan, the manufacturer may determine that the individual's insulin needs are better addressed by
providing financial assistance for copayments and other cost-sharing requirements of the
individual's individual or group health plan. The manufacturer shall establish a copayment
assistance program to provide such financial assistance. The manufacturer shall inform the
individual and provide the individual with the necessary coupons to submit to a pharmacy. Under
the manufacturer's copayment assistance program, an eligible individual may not be required to
pay more than a copayment of $35 for a 30‑day supply of insulin. [PL 2021, c. 303, §1 (NEW).]
F. The eligible individual shall submit to a pharmacy the eligibility statement provided by the
manufacturer under paragraph D. Upon receipt of an individual's eligibility status, the pharmacy
shall dispense insulin in accordance with this paragraph.
(1) The pharmacy shall submit an order containing the name of the insulin product and the
daily dosage amount as contained in a valid prescription to the product's manufacturer. The
pharmacy shall include with the order to the manufacturer the following information: the
pharmacy's name and shipping address; office telephone number, fax number, e-mail address
and contact name; and any specific days or times when deliveries are not accepted by the
pharmacy.
(2) Upon receipt of an order from a pharmacy and the information described in this paragraph,
the manufacturer shall send to the pharmacy a 90-day supply of insulin as ordered, unless a
lesser amount is requested in the order, at no charge to the individual or pharmacy. Except as
authorized under paragraph E, the pharmacy shall provide the insulin to the individual at no
charge to the individual. The pharmacy may not provide insulin received from the
manufacturer to any individual other than the individual associated with the specific order.
(3) The pharmacy may not seek reimbursement for the insulin received from the manufacturer
or from any 3rd-party payor. The pharmacy may collect a copayment from the individual to
cover the pharmacy's costs for processing and dispensing in an amount not to exceed $50 for
each 90-day supply if the insulin is sent to the pharmacy.
(4) The pharmacy may submit to a manufacturer a reorder for an individual if the individual's
eligibility statement under paragraph D has not expired. Upon receipt of a reorder from a
pharmacy, the manufacturer shall send to the pharmacy an additional 90-day supply of the
product, unless a lesser amount is requested, at no charge to the individual or pharmacy if the
individual's eligibility statement has not expired.
(5) Notwithstanding subparagraph (2), a manufacturer may send the insulin as ordered directly
to the individual if the manufacturer provides a mail order service option. [PL 2021, c. 303,
§1 (NEW).]
G. If an individual disagrees with a manufacturer's determination of eligibility under this
subsection, the individual may contact the board to request a review of eligibility. The review of
eligibility must be conducted by the board administrator, in consultation with a board member. The
individual requesting the review shall submit to the board, with the request, all documents
submitted by the individual to the manufacturer. The board shall provide the reviewer or reviewers
with the documents submitted by the individual. The review of eligibility must be completed within
10 business days of receipt of all the necessary documents from the individual. The review decision
is final. If the review determines that the individual is eligible for the manufacturer's patient
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assistance program, the manufacturer shall provide the individual with an eligibility statement in
accordance with this subsection. [PL 2021, c. 303, §1 (NEW).]
[PL 2021, c. 303, §1 (NEW).]
5. Additional 30-day urgent-need insulin supply pending eligibility for other coverage or
assistance. If an individual has applied for MaineCare coverage but has not been determined eligible
or has been determined eligible but MaineCare coverage has not become effective or if the individual
has been determined ineligible for the manufacturer's patient assistance program by the manufacturer
and the individual has requested a review pursuant to subsection 4, paragraph G but the reviewer has
not rendered a decision, the individual is entitled to access insulin under the provisions of subsection 3
if the individual has an urgent need of insulin. To access insulin under this subsection, the individual
must attest to the pharmacy that the individual meets the requirements of subsection 2.
[PL 2021, c. 303, §1 (NEW).]
6. Dissemination of information about program. In consultation with the Health Insurance
Consumer Assistance Program, established in Title 24‑A, chapter 56‑A, subchapter 2‑A, the board shall
develop an information sheet to post on its publicly accessible website and provide a link to the
information sheet on the website to be used by pharmacies, health care practitioners, hospital
emergency departments, urgent care clinics and community health clinics. The information sheet must
contain: a description of the urgent need insulin safety net, including how to apply for the benefits of
the program; a description of each insulin manufacturer's patient assistance program, including contact
information for accessing the assistance programs for each manufacturer; information on how to contact
the Health Insurance Consumer Assistance Program, established in Title 24‑A, chapter 56‑A,
subchapter 2‑A; and information on how to contact the board if a manufacturer determines that an
individual is not eligible for the manufacturer's patient assistance program.
[PL 2021, c. 303, §1 (NEW).]
7. Enforcement; penalty for noncompliance. A person who violates this chapter is subject to
enforcement action by the board through any board action authorized in accordance with section 13731
or any civil penalty or criminal or civil action authorized in section 13731.
[PL 2021, c. 303, §1 (NEW).]
8. Confidential information. Any health information or records provided to the board under this
section are confidential if the information or records identify or permit the identification of an
individual who is seeking to access urgently needed insulin under subsection 3 or to participate in a
manufacturer's patient assistance program under this section. A manufacturer shall maintain the
confidentiality of any information received from any individual applying for the manufacturer's patient
assistance program under this section and is prohibited from selling, sharing or disseminating data
received under this section unless required to under this section or unless the individual has provided
the manufacturer with a signed authorization.
[PL 2021, c. 303, §1 (NEW).]
9. Reports. Beginning February 15, 2023 and annually thereafter, each manufacturer shall report
to the board on the number of Maine residents who accessed and received insulin on an urgent-need
basis in the preceding calendar year; the number of Maine residents participating in the manufacturer's
patient assistance program in the preceding calendar year, including the number of Maine residents
who the manufacturer determined were ineligible for its patient assistance program; and the total value
of the insulin, determined by the wholesale acquisition cost of the insulin, provided by the manufacturer
in the preceding calendar year. Beginning April 15, 2023 and annually thereafter, the board shall submit
a report of the aggregate information reported by manufacturers pursuant to this subsection to the joint
standing committee of the Legislature having jurisdiction over health coverage, insurance and financial
services matters.
[PL 2021, c. 303, §1 (NEW).]
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10. Repeal. This section is repealed January 1, 2027.
[PL 2021, c. 303, §1 (NEW).]
SECTION HISTORY
PL 2021, c. 303, §1 (NEW).
SUBCHAPTER 3
LICENSING
§13731. Unlawful practice; penalties; injunctions
1. Applicability. It is unlawful for any person to engage in the practice of pharmacy unless
licensed to practice under this Act, except that:
A. Physicians, dentists, veterinarians or other practitioners of the healing arts who are licensed
under the laws of this State may dispense and administer prescription drugs to their patients in the
practice of their respective professions where specifically authorized to do so by law; [PL 2013,
c. 373, §1 (NEW).]
B. A licensed retail pharmacy that is located in Canada, the United Kingdom of Great Britain and
Northern Ireland, the Commonwealth of Australia or New Zealand that meets its country's statutory
and regulatory requirements may export prescription drugs by mail or carrier to a resident of this
State for that resident’s personal use. A licensed retail pharmacy described in this paragraph is
exempt from licensure under this Act; and [PL 2013, c. 373, §1 (NEW).]
C. An entity that contracts to provide or facilitate the exportation of prescription drugs from a
licensed retail pharmacy described in paragraph B may provide or facilitate the provision of
prescription drugs from that pharmacy by mail or carrier to a resident of this State for that resident's
personal use. An entity that provides or facilitates the provision of prescription drugs pursuant to
this paragraph is exempt from licensure under this Act. [PL 2013, c. 373, §1 (NEW).]
[PL 2013, c. 373, §1 (AMD).]
2. Authorization to deal with dangerous substances. Practitioners, drug jobbers, drug
wholesalers, drug manufacturers, pharmacists and pharmacies licensed under this chapter and approved
animal shelters as provided in Title 7, section 3913, are authorized to deal professionally with
dangerous substances. A dangerous substance is:
A. Any substance listed under the Federal Uniform Controlled Substance Act, sections 1 through
5; or [PL 1987, c. 710, §5 (NEW).]
B. Anything deemed to be dangerous by the Federal Drug Administration, other federal agency,
or the Attorney General of the United States. [PL 1987, c. 710, §5 (NEW).]
[PL 2007, c. 402, Pt. DD, §12 (AMD).]
3. Violation. Any person who violates this chapter commits a Class E crime and, notwithstanding
Title 17‑A, sections 1704 and 1705, may be punished by a fine of not more than $1,000. Each violation
of each section of this chapter constitutes a separate offense.
[PL 2019, c. 113, Pt. C, §84 (AMD).]
4. Violation; suspension; penalty. For any violation of this chapter, in addition to other
disciplinary action which may be taken by the board, the board may suspend the violator's license for
up to 90 days or impose a civil penalty of up to $500, or both, for each violation of each section of this
chapter. The jurisdiction to suspend a license for up to 90 days shall be concurrent with that of the
District Court.
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[PL 1987, c. 710, §5 (NEW); PL 1999, c. 547, Pt. B, §78 (AMD); PL 1999, c. 547, Pt. B, §80
(AFF).]
5. Action to enjoin. The State may bring an action to enjoin any licensee or person from violating
this chapter, regardless of whether proceedings have been or may be instituted in the District Court or
whether criminal proceedings have been or may be instituted.
[PL 1987, c. 710, §5 (NEW); PL 1999, c. 547, Pt. B, §78 (AMD); PL 1999, c. 547, Pt. B, §80
(AFF).]
6. Fees; fines; forfeitures.
[PL 1995, c. 397, §112 (RP).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1995, c. 397, §112 (AMD). PL 1999, c. 547, §B78 (AMD). PL
1999, c. 547, §B80 (AFF). PL 2007, c. 402, Pt. DD, §12 (AMD). PL 2013, c. 373, §1 (AMD).
PL 2019, c. 113, Pt. C, §84 (AMD).
§13732. Qualifications for licensure by examination
1. Requirements. To obtain a license to engage in the practice of pharmacy, an applicant for
licensure by examination must:
A. Have submitted a written application in the form prescribed by the board together with the
required examination and license fee as set under section 13724; [PL 2005, c. 262, Pt. B, §4
(AMD).]
B. Have attained the age of 21 years; [PL 1987, c. 710, §5 (NEW).]
C. [PL 2021, c. 289, §7 (RP).]
D. Have graduated and received the first professional undergraduate degree from a pharmacy
degree program accredited by the American Council on Pharmaceutical Education or have received
a degree from an equivalent program, which has been approved by the board, from a school outside
the United States; [PL 1987, c. 710, §5 (NEW).]
E. Have completed an internship or other program that has been approved by the board or
demonstrated, to the board's satisfaction, experience in the practice of pharmacy that meets or
exceeds the minimum internship requirement of the board; and [PL 2005, c. 262, Pt. B, §4
(AMD).]
F. Have successfully passed an examination approved by the board. [PL 2005, c. 262, Pt. B, §4
(AMD).]
G. [PL 2005, c. 262, Pt. B, §5 (RP).]
[PL 2021, c. 289, §7 (AMD).]
2. Examinations. Examinations shall be prepared and administered according to this subsection.
A. The examination shall be prepared to measure the competence of the applicant to engage in the
practice of pharmacy. The board may employ and cooperate with any organization or consultant in
the preparation and grading of an appropriate examination, but shall retain the sole discretion and
responsibility of determining which applicants have successfully passed the examination. [PL
1987, c. 710, §5 (NEW).]
B. [PL 2007, c. 402, Pt. DD, §13 (RP).]
[PL 2007, c. 402, Pt. DD, §13 (AMD).]
3. Internship and other training programs. Internship and practical experience requirements
shall be determined as follows.
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A. All applicants for licensure by examination must obtain practical experience in the practice of
pharmacy concurrent with or after college attendance under such terms and conditions as the board
may determine. [PL 1987, c. 710, §5 (NEW).]
B. The board shall establish standards for internship or any other program necessary to qualify an
applicant for the licensure examination and shall also determine the necessary qualifications of any
preceptors used in any internship or other program. [PL 1987, c. 710, §5 (NEW).]
[PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2005, c. 262, §§B4,5 (AMD). PL 2007, c. 402, Pt. DD, §13
(AMD). PL 2021, c. 289, §7 (AMD).
§13733. Qualifications for licensure by endorsement
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1995, c. 257, §1 (AMD). PL 1999, c. 130, §7 (AMD). PL 2005,
c. 262, §§B6-8 (AMD). PL 2007, c. 402, Pt. DD, §14 (AMD). PL 2021, c. 289, §8 (RP).
§13733-A. Licensure by endorsement
In order to obtain a license as a pharmacist by endorsement, an applicant for licensure must meet
the requirements of Title 10, section 8003‑H and any applicable rules adopted pursuant to that section.
[PL 2021, c. 289, §9 (NEW).]
SECTION HISTORY
PL 2021, c. 289, §9 (NEW).
§13734. Renewal of licenses
1. Renewal. A license expires on the date set by the commissioner pursuant to Title 10, section
8003, subsection 4 for the licensing period for which the license was issued. A renewal license is issued
for each ensuing licensing period in the absence of any reason or condition that might warrant the
refusal to grant a license, upon receipt by the board of the written request of the applicant and the fee
for the license as set under section 13724 and upon the applicant's presenting evidence of compliance
with the requirements of section 13735.
Licenses may be renewed up to 90 days after the date of expiration upon payment of a late fee as set
under section 13724 in addition to the renewal fee as set under section 13724. Any person who submits
an application for renewal more than 90 days after the license renewal date is subject to all requirements
governing new applicants under this chapter, including a late fee, renewal fee and additional late fee as
set under section 13724, except that the board may, giving due consideration to the protection of the
public, waive examination if that renewal application is made within 2 years from the date of that
expiration.
[PL 2007, c. 402, Pt. DD, §15 (AMD).]
2. Inactive renewal license. A licensed pharmacist not practicing pharmacy within this State shall
pay, on or before the expiration date as determined by the commissioner, a renewal fee as set under
section 13724, in return for which an inactive renewal license must be issued.
A licensed pharmacist holding an inactive renewal license who desires to practice pharmacy in this
State is required to submit proof satisfactory to the board that, during the calendar year preceding
application for active licensure, the pharmacist has participated in not less than 15 hours of approved
courses of continuing professional pharmaceutical education as defined in section 13735. The board
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may make exceptions to the continuing education requirement of this section in emergency or hardship
cases.
If any person fails or neglects to procure the annual inactive renewal license, after the expiration of 30
days that person's original license expires. That person, in order to regain licensure, is required to pay
one renewal fee as set under section 13724 in addition to the sum of all fees that person may be in
arrears.
[PL 2007, c. 402, Pt. DD, §15 (AMD).]
3. Fees.
[PL 2005, c. 262, Pt. B, §9 (RP).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 600, §A270 (AMD). PL 2005, c. 262, §B9 (AMD). PL
2007, c. 402, Pt. DD, §15 (AMD).
§13735. Continuing pharmacy education
An annual renewal license may not be issued by the board until the applicant certifies to the board
that, during the calendar year preceding an application for renewal, the applicant has participated in not
less than 15 hours of approved courses of continuing professional pharmaceutical education as set out
in this section. For a pharmacist authorized to administer drugs and immunizations, of the 15 hours to
be completed, at least 2 hours must be in board-approved courses on drug administration as described
in section 13702‑A, subsection 28. A pharmacist who enters into a collaborative practice agreement
must agree to complete, in each year of the agreement, 5 of the 15 hours required in this section in the
areas of practice covered by the agreement. The continuing professional pharmaceutical educational
courses consist of postgraduate studies, institutes, seminars, workshops, lectures, conferences,
extension studies, correspondence courses or such other forms of continuing professional
pharmaceutical education as may be approved by the board. [PL 2021, c. 84, §1 (AMD).]
These courses consist of subject matter pertinent to the following general areas of professional
pharmaceutical education: the socioeconomic and legal aspects of health care; the properties and
actions of drugs and dosage forms; and the ideology, characteristics and therapeutics of the disease
state. The specific subject matter of the courses may include, but is not limited to, pharmacology,
biochemistry, physiology, pharmaceutical chemistry, pharmacy administration, drug administration as
it relates to the area of permitted practice, pharmacy jurisprudence, public health and communicable
diseases, pharmaceutical marketing, professional practice management, anatomy, histology and such
other subject matter as represented in curricula of accredited colleges of pharmacy. The content of each
course offered for credit under this continuing professional educational program must be approved in
advance of the course by the board or its representative. The board may make exceptions to this section
in emergency or hardship cases. [PL 2009, c. 308, §2 (AMD).]
Each application for approval of a continuing education program or course must be submitted
according to the guidelines prescribed by rule by the board, together with a fee as set under section
13724. [PL 2007, c. 402, Pt. DD, §16 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1999, c. 130, §8 (AMD). PL 2005, c. 262, §B10 (AMD). PL
2007, c. 402, Pt. DD, §16 (AMD). PL 2009, c. 308, §2 (AMD). PL 2013, c. 308, §3 (AMD). PL
2021, c. 84, §1 (AMD).
SUBCHAPTER 4
DISCIPLINE
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§13741. Informal conference
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 600, §A271 (AMD). PL 1999, c. 130, §9 (AMD). PL
2007, c. 402, Pt. DD, §17 (AMD). PL 2011, c. 286, Pt. K, §1 (RP).
§13742. Grounds for discipline
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 600, §A272 (AMD). PL 1999, c. 130, §10 (AMD). PL
2007, c. 402, Pt. DD, §18 (RP).
§13742-A. Denial or refusal to renew license; disciplinary sanctions; crimes; criminal
prosecutions
1. Disciplinary action. In addition to the grounds enumerated in Title 10, section 8003, subsection
5‑A, paragraph A, the board may deny a license, refuse to renew a license or impose the disciplinary
sanctions authorized by Title 10, section 8003, subsection 5‑A for:
A. Misuse of alcohol, drugs or other substances that has resulted or may result in the applicant or
licensee performing duties in a manner that endangers the health or safety of patients; [PL 2013,
c. 105, §9 (AMD).]
B. A professional diagnosis of a mental or physical condition that has resulted or may result in the
applicant or licensee performing duties in a manner that endangers the health or safety of patients;
[PL 2007, c. 402, Pt. DD, §19 (NEW).]
C. Engaging in unprofessional conduct by violating any standard of professional behavior,
including but not limited to a breach of confidentiality of health care information pursuant to state
law, that has been established in the practice for which the licensee is licensed; [PL 2017, c. 434,
§2 (AMD).]
D. Engaging in false, misleading or deceptive advertising; [PL 2019, c. 165, §27 (AMD).]
E. Failing to comply with section 13800; [PL 2021, c. 303, §2 (AMD).]
F. A violation of section 13800‑B; or [PL 2021, c. 303, §3 (AMD).]
G. A violation of section 13725. [PL 2021, c. 303, §4 (NEW).]
This subsection applies to all types of licenses issued by the board.
[PL 2021, c. 303, §§2-4 (AMD).]
2. Crime in course of business. If any licensed pharmacist is convicted in state or federal court
of a crime that is committed during the course of duties performed as a licensed pharmacist or
committed through the use of the pharmacy in which the pharmacist is employed, or that the pharmacist
owns or operates, and that demonstrates unfitness to practice as a pharmacist, including, but not limited
to, convictions for defrauding the Medicaid program and for illegally distributing prescription drugs,
the pharmacist's license is subject to disciplinary action as set forth in subsection 1.
[PL 2007, c. 402, Pt. DD, §19 (NEW).]
3. Criminal prosecutions. Nothing in this chapter bars criminal prosecution for any violation of
this chapter when that violation is a criminal offense under the laws of this State or of the United States.
[PL 2007, c. 402, Pt. DD, §19 (NEW).]
4. Injunction. Notwithstanding any other provision of law, the Attorney General may seek
injunctive relief against a person who violates subsection 1, paragraph E. If the Attorney General
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prevails in an action under this subsection, the court must order the person to reimburse the State for
the Attorney General's costs of prosecuting the action, including reasonable attorney's fees.
[PL 2017, c. 434, §4 (NEW).]
SECTION HISTORY
PL 2007, c. 402, Pt. DD, §19 (NEW). PL 2013, c. 105, §9 (AMD). PL 2017, c. 434, §§2-4
(AMD). PL 2019, c. 165, §§27-29 (AMD). PL 2021, c. 303, §§2-4 (AMD).
§13743. Reinstatement
1. Penalties.
[PL 2007, c. 402, Pt. DD, §20 (RP).]
2. Reinstatement. Any person whose license to practice pharmacy in this State has been
suspended, revoked or restricted pursuant to this chapter, whether voluntarily or by action of the board,
may at reasonable intervals petition the board for reinstatement of the license. The petition must be
made in writing in a form prescribed by the board. Upon investigation and hearing, the board may grant
or deny the petition or it may modify its original finding to reflect any circumstances which have
changed sufficiently to warrant those modifications.
[PL 1987, c. 710, §5 (NEW).]
3. Criminal prosecutions.
[PL 2007, c. 402, Pt. DD, §20 (RP).]
4. Judicial review.
[PL 2007, c. 402, Pt. DD, §20 (RP).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2007, c. 402, Pt. DD, §20 (AMD).
SUBCHAPTER 5
PHARMACY FACILITIES
§13751. Registration
1. Licensure. All pharmacies, manufacturers, wholesalers and mail order contact lens suppliers
shall annually obtain a license from the board.
[PL 2007, c. 402, Pt. DD, §21 (AMD).]
2. Classifications. Pharmacies must be licensed in classifications set out in this subsection.
Each pharmacy must apply for a license in one of the following classifications:
A. Retail pharmacy; [PL 2007, c. 402, Pt. DD, §22 (AMD).]
B. Mail order prescription pharmacy; [PL 2007, c. 402, Pt. DD, §22 (AMD).]
C. Wholesale pharmacy; [PL 2007, c. 402, Pt. DD, §22 (AMD).]
D. Rural health center; [PL 2019, c. 454, §1 (AMD).]
E. Free clinic; or [PL 2019, c. 454, §1 (AMD).]
F. Vending machine outlet. [PL 2019, c. 454, §1 (NEW).]
[PL 2019, c. 454, §1 (AMD).]
3. Rules. The board shall establish by rule the criteria that each pharmacy must meet to qualify
for licensure in each classification designated in subsection 2. The board may issue various types of
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licenses with varying restrictions to the pharmacies referred to in subsection 2, paragraph A when the
board determines it necessary by reason of the type of pharmacy requesting a license.
[PL 2007, c. 402, Pt. DD, §23 (AMD).]
3-A. Mail order contact lens suppliers. In order to meet the board's minimum licensure
requirements, a mail order contact lens supplier must:
A. Apply for a license, if filling contact lens prescriptions by mail or carrier for a patient that
resides in this State; [PL 2005, c. 262, Pt. B, §11 (AMD).]
B. Pay a license fee, as set under section 13724; [PL 2005, c. 262, Pt. B, §11 (AMD).]
C. Provide the name and address of the owner, partners or corporation and its officers; [PL 1997,
c. 117, §11 (NEW).]
D. Fill only written contact lens prescriptions containing expiration dates that do not exceed 24
months from the date of issue; [PL 1997, c. 117, §11 (NEW).]
E. Maintain a record of every contact lens prescription filled for a period of 5 years; and [PL
1997, c. 117, §11 (NEW).]
F. Supply, upon request, all information needed by the board to ensure compliance with this
subchapter. [PL 1997, c. 117, §11 (NEW).]
The board may adopt rules establishing additional licensure requirements and disciplinary actions for
violation of this subchapter and board rules. Rules adopted pursuant to this subsection are routine
technical rules as defined by Title 5, chapter 375, subchapter 2‑A.
[PL 2005, c. 262, Pt. B, §11 (AMD).]
4. Nonprescription drugs. It shall be lawful for a person to sell and distribute nonprescription
drugs. Any person engaging in the sale and distribution of those items shall not be deemed to be
improperly engaged in the practice of pharmacy. No rule may be adopted by the board under this Act
which requires the sale of nonprescription drugs by a licensed pharmacist or under the supervision of a
licensed pharmacist or otherwise applies to or interferes with the sale and distribution of those
medicines.
[PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1997, c. 117, §§10,11 (AMD). PL 1999, c. 42, §§4,5 (AMD).
PL 2005, c. 262, §B11 (AMD). PL 2007, c. 402, Pt. DD, §§21-23 (AMD). PL 2019, c. 454, §1
(AMD).
§13752. Application
1. Procedures. The board shall specify by rule the licensing procedures to be followed, including,
but not limited to, specification of forms for use in applying for licensure and the times and places for
filing an application.
[PL 2007, c. 402, Pt. DD, §24 (AMD).]
2. Required information. Applications for licenses must include the fee as set under section
13724 and the following information about the proposed pharmacy and pharmacist in charge:
A. Ownership of the pharmacy; [PL 2007, c. 402, Pt. DD, §24 (AMD).]
B. Location of the pharmacy; [PL 2007, c. 402, Pt. DD, §24 (AMD).]
C. Identity of the pharmacist licensed to practice in the State who will be the pharmacist in charge
of the pharmacy, when one is required by this chapter, and such further information as the board
may determine necessary. The board shall adopt rules identifying the duties and responsibilities of
the pharmacist in charge, which must include, at a minimum, responsibility for ensuring the
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pharmacy's compliance with all state and federal laws, rules and regulations pertaining to the
practice of pharmacy, the distribution of drugs by the pharmacy and the licensure of pharmacy
personnel. A pharmacist may be the pharmacist in charge for only one pharmacy, except as
otherwise determined by the board by rule. The position of pharmacist in charge may not be held
by a qualified assistant pharmacist; and [PL 2021, c. 289, §10 (AMD).]
D. Attestation by the pharmacist identified as the pharmacist in charge that the pharmacist has read
and understands the requirements and duties of a pharmacist in charge set forth in board rules. [PL
2021, c. 289, §11 (AMD).]
[PL 2021, c. 289, §§10, 11 (AMD).]
3. Transferability. Licenses issued by the board pursuant to this chapter are not transferable or
assignable.
[PL 2007, c. 402, Pt. DD, §24 (AMD).]
4. Professional responsibility. The board shall specify by rule minimum standards for the
professional responsibility in the conduct of any pharmacy that has employees or personnel engaged in
the practice of pharmacy. The board may require that the portion of the facility to which the license
applies be operated only under the direct supervision of no less than one pharmacist licensed to practice
in this State and not otherwise and to provide such other special requirements as necessary. A change
in the pharmacist in charge who is responsible for the pharmacy must be reported to the board together
with the fee as set under section 13724.
[PL 2007, c. 402, Pt. DD, §24 (AMD).]
5. Minimum inventory. The board shall ascertain that the applicant has a sufficient amount of
prescription inventory on location to respond appropriately to prescription orders.
[PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1999, c. 130, §11 (AMD). PL 2005, c. 262, §§B12-14 (AMD).
PL 2007, c. 402, Pt. DD, §24 (AMD). PL 2021, c. 289, §§10, 11 (AMD).
§13752-A. Site inspection required
1. Opening facility. Pharmacies licensed pursuant to this subchapter may open and operate the
facility only:
A. Upon the approval of the board or its representative; or [PL 2007, c. 402, Pt. DD, §25
(AMD).]
B. Upon the pharmacist in charge certifying to the board, on forms prescribed by the board, that
the facility is secure, suitable for operation as a pharmacy and in compliance with applicable federal
and state laws, rules and regulations governing the practice of pharmacy. [PL 2007, c. 402, Pt.
DD, §25 (AMD).]
[PL 2007, c. 402, Pt. DD, §25 (AMD).]
2. Facility inspection. Licensed pharmacies that open and operate pursuant to subsection 1,
paragraph B must be inspected by a member of the board or its representative within 30 days of opening.
Facilities that are found to be insecure, not suitable for operation as a pharmacy or not in compliance
with applicable federal and state laws, rules and regulations governing the practice of pharmacy are
subject to a board-ordered emergency revocation of the license. The pharmacy may not operate after
revocation. The emergency revocation is a final agency action and is not subject to judicial review, but
a new application for licensure may be submitted pursuant to section 13752, and if approved, a site
inspection must be performed pursuant to subsection 1, paragraph A.
[PL 2007, c. 402, Pt. DD, §25 (AMD).]
SECTION HISTORY
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PL 1999, c. 130, §12 (NEW). PL 2007, c. 402, Pt. DD, §25 (AMD).
§13753. Notifications
1. Changes. All licensed pharmacies shall report to the board, by mail, fax or electronic
communication as accepted by the board, the occurrence of any of the following changes:
A. Permanent closing, which requires 10 calendar days' prior notice to the public and to the board;
[PL 2021, c. 289, §12 (AMD).]
B. Change of ownership, which requires 10 calendar days' prior notice to the board; [PL 2021, c.
289, §12 (AMD).]
C. Change of pharmacist, in charge which requires notice no later than 10 calendar days after the
change; and [PL 2021, c. 289, §12 (AMD).]
D. Any other matters and occurrences as the board may require by rule. [PL 1987, c. 710, §5
(NEW).]
[PL 2021, c. 289, §12 (AMD).]
2. Other reportable events. Disasters, accidents and emergencies which may affect the strength,
purity or labeling of drugs, medications, devices or other materials used in the diagnosis or the treatment
of injury, illness and disease shall be immediately reported to the board.
[PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2007, c. 402, Pt. DD, §26 (AMD). PL 2021, c. 289, §12 (AMD).
§13754. Violations and penalties
1. Unlicensed practice. No pharmacy licensed pursuant to section 13751 may be operated until a
license has been issued to that facility by the board. Any person who violates this section is subject to
the provisions of Title 10, section 8003‑C.
[PL 2007, c. 402, Pt. DD, §27 (AMD).]
2. Reinstatement. Reinstatement of a license that has been suspended, revoked or restricted by
the board may be granted in accordance with the procedures specified by section 13743, subsection 2.
[PL 2007, c. 402, Pt. DD, §27 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2007, c. 402, Pt. DD, §27 (AMD).
§13755. Vaccine clinics
A pharmacy may operate a vaccine administration clinic inside, outside or off the pharmacy's
premises. [PL 2011, c. 577, §2 (NEW).]
SECTION HISTORY
PL 2011, c. 577, §2 (NEW).
§13756. Electronic prescribing of opioid medication
By July 1, 2017, a pharmacy must have the capability to process electronic prescriptions from
prescribers for an opioid medication or request a waiver from the Commissioner of Health and Human
Services stating the reasons for the waiver including but not limited to a lack of capability, the
availability of broadband infrastructure and a plan for developing the ability to receive electronically
prescribed opioid medication. The commissioner may grant a waiver for circumstances in which
exceptions are appropriate, including technological failures. [PL 2015, c. 488, §29 (NEW).]
SECTION HISTORY
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PL 2015, c. 488, §29 (NEW).
SUBCHAPTER 6
MANUFACTURERS AND WHOLESALERS
§13758. Licensure
1. Purpose; statement of intent. The purpose of this section is to require licensure of
manufacturers and wholesalers within or outside the State. The intent of the Legislature is that the
board may not adopt rules regarding companies without wholesale facilities or manufacturers' facilities
located in this State that are more restrictive than federal law or regulation.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
2. Licensure, manufacturers and wholesalers. All manufacturers and wholesalers whose
products are distributed in the State in any manner must be licensed by the board.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
3. Licensure, individuals. An individual who is employed by a manufacturer or wholesaler that
is licensed under this subchapter need not obtain licensure under this subchapter.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
4. Form. License forms must state: Applicant's name; address; day phone; 24-hour phone;
ownership status; manufacturer or wholesaler designation; Drug Enforcement Agency and Federal
Drug Administration numbers; and date executed. License forms must be executed by an owner or
officer of the entity, providing printed name and title.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
5. Fees. Each licensee shall pay a fee as set under section 13724.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
6. Violations. It is unlawful for manufacturers or wholesale companies to distribute prescription
drugs in this State unless licensed under the provisions of this subchapter or subchapter 5.
[PL 2007, c. 402, Pt. DD, §28 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1987, c. 861, §18 (AMD). PL 1989, c. 502, §B75 (AMD). PL
1997, c. 245, §11 (AMD). PL 2005, c. 262, §B15 (AMD). PL 2007, c. 402, Pt. DD, §28 (AMD).
§13759. Gifts to practitioners prohibited
1. Prohibition. Except as provided in subsection 2, a manufacturer or wholesaler licensed under
section 13758 or an agent of a manufacturer or wholesaler licensed under section 13758 may not offer
or give the following to a practitioner:
A. A cash gift in any amount; or [PL 2017, c. 267, §1 (NEW).]
B. A gift for which reciprocity is expected or implied. [PL 2017, c. 267, §1 (NEW).]
[PL 2017, c. 267, §1 (NEW).]
2. Exceptions. A manufacturer or wholesaler licensed under section 13758 does not violate
subsection 1 by engaging in the following activities:
A. Giving noncash items of minimal value that will directly benefit the practitioner's patients,
including:
(1) Prescription drug samples for distribution to patients;
(2) Educational materials; and
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(3) Modest meals and refreshments, as defined by the board by rule pursuant to section 13720,
provided to a practitioner in connection with a meeting or presentation about the benefits, risks
and appropriate uses of prescription drugs or medical devices, disease states or other scientific
information, as long as the meeting or presentation occurs in a venue and manner conducive to
informational communication; [PL 2017, c. 267, §1 (NEW).]
B. Giving funding to academic institutions and residency and fellowship programs to support the
participation of medical, nursing, physician assistant, veterinarian and pharmacy students, residents
and fellows in professional meetings, including educational meetings, as long as the program
identifies such funding recipients based on independent institutional criteria and the funds are
distributed to recipients without specific attribution to sponsors; or [PL 2017, c. 267, §1 (NEW).]
C. Giving reasonable honoraria to a practitioner and making payment of the reasonable expenses,
as defined by the board by rule pursuant to section 13720, of a practitioner at a professional or
educational conference or meeting. [PL 2017, c. 267, §1 (NEW).]
Rules adopted pursuant to this subsection are major substantive rules as defined in Title 5, chapter 375,
subchapter 2‑A.
[PL 2017, c. 267, §1 (NEW).]
SECTION HISTORY
PL 2017, c. 267, §1 (NEW).
SUBCHAPTER 7
SERVICES AT RURAL HEALTH CENTERS
§13761. Definitions
As used in this subchapter, unless the context otherwise indicates, the following terms have the
following meanings. [PL 1987, c. 710, §5 (NEW).]
1. Pharmacy provider. "Pharmacy provider" means a pharmacy licensed in this State
participating with a rural health center under this subchapter.
[PL 1993, c. 716, §2 (AMD).]
2. Rural community health center.
[PL 1993, c. 716, §3 (RP).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 716, §§2,3 (AMD).
§13762. Center to be licensed
1. License required. A rural health center that desires to contract for pharmaceutical services
with a pharmacy shall submit an application together with the required fee as set under section 13724.
The board may adopt rules that are no more restrictive than those regulating private pharmacy practice
in the State. A rural health center is eligible for licensure under this subchapter if:
A. It serves a rural area without a pharmacy; [PL 1993, c. 716, §4 (NEW).]
B. It is located in a community where available pharmacy services can not meet the documented
need; or [PL 1993, c. 716, §4 (NEW).]
C. It requires a license in order to receive pharmaceutical discounts authorized by the federal
Veterans' Health Care Act of 1992, Title VI. [PL 1993, c. 716, §4 (NEW).]
[PL 2005, c. 262, Pt. B, §16 (AMD).]
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2. Renewal. A license expires on the date set by the commissioner pursuant to Title 10, section
8003, subsection 4 for the licensing period for which the license was issued. A renewal license is issued
for each ensuing licensing period in the absence of any reason or condition that might warrant the
refusal to grant a license and upon receipt by the board of the written request of the applicant and the
required fee for the license as set under section 13724.
Licenses may be renewed up to 90 days after the date of expiration upon payment of a late fee in
addition to a renewal fee as set under section 13724. Any person who submits an application for
renewal more than 90 days after the license renewal date is subject to all requirements governing new
applicants under this chapter, including a late fee, renewal fee and additional late fee as set under section
13724.
[PL 2007, c. 402, Pt. DD, §29 (AMD).]
3. Notice. Any rural health center wishing to be licensed under this subchapter shall notify the
board of its intent to establish a contract with a pharmacy for pharmaceutical services and shall apply
for a license, submit floor plans of the physical plant and pay a required fee as set under section 13724.
The application must include the name, address and registration number of the provider of
pharmaceutical services.
[PL 2005, c. 262, Pt. B, §18 (AMD).]
4. Board action. The board shall approve or disapprove of the application within 60 days of
receipt and shall notify the applicant in writing of its decision and the reason for the decision.
[PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 716, §4 (AMD). PL 2005, c. 262, §§B16-18 (AMD).
PL 2007, c. 402, Pt. DD, §29 (AMD).
§13763. Scope of license
A licensee under this subchapter shall comply with section 13784; section 13785, subsections 1 to
7; and any applicable rules adopted by the board. No licensee may refill a prescription and all orders
must be treated as new orders. In all other respects, notwithstanding any other provision of law, a
licensee may provide pharmaceutical services under this subchapter subject to section 13764. A
licensee may purchase drugs. [PL 1993, c. 716, §5 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 716, §5 (AMD).
§13764. Rules
The board shall adopt rules in conformity with the Maine Administrative Procedure Act, Title 5,
chapter 375, to carry out the purposes of this subchapter. [PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
SUBCHAPTER 8
THIRD-PARTY PRESCRIPTION PROGRAM ACT
§13771. Short title
This subchapter shall be known and may be cited as the "Third-party Prescription Program Act."
[PL 1987, c. 710, §5 (NEW).]
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SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13772. Definitions
As used in this subchapter, unless the context otherwise indicates, the following terms have the
following meanings. [PL 1987, c. 710, §5 (NEW).]
1. Third-party prescription program. "Third-party prescription program" means any system of
providing for the reimbursement of pharmaceutical goods and services under a contractual arrangement
or agreement between a provider of goods and services and another party who is not the consumer of
those goods and services. These programs include, but are not limited to, insurance plans which provide
coverage for prescription drugs or other pharmaceutical services.
[PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13773. Notice
A 3rd-party prescription program may not be instituted in this State until the program provider has
filed written notice of the provisions of the program with the Superintendent of Insurance and the board
and given written notice to all pharmacies that are located within the counties covered by the program
at least 30 days prior to the commencement of the program. In the case of chain or branch pharmacies,
the notice must be given to the main office or headquarters. These pharmacies have 30 days from the
date of notice to enroll in the program. [PL 1997, c. 245, §12 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1989, c. 720, §1 (AMD). PL 1997, c. 245, §12 (AMD).
§13774. Denial of payment
No program administrator may deny to any pharmacy payment for services which may have
resulted from the fraudulent or illegal use of an identification card by any person, unless the pharmacy
has been notified that the card has been canceled or discontinued and that the program administrator
has been unsuccessful in attempting to regain possession of the card. [PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13775. Reimbursement rates
A 3rd-party prescription program is prohibited from charging a pharmacy a registration fee or other
fixed charge, either annually or otherwise, except in cases where a charge is necessary to specifically
cover any equipment, forms or materials required by the program. [PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13776. Contract renewal and changes
Any changes in benefits or provisions in any contract may not be made unilaterally by either the
program administrator or the pharmacy. Any change in a contract offered to one pharmacy shall be
offered to all the state pharmacies participating in the program. [PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13777. Exceptions
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This Act does not apply to any medical assistance or public health programs administered by the
Department of Health and Human Services, including, but not limited to, the Medicaid program and
the Low Cost Drug Program; to any employee benefit plan that is subject to the Employee Retirement
Income Security Act of 1974, 29 United States Code, Section 1001, et seq.; and to any 3rd-party
prescription programs administered in accordance with and subject to the limitations of the former
Nonprofit Service Organizations Preferred Provider Arrangement Act of 1985, Title 24, chapter 19,
subchapter II, or the Preferred Provider Arrangement Act, Title 24‑A, chapter 32. [PL 1999, c. 790,
Pt. A, §39 (AMD); PL 2003, c. 689, Pt. B, §6 (REV).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1989, c. 720, §2 (AMD). PL 1999, c. 790, §A39 (AMD). PL
2003, c. 689, §B6 (REV).
SUBCHAPTER 9
MISCELLANEOUS PROVISIONS
§13781. Generic and therapeutically equivalent substitution
A written prescription issued by a practitioner in this State may contain a box in the lower right-
hand corner of the prescription form. The following words must appear to the left of this box: "Any
drug that is the generic and therapeutic equivalent of the drug or any biological product that is an
interchangeable biological product of the biological product specified above in this prescription must
be dispensed, provided that no check mark ( ) has been handwritten in the box in the lower right-hand
corner." [PL 2019, c. 34, §4 (AMD).]
Except with regard to a patient who is paying for a drug or biological product with the patient's
own resources, any pharmacist receiving a prescription in which no handwritten check mark ( ) is found
in the box provided shall substitute a generic and therapeutically equivalent drug for the drug or an
interchangeable biological product for the biological product specified on the prescription if the
substituted drug or interchangeable biological product is distributed by a business entity doing business
in the United States that is subject to suit and the service of legal process in the United States and the
price of the substituted drug or interchangeable biological product does not exceed the price of the drug
or biological product specified by the practitioner; except that, when the cost of a prescription is to be
reimbursed under the MaineCare program pursuant to Title 22, chapter 855, the pharmacist shall
substitute a generic and therapeutically equivalent drug or an interchangeable biological product only
when the Department of Health and Human Services has determined that the substitute drug or
interchangeable biological product would be a more cost-effective alternative than the drug or
biological product prescribed by the practitioner. Except for prescribed drugs listed under the
Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 United States Code, Section 812,
as amended, as Schedule II drugs, with regard to a patient who is paying for a drug or biological product
with the patient's own resources, a pharmacist shall inquire about the patient's preference for either the
brand-name drug or generic and therapeutically equivalent drug or for either the prescribed biological
product or interchangeable biological product and dispense the drug or biological product that the
patient prefers. [PL 2019, c. 34, §4 (AMD).]
Except with regard to a patient who is paying for a drug or biological product with the patient's
own resources, if a written prescription issued by a practitioner in this State does not contain the box
described in this section, a pharmacist shall substitute a generic and therapeutically equivalent drug for
the drug or an interchangeable biological product for the biological product specified on the prescription
if the substituted drug or interchangeable biological product is distributed by a business entity doing
business in the United States that is subject to suit and the service of legal process in the United States
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and the price of the substituted drug or interchangeable biological product does not exceed the price of
the drug or biological product specified by the practitioner, unless a practitioner has handwritten on the
prescription form, along with the practitioner's signature, "dispense as written," "DAW," "brand,"
"brand necessary" or "brand medically necessary"; except that, when the cost of a prescription is to be
reimbursed under the MaineCare program pursuant to Title 22, chapter 855, the pharmacist shall
substitute a generic and therapeutically equivalent drug or an interchangeable biological product only
when the Department of Health and Human Services has determined that the substitute drug or
interchangeable biological product would be a more cost-effective alternative than the drug or
biological product prescribed by the practitioner. Except for prescribed drugs listed under the
Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 United States Code, Section 812,
as amended, as Schedule II drugs, with regard to a patient who is paying for a drug or biological product
with the patient's own resources, a pharmacist shall inquire about the patient's preference for either the
brand-name drug or generic and therapeutically equivalent drug or for either the prescribed biological
product or interchangeable biological product and dispense the drug or biological product that the
patient prefers. [PL 2019, c. 34, §4 (AMD).]
Any pharmacist who substitutes a generic and therapeutically equivalent drug or an interchangeable
biological product under this section shall inform the person to whom the drug or interchangeable
biological product is dispensed of the substitution. When any substitution is made under this section,
the pharmacist shall cause all information as required by section 13794, the name of the generic and
therapeutically equivalent drug and the name or abbreviation of the drug manufacturer or distributor of
that substitute drug or, in the case of an interchangeable biological product, the proper name and the
name of the manufacturer of the interchangeable biological product, to appear on the container label of
the drug or interchangeable biological product dispensed. [PL 2019, c. 34, §4 (AMD).]
This section does not apply to prescriptions ordered by practitioners for patients in hospitals when
those prescriptions are filled by a hospital pharmacy or in any institution where a formulary system is
established. [PL 1987, c. 710, §5 (NEW).]
Within 5 business days after a pharmacist dispenses a biological product, the dispensing pharmacist
or the pharmacist's designee shall enter in an electronic records system that is electronically accessible
to the practitioner who prescribed the biological product the specific biological product dispensed,
including the name of the biological product and the manufacturer. For purposes of this paragraph,
"electronic records system" means an interoperable electronic medical records system, an electronic
prescribing technology, a pharmacist benefit management system or an electronic pharmacy record.
Entry into an electronic records system as described in this paragraph is presumed to provide notice to
the practitioner. If a pharmacist cannot make an entry in an electronic records system, the pharmacist
shall notify the practitioner of the specific biological product dispensed by facsimile, telephone,
electronic transmission or other similar means. Notice to a practitioner under this paragraph is not
required if the federal Food and Drug Administration has not approved an interchangeable biological
product for the product prescribed or a refill prescription is not changed from the biological product
dispensed on the prior filling of the prescription. [PL 2019, c. 34, §4 (NEW).]
The board shall maintain a link on the board's publicly accessible website to the current list of all
biological products determined by the federal Food and Drug Administration to be an interchangeable
biological product. [PL 2019, c. 34, §4 (NEW).]
For the purposes of this section, "drug" does not include biological products. [PL 2019, c. 34, §4
(NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1997, c. 245, §§13,14 (AMD). PL 2003, c. 384, §1 (AMD). PL
2003, c. 689, §B6 (REV). PL 2007, c. 85, §§1, 2 (AMD). PL 2019, c. 34, §4 (AMD).
§13782. Advertising
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It is lawful for any pharmacy, pharmacist or other licensee of the board to advertise to the public
the current retail price charged for any drugs, medicines or appliances as defined in the United States
Code, Title 21, Section 3211 (g) (1) which bears the legend "Caution: Federal law prohibits dispensing
without prescription." The advertising may be according to either the brand name or the generic name
of the drug. No media advertising of any drugs included in the United States Comprehensive Drug
Abuse Prevention and Control Act of 1970, 84 Stat. 1236, is permitted. [PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13782-A. Price disclosure
1. Price disclosure required. A pharmacist or pharmacy technician employed by a pharmacy
shall disclose upon the request of any person making an inquiry in person or by telephone the price of
any brand or generic drug sold by that pharmacy.
[PL 2007, c. 402, Pt. DD, §30 (AMD).]
2. Information required for price disclosure. In order to have sufficient information to disclose
a prescription price, a pharmacist or pharmacy technician may ask the person making the inquiry for
the following information:
A. The brand or generic name of the medication; [PL 1997, c. 245, §15 (NEW).]
B. The dose or strength of the medication, if applicable; or [PL 1997, c. 245, §15 (NEW).]
C. The quantity of the medication. [PL 1997, c. 245, §15 (NEW).]
[PL 1997, c. 245, §15 (NEW).]
3. Information not provided. If the inquiring person can not provide some or all of the
information in subsection 2 and this information is necessary for the requested price to be determined,
then the pharmacist or pharmacy technician may contact the prescribing practitioner in order to obtain
the necessary information prior to disclosing the prescription price.
[PL 1997, c. 245, §15 (NEW).]
SECTION HISTORY
PL 1997, c. 245, §15 (NEW). PL 2007, c. 402, Pt. DD, §30 (AMD).
§13783. Posting prices
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1997, c. 245, §16 (RP).
§13784. Patient information regulation
1. Explanation by pharmacist. With each new prescription dispensed, the pharmacist, in addition
to labeling the prescription in accordance with the requirements of the State, must orally explain to the
patient or the patient's agent the directions for use and any additional information, in writing if
necessary, to assure the proper utilization of the medication or device prescribed. For those
prescriptions delivered outside the confines of the pharmacy, the explanation shall be by telephone or
in writing. This section does not apply to those prescriptions for patients in hospitals or institutions
where the medication is to be administered by a nurse or other individual licensed to administer
medications or to those prescriptions for patients who are to be discharged from a hospital or institution.
[PL 1987, c. 710, §5 (NEW).]
2. Maintenance of current reference material. To ensure that proper information is available to
each pharmacist, each pharmacy or pharmacist shall maintain current reference material on drug
interactions.
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[PL 1987, c. 710, §5 (NEW).]
3. Retail price. With each prescription dispensed, the pharmacist shall disclose to the patient in
writing the usual and customary price of the prescription and the cost of any payment toward the price
required of the patient.
[RR 2003, c. 2, §120 (AFF); PL 2003, c. 375, §1 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). RR 2003, c. 2, §120 (AFF). PL 2003, c. 375, §1 (AMD). PL 2003,
c. 375, §2 (AFF).
§13785. Patient profile record system regulation
A patient profile record system shall be maintained in all pharmacies for persons for whom
prescriptions are dispensed. The patient profile record system shall be devised to enable the immediate
retrieval of information necessary for the dispensing pharmacist to identify previously dispensed
medication at the time a prescription is presented for dispensing. One profile record or document may
be maintained for all members of a family living at the same address and possessing the same family
name. The following information shall be recorded: [PL 1987, c. 710, §5 (NEW).]
1. Name. The family name and the first name of the person for whom the medication is intended;
[PL 1987, c. 710, §5 (NEW).]
2. Address. The address to correspond to the name in subsection 1;
[PL 1987, c. 710, §5 (NEW).]
3. Age group. An indication of the patient's age group, that is, infant, child or adult;
[PL 1987, c. 710, §5 (NEW).]
4. Original date of dispensing. The original date the medication is dispensed pursuant to the
receipt of a practitioner's prescription;
[PL 1987, c. 710, §5 (NEW).]
5. Prescription identification. The number or designation identifying the prescription;
[PL 1987, c. 710, §5 (NEW).]
6. Prescriber's name. The name of the person prescribing the drug or device;
[PL 1987, c. 710, §5 (NEW).]
7. Drug information. The name, strength and quantity of the drug; and
[PL 1987, c. 710, §5 (NEW).]
8. Initials of pharmacist; date of refill. The initials of the dispensing pharmacist and the date of
dispensing the medication as a renewal or refill, if those initials and that date are not recorded on the
back of the original prescription.
[PL 1987, c. 710, §5 (NEW).]
The pharmacist shall attempt to ascertain and shall record any allergies and idiosyncrasies of the
patient and any chronic conditions which may relate to drug utilization as communicated to the
pharmacy by the patient. [PL 1987, c. 710, §5 (NEW).]
Upon receipt of a prescription, a pharmacist shall examine the patient's profile record before
dispensing the medication to determine the possibility of a harmful drug interaction or reaction. Upon
recognizing a potentially harmful reaction or interaction, the pharmacist shall take appropriate action
to avoid or minimize the problem which may include consultation with the practitioner. [PL 1987, c.
710, §5 (NEW).]
A patient profile record must be maintained for a period of not less than the amount of time required
under federal Medicare laws, beginning from the date of the last entry in the profile record. As used in
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this section, "Medicare" means the Health Insurance for the Aged Act, Title XVIII of the Social
Security Amendments of 1965, as amended. [PL 1999, c. 130, §13 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1999, c. 130, §13 (AMD).
§13786. Identification of persons prescribing medicines on hospital prescription blanks
Any practitioner who writes a prescription upon a prescription blank of a hospital or clinic shall
sign that practitioner's name and cause that name to be printed, stamped or typed on the blank. [PL
1987, c. 710, §5 (NEW).]
This section applies to any registered nurse who writes a prescription while working under the
control or supervision of a physician. The name of the physician under whom the nurse works must be
printed, stamped or typed on the blank. [PL 2019, c. 627, Pt. B, §19 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2019, c. 627, Pt. B, §19 (AMD).
§13786-A. Security requirements; rules
1. Rules. The Department of Public Safety, after consultation with the Board of Osteopathic
Licensure, the Board of Licensure in Medicine and the Board of Pharmacy, shall adopt rules that
establish security requirements for all written prescriptions for schedule II drugs issued by health care
providers. For purposes of this section, "schedule II drug" has the same meaning as in the federal
Controlled Substances Act of 1970, 21 United States Code, Section 812. Rules adopted pursuant to
this subsection are major substantive rules as defined in Title 5, chapter 375, subchapter II‑A and must
be brought back for review by the joint standing committee of the Legislature having jurisdiction over
criminal justice matters during the 2nd Regular Session of the 120th Legislature. The rules must include
a procedure to obtain a waiver for prescription blanks that provide substantially equivalent protection
against forgery. The rules must deal with the following subjects:
A. Measures designed to prevent unauthorized copying of a completed or blank prescription form;
[PL 2001, c. 419, §23 (NEW).]
B. Measures designed to prevent the erasure or modification of information written on the
prescription by the prescribing health care provider; and [PL 2001, c. 419, §23 (NEW).]
C. Measures to prevent the use of counterfeit prescription forms. [PL 2001, c. 419, §23 (NEW).]
[PL 2001, c. 419, §23 (NEW).]
2. Out-of-state prescription security requirements. Notwithstanding any law or rule to the
contrary, a prescription for a schedule II drug written by an out-of-state practitioner on a prescription
blank that does not comply with the requirements for a security prescription blank, as defined in the
Department of Public Safety rule pursuant to subsection 1, may be filled by a pharmacist only if:
A. The pharmacist receives and makes a record of oral confirmation of the validity of the
prescription from the out-of-state practitioner or the practitioner's agent and the pharmacist makes
a reasonable effort to determine that the oral confirmation came from the practitioner or the
practitioner's agent, which may include a telephone call to the practitioner's telephone number listed
in a telephone directory or other directory or other good faith efforts to confirm the identity of the
person giving the oral confirmation; and [PL 2003, c. 326, §1 (NEW).]
B. The pharmacist demands, inspects and records a valid photographic identification from any
person presenting a prescription or receiving a filled prescription unless:
(1) The person is the patient for whom the prescription is written;
(2) The person's identity is personally known to the pharmacist; and
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(3) The pharmacist confirms by reviewing the pharmacy records that the pharmacist has
previously demanded, inspected and recorded a valid photographic identification from the
person. [PL 2003, c. 326, §1 (NEW).]
[PL 2003, c. 326, §1 (NEW).]
3. Valid photographic identification. For the purposes of subsection 2, a valid photographic
identification is limited to the following:
A. A valid Maine motor vehicle operator's license; [PL 2003, c. 326, §1 (NEW).]
B. A valid Maine identification card issued under Title 29‑A, section 1410; [PL 2003, c. 326,
§1 (NEW).]
C. A valid United States passport; or [PL 2003, c. 326, §1 (NEW).]
D. A valid passport or motor vehicle operator's license of another state, territory or possession of
the United States or a foreign country only if it:
(1) Contains a photograph of the person presenting the prescription;
(2) Is encased in tamper-resistant plastic or is otherwise tamper-resistant; and
(3) Identifies the date of birth of the person presenting the prescription. [PL 2003, c. 326,
§1 (NEW).]
[PL 2003, c. 326, §1 (NEW).]
4. Partial filling of out-of-state prescriptions. The partial filling of a prescription for a schedule
II drug written by an out-of-state practitioner on a prescription blank that does not comply with the
requirements for a security prescription blank, as defined in the Department of Public Safety rule
pursuant to subsection 1, is permissible if the pharmacist is unable after reasonable effort to obtain the
oral confirmation described in subsection 2 in the case of the practitioner's office being closed during
nights, weekends or holidays. The partial filling is limited to a 72-hour supply of the controlled
substance. The remaining portion of the prescription may be filled within the 72-hour period upon
obtaining the oral confirmation. No further quantity may be filled beyond the 72 hours without a new
prescription.
[PL 2003, c. 326, §1 (NEW).]
SECTION HISTORY
PL 2001, c. 419, §23 (NEW). PL 2003, c. 326, §1 (AMD).
§13786-B. Partial dispensing of prescription for opioid medication
1. Partial dispensing authorized. Notwithstanding any law or rule to the contrary, a pharmacist
may partially dispense a prescription for an opioid medication in a lesser quantity than the
recommended full quantity indicated on the prescription if requested by the patient for whom the
prescription is written. The remaining quantity of the prescription in excess of the recommended full
quantity is void and may not be dispensed without a new prescription.
[PL 2015, c. 488, §30 (NEW).]
2. Notice to practitioner. If a pharmacist partially dispenses a prescription for an opioid
medication as permitted under this section, the pharmacist or the pharmacist's designee shall, within a
reasonable time following the partial dispensing but not more than 7 days, notify the practitioner of the
quantity of the opioid medication actually dispensed. The notice may be conveyed by a notation on the
patient's electronic health record or by electronic transmission, by facsimile or by telephone to the
practitioner.
[PL 2015, c. 488, §30 (NEW).]
SECTION HISTORY
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PL 2015, c. 488, §30 (NEW).
§13786-C. Dispensing of prescription of opioid medication; immunity
A pharmacist who dispenses opioid medication in good faith is immune from any civil liability that
might otherwise result from dispensing medication in excess of the limit established in section 2210,
subsection 1, paragraphs A and B; section 2600‑C, subsection 1, paragraphs A and B; section 3300‑F,
subsection 1, paragraphs A and B; section 3657, subsection 1, paragraphs A and B; or section 18308,
subsection 1, paragraphs A and B, if the medication was dispensed in accordance with a prescription
issued by a practitioner. In a proceeding regarding immunity from liability, there is a rebuttable
presumption of good faith. [PL 2015, c. 488, §31 (NEW).]
SECTION HISTORY
PL 2015, c. 488, §31 (NEW).
§13786-D. Prescribing and dispensing insulin
1. Definitions. As used in this section, unless the context otherwise indicates, the following terms
have the following meanings.
A. "Insulin" includes various types of insulin analogs and insulin-like medications, regardless of
activation period or whether the solution is mixed before or after dispensation. [PL 2019, c. 666,
Pt. B, §1 (NEW).]
B. "Insulin-related devices and supplies" means needles, syringes, cartridge systems, prefilled pen
systems, glucose meters and test strips. "Insulin-related devices and supplies" does not include
insulin pump devices. [PL 2019, c. 666, Pt. B, §1 (NEW).]
[PL 2019, c. 666, Pt. B, §1 (NEW).]
2. Authorization. As authorized by the board in accordance with rules adopted under subsection
3, a pharmacist may dispense emergency refills of insulin and associated insulin-related devices and
supplies by prescription drug order or standing order or pursuant to a collaborative practice agreement
authorizing insulin to be dispensed. The insulin dispensed under this subsection must be in a quantity
that is at least a 30-day supply unless the intended recipient requests a lesser quantity upon consultation
with the pharmacist. The intended recipient shall provide evidence of a previous prescription from a
practitioner and attest that a refill of that previous prescription may not be readily or easily obtained
under the circumstances. Upon receiving evidence of a previous prescription from a practitioner, the
pharmacist shall immediately notify that practitioner that an emergency refill of insulin was dispensed
and instruct the recipient to seek follow-up care from the practitioner as soon as possible.
[PL 2021, c. 20, §1 (AMD).]
3. Rules; protocols. The board by rule shall establish standards for authorizing pharmacists to
dispense insulin in accordance with subsection 2, including protocols for notifying practitioners when
emergency refills of insulin are dispensed. Rules adopted under this subsection are routine technical
rules as defined in Title 5, chapter 375, subchapter 2‑A.
[PL 2021, c. 20, §2 (AMD).]
SECTION HISTORY
PL 2019, c. 666, Pt. B, §1 (NEW). PL 2021, c. 20, §§1, 2 (AMD).
§13786-E. Prescribing, dispensing and administering HIV prevention drugs
1. Definitions. As used in this section, unless the context otherwise indicates, the following terms
have the following meanings.
A. "CDC guidelines" means guidelines related to nonoccupational exposure to potential HIV
infection, or any subsequent guidelines, published by the federal Department of Health and Human
Services, Centers for Disease Control and Prevention. [PL 2021, c. 265, §6 (NEW).]
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B. "HIV prevention drug" means a preexposure prophylaxis drug, post-exposure prophylaxis drug
or other drug approved for the prevention of HIV infection by the federal Food and Drug
Administration. [PL 2021, c. 265, §6 (NEW).]
C. "Post-exposure prophylaxis drug" means a drug or drug combination that meets the clinical
eligibility recommendations provided in CDC guidelines following potential exposure to HIV
infection. [PL 2021, c. 265, §6 (NEW).]
D. "Preexposure prophylaxis drug" means a drug or drug combination that meets the clinical
eligibility recommendations provided in CDC guidelines to prevent HIV infection. [PL 2021, c.
265, §6 (NEW).]
[PL 2021, c. 265, §6 (NEW).]
2. Authorization. Notwithstanding any provision of law to the contrary and as authorized by the
board in accordance with rules adopted under subsection 3, a pharmacist may prescribe, dispense and
administer HIV prevention drugs pursuant to a standing order or collaborative practice agreement or to
protocols developed by the board for when there is no prescription drug order, standing order or
collaborative practice agreement in accordance with the requirements in this subsection and may also
order laboratory testing for HIV infection as necessary.
A. Before furnishing an HIV prevention drug to a patient, a pharmacist shall complete a training
program approved by the board on the use of protocols developed by the board for prescribing,
dispensing and administering an HIV prevention drug, on the requirements for any laboratory
testing for HIV infection and on guidelines for prescription adherence and best practices to counsel
patients prescribed an HIV prevention drug. [PL 2021, c. 265, §6 (NEW).]
B. A pharmacist shall dispense or administer a preexposure prophylaxis drug in at least a 30-day
supply, and up to a 60-day supply, as long as all of the following conditions are met:
(1) The patient tests negative for HIV infection, as documented by a negative HIV test result
obtained within the previous 7 days. If the patient does not provide evidence of a negative HIV
test result in accordance with this subparagraph, the pharmacist shall order an HIV test. If the
test results are not transmitted directly to the pharmacist, the pharmacist shall verify the test
results to the pharmacist's satisfaction. If the patient tests positive for HIV infection, the
pharmacist or person administering the test shall direct the patient to a primary care provider
and provide a list of primary care providers and clinics within a reasonable travel distance of
the patient's residence;
(2) The patient does not report any signs or symptoms of acute HIV infection on a self-
reporting checklist of acute HIV infection signs and symptoms;
(3) The patient does not report taking any contraindicated medications;
(4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on the
ongoing use of a preexposure prophylaxis drug. The pharmacist shall notify the patient that
the patient must be seen by a primary care provider to receive subsequent prescriptions for a
preexposure prophylaxis drug and that a pharmacist may not dispense or administer more than
a 60-day supply of a preexposure prophylaxis drug to a single patient once every 2 years
without a prescription;
(5) The pharmacist documents, to the extent possible, the services provided by the pharmacist
in the patient's record in the patient profile record system maintained by the pharmacy. The
pharmacist shall maintain records of preexposure prophylaxis drugs dispensed or administered
to each patient;
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(6) The pharmacist does not dispense or administer more than a 60-day supply of a preexposure
prophylaxis drug to a single patient once every 2 years, unless otherwise directed by a
practitioner; and
(7) The pharmacist notifies the patient's primary care provider that the pharmacist completed
the requirements specified in this paragraph. If the patient does not have a primary care
provider, or refuses consent to notify the patient's primary care provider, the pharmacist shall
provide the patient a list of physicians, clinics or other health care providers to contact
regarding follow-up care. [PL 2021, c. 265, §6 (NEW).]
C. A pharmacist shall dispense or administer a complete course of a post-exposure prophylaxis
drug as long as all of the following conditions are met:
(1) The pharmacist screens the patient and determines that the exposure occurred within the
previous 72 hours and the patient otherwise meets the clinical criteria for a post-exposure
prophylaxis drug under CDC guidelines;
(2) The pharmacist provides HIV testing to the patient or determines that the patient is willing
to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo HIV
testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, the
pharmacist may dispense or administer a post-exposure prophylaxis drug;
(3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on the
use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the
availability of a preexposure prophylaxis drug for persons who are at substantial risk of
acquiring HIV; and
(4) The pharmacist notifies the patient's primary care provider of the dispensing or
administering of the post-exposure prophylaxis drug. If the patient does not have a primary
care provider, or refuses consent to notify the patient's primary care provider, the pharmacist
shall provide the patient a list of physicians, clinics or other health care providers to contact
regarding follow-up care. [PL 2021, c. 265, §6 (NEW).]
[PL 2021, c. 265, §6 (NEW).]
3. Rules; protocols. The board by rule shall establish standards for authorizing pharmacists to
prescribe, dispense and administer HIV prevention drugs in accordance with subsection 2, including
adequate training requirements and protocols for when there is no prescription drug order, standing
order or collaborative practice agreement. Rules adopted under this subsection are routine technical
rules as defined in Title 5, chapter 375, subchapter 2‑A.
[PL 2021, c. 265, §6 (NEW).]
SECTION HISTORY
PL 2021, c. 265, §6 (NEW).
§13786-F. Dispensing of emergency supplies of chronic maintenance drug
1. Definition. For the purposes of this section, "chronic maintenance drug" means a medication
prescribed to treat a chronic, long-term condition and that is taken on a regular, recurring basis.
[PL 2021, c. 566, §2 (NEW).]
2. Emergency supply. A pharmacist may dispense an emergency supply of a chronic maintenance
drug without a current, valid prescription from a practitioner, subject to the following requirements:
A. The pharmacy at which the pharmacist is practicing has a record of a prescription for the chronic
maintenance drug in the name of the patient who is requesting the emergency supply, including the
amount of the chronic maintenance drug dispensed as provided in the most recent prescription or
the standard unit of dispensing for the chronic maintenance drug, and the record of that prescription
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for the chronic maintenance drug does not include a notation from a practitioner that no emergency
supply is permitted; [PL 2021, c. 566, §2 (NEW).]
B. The pharmacist attempts but is unable to obtain authorization to refill the prescription described
in paragraph A from the practitioner who issued the prescription or another practitioner responsible
for the patient's care; [PL 2021, c. 566, §2 (NEW).]
C. In the pharmacist's professional judgment, the chronic maintenance drug is essential to sustain
the life of the patient or to continue therapy for a chronic condition of the patient and failure to
dispense the chronic maintenance drug could reasonably produce undesirable health consequences
or cause physical or mental discomfort; [PL 2021, c. 566, §2 (NEW).]
D. Except as provided in this subsection, the amount of the chronic maintenance drug dispensed
does not exceed a 30-day supply as provided in the prescription or, if the standard unit of dispensing
for the chronic maintenance drug exceeds a 30-day supply, the amount of the chronic maintenance
drug dispensed does not exceed the smallest standard unit of dispensing; [PL 2021, c. 566, §2
(NEW).]
E. With respect to a chronic maintenance drug that is a controlled substance included in Schedule
III or IV of 21 United States Code, Section 812 or 21 Code of Federal Regulations, Section 1308,
the amount of the chronic maintenance drug dispensed does not exceed a 7-day supply; [PL 2021,
c. 566, §2 (NEW).]
F. The chronic maintenance drug is not a controlled substance included in Schedule I or II of 21
United States Code, Section 812 or 21 Code of Federal Regulations, Section 1308; and [PL 2021,
c. 566, §2 (NEW).]
G. The pharmacist has not dispensed the chronic maintenance drug in an emergency supply under
this subsection to the same patient more than twice in the preceding 12-month period. [PL 2021,
c. 566, §2 (NEW).]
The pharmacist shall exercise professional judgment in determining the amount of the chronic
maintenance drug to be dispensed, up to the maximum amount specified in this subsection. The
pharmacist shall notify the practitioner who issued the prescription or another practitioner responsible
for the patient's care no later than 72 hours after the chronic maintenance drug is dispensed. The
pharmacist shall fulfill all documentation and other requirements established by the board when
dispensing an emergency supply of a chronic maintenance drug.
[PL 2021, c. 566, §2 (NEW).]
3. Rules. The board may adopt rules for determining what constitutes a chronic maintenance drug
and what reporting procedures are necessary in dispensing an emergency supply of a chronic
maintenance drug. Rules adopted by the board pursuant to this subsection are routine technical rules as
defined in Title 5, chapter 375, subchapter 2‑A.
[PL 2021, c. 566, §2 (NEW).]
SECTION HISTORY
PL 2021, c. 566, §2 (NEW).
§13787. Hypodermic syringes; prescriptions
(REPEALED)
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 394, §1 (RP).
§13787-A. Sale of hypodermic apparatus
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1. Authorized seller. A hypodermic apparatus, as defined in Title 17‑A, section 1101, subsection
2, may be sold only by a manufacturer or dealer of embalming supplies, manufacturer or dealer of
medical or dental supplies, wholesale druggist, manufacturing pharmacist, pharmacist, veterinarian,
agricultural supply store or manufacturer of surgical instruments.
[PL 1993, c. 394, §2 (NEW).]
2. Purchaser. Any person who is 18 years of age or older may purchase a hypodermic apparatus
from a seller described in subsection 1.
[PL 1993, c. 394, §2 (NEW).]
3. Criminal immunity.
[PL 2021, c. 434, §12 (RP).]
4. Immunity limited. This section does not limit prosecution for violation of any law prohibiting
or regulating the use, possession, dispensing, distribution or promotion of controlled substances or
scheduled drugs.
[PL 2021, c. 434, §13 (AMD).]
5. Medicaid not affected. This section does not diminish, expand or otherwise affect Medicaid
reimbursement for hypodermic apparatuses.
[PL 1993, c. 394, §2 (NEW).]
SECTION HISTORY
PL 1993, c. 394, §2 (NEW). PL 2003, c. 688, §A39 (AMD). PL 2021, c. 434, §§12, 13 (AMD).
§13788. Sale of poisonous drugs
Each licensed pharmacist who sells a poison shall affix to the package sold a label plainly marked
with the name and address of the store and the word "POISON" and the name of the poison sold, and
shall enter at the time of sale in a permanently bound book to be kept for that purpose the name and
address of the purchaser, the date of sale, the name of the poison and the quantity sold and the person
making the sale shall sign the entry. This section shall not apply to sales on prescription of practitioners,
sales at wholesale to pharmacists or sales to hospitals, colleges or public institutions. [PL 1987, c.
710, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13789. Possession of drug samples
No person may purchase manufacturers' drug samples from any person for purposes of resale. If
those samples are given gratuitously to a licensed pharmacist, qualified assistant pharmacist or medical
practitioner, any such sample may be given to any person, as long as the sample is kept in containers
suitably labeled to conform to the Federal Food and Drug Act and the state food and drug laws and this
gift is subject to the laws relating to the sale of drugs. [PL 2007, c. 402, Pt. DD, §31 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2007, c. 402, Pt. DD, §31 (AMD).
§13790. Using drugs not in prescription
If a pharmacist knowingly uses any drugs or ingredients in preparing or compounding a written or
oral prescription of any practitioner different from those named in the prescription, that use shall
constitute a civil violation for which a forfeiture of not more than $1,000 nor less than $50 may be
adjudged. [PL 1987, c. 710, §5 (NEW).]
SECTION HISTORY
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PL 1987, c. 710, §5 (NEW).
§13791. Return of drugs
A drug or pharmaceutical preparation that has been dispensed on prescription may be returned to
pharmacy stock after being in possession and under the control of another person and may be dispensed
again if the drug is packaged in an unbroken, sealed container or if, in the case of a hospital, a licensed
pharmacist determines that the drug has not been impaired. [PL 1993, c. 231, §1 (AMD).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1993, c. 231, §1 (AMD).
§13792. Sale by certain methods prohibited
1. Methods of sale prohibited. A person may not sell, distribute, vend or otherwise dispose of
any drug, medicine or pharmaceutical or medical preparation by means of any public exhibition,
entertainment, performance, carnival or by vending machines, except as described in subsection 2.
[PL 2019, c. 454, §2 (NEW).]
2. Sale of nonprescription drugs by vending machines. The Maine Board of Pharmacy shall
adopt rules to allow a pharmacy licensed as a vending machine outlet in accordance with section 13751
to sell or distribute nonprescription drugs by vending machines. The rules must include, but are not
limited to, the following:
A. A requirement that only nonprescription drugs may be dispensed by a vending machine; [PL
2019, c. 454, §2 (NEW).]
B. A requirement that nonprescription drugs dispensed by a vending machine must be stored in
accordance with manufacturer recommendations, including those that require a stable temperature;
[PL 2019, c. 454, §2 (NEW).]
C. A requirement that nonprescription drugs dispensed by a vending machine must be sold only in
the manufacturer's clearly labeled, original, unbroken, tamper‑proof and expiration‑dated
packaging; [PL 2019, c. 454, §2 (NEW).]
D. A requirement that nonprescription drugs dispensed by a vending machine may not be older
than the manufacturer's expiration date; [PL 2019, c. 454, §2 (NEW).]
E. [PL 2023, c. 160, §1 (RP).]
F. A requirement that a vending machine through which nonprescription drugs are dispensed must
have an obvious and legible statement on the machine that identifies the owner of the machine, a
toll‑free telephone number at which the consumer may contact the owner of the machine, a
statement advising the consumer to check the expiration date of the product before using the
product and the telephone number of the board; [PL 2019, c. 454, §2 (NEW).]
G. Identification of any nonprescription drugs that may not be dispensed by a vending machine;
and [PL 2019, c. 454, §2 (NEW).]
H. Identification of locations at which a vending machine dispensing nonprescription drugs may
not be located, including the following:
(1) Private schools as defined in Title 20‑A, section 1, subsection 22;
(2) Public preschool programs as defined in Title 20‑A, section 1, subsection 23‑A;
(3) Public schools as defined in Title 20‑A, section 1, subsection 24; and
(4) Child care facilities as defined in Title 22, section 8301‑A, subsection 1‑A, paragraph B.
[PL 2019, c. 454, §2 (NEW).]
[PL 2023, c. 160, §1 (AMD).]
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SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 2019, c. 454, §2 (RPR). PL 2023, c. 160, §1 (AMD).
§13793. Adulterating and selling drugs
Whoever fraudulently adulterates, for the purpose of sale, any drug or medicine or sells any
fraudulently adulterated drug or medicine, knowing the same to be adulterated, shall be punished by a
fine of not more than $1,000 or by imprisonment for not more than 11 months. These adulterated drugs
and medicines shall be forfeited and destroyed under the direction of the court. [PL 1987, c. 710, §5
(NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW).
§13794. Labeling of prescriptions
Every drug dispensed pursuant to prescription, whether for a legend drug or not, must carry on the
label the following information: the prescription number; the date of filling; the patient's name;
directions for use; the name and strength of the drug and the amount dispensed, including either the
brand name of the drug or, if a generic and therapeutically equivalent drug or interchangeable biological
product is dispensed the label must be in accordance with section 13781; the beyond use date of the
drug; the name of the practitioner prescribing the drug; and the name, address and telephone number
of the pharmacy where the prescription was compounded and dispensed. For purposes of this section,
"beyond use date" means a date beyond which the contents of the prescription are not recommended to
be used. [PL 2019, c. 34, §5 (AMD).]
A drug dispensed in accordance with the provisions of Title 22, chapter 251, subchapter 3, article
5 does not require the name of the patient's sexual partner on the label. [PL 2009, c. 533, §5 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1999, c. 130, §14 (AMD). PL 2009, c. 533, §5 (AMD). PL 2019,
c. 34, §5 (AMD).
§13795. Photographic proof of identification; discretion to sell or dispense; immunity
1. Photographic proof of identification. As a precondition to filling any prescription, dispensing
any drug or selling any targeted methamphetamine precursor, a pharmacist or person acting at the
direction of a pharmacist may demand, inspect and record proof of identification, including valid
photographic identification, from any patient presenting a prescription or any person acting on behalf
of the patient or person purchasing a targeted methamphetamine precursor. Valid photographic
identification includes but is not limited to the following:
A. A valid Maine motor vehicle operator's license; [PL 1995, c. 175, §1 (NEW).]
B. A valid Maine identification card issued under Title 29‑A, section 1410; [PL 1997, c. 437,
§46 (AMD).]
C. A valid United States passport; [PL 1995, c. 175, §1 (NEW).]
D. A valid passport, motor vehicle operator's license of another state, territory, possession or
foreign country or official identification card issued by the United States Government only if it:
(1) Contains a photograph of the person presenting the identification;
(2) Is encased in tamper-resistant plastic or otherwise possesses indicia of tamper-resistance;
and
(3) Identifies the person's date of birth; or [PL 2005, c. 430, §7 (AMD); PL 2005, c. 430,
§10 (AFF).]
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E. Other valid, tamper-resistant, photographic identification as provided in rules adopted by the
board pursuant to section 13722, subsection 1, paragraph A and in accordance with Title 5, chapter
375. [PL 1997, c. 245, §17 (AMD).]
[PL 2005, c. 430, §7 (AMD); PL 2005, c. 430, §10 (AFF).]
2. Refusal to fill prescription, dispense drug or sell targeted methamphetamine precursor;
law enforcement reporting. A pharmacist or person acting at the direction of a pharmacist may
exercise discretion and refuse to fill any prescription, dispense any drug or sell any targeted
methamphetamine precursor if unsatisfied as to the legitimacy or appropriateness of any prescription
presented, the validity of any photographic identification or the identity of any patient presenting a
prescription or any person acting on behalf of the patient, or the intention of the customer to use the
drug or targeted methamphetamine precursor according to the instructions for use. A pharmacist or
person acting at the direction of a pharmacist may make a report to a law enforcement agency when
that person has reasonable cause to suspect that a prescription is not legitimate or appropriate, that a
person has presented photographic identification that is not valid or that a customer has the intention to
use a drug or targeted methamphetamine precursor in a manner inconsistent with the instructions for
use.
[PL 2005, c. 430, §7 (AMD); PL 2005, c. 430, §10 (AFF).]
3. Immunity; presumption of good faith. A pharmacist or person acting at the direction of a
pharmacist who in good faith and pursuant to subsection 2 refuses to fill any prescription, dispense any
drug or sell any targeted methamphetamine precursor or who makes a report to a law enforcement
agency is immune from any civil liability that might otherwise result from that action, including, but
not limited to, any civil liability that might otherwise arise under state or local laws or rules regarding
confidentiality of information. In a proceeding regarding immunity from liability, there is a rebuttable
presumption of good faith.
[PL 2005, c. 430, §7 (NEW); PL 2005, c. 430, §10 (AFF).]
4. Record keeping. With regard to purchases of targeted methamphetamine precursors, a
pharmacy may keep a log of information about the purchaser, which may include name, date of birth,
address and amount of targeted methamphetamine precursors purchased.
[PL 2005, c. 430, §7 (NEW); PL 2005, c. 430, §10 (AFF).]
5. Rulemaking. The Commissioner of Health and Human Services may adopt rules to implement
this subsection. Rules adopted pursuant to this subsection are major substantive rules as defined in
Title 5, chapter 375, subchapter 2‑A.
A. If the Director of the Maine Drug Enforcement Agency within the Department of Public Safety
finds that the ease of availability of liquid, liquid-filled capsule or glycerin matrix forms of products
containing ephedrine, pseudoephedrine or phenylpropanolamine or their salts, isomers or salts of
isomers, either alone or in combination with other ingredients, referred to in this paragraph as
"products," is a threat to the public health, safety and welfare, then the Director of the Maine Drug
Enforcement Agency shall notify the Commissioner of Health and Human Services. The
Commissioner of Health and Human Services shall consult with the joint standing committee of
the Legislature having jurisdiction over health and human services matters, providing the reasons
for undertaking rulemaking, and may, after consultation, adopt rules designating the products as
targeted methamphetamine precursors pursuant to section 13702‑A, subsection 33, paragraph B.
[PL 2011, c. 657, Pt. AA, §84 (AMD).]
B. If the Director of the Maine Drug Enforcement Agency finds that sales of targeted
methamphetamine precursors that are made without verifying the identity of the purchaser pose a
threat to public health, safety and welfare, then the Director of the Maine Drug Enforcement
Agency shall notify the Commissioner of Health and Human Services. The Commissioner of
Health and Human Services shall consult with the joint standing committee of the Legislature
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having jurisdiction over health and human services matters, providing the reasons for undertaking
rulemaking, and may, after consultation, adopt rules requiring a person making a sale of a targeted
methamphetamine precursor pursuant to section 13796 to demand from the purchaser and to inspect
and record prior to the sale proof of identification, including valid photographic identification, and
to keep a log of sales. [PL 2011, c. 657, Pt. AA, §84 (AMD).]
[PL 2011, c. 657, Pt. AA, §84 (AMD).]
SECTION HISTORY
PL 1995, c. 175, §1 (NEW). PL 1997, c. 245, §17 (AMD). PL 1997, c. 437, §46 (AMD). PL
2005, c. 430, §7 (AMD). PL 2005, c. 430, §10 (AFF). PL 2007, c. 695, Pt. B, §18 (AMD). PL
2011, c. 657, Pt. AA, §84 (AMD).
§13796. Retail sale of targeted methamphetamine precursors
1. Definitions.
[PL 2011, c. 584, §1 (RP).]
1-A. Definitions. As used in this section, unless the context otherwise indicates, the following
terms have the following meanings.
A. "Electronic logging system" means a system that:
(1) Blocks the illegal sale of over-the-counter cold and allergy medications containing a
targeted methamphetamine precursor;
(2) Is available free of charge to the State and its taxpayers, retailers and law enforcement;
(3) Operates in real time and communicates across state lines in real time with similar systems;
and
(4) Complies with the requirements of the national Criminal Justice Information Exchange or
its successor program and the National Information Exchange Model or its successor program.
[PL 2011, c. 584, §2 (NEW).]
B. "Override function" means a function in an electronic logging system that may be used to
override a stop-sale alert and allows the completion of a sale. [PL 2011, c. 584, §2 (NEW).]
C. "Package" means an item packaged and marked for retail sale that is not designed to be broken
down or subdivided for the purpose of retail sale. [PL 2011, c. 584, §2 (NEW).]
D. "Retailer" or "retail store" means a person or business entity engaged in this State in the business
of selling products to the general public on a retail basis, including pharmacies. [PL 2011, c. 584,
§2 (NEW).]
E. "Sale" or "sold" includes barter, exchange, transfer and gift. [PL 2011, c. 584, §2 (NEW).]
F. "Stop-sale alert" means a notification that alerts the retailer that completion of the sale would
result in the seller's or purchaser's violating the targeted methamphetamine precursor quantity
limits. [PL 2011, c. 584, §2 (NEW).]
[PL 2011, c. 584, §2 (NEW).]
2. Restrictions on packaging.
[PL 2013, c. 223, §1 (RP).]
3. Restrictions on the sale of targeted methamphetamine precursors. The following
restrictions on location in the retail store, manner of sale and amount of sale apply to sales of targeted
methamphetamine precursors. The limits under this subsection on the amount of targeted
methamphetamine precursors that may be sold apply to the total amount of base ephedrine,
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phenylpropanolamine and pseudoephedrine contained in packages and not the overall weight of the
packages.
A. A retailer may not sell to the same person a targeted methamphetamine precursor that causes
the sales to that person of targeted methamphetamine precursors within a 24-hour period to exceed
3.6 grams. [PL 2011, c. 584, §3 (AMD).]
A-1. A person may not purchase more than 3.6 grams of a targeted methamphetamine precursor
within a 24-hour period. [PL 2011, c. 584, §3 (NEW).]
A-2. A retailer may not sell to the same person a targeted methamphetamine precursor that causes
the sale to that person of targeted methamphetamine precursors within a 30-day period to exceed 9
grams. [PL 2011, c. 584, §3 (NEW).]
A-3. A person may not purchase more than 9 grams of a targeted methamphetamine precursor
within a 30-day period. [PL 2011, c. 584, §3 (NEW).]
B. Except with regard to single-dose packages of not more than 60 milligrams that are kept within
30 feet and in direct line of sight of a staffed cash register or store counter, a retailer shall keep
targeted methamphetamine precursors in a location that is locked or otherwise not accessible by
customers. [PL 2011, c. 584, §3 (AMD).]
C. Except with regard to single-dose packages of not more than 60 milligrams that are kept within
30 feet and in direct line of sight of a staffed cash register or store counter, the sale of targeted
methamphetamine precursors must be completed by:
(1) A licensed pharmacist or licensed pharmacy technician; or
(2) An employee of the retailer who accepts payment for the targeted methamphetamine
precursor as long as:
(a) The employee works under the direct supervision of a pharmacist in the pharmacy area
of the retail store; and
(b) A licensed pharmacist or licensed pharmacy technician has given individual, express
approval for the purchase. [PL 2007, c. 402, Pt. DD, §33 (AMD).]
D. Except with regard to single-dose packages of not more than 60 milligrams that are kept within
30 feet and in direct line of sight of a staffed cash register or store counter, a retailer shall require a
person purchasing a targeted methamphetamine precursor to present a valid government-issued
photograph identification document at the point of sale. A retailer shall record the:
(1) Name and address of the purchaser;
(2) Name of the targeted methamphetamine precursor purchased including the number of
grams the product contains;
(3) Date and time of purchase; and
(4) Form of identification presented, issuing government entity and corresponding
identification number. [PL 2011, c. 584, §3 (NEW).]
E. Except with regard to single-dose packages of not more than 60 milligrams that are kept within
30 feet and in direct line of sight of a staffed cash register or store counter, a retailer shall maintain
a written or electronic logbook and require a person purchasing a targeted methamphetamine
precursor to sign the logbook. A purchaser must sign the logbook acknowledging that the purchaser
understands the applicable sales limit and that providing false statements or misrepresentations in
the logbook may subject the purchaser to criminal penalties under 18 United States Code, Section
1001. [PL 2011, c. 584, §3 (NEW).]
[PL 2011, c. 584, §3 (AMD).]
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4. Exceptions. The provisions of this section do not apply to a targeted methamphetamine
precursor that is obtained by prescription or by sale or transfer in the regular course of lawful business
to a veterinarian, physician, pharmacist, retail distributor, wholesaler, manufacturer, warehouse
operator or common carrier or an agent of that person or entity.
[PL 2005, c. 430, §8 (NEW); PL 2005, c. 430, §10 (AFF).]
5. Electronic logging. Beginning January 1, 2013, a retailer who has access to the Internet shall,
before completing a sale under this section, electronically submit the information obtained pursuant to
subsection 3, paragraph D to an electronic logging system. If the electronic logging system generates a
stop-sale alert, the retailer may not complete the sale. If the retailer has concern for personal safety or
the safety of others if a sale is not completed, the retailer may use the system's override function to
complete the sale and must maintain a log of the sale. If the retailer experiences mechanical or
electronic failure of the electronic logging system and is unable to comply with the electronic logging
requirement, the retailer shall maintain a written log or an alternative electronic record-keeping
mechanism until such time as the retailer is able to comply with the electronic logging requirement.
[PL 2011, c. 584, §4 (NEW).]
6. Immunity; presumption of good faith. A retailer is immune from liability for any claims,
costs, expenses, injuries, liabilities, losses or damages of any kind resulting from the retailer's use of
the electronic logging system in accordance with this section unless the injury or loss is the result of
willful, reckless or intentional misconduct by the retailer. In a civil proceeding in which the retailer's
use of an electronic logging system pursuant to this section is an issue, there is a rebuttable presumption
of good faith on the part of the retailer.
[PL 2011, c. 584, §4 (NEW).]
7. Political subdivision ordinances. A political subdivision, as defined in Title 30‑A, section
2252, may not adopt an ordinance regulating the sale or purchase of a targeted methamphetamine
precursor, and any ordinance that violates this subsection is void and has no force or effect.
[PL 2011, c. 584, §4 (NEW).]
SECTION HISTORY
PL 2005, c. 430, §8 (NEW). PL 2005, c. 430, §10 (AFF). PL 2007, c. 402, Pt. DD, §§32, 33
(AMD). PL 2011, c. 584, §§1-4 (AMD). PL 2013, c. 223, §1 (AMD).
§13797. Prescription drug price information
A pharmacist or person acting at the direction of a pharmacist who is asked for consumer price
information regarding prescription drugs shall provide to the consumer, on the telephone or in person,
depending on the circumstances, the current usual and customary price for cash customers and, if
reasonably obtainable by the pharmacist or person acting at the direction of the pharmacist, the price
applicable to the consumer. A pharmacy shall post a notice to consumers informing them that they
may obtain current usual and customary price information from the pharmacist. [PL 2005, c. 610, §1
(NEW).]
SECTION HISTORY
PL 2005, c. 610, §1 (NEW).
§13798. Expedited partner therapy
An individual licensed under this chapter may not be disciplined for dispensing drugs pursuant to
a lawful prescription in accordance with the provisions of Title 22, chapter 251, subchapter 3, article 5.
[PL 2009, c. 533, §6 (NEW).]
SECTION HISTORY
PL 2009, c. 533, §6 (NEW).
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§13799. Consumer choice preserved
Nothing in this chapter may be construed to prohibit: [PL 2013, c. 373, §2 (NEW).]
1. Ordering or receiving prescription drugs. An individual who is a resident of the State from
ordering or receiving prescription drugs for that individual’s personal use from outside the United States
by mail or carrier from a licensed retail pharmacy described in section 13731, subsection 1, paragraph
B or an entity described in section 13731, subsection 1, paragraph C; or
[PL 2013, c. 373, §2 (NEW).]
2. Dispensing or providing prescription drugs. A licensed retail pharmacy described in section
13731, subsection 1, paragraph B or an entity described in section 13731, subsection 1, paragraph C
from dispensing, providing or facilitating the provision of prescription drugs from outside the United
States by mail or carrier to a resident of the State for that resident's personal use.
[PL 2013, c. 373, §2 (NEW).]
SECTION HISTORY
PL 2013, c. 373, §2 (NEW).
§13800. Access to distributed drugs
A manufacturer or wholesaler licensed under section 13758 shall make a drug distributed in this
State available for sale in this State to an eligible product developer for purposes of conducting testing
required to support an application for approval of a drug under the Federal Food, Drug, and Cosmetic
Act, Section 505(b) or 505(j) or the licensing of a biological product under the federal Public Health
Service Act, Section 351. [PL 2017, c. 434, §5 (NEW).]
The manufacturer or wholesaler licensed under section 13758 shall make the drug available for sale
at a price no greater than the wholesale acquisition cost and without any restriction that would block or
delay the eligible product developer's application in a manner inconsistent with Section 505‑1(f)(8) of
the Federal Food, Drug, and Cosmetic Act, 21 United States Code, Section 355‑1(f)(8) (2016). [PL
2017, c. 434, §5 (NEW).]
An eligible product developer that receives a drug at a price no greater than the wholesale
acquisition cost for that drug pursuant to this section shall charge consumers in this State the same price
or less for the drug manufactured by that eligible product developer. [PL 2017, c. 434, §5 (NEW).]
As used in this section, "wholesale acquisition cost" means the manufacturer's list price for a brand-
name drug or a generic drug per person per year or course of treatment when sold to wholesalers or
direct purchasers in the United States, not including discounts or rebates, for the most recent month for
which information is available. [PL 2017, c. 434, §5 (NEW).]
SECTION HISTORY
PL 2017, c. 434, §5 (NEW).
§13800-A. Liability for product of another; exemption
A manufacturer or wholesaler licensed under section 13758 is not liable for injuries alleged to have
been caused by the failure to include adequate safety warnings on a product's label or by a defect in the
product's design if: [PL 2017, c. 434, §5 (NEW).]
1. Access to distributed drugs. The manufacturer or wholesaler has made the product distributed
in this State available to an eligible product developer in accordance with section 13800; and
[PL 2017, c. 434, §5 (NEW).]
2. Manufactured or sold by another. The product was not manufactured or sold by that
manufacturer or wholesaler.
[PL 2017, c. 434, §5 (NEW).]
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SECTION HISTORY
PL 2017, c. 434, §5 (NEW).
§13800-B. Prohibition on providing conversion therapy to minors
An individual licensed under this chapter may not advertise, offer or administer conversion therapy
to a minor. [PL 2019, c. 165, §30 (NEW).]
SECTION HISTORY
PL 2019, c. 165, §30 (NEW).
§13800-C. Opioid medication product registration fee
This section governs opioid medication product registration fees. As used in this section, "unit of
an opioid medication" means the lowest identifiable quantity of the opioid medication that is dispensed.
[PL 2019, c. 536, §4 (NEW).]
1. Registration fee. Except as provided in subsection 2, a manufacturer that sells, delivers or
distributes an opioid medication in this State shall pay an annual registration fee of $250,000 to the
board on December 31st of each year.
[PL 2019, c. 536, §4 (NEW).]
2. Exception. A manufacturer that does not sell, deliver or distribute 2,000,000 or more units of
an opioid medication within this State in the year in which a registration fee is due is not required to
pay the registration fee. To qualify for the exception under this subsection, a manufacturer must
demonstrate to the board, by January 31st of the year following the year in which the registration fee is
due, in a manner determined by the board, that the manufacturer did not sell, deliver or distribute
2,000,000 or more units of an opioid medication within this State in the year in which the manufacturer
seeks to claim the exception. The board may adopt rules to implement this section. Rules adopted
pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2‑A.
[PL 2019, c. 536, §4 (NEW).]
3. Calculation of units of an opioid medication sold, delivered or distributed. When
calculating the number of units of an opioid medication sold, delivered or distributed by a manufacturer
under subsection 2, units of an opioid medication may be excluded when prescribed for the purpose of
medication-assisted treatment of substance use disorder. The board periodically shall provide to the
Department of Health and Human Services a list of medications exempted under this subsection.
[PL 2019, c. 536, §4 (NEW).]
4. Registration fee review and report.
[PL 2019, c. 536, §4 (NEW); MRSA T. 32 §13800-C, sub-§4 (RP).]
SECTION HISTORY
PL 2019, c. 536, §4 (NEW).
§13800-D. Insulin product registration fee
(CONTAINS TEXT WITH VARYING EFFECTIVE DATES)
(WHOLE SECTION TEXT EFFECTIVE UNTIL 1/01/27)
(WHOLE SECTION TEXT REPEALED 1/01/27)
This section governs insulin product registration fees. As used in this section, "unit of insulin"
means the lowest identifiable quantity of insulin that is dispensed. [PL 2021, c. 303, §5 (NEW).]
1. Registration fee. Except as provided in subsection 2, a manufacturer that produces insulin that
is sold, delivered or distributed in this State shall pay an annual registration fee of $75,000 to the board
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on December 31st of each year in addition to any license renewal fee required to be paid by the
manufacturer under this chapter.
[PL 2021, c. 303, §5 (NEW).]
2. Exception. A manufacturer whose aggregate total of insulin sold, delivered or distributed in
this State does not exceed 500,000 units of insulin in the year in which a registration fee under
subsection 1 is due is not required to pay the registration fee. To qualify for the exception under this
subsection, a manufacturer must demonstrate to the board, by January 31st of the year following the
year in which the registration fee is due, in a manner determined by the board, that the aggregate total
of insulin produced by the manufacturer that was sold, delivered or distributed within this State in the
year in which the manufacturer seeks to claim the exception did not exceed 500,000 units. The board
may adopt rules to implement this section. Rules adopted pursuant to this subsection are routine
technical rules as defined in Title 5, chapter 375, subchapter 2‑A.
[PL 2021, c. 303, §5 (NEW).]
This section is repealed January 1, 2027. [PL 2021, c. 303, §5 (NEW).]
SECTION HISTORY
PL 2021, c. 303, §5 (NEW).
SUBCHAPTER 10
NONDISCRIMINATION IN PHARMACEUTICALS PRICING
(REPEALED)
§13801. Definitions
(REPEALED)
SECTION HISTORY
PL 1993, c. 716, §6 (NEW). PL 1999, c. 574, §1 (RP).
§13802. Price discrimination prohibited
(REPEALED)
SECTION HISTORY
PL 1993, c. 716, §6 (NEW). PL 1999, c. 574, §1 (RP).
§13803. Purchases by State
(REPEALED)
SECTION HISTORY
PL 1993, c. 716, §6 (NEW). PL 1999, c. 574, §1 (RP).
§13804. Exceptions
(REPEALED)
SECTION HISTORY
PL 1993, c. 716, §6 (NEW). PL 1995, c. 548, §1 (AMD). PL 1999, c. 574, §1 (RP).
§13805. Enforcement
(REPEALED)
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SECTION HISTORY
PL 1993, c. 716, §6 (NEW). PL 1999, c. 574, §1 (RP).
SUBCHAPTER 11
NONCONTROLLED PRESCRIPTION DRUG DISPENSING AND ADMINISTRATION
§13810. Drug administration by nurses under certain conditions
A professional nurse or an advanced practice registered nurse who is an employee of a home health
care provider, as defined in Title 22, section 2142, subsection 3, or a hospice program or hospice
provider, as defined in Title 22, section 8621, subsection 10, may: [PL 1997, c. 109, §1 (NEW).]
1. Possession. Possess, in the course of employment, such noncontrolled prescription drugs as are
approved by the board. In adopting the rules the board shall consult with the Board of Licensure in
Medicine, the Board of Osteopathic Licensure, the State Board of Nursing, the Maine Hospice Council,
the Department of Health and Human Services and the Home Care Alliance of Maine. Rules adopted
pursuant to this subsection are routine technical rules as defined by Title 5, chapter 375, subchapter
II‑A; and
[PL 1997, c. 109, §1 (NEW); PL 2003, c. 689, Pt. B, §6 (REV).]
2. Administration. Administer, in the course of employment, such drugs as are approved under
subsection 1 according to written protocols approved annually by the employer's professional advisory
committee, which must include a physician licensed under chapter 36 or chapter 48.
[PL 1997, c. 109, §1 (NEW).]
SECTION HISTORY
PL 1997, c. 109, §1 (NEW). PL 2003, c. 689, §B6 (REV).
§13811. Drug administration by certified midwives under certain conditions
(CONTAINS TEXT WITH VARYING EFFECTIVE DATES)
(WHOLE SECTION TEXT EFFECTIVE UNTIL CONTINGENCY: See PL 2015, c. 502, §16)
A midwife who can verify to a licensed pharmacist by certification card that the midwife has met
the certification standards of an international certification agency whose mission is to establish and
administer certification for the credential of certified professional midwife or other certifying body
recognized by the board may: [PL 2007, c. 669, §1 (NEW).]
1. Possession. Possess, in the course of the practice of midwifery, only the noncontrolled
prescription drugs and substances set out in this subsection:
A. Oxygen; [PL 2007, c. 669, §1 (NEW).]
B. Oxytocin, excluding the oxytocic drug methergine, for the sole purpose of postpartum control
of maternal hemorrhage; [PL 2007, c. 669, §1 (NEW).]
C. Vitamin K; [PL 2007, c. 669, §1 (NEW).]
D. Eye prophylaxis; and [PL 2007, c. 669, §1 (NEW).]
E. Local anesthetics or numbing agents for repair of lacerations; and [PL 2007, c. 669, §1
(NEW).]
[PL 2007, c. 669, §1 (NEW).]
2. Administration. Administer, in the course of the practice of midwifery, those drugs that are
listed in subsection 1. When administering oxytocin, a certified midwife may not administer more than
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20 units of oxytocin to a single patient. Oxytocin may be administered only for postpartum purposes
in order to treat hemorrhaging and specifically may not be used to induce labor. When a certified
midwife administers oxytocin in accordance with this subsection, the certified midwife shall report that
use to the maternal and child health division of the Department of Health and Human Services, the
Maine Center for Disease Control and Prevention within 7 days of the use of oxytocin.
[PL 2007, c. 669, §1 (NEW).]
SECTION HISTORY
PL 2007, c. 669, §1 (NEW). PL 2015, c. 502, §12 (RP). PL 2015, c. 502, §16 (AFF).
§13811. Drug administration by certified midwives under certain conditions
(CONTAINS TEXT WITH VARYING EFFECTIVE DATES)
(WHOLE SECTION TEXT REPEALED ON CONTINGENCY: See PL 2015, c. 502, §16)
(REPEALED)
SECTION HISTORY
PL 2007, c. 669, §1 (NEW). PL 2015, c. 502, §12 (RP). PL 2015, c. 502, §16 (AFF).
§13812. Dispensing of medication by pharmacist
(CONTAINS TEXT WITH VARYING EFFECTIVE DATES)
(WHOLE SECTION TEXT EFFECTIVE UNTIL CONTINGENCY: See PL 2015, c. 502, §16)
1. Dispensing of medication. A pharmacist, who in good faith relies upon a certification card
presented by a midwife identifying that the midwife has met the certification standards described under
section 13811, may sell and dispense to the midwife the noncontrolled prescription drugs and
substances identified in section 13811.
[PL 2007, c. 669, §2 (NEW).]
2. Good faith. A pharmacist, or person acting at the direction of a pharmacist, who:
A. In good faith sells and dispenses noncontrolled prescription drugs and substances to a midwife
pursuant to this section is not liable for any adverse reactions caused by any method of use by the
midwife; and [PL 2007, c. 669, §2 (NEW).]
B. Makes a report relating to the dispensing of noncontrolled prescription drugs and substances to
a midwife pursuant to section 13811 to an enforcement agency is immune from any civil liability
that may result from that action, including, but not limited to, any civil liability that might otherwise
arise under state or local laws or rules regarding confidentiality of information. [PL 2007, c. 669,
§2 (NEW).]
In a proceeding in which a pharmacist, or person acting at the direction of a pharmacist, invokes the
immunity provided pursuant to this section, there is a rebuttable presumption of good faith.
[PL 2007, c. 669, §2 (NEW).]
SECTION HISTORY
PL 2007, c. 669, §2 (NEW). PL 2015, c. 502, §13 (RP). PL 2015, c. 502, §16 (AFF).
§13812. Dispensing of medication by pharmacist
(CONTAINS TEXT WITH VARYING EFFECTIVE DATES)
(WHOLE SECTION TEXT REPEALED ON CONTINGENCY: See PL 2015, c. 502, §16)
(REPEALED)
SECTION HISTORY
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PL 2007, c. 669, §2 (NEW). PL 2015, c. 502, §13 (RP). PL 2015, c. 502, §16 (AFF).
SUBCHAPTER 11-A
PRESCRIBING AND DISPENSING OF NALOXONE HYDROCHLORIDE AND OTHER
OPIOID OVERDOSE-REVERSING MEDICATIONS
§13815. Authorization
1. Rules for dispensing naloxone hydrochloride.
[PL 2017, c. 364, §6 (RP).]
2. Rules for prescribing and dispensing naloxone hydrochloride or another opioid overdose-
reversing medication. The board by rule shall establish standards for authorizing pharmacists to
prescribe and dispense naloxone hydrochloride or another opioid overdose-reversing medication in
accordance with Title 22, section 2353, subsection 2, paragraphs A‑1 and C‑1. The rules must establish
adequate training requirements and protocols for prescribing and dispensing naloxone hydrochloride
or another opioid overdose-reversing medication when there is no prescription drug order, standing
order or collaborative practice agreement authorizing naloxone hydrochloride or another opioid
overdose-reversing medication to be dispensed to the intended recipient. Rules adopted under this
subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2‑A. A pharmacist
authorized by the board pursuant to this subsection to prescribe and dispense naloxone hydrochloride
or another opioid overdose-reversing medication may prescribe and dispense naloxone hydrochloride
or another opioid overdose-reversing medication in accordance with Title 22, section 2353, subsection
2, paragraphs A‑1 and C‑1. An opioid overdose-reversing medication referenced in this subsection must
be approved by the federal Food and Drug Administration.
[PL 2023, c. 161, §8 (AMD).]
SECTION HISTORY
PL 2015, c. 508, §5 (NEW). PL 2017, c. 249, §2 (RPR). PL 2017, c. 364, §§6, 7 (AMD). PL
2023, c. 161, §8 (AMD).
SUBCHAPTER 12
COLLABORATIVE PRACTICE FOR EMERGENCY CONTRACEPTION
§13821. Short title
This subchapter is known and may be cited as "the Collaborative Practice for Emergency
Contraception Act." [PL 2003, c. 524, §1 (NEW).]
SECTION HISTORY
PL 2003, c. 524, §1 (NEW).
§13822. Collaborative practice authorized
Notwithstanding any other provision of law, a licensed pharmacist who has completed the training
required in section 13823 may initiate emergency contraception drug therapy in accordance with
standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is
acting within the prescriber's scope of practice. [PL 2003, c. 524, §1 (NEW).]
SECTION HISTORY
PL 2003, c. 524, §1 (NEW).
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§13823. Training required
Prior to performing any procedure authorized under this chapter, a pharmacist must have completed
a training program on emergency contraception, delivered by an entity authorized by a national council
on pharmaceutical education, or another training program approved by the board. The training program
must include, but is not limited to, conduct of sensitive communications, quality assurance, referral to
additional services and documentation. [PL 2003, c. 524, §1 (NEW).]
SECTION HISTORY
PL 2003, c. 524, §1 (NEW).
§13824. Provision of standardized fact sheet required
For each emergency contraception drug therapy initiated pursuant to this subchapter, the pharmacist
shall provide the recipient of the emergency contraceptive drugs with a standardized fact sheet
developed by the board that includes, but is not limited to, the indications for use of the drug, the
appropriate method for using the drug, the need for medical follow-up and referral information,
information on sexual assault and referral information and other appropriate information. [PL 2003,
c. 524, §1 (NEW).]
SECTION HISTORY
PL 2003, c. 524, §1 (NEW).
§13825. Confidentiality
Nothing in this subchapter affects the provisions of law relating to maintaining the confidentiality
of medical records. [PL 2003, c. 524, §1 (NEW).]
SECTION HISTORY
PL 2003, c. 524, §1 (NEW).
SUBCHAPTER 12-A
PRESCRIBING, DISPENSING AND ADMINISTERING CONTRACEPTIVES
§13826. Authorization to prescribe, dispense and administer contraceptives
1. Definitions. As used in this subchapter, unless the context otherwise indicates, the following
terms have the following meanings.
A. "Injectable hormonal contraceptive" means a drug composed of a hormone or a combination of
hormones that is approved by the United States Food and Drug Administration to prevent
pregnancy and that is administered by injection. [PL 2023, c. 115, §1 (NEW).]
B. "Self-administered hormonal contraceptive" means a drug composed of a single hormone or a
combination of hormones that is approved by the United States Food and Drug Administration to
prevent pregnancy and that the patient to whom the drug is prescribed may self-administer. "Self-
administered hormonal contraceptive" includes an oral hormonal contraceptive, a hormonal vaginal
ring and a hormonal contraceptive patch. [PL 2023, c. 115, §1 (NEW).]
[PL 2023, c. 115, §1 (NEW).]
2. Authorization. A pharmacist may prescribe, dispense or administer a self-administered
hormonal contraceptive or injectable hormonal contraceptive in accordance with the requirements set
forth in subsection 3.
[PL 2023, c. 115, §1 (NEW).]
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3. Requirements. In order to prescribe, dispense or administer contraceptives under this section,
a pharmacist shall:
A. Successfully complete a training program approved by the board related to prescribing,
dispensing and administering contraceptives that reflects evidence-based medical eligibility
guidelines for contraceptive use and best practices to counsel patients; [PL 2023, c. 115, §1
(NEW).]
B. Obtain a certificate of authorization issued by the board pursuant to subsection 4; [PL 2023,
c. 115, §1 (NEW).]
C. Obtain a completed self-screening risk assessment from a patient prior to counseling the patient
and issuing a prescription to the patient for a self-administered hormonal contraceptive or injectable
hormonal contraceptive. The self-screening risk assessment and counseling provided by a
pharmacist must be based on evidence-based medical eligibility guidelines for contraceptive use
and best practices to counsel patients; [PL 2023, c. 115, §1 (NEW).]
D. Refer the patient to the patient's practitioner upon dispensing a self-administered hormonal
contraceptive or administering an injectable hormonal contraceptive or, if the patient does not have
a practitioner responsible for the patient's regular care, advise the patient to consult a practitioner;
[PL 2023, c. 115, §1 (NEW).]
E. Provide the patient with a written record of the prescribed self-administered hormonal
contraceptive or injectable hormonal contraceptive; and [PL 2023, c. 115, §1 (NEW).]
F. Dispense the self-administered hormonal contraceptive or administer the injectable hormonal
contraceptive to the patient as soon as practicable after the pharmacist issues the prescription. [PL
2023, c. 115, §1 (NEW).]
[PL 2023, c. 115, §1 (NEW).]
4. Certificate of authorization. A pharmacist shall apply in the form prescribed by the board and
submit a certificate fee as set forth in section 13724 for a certificate of authorization to prescribe,
dispense and administer contraceptives pursuant to this section. The certificate of authorization expires
and is subject to conditions in the same manner as in section 13734. The board shall issue a certificate
of authorization to a pharmacist who holds a valid unrestricted license in this State and who submits
evidence acceptable to the board that the pharmacist has completed the training described in subsection
3, paragraph A.
[PL 2023, c. 115, §1 (NEW).]
5. Rulemaking. The board shall adopt rules to implement the requirements of this section. Rules
adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375,
subchapter 2‑A.
[PL 2023, c. 115, §1 (NEW).]
SECTION HISTORY
PL 2023, c. 115, §1 (NEW).
SUBCHAPTER 13
ADMINISTRATION OF DRUGS AND VACCINES
§13831. Authority
1. Administration of influenza vaccines. A pharmacist licensed in this State who meets the
qualifications and requirements of section 13832 and rules adopted by the board may administer
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topically or by injection or by inhalation all forms of influenza vaccines, including intranasal influenza
vaccines, to a person 3 years of age or older without a prescription.
[PL 2023, c. 170, §1 (AMD).]
2. Administration of other vaccines. A pharmacist licensed in this State who meets the
qualifications and requirements of section 13832 and rules adopted by the board, in addition to
influenza vaccines under subsection 1, may administer vaccines licensed by the United States Food and
Drug Administration that are recommended by the United States Centers for Disease Control and
Prevention Advisory Committee on Immunization Practices, or successor organization, for
administration to a person 18 years of age or older A pharmacist may administer vaccines licensed by
the United States Food and Drug Administration that are recommended by the United States Centers
for Disease Control and Prevention Advisory Committee on Immunization Practices, or successor
organization, for administration to a person 3 years of age or older and under 18 years of age according
to a valid prescription from a prescriber licensed under chapters 31, 36 or 48. A pharmacist may
administer vaccines licensed by the United States Food and Drug Administration that are outside the
guidelines recommended by the United States Centers for Disease Control and Prevention Advisory
Committee on Immunization Practices, or successor organization, for administration to a person 18
years of age or older according to a valid prescription if the prescription specifically states that the
vaccine is medically necessary.
[PL 2023, c. 170, §2 (AMD).]
2-A. Administration of COVID-19 vaccines. A pharmacist licensed in this State who meets the
qualifications and requirements of section 13832 and rules adopted by the board may administer and
order COVID-19 vaccines licensed or authorized under an emergency use authorization by the United
States Food and Drug Administration that are recommended by the United States Centers for Disease
Control and Prevention Advisory Committee on Immunization Practices, or successor organization, to
a person 3 years of age or older. For the purposes of this subsection, "COVID-19" has the same meaning
as in Title 24‑A, section 4320‑P, subsection 1, paragraph A.
[PL 2021, c. 28, Pt. B, §2 (NEW).]
3. Emergency administration of certain drugs. A pharmacist may administer epinephrine or
diphenhydramine, or both, to a person in an emergency situation resulting from an adverse reaction to
a vaccine administered by the pharmacist.
[PL 2011, c. 577, §3 (AMD).]
4. Vaccine clinics. A pharmacist or pharmacy licensed under this chapter may operate a vaccine
administration clinic inside, outside or off the pharmacy's premises if the pharmacist or pharmacy
obtains approval from the board for the plan of operation of such clinics pursuant to rules adopted under
section 13835, subsection 1.
[PL 2011, c. 577, §4 (NEW).]
5. Administration of injectable drugs. A pharmacist who meets the qualifications and
requirements of section 13832 and rules adopted by the board may administer to adults by intramuscular
and subcutaneous injection drugs approved by the United States Food and Drug Administration under
the following conditions:
A. Upon the order of a practitioner to dispense and administer the drug, as long as the practitioner
is notified after administration is complete in accordance with section 13833, subsection 3; or [PL
2021, c. 271, §3 (NEW).]
B. While engaged in collaborative drug therapy management pursuant to a collaborative practice
agreement in accordance with the requirements of subchapter 14. [PL 2021, c. 271, §3 (NEW).]
[PL 2021, c. 271, §3 (NEW).]
6. Administration of vaccines by pharmacy technician. A pharmacy technician may administer
vaccines in accordance with the requirements of this section if the pharmacy technician:
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A. Holds a valid unrestricted pharmacy technician license in this State; [PL 2023, c. 245, §1
(NEW).]
B. Consistent with rules adopted by the board, works under the direct supervision of a pharmacist
who meets the requirements of section 13832; [PL 2023, c. 245, §1 (NEW).]
C. Possesses a current certificate of administration issued by the board. The pharmacy technician
must submit an application in the form prescribed by the board together with the requirements set
forth under this section and certificate fee as set forth under section 13724. The certificate of
administration expires and is subject to the conditions in the same manner as in section 13734; and
[PL 2023, c. 245, §1 (NEW).]
D. Submits evidence acceptable to the board that the pharmacy technician has completed a
certification program approved by the board consisting of at least 6 hours of vaccine-related
training that includes, at a minimum, training on the safe and effective administration of vaccines,
hands-on injection technique, clinical evaluation of indications and contraindications of vaccines
and the recognition and treatment of emergency reactions to vaccines and cardiovascular life
support training as described in section 13832, subsection 5. [PL 2023, c. 245, §1 (NEW).]
[PL 2023, c. 245, §1 (NEW).]
REVISOR'S NOTE: (Subsection 6 as enacted by PL 2023, c. 170, §3 is REALLOCATED TO TITLE
32, SECTION 13831, SUBSECTION 7)
7. (REALLOCATED FROM T. 32, §13831, sub-§6) Notification of vaccines administration.
A pharmacist licensed in this State who meets the qualifications and requirements of section 13832 and
rules adopted by the board shall provide a written immunization record to the person, or the person's
representative, receiving a vaccine administered under this section. Within 72 hours of administering a
vaccine, a pharmacist shall notify the person's primary care provider, if any, of administration of the
vaccine. Beginning August 1, 2023, a pharmacist shall report the administration of the vaccine to the
appropriate state immunization information reporting system within 72 hours of administering the
vaccine.
[PL 2023, c. 170, §3 (NEW); RR 2023, c. 1, Pt. A, §28 (RAL).]
SECTION HISTORY
PL 2009, c. 308, §3 (NEW). PL 2011, c. 577, §§3, 4 (AMD). PL 2013, c. 6, §1 (AMD). PL 2015,
c. 211, §1 (AMD). PL 2021, c. 28, Pt. B, §2 (AMD). PL 2021, c. 271, §3 (AMD). PL 2023, c.
170, §§1-3 (AMD). PL 2023, c. 245, §1 (AMD). RR 2023, c. 1, Pt. A, §28 (COR).
§13832. Qualifications; requirements
In order to administer a drug or vaccine under this subchapter, a pharmacist must: [PL 2011, c.
577, §5 (AMD).]
1. Certificate; application and fee. Possess a current certificate of administration issued by the
board pursuant to this subchapter. The pharmacist must submit an application in the form prescribed
by the board together with the requirements set forth under this subchapter and certificate fee as set
forth under section 13724. The certificate of administration expires and is subject to the conditions in
the same manner as stated in section 13734;
[PL 2009, c. 308, §3 (NEW).]
2. License. Hold a valid unrestricted pharmacist license in this State;
[PL 2009, c. 308, §3 (NEW).]
3. Training. Submit evidence acceptable to the board that the pharmacist:
A. Has completed a 20-hour course of study in the areas of drug administration authorized under
this subchapter and as described in subsection 4 within the 3 years immediately preceding
application for a certificate of administration; [PL 2023, c. 245, §2 (AMD).]
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B. Has graduated with a Doctor of Pharmacy degree from a college of pharmacy accredited by the
American Council on Pharmaceutical Education or successor organization within the 3 years
immediately preceding application for a certificate of administration that includes completion of
training in the areas of drug administration authorized under this subchapter satisfactory to the
board, including instruction in the areas identified in subsection 4 received as part of the
pharmacist's pharmacy degree program; or [PL 2023, c. 245, §2 (AMD).]
C. Has a valid certificate of administration issued by any jurisdiction of the United States or its
territories within the 3 years immediately preceding application for a certificate of administration
that authorizes the pharmacist to administer drugs comparable to those authorized under this
chapter and that is based on the pharmacist's completion of training or course work as described in
subsection 4, or its equivalent as determined by the board, and has continuous administration
practice since the pharmacist received such training or since completion of a retraining program as
required in this subchapter, as long as such retraining incorporates the areas identified in subsection
4; [PL 2023, c. 245, §2 (AMD).]
[PL 2023, c. 245, §2 (AMD).]
4. Didactic; practical course. Satisfactorily complete a didactic and practical course approved
by the board that includes the current guidelines and recommendations of the federal Department of
Health and Human Services, Centers for Disease Control and Prevention, the American Council on
Pharmaceutical Education or a similar health authority or professional body, and that includes, but is
not limited to, disease epidemiology, indications for use of vaccines, vaccine characteristics, injection
techniques, adverse reactions to vaccines, emergency response to adverse events, immunization
screening, informed consent, record keeping, registries, including the immunization information system
established under Title 22, section 1064, registry training and reporting mechanisms, including
reporting adverse events, life support training, biohazard waste disposal and sterile techniques and
related topics; and
[PL 2009, c. 308, §3 (NEW).]
5. Life support training. Submit evidence of completing cardiovascular life support training
accepted by the American Heart Association, the American Red Cross or other similar training
organization.
[PL 2009, c. 308, §3 (NEW).]
SECTION HISTORY
PL 2009, c. 308, §3 (NEW). PL 2011, c. 577, §5 (AMD). PL 2023, c. 245, §2 (AMD).
§13833. Treatment protocol
A pharmacist shall administer drugs and vaccines in compliance with a treatment protocol
established by a practitioner authorized under the laws of this State to order administration of those
drugs and vaccines approved by the board. A copy of the original treatment protocol and any
subsequent revisions to the treatment protocol must be kept on the premises of the pharmacy and be
available to the board or the board's representative upon request. At a minimum the treatment protocol
must include: [PL 2021, c. 289, §13 (AMD).]
1. Standards. Standards for observation of the person receiving the drug or vaccine to determine
whether the person has an adverse reaction, as adopted in rules by the board;
[PL 2011, c. 577, §6 (AMD).]
2. Procedures. Procedures to be followed by the pharmacist when administering epinephrine or
diphenhydramine, or both, to a person who has an adverse reaction to a vaccine administered by the
pharmacist; and
[PL 2011, c. 577, §6 (AMD).]
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3. Notification. Notification to the authorized practitioner who issued the prescription, standing
order or protocol under section 13831, subsection 2 of the administration by the pharmacist of the drug
or vaccine, or both, within 3 business days.
[PL 2011, c. 577, §6 (AMD).]
SECTION HISTORY
PL 2009, c. 308, §3 (NEW). PL 2011, c. 577, §6 (AMD). PL 2021, c. 289, §13 (AMD).
§13834. Prohibited acts
1. Delegate authority. A pharmacist may not delegate the pharmacist's authority to administer
drugs or vaccines; except that a pharmacist licensed under this chapter who has obtained a certificate
of administration pursuant to section 13832 may delegate the authority to administer vaccines to a
pharmacy technician who is under that pharmacist's direct supervision and has met the requirements of
section 13831, subsection 6 or may delegate the authority to administer drugs and vaccines to a
pharmacy intern who is under that pharmacist's direct supervision and who has obtained drug
administration training pursuant to section 13832, subsection 3. A pharmacy intern may administer
drugs and vaccines only to a person 18 years of age or older.
[PL 2023, c. 245, §3 (AMD).]
2. Administer drugs or vaccines. A pharmacist may not engage in the administration of drugs or
vaccines unless the pharmacist meets the qualifications and requirements of section 13832 and the
pharmacist has obtained a board-issued certificate of administration. A pharmacy technician may not
engage in the administration of vaccines unless the pharmacy technician meets the qualifications and
requirements of section 13831, subsection 6 and the pharmacy technician has obtained a board-issued
certificate of administration.
[PL 2023, c. 245, §3 (AMD).]
SECTION HISTORY
PL 2009, c. 308, §3 (NEW). PL 2011, c. 577, §7 (AMD). PL 2013, c. 98, §1 (AMD). PL 2023,
c. 245, §3 (AMD).
§13835. Rules
The board, after consultation with the Maine Center for Disease Control and Prevention and the
Board of Licensure in Medicine, shall adopt rules to implement this subchapter. The rules must include,
at a minimum: [PL 2009, c. 308, §3 (NEW).]
1. Criteria. Criteria for the operation of a vaccine administration clinic inside, outside or off the
premises of a retail pharmacy, rural health clinic or free clinic licensed under section 13751. The rules
must require the plan of operation for any vaccine administration clinics to be operated by a pharmacist
or pharmacy. Criteria for the administration of drugs by intramuscular or subcutaneous injection inside,
outside or off the premises of a retail pharmacy, rural health clinic or free clinic licensed under section
13751 and must require one-time board approval of the plan for the administration of drugs by
intramuscular or subcutaneous injection by a pharmacist or pharmacy and may not require board
approval for each administration;
[PL 2021, c. 271, §4 (AMD); PL 2021, c. 289, §14 (AMD).]
2. Record keeping. Record keeping and documentation procedures and reporting requirements,
giving preference to electronic means when available; and
[PL 2009, c. 308, §3 (NEW).]
3. Recipient assessment. Recipient assessment, consent and rights.
[PL 2009, c. 308, §3 (NEW).]
Rules adopted pursuant to this section are routine technical rules as defined in Title 5, chapter 375,
subchapter 2‑A. [PL 2009, c. 308, §3 (NEW).]
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SECTION HISTORY
PL 2009, c. 308, §3 (NEW). PL 2011, c. 577, §8 (AMD). PL 2021, c. 271, §4 (AMD). PL 2021,
c. 289, §14 (AMD).
SUBCHAPTER 14
COLLABORATIVE DRUG THERAPY MANAGEMENT
§13841. Authority
1. Engage in collaborative drug therapy management. A pharmacist licensed in this State who
meets the qualifications and requirements of section 13842 and rules adopted by the board may engage
in collaborative drug therapy management pursuant to a collaborative practice agreement with a
practitioner.
[PL 2013, c. 308, §4 (NEW).]
2. Scope of authority. A pharmacist engaging in collaborative drug therapy management pursuant
to subsection 1 is entitled to adequate access to a patient's history, disease status, drug therapy and
laboratory and procedure results and may:
A. Collect and review a patient's history; [PL 2013, c. 308, §4 (NEW).]
B. Obtain and check vital signs; [PL 2013, c. 308, §4 (NEW).]
C. Order and evaluate the results of laboratory tests directly related to drug therapy under the
supervision of, or in direct consultation with, a practitioner and in accordance with approved
protocols applicable to the practice setting and when the evaluation does not include a diagnostic
component; and [PL 2013, c. 308, §4 (NEW).]
D. Initiate, administer, monitor, modify and discontinue drug therapy for a particular patient
pursuant to the collaborative practice agreement with a practitioner who is treating the patient, as
long as the action is reported to the practitioner in a timely manner as determined by rules adopted
pursuant to section 13846. [PL 2021, c. 271, §5 (AMD).]
[PL 2021, c. 271, §5 (AMD).]
SECTION HISTORY
PL 2013, c. 308, §4 (NEW). PL 2021, c. 271, §5 (AMD).
§13842. Qualifications
In order to enter into a collaborative practice agreement with a practitioner under this subchapter,
a pharmacist must: [PL 2013, c. 308, §4 (NEW).]
1. License. Hold a valid unrestricted pharmacist license in this State;
[PL 2013, c. 308, §4 (NEW).]
2. Training. Submit evidence acceptable to the board that the pharmacist:
A. Possesses certification from the Board of Pharmacy Specialties or successor organization or has
completed an accredited residency program. If the residency program is not in the area of practice
covered by the agreement, the pharmacist must complete a continuing education certificate program
of at least 15 hours of continuing education in each clinical area of practice covered by the
agreement; [PL 2013, c. 308, §4 (NEW).]
B. Has graduated with a Doctor of Pharmacy degree from a college of pharmacy accredited by the
American Council on Pharmaceutical Education, has 2 years of professional experience and has
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completed a continuing education certificate program of at least 15 hours of continuing education
in each clinical area of practice covered by the agreement; or [PL 2013, c. 308, §4 (NEW).]
C. Has graduated with a Bachelor of Science in Pharmacy degree from a college of pharmacy
accredited by the American Council on Pharmaceutical Education, has 3 years of professional
experience and has completed a continuing education certificate program of at least 15 hours of
continuing education in each clinical area of practice covered by the agreement. [PL 2013, c. 308,
§4 (NEW).]
[PL 2013, c. 308, §4 (NEW).]
SECTION HISTORY
PL 2013, c. 308, §4 (NEW).
§13843. Collaborative practice agreement
A pharmacist may engage in collaborative drug therapy management pursuant to a collaborative
practice agreement in accordance with this section. [PL 2013, c. 308, §4 (NEW).]
1. Submit to board. The pharmacist shall submit a copy of the collaborative practice agreement
to the board and the licensing board that licenses the practitioner prior to the commencement of the
collaborative practice.
[PL 2013, c. 308, §4 (NEW).]
2. Review and revision. The signatories to a collaborative practice agreement shall establish a
procedure for reviewing and, if necessary, revising the procedures and protocols of the collaborative
practice agreement.
[PL 2013, c. 308, §4 (NEW).]
3. Health information privacy. Services provided pursuant to a collaborative practice agreement
must be performed in compliance with the federal Health Insurance Portability and Accountability Act
of 1996, 42 United States Code, Section 1320d et seq. and its regulations, 45 Code of Federal
Regulations, Parts 160-164.
[PL 2013, c. 308, §4 (NEW).]
4. Amendments to agreement. Amendments to a collaborative practice agreement must be
documented, signed and dated.
[PL 2013, c. 308, §4 (NEW).]
5. Assessment; risk management. A collaborative practice agreement must include a plan for
measuring and assessing patient outcomes and must include proof that liability insurance is maintained
by all parties to the agreement.
[PL 2013, c. 308, §4 (NEW).]
6. Contents of agreement. A practitioner and a pharmacist desiring to engage in collaborative
practice in accordance with this subchapter shall execute a collaborative practice agreement that must
contain, but is not limited to:
A. A provision that states that activity in the initial 3 months of a collaborative practice agreement
is limited to monitoring drug therapy. After the initial 3 months, the practitioner and pharmacist
shall meet to review the collaborative practice agreement and determine the scope of the agreement,
which may after the initial 3 months include a pharmacist's initiating, administering, monitoring,
modifying and discontinuing a patient's drug therapy and reporting these actions to the practitioner
in a timely manner in accordance with rules adopted pursuant to section 13846; [PL 2021, c. 271,
§6 (AMD).]
B. Identification and signatures of the parties to the collaborative practice agreement, the dates the
agreement is signed and the beginning and ending dates of the period of time during which the
agreement is in effect; [PL 2013, c. 308, §4 (NEW).]
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C. A provision that allows either party to cancel the collaborative practice agreement by written
notification; [PL 2013, c. 308, §4 (NEW).]
D. Specification of the site and setting at which the collaborative practice will occur; [PL 2013,
c. 308, §4 (NEW).]
E. Specification of the qualifications of the participants in the collaborative practice agreement;
[PL 2013, c. 308, §4 (NEW).]
F. A detailed description of the types of diseases, drugs or drug categories involved and
collaborative drug therapy management allowed in each patient's case; and [PL 2013, c. 308, §4
(NEW).]
G. A procedure for the referral of each patient to the practitioner. [PL 2013, c. 308, §4 (NEW).]
[PL 2021, c. 271, §6 (AMD).]
SECTION HISTORY
PL 2013, c. 308, §4 (NEW). PL 2021, c. 271, §6 (AMD).
§13844. Conditions or diseases managed; scope of practice
1. Generally accepted standards of care. A pharmacist may engage in collaborative drug therapy
management pursuant to a collaborative practice agreement only for conditions or diseases with
generally accepted standards of care.
[PL 2013, c. 308, §4 (NEW).]
2. Prohibition. A pharmacist who is engaged in collaborative drug therapy management pursuant
to a collaborative practice agreement may not, as part of the collaborative practice, participate in
research or clinical or investigational trials.
[PL 2013, c. 308, §4 (NEW).]
3. Limitation. A collaborative practice agreement may include only the conditions or diseases to
be managed that meet the qualifications and scope of practice for each party to the agreement.
[PL 2013, c. 308, §4 (NEW).]
SECTION HISTORY
PL 2013, c. 308, §4 (NEW).
§13845. Practice protocols
A pharmacist may engage in collaborative drug therapy management in compliance with a
treatment protocol established by the practitioner with whom the pharmacist has a collaborative practice
agreement. A copy of the treatment protocol must be submitted to the board. At a minimum, the
treatment protocol must include a statement by the practitioner that describes the activities in which the
pharmacist is authorized to engage and a provision that allows the practitioner, when appropriate, to
override a collaborative practice decision made by the pharmacist. [PL 2013, c. 308, §4 (NEW).]
SECTION HISTORY
PL 2013, c. 308, §4 (NEW).
§13846. Rules
The board and the Board of Licensure in Medicine, after consultation with the Department of Health
and Human Services, shall adopt rules to implement this subchapter. The rules must include rules
establishing record-keeping and documentation procedures and reporting requirements and must allow
for electronic filing when possible. Rules adopted pursuant to this section are routine technical rules
as defined in Title 5, chapter 375, subchapter 2‑A. [PL 2013, c. 308, §4 (NEW).]
SECTION HISTORY
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PL 2013, c. 308, §4 (NEW).
§13847. Exemptions
Nothing in this subchapter may be construed to limit the scope of practice of a pharmacist pursuant
to this chapter or to apply to collaborative practice agreements entered into between a pharmacist and
a hospital solely for the treatment of inpatients at the hospital. [PL 2013, c. 308, §4 (NEW).]
SECTION HISTORY
PL 2013, c. 308, §4 (NEW).
SUBCHAPTER 15
TELEHEALTH SERVICES
§13848. Definitions
As used in this subchapter, unless the context otherwise indicates, the following terms have the
following meanings. [PL 2021, c. 291, Pt. B, §19 (NEW).]
1. Asynchronous encounter. "Asynchronous encounter" means an interaction between a patient
and a person licensed under this chapter through a system that has the ability to store digital information,
including, but not limited to, still images, video files, audio files, text files and other relevant data, and
to transmit such information without requiring the simultaneous presence of the patient and the person
licensed under this chapter.
[PL 2021, c. 291, Pt. B, §19 (NEW).]
2. Store and forward transfer. "Store and forward transfer" means the transmission of a patient's
records through a secure electronic system to a person licensed under this chapter.
[PL 2021, c. 291, Pt. B, §19 (NEW).]
3. Synchronous encounter. "Synchronous encounter" means a real-time interaction conducted
with an interactive audio or video connection between a patient and a person licensed under this chapter
or between a person licensed under this chapter and another health care provider.
[PL 2021, c. 291, Pt. B, §19 (NEW).]
4. Telehealth services. "Telehealth services" means health care services delivered through the
use of information technology and includes synchronous encounters, asynchronous encounters, store
and forward transfers and telemonitoring.
[PL 2021, c. 291, Pt. B, §19 (NEW).]
5. Telemonitoring. "Telemonitoring" means the use of information technology to remotely
monitor a patient's health status via electronic means, allowing the person licensed under this chapter
to track the patient's health data over time. Telemonitoring may be synchronous or asynchronous.
[PL 2021, c. 291, Pt. B, §19 (NEW).]
SECTION HISTORY
PL 2021, c. 291, Pt. B, §19 (NEW).
§13849. Telehealth services permitted
A person licensed under this chapter may provide telehealth services as long as the licensee acts
within the scope of practice of the licensee's license, in accordance with any requirements and
restrictions imposed by this subchapter and in accordance with standards of practice. [PL 2021, c.
291, Pt. B, §19 (NEW).]
SECTION HISTORY
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PL 2021, c. 291, Pt. B, §19 (NEW).
§13849-A. Confidentiality
When providing telehealth services, a person licensed under this chapter shall comply with all state
and federal confidentiality and privacy laws. [PL 2021, c. 291, Pt. B, §19 (NEW).]
SECTION HISTORY
PL 2021, c. 291, Pt. B, §19 (NEW).
§13849-B. Professional responsibility
All laws and rules governing professional responsibility, unprofessional conduct and generally
accepted standards of practice that apply to a person licensed under this chapter also apply to that
licensee while providing telehealth services. [PL 2021, c. 291, Pt. B, §19 (NEW).]
SECTION HISTORY
PL 2021, c. 291, Pt. B, §19 (NEW).
§13849-C. Rulemaking
The board shall adopt rules governing telehealth services by persons licensed under this chapter.
These rules must establish standards of practice and appropriate restrictions for the various types and
forms of telehealth services. Rules adopted pursuant to this section are routine technical rules as defined
by Title 5, chapter 375, subchapter 2‑A. [PL 2021, c. 291, Pt. B, §19 (NEW).]
SECTION HISTORY
PL 2021, c. 291, Pt. B, §19 (NEW).
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Refer to the Maine Revised Statutes Annotated and supplements for certified text.
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