An Act To Make Donated Medicines Available to Maine Patients at an Affordable Cost
Maine Legislature, Session 130, LD 1584
Committee: Health and Human Services
Sponsors: CLAXTON
Amends: 22 MRSA §2700, 36 MRSA §5218-B

Legislative Document
No. 1584
S.P. 508
In Senate, April 27, 2021
An Act To Make Donated Medicines Available to Maine Patients at 
an Affordable Cost
Reference to the Committee on Health and Human Services suggested and ordered printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator CLAXTON of Androscoggin.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  22 MRSA §2700, sub-§3, as amended by PL 2013, c. 121, §1, is further 
amended to read:
3.  Return of pharmaceuticals.  The agency may create systems for the safe, effective 
and proper disposal of unused pharmaceuticals.  The systems may include the use of 
prepaid mailing envelopes into which the unused pharmaceuticals are placed and returned 
to a single collection location.  The prepaid mailing envelopes must be made available to 
the public at various locations, including, but not limited to, pharmacies, physicians' offices 
and post offices.  The agency may randomly assess the toxicity of materials received under 
the program as long as the assessment results do not identify the patient, person who mailed 
the material, prescriber or pharmacy.  The agency shall consult with the department to 
determine the suitability of unused pharmaceuticals for donation to the medicine donation 
and redispensing program under section 2700-B and transfer suitable pharmaceuticals to 
the medicine donation and redispensing program.
Sec. 2.  22 MRSA §2700, sub-§4, as amended by PL 2013, c. 121, §1, is further 
amended to read:
4.  Disposal of pharmaceuticals.  All Except for pharmaceuticals donated to the 
medicine donation and redispensing program under subsection 3, all unused 
pharmaceuticals received under the program must be disposed of in a manner that is 
designed to be effective, secure and in compliance with local, state and federal 
environmental requirements, including the federal Resource Conservation and Recovery 
Act of 1976, as amended.
Sec. 3.  22 MRSA c. 606 is enacted to read:
CHAPTER 606
MEDICINE DONATION AND REDISPENSING PROGRAM
§2700-B.  Medicine Donation and Redispensing Program
1.  Definitions.  As used in this chapter, unless the context otherwise indicates, the 
following terms have the following meanings.
A.  "Deliver" or "delivery" has the same meaning as in Title 32, section 13702-A, 
subsection 6.
B.  "Dispense" or "dispensing" has the same meaning as in Title 32, section 13702-A, 
subsection 9.
C.  "Donor" means a person who meets the requirements of subsection 5 to donate 
medicines to a recipient.
D.  "Eligible patient" means an individual who may receive redispensed medicines 
from a recipient and meets the requirements of subsection 4.
E.  "Interchangeable biological product" has the same meaning as in Title 32, section 
13702-A, subsection 14.
F.  "Licensed health care professional" means any individual licensed to authorize, 
prescribe, dispense or administer medicines under Title 32, chapter 31, 34-A, 36, 48, 
51, 117 or 143.
G.  "Manufacturer" has the same meaning as in Title 32, section 13702-A, subsection 
19.
H.  "Medicine" means a nonprescription drug as defined in Title 32, section 13702-A, 
subsection 20, a prescription drug or legend drug as defined in Title 32, section 
13702-A, subsection 30, a device as defined in Title 32, section 13702-A, subsection 8 
or a drug approved by the United States Food and Drug Administration in accordance 
with 21 Code of Federal Regulations, Part 312.
I.  "Orally administered cancer medicine" means an orally administered medicine that 
is used to treat cancer or its side effects or the side effects of a medicine used to treat 
cancer.
J.  "Pharmacy" has the same meaning as in Title 32, section 13702-A, subsection 24.
K.  "Prescription drug order" has the same meaning as in Title 32, section 13702-A, 
subsection 31.
L.  "Program" means the Medicine Donation and Redispensing Program established in 
subsection 2.
M.  "Public assistance program" means aid, assistance or benefits available through:
(1)  A program of temporary assistance for needy families administered in this 
State pursuant to chapter 1053-B or the Parents as Scholars program pursuant to 
chapter 1054-B;
(2)  A program of medical assistance administered in this State pursuant to chapter 
855; or 
(3)  Any other program that is based on need and is conducted or administered by 
this State.
N.  "Recipient" means a nonprofit entity that has contracted with the department to 
operate the program in accordance with subsection 3.
O.  "Returns processor" has the same meaning as in 21 United States Code, Section 
360eee(18).
P.  "Wholesaler" has the same meaning as in Title 32, section 13702-A, subsection 34.
2.  Establishment.  The Medicine Donation and Redispensing Program is established 
to accept donated, unused medicines and redispense those medicines to eligible patients 
who cannot afford to purchase them.
3.  Contract for operation.  The department shall contract with nonprofit entities that 
are in good standing and legally authorized to possess medicine in the State to operate the 
program.  The entities may accept and redispense medicine in accordance with this chapter 
to the extent authorized by federal law.
4.  Eligible patients.  A patient is eligible to receive medicine donated and redispensed 
in accordance with this chapter as long as the patient does not have health insurance, is 
enrolled in a public assistance program or otherwise meets the criteria established by the 
department in accordance with subsection 15.
5.  Donors.  Any person, including, but not limited to, any individual, manufacturer, 
licensed health care professional, pharmacy, health care facility licensed under this Title or 
the Unused Pharmaceutical Disposal Program under section 2700, may donate a medicine 
to a recipient.  A donor must remove or redact any patient names and prescription numbers 
on donated medicines or otherwise maintain patient confidentiality by executing a 
confidentiality agreement with the recipient.
6. Medicines and disposal.  Medicine donated to a recipient and redispensed by the 
recipient must meet the following requirements.  The medicine:
A.  Must be in the medicine's original, unopened, sealed packaging or, if the outside 
packaging is opened or disturbed, the contents are one or more single-unit doses that 
are individually contained in unopened, tamper-evident packaging, except that orally 
administered cancer medicine may be in opened packaging;
B.  May not be adulterated or misbranded;
C.  May not be a controlled substance as defined in 21 Code of Federal Regulations, 
Sections 1308.11 to 1308.15 (2020);
D.  Must be maintained in accordance with 21 United States Code, Section 355-1 
(2020) relating to risk and evaluation strategies, if applicable;
E.  Must have a method to detect improper temperature variations of the medicine, if 
applicable; and
F.  Must be maintained in accordance with 21 United States Code, Sections 360eee-1 
to 360eee-4 (2020) relating to supply chain security, if applicable.
A recipient shall ensure that a licensed health care professional verifies that the donated 
medicine meets the requirements of this subsection before it is redispensed to an eligible 
patient.  Medicine that does not meet the requirements of this subsection must be disposed 
of by returning it to the donor, destroying it by an incinerator, medical waste hauler or other 
lawful method or transferring it to a returns processor.  The recipient shall maintain a record 
of any medicine that is disposed of that includes the disposal method, the date of disposal 
and the name, strength and quantity of each medicine disposed of.
7. Record-keeping requirements.  A recipient shall maintain records in accordance 
with this subsection.  A recipient:
A.  Shall verify and record donor information, including the following:
(1)  That the donor is qualified in accordance with subsection 5; and
(2)  The donor's name, address, phone number and license number, if applicable;
B.  Shall maintain a written or electronic record of the donated medicine, including the 
name, strength and quantity of each accepted medicine and the name, address and 
phone number of the donor of that medicine, except that this requirement does not 
apply if the donor and recipient are under common ownership or common control;
C.  Shall maintain separate written or electronic records of the donated medicines from 
the recipient's other inventory;
D.  Shall maintain records consistent with requirements for returns of an unsalable 
product by a returns processor in accordance with federal law;
E.  Shall retain all records in a physical or electronic format, on or off the recipient's 
premises for 6 years;
F.  May contract with a 3rd party to create or maintain records on the recipient's behalf;
G.  Shall maintain records showing the history of the medicine, beginning with the 
donor of the medicine, prior donations by the donor, whether the medicine was 
previously dispensed and the information required to be on the patient label in 
accordance with applicable rules adopted by the Maine Board of Pharmacy pursuant to 
Title 32, section 13720;
H.  Shall use an identifier, such as a serial number or barcode, in place of information 
in a record or on a label as long as the information is readily retrievable and as long as, 
upon request of the department in accordance with paragraph I, the identifier used for 
the requested records is replaced with the original information, except that an identifier 
may not be used on eligible patient labels when dispensing or administering a medicine; 
and
I. Shall make all records available for audit by the department within 5 business days 
of the department's request.
8.  Medicine storage requirements.  A recipient shall maintain donated medicine in 
accordance with this subsection.  A recipient shall:
A.  Store and maintain donated medicine separate from the recipient's other inventory; 
and
B.  Store and maintain donated medicine in a temperature-controlled environment 
appropriate for the medicine, as applicable.
9.  Delivery of donated medicine.  A recipient may deliver donated medicine to 
another recipient or to an entity participating in a medicine donation program operated by 
another state.
10.  Repackaging of donated medicine.  A recipient may repackage donated medicine 
in accordance with this subsection as necessary for storing, dispensing, administering or 
delivering the medicine.  Repackaged medicine must be:
A.  Labeled with the medicine name, strength and expiration date;
B.  Kept in a separate, designated area until it is inspected and verified by a licensed 
health care professional; and
C.  Labeled with the nearest expiration date, if donated medicines with different 
expiration dates are repackaged together.
11.  Redispensing of donated medicines to eligible patients.  A medicine may only 
be redispensed to an eligible patient by a recipient if, in addition to all other requirements 
of this chapter, the provisions of this subsection are met.
A.  A recipient may dispense or administer a medicine to an eligible patient only if 
otherwise permitted by law.
B.  A medicine that is a prescription drug, as defined in Title 32, section 13702-A, 
subsection 30, may be dispensed or administered only to an eligible patient pursuant to 
a valid prescription drug order.
C.  A recipient must maintain eligible patient-specific written or electronic records 
maintained in accordance with rules adopted by the Maine Board of Pharmacy pursuant 
to Title 32, section 13720.
D.  A medicine must be repackaged into a new container or have all previous patient 
information on the donated container redacted or removed.
E.  A medicine must be properly labeled in accordance with applicable rules adopted 
by the Maine Board of Pharmacy pursuant to Title 32, section 13720.
F.  The expiration date of a medicine may not occur before the eligible patient will use 
the medicine based on the directions for use of the licensed health care professional 
who prescribed the prescription for the eligible patient or on the package's label.
G.  A recipient may substitute an oral tablet, capsule or liquid form of the medicine as 
long as that form has the same dose schedule and is an interchangeable biological 
product.
H.  A recipient may replenish medicine of the same medicine name and strength 
previously dispensed or administered to an eligible patient in accordance with federal 
law.
I.  A recipient may charge a person, including but not limited to an eligible patient, 
health plan, pharmacy benefits manager or government agency, its usual and customary 
charges for handling or dispensing the medicine as long as those charges do not exceed 
the authorized recipient's actual costs of providing the medicine, including, but not 
limited to, the current and anticipated costs of educating donors, providing technical 
support to donors, shipping and handling, labor, storage, licensing, utilities, 
advertising, technology, supplies or equipment.
12.  Medicine donation programs in other states.  A recipient may deliver donated 
medicine to an entity participating in a medicine donation program operated by another 
state.  An entity participating in a medicine donation program operated by another state 
may dispense donated medicine to residents of this State.  An entity participating in a 
medicine donation program operated by another state must comply with all laws and rules 
in this State unless the laws and rules conflict with the laws or rules of the state in which 
the entity is located.
13.  Construction.  This chapter may not be construed to:
A.  Require a donor or recipient to be licensed as a wholesaler solely on the basis of 
the donor's or recipient's participation in the program;
B.  Permit the resale of medicine donated as part of the program; or
C.  Change ownership of the donated medicine from the donor to the recipient, unless 
the ownership change is specified by the recipient.
14. Immunity from liability.  A person may not be subject to any civil or criminal 
liability, or to any discipline by a professional licensing board, for any action taken in good 
faith in accordance with this chapter.
15.  Department duties.  The department shall:
A.  Establish by rule eligibility criteria for eligible patients, including, but not limited 
to, eligibility for indigent or underinsured patients or patients who do not meet the 
criteria established in subsection 4, but may be eligible for the program if there is an 
excess of donated medicines in a recipient's inventory;
B.  Establish by rule a process by which a donor, recipient or patient in the program 
may request a waiver from the department from the requirements of this chapter or any 
rules adopted in accordance with this chapter, except that the department may not adopt 
a rule that establishes a waiver from the immunity from liability under subsection 14.  
The department shall grant or deny a waiver submitted in accordance with this 
paragraph and rules adopted in accordance with this paragraph within 30 days of its 
submission to the department based on its potential effects on medicine access and 
safety of eligible patients; and
C.  Establish by rule a method by which the department may revoke the authority of a 
recipient to participate in the program by issuing a written notice to the recipient.  The 
rule must require the department to identify the specific requirements the recipient 
violated and the required corrective actions for the recipient to resume its participation 
in the program.
16.  Rules.  The department may adopt rules to carry out the purposes of the program. 
Rules adopted pursuant to this subsection are routine technical rules as defined by Title 5, 
chapter 375, subchapter 2-A.
Sec. 4.  36 MRSA §5218-B is enacted to read:
§5218-B.  Credit for donated medicine
1.  Definitions.  As used in this section, unless the context otherwise indicates, the 
following terms have the following meanings.
A.  "Donor" has the same meaning as in Title 22, section 2700-B, subsection 1, 
paragraph C.
B.  "Medicine" has the same meaning as in Title 22, section 2700-B, subsection 1, 
paragraph H.
C.  "Program" means the Medicine Donation and Redispensing Program established 
under Title 22, section 2700-B, subsection 2.
D.  "Recipient" has the same meaning as in Title 22, section 2700-B, subsection 1, 
paragraph N.
2.  Credit allowed.  For tax years beginning January 1, 2022, a donor participating in 
the program is allowed a credit against the tax imposed by this Part in an amount equal to 
the sum of:
A.  The cost to the donor of the medicine donated pursuant to the program during the 
taxable year as determined pursuant to the Code, Section 170(e)(3)(A); and
B.  The verifiable cost to the donor to make the donation of the medicine to a recipient 
during the taxable year.
3.  Limitation.  The amount of the credit that may be used by a donor under this section 
for a taxable year may not exceed the amount of tax otherwise due under this Part.  Any 
unused credit may be carried over to the following year or years for a period not to exceed 
years.
Sec. 5.  Department of Health and Human Services to adopt rules regarding 
medicine donation program.  The Department of Health and Human Services shall, 
within 6 months of the effective date of this Act, adopt rules to create a waiver process and 
a revocation process in accordance with the Maine Revised Statutes, Title 22, section 
2700-B, subsection 15, paragraphs B and C.
SUMMARY
This bill establishes the Medicine Donation and Redispensing Program operated by 
nonprofit entities contracted by the Department of Health and Human Services. The 
program collects donations of unused medicines from health care providers, health care 
facilities and other sources and redispenses the medicines to qualified low-income persons.