APPROVED CHAPTER
JUNE 8, 2021 94
BY GOVERNOR PUBLIC LAW
STATE OF MAINE
_____
IN THE YEAR OF OUR LORD
TWO THOUSAND TWENTY-ONE
_____
S.P. 15 - L.D. 8
An Act To Support Collection and Proper Disposal of Unwanted Drugs
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 22 MRSA §2700, sub-§8 is enacted to read:
8. Drug take-back stewardship program participation. Nothing in this section
prohibits a law enforcement agency from participating as an authorized collector in a drug
take-back stewardship program implemented under Title 38, section 1612.
Sec. 2. 38 MRSA §1612 is enacted to read:
§1612. Drug take-back stewardship program
1. Definitions. As used in this section, unless the context otherwise indicates, the
following terms have the following meanings.
A. "Authorized collector" means:
(1) A person, company, corporation or other entity registered with the United
States Department of Justice, Drug Enforcement Administration to collect
controlled substances and noncontrolled substances for the purposes of safe
disposal and destruction;
(2) A law enforcement agency; or
(3) A person, company, corporation or other entity authorized by the department
to provide alternative collection methods for covered drugs that are household
pharmaceutical waste and that are noncontrolled substances.
"Authorized collector" includes a mandatory pharmacy collector.
B. "Brand" means a name, symbol, word or mark that identifies a covered drug, rather
than its components, and attributes a covered drug to the owner of the brand.
C. "Collection receptacle" means a secure box, kiosk or other container:
(1) Into which a person may deposit for disposal covered drugs that are household
pharmaceutical waste and that is prominently labeled in a manner indicating that
only such types of covered drugs may be deposited for disposal;
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 (2) That meets applicable federal standards for the use described in subparagraph
(1); and
(3) That is located on the premises of an authorized collector participating in a
stewardship program under this section.
D. "Covered drug" means any substance recognized as a drug under 21 United States
Code, Section 321(g)(1), as amended, and any regulations adopted pursuant to that
provision, that is sold, offered for sale or dispensed in the State, whether directly or
through a wholesaler, in any form, including, but not limited to, prescription and
nonprescription drugs, drugs in medical devices and combination products, brand and
generic drugs and drugs for veterinary use.
"Covered drug" does not include:
(1) Vitamins or supplements;
(2) Herbal-based remedies and homeopathic drugs, products or remedies;
(3) Cosmetics, soap with or without germicidal agents, laundry detergent, bleach,
household cleaning products, shampoo, sunscreen, toothpaste, lip balm,
antiperspirant or other personal care products that are regulated as both cosmetics
and nonprescription drugs under the Federal Food, Drug, and Cosmetic Act;
(4) Pet pesticide products contained in pet collars, powders, shampoos, topical
applications or other forms and prescription pet food;
(5) Drugs that are biological products, as defined in 21 Code of Federal
Regulations, Section 600.3(h), if the manufacturer provides a program to take back
that drug;
(6) Drugs for which a manufacturer provides a program to take back those drugs
as part of a United States Department of Health and Human Services, Food and
Drug Administration managed risk evaluation and mitigation strategy;
(7) Emptied syringes or emptied medical devices or the component parts or
accessories of those products or devices;
(8) Drugs that are used solely in a clinical setting; and
(9) Dialysate drugs required to perform home kidney dialysis.
E. "Drug take-back stewardship organization" or "stewardship organization" means a
corporation, nonprofit organization or other legal entity created by one or more
manufacturers to implement a stewardship program under this section.
F. "Drug take-back stewardship plan" or "plan" means a plan designed by a
manufacturer or stewardship organization for the establishment of a stewardship
program.
G. "Drug take-back stewardship program" or "stewardship program" means a system
implemented under this section for the collection, transportation and disposal of
covered drugs that are household pharmaceutical waste.
H. "Household pharmaceutical waste" means useless, unwanted, expired or discarded
drugs generated by a household.
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 For the purposes of this paragraph, "household" includes, but is not limited to, a single
residential unit, a multifamily residential unit, an apartment and an independent living
community. "Household" does not include a hospital, health clinic, hospice facility,
skilled nursing facility or other long-term care facility, physician's office, pharmacy or
veterinary office or clinic.
I. "Mail-back envelope" means a prepaid, preaddressed mailing envelope, as
authorized by federal law and regulation, that is provided by or through a company or
organization licensed or otherwise authorized to dispose of covered drugs that are
household pharmaceutical waste received in such mailing envelopes and that is made
available through a stewardship program to persons seeking to dispose of covered
drugs that are household pharmaceutical waste.
J. "Mandatory pharmacy collector" means a pharmacy licensed by the Maine Board of
Pharmacy pursuant to Title 32, section 13751.
For the purposes of this paragraph, "pharmacy" has the same meaning as in Title 32,
section 13702-A, subsection 24, except that "pharmacy" does not include a pharmacy
that purchases drugs for and dispenses drugs to a limited, institutional patient
population.
K. "Manufacturer" means:
(1) A person that has legal ownership of the brand of a covered drug sold in or
into the State; or
(2) If the person to which subparagraph (1) applies has no physical presence in the
United States, a person that imports a covered drug that is branded by the person
to which subparagraph (1) applies.
"Manufacturer" does not include a wholesaler that sells or offers for sale in the State at
wholesale a covered drug if the covered drug is manufactured by a manufacturer that
is a participant in a stewardship program.
"Manufacturer" does not include a retailer that sells or offers for sale in the State at
retail a covered drug under the retailer's brand or store label if the covered drug is
manufactured by a manufacturer that is a participant in a stewardship program.
L. "Operator" means a manufacturer or a stewardship organization that implements
and operates a stewardship program.
M. "Proprietary information" means information that is a trade secret or production,
commercial or financial information the disclosure of which would impair the
competitive position of the submitter and would make available information not
otherwise publicly available.
2. Manufacturer responsibility. A manufacturer shall:
A. Individually or jointly with one or more manufacturers, implement, administer and
operate a stewardship program pursuant to a plan that has been approved by the
department; or
B. Enter into an agreement with a stewardship organization to implement, administer
and operate a stewardship program pursuant to a plan that has been approved by the
department.
3. Submittal of plan. A manufacturer, individually or jointly with one or more
manufacturers, or a stewardship organization contracted by one or more manufacturers,
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shall submit to the department for approval a proposed plan. The plan must include, at a
minimum:
A. A certification that the stewardship program will accept all covered drugs that are
household pharmaceutical waste regardless of who manufactured the covered drugs;
B. Contact information for the person submitting the plan to whom the department
shall direct all related inquiries, a list of participating manufacturers and their brands,
contact information for each participating manufacturer and a list of the covered drugs
manufactured by any participating manufacturer that are branded or labeled for sale in
the State by a retailer under the retailer's own brand or store label;
C. A description of how the stewardship program will make available free, convenient
and ongoing collection opportunities for covered drugs that are household
pharmaceutical waste to all persons seeking to dispose of such covered drugs and how
the collection opportunities will be geographically distributed in a way to ensure access
in rural and underserved areas, as determined based on geographic information systems
modeling. The plan must include a list of authorized collectors and collection
locations;
D. A description of the collection methods to be used to ensure that only covered drugs
that are household pharmaceutical waste will be collected by authorized collectors
under the stewardship program and a description of how separation of those covered
drugs from packaging by consumers will be encouraged to reduce transportation and
disposal costs. The plan must ensure that collection methods used under the program
include mail-back envelopes and collection receptacles and do not include home
disposal methods involving packets, bottles or other containers that a person may use
to render nonretrievable or destroy a covered drug that is household pharmaceutical
waste by means of a chemical process;
E. A certification that, upon implementation of the plan, the operator, jointly with the
operators of other approved plans if any, will develop and administer a publicly
accessible website that includes:
(1) A list of authorized collectors, collection locations and the collection methods
available at each collection location available under each stewardship program,
updated as necessary;
(2) General information regarding the purpose and scope of the stewardship
program or programs and the opportunities available to consumers under the
program or programs for the safe disposal of covered drugs that are household
pharmaceutical waste; and
(3) A statement that the stewardship program or programs are designed for the
collection of covered drugs that are household pharmaceutical waste only;
F. Information on how covered drugs that are household pharmaceutical waste will be
safely and securely tracked, handled and transported from collection through final
disposition and policies to ensure security and compliance with all applicable federal
and state laws, rules and regulations including, but not limited to, 21 Code of Federal
Regulations, Section 1317.90 and 40 Code of Federal Regulations, Sections 239 to 282;
G. A description of how the collection system will be designed and monitored to
prevent tampering;
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 H. A description of how the stewardship program will measure the amount of collected
and disposed of covered drugs that are household pharmaceutical waste;
I. A description of the education and outreach materials that will be used by the
stewardship program to encourage consumer awareness and participation and to meet
the performance goals established pursuant to paragraph J, including, but not limited
to, a publicly accessible website with the information described in paragraph E and
printed materials, including brochures and signage, containing similar information for
use by authorized collectors and at collection locations. The plan must ensure that the
program provides education and outreach materials to authorized collectors for
distribution to consumers in accordance with subsection 8, paragraph E;
J. A description of the performance goals to be established under the stewardship
program to measure the success of the program and a description of how the program
will be designed to achieve or exceed those goals. Performance goals must include,
but are not limited to, the implementation of education and outreach efforts designed
to:
(1) Ensure awareness of the program by 60% of residents of the State after one
year of stewardship program implementation, by 70% of residents of the State after
2 years of implementation and by 75% of residents of the State after 4 years of
implementation; and
(2) Discourage the use of improper disposal methods for covered drugs that are
household pharmaceutical waste, such as flushing the drugs or placing them in the
garbage;
K. A description of how the manufacturer or stewardship organization will fund a
representative survey of residents of the State by an independent 3rd party prior to
implementation of the stewardship program to assess baseline public awareness
regarding proper disposal methods for unwanted drugs; and
L. Information on how the stewardship program will be financed in accordance with
subsection 5.
4. Approval of plan; amendments to plan; program audits. Within 120 business
days of receipt of a plan submitted under subsection 3, the department shall review the plan
and approve, approve with conditions or reject the plan. The department may hold a public
hearing prior to deciding whether to approve, approve with conditions or reject a submitted
plan. The department shall notify the person or persons that submitted the plan in writing
of the department's determination and, if the plan is approved with conditions or rejected,
include in the notification the basis for the department's determination.
A. A manufacturer or stewardship organization whose plan is rejected shall submit a
revised plan to the department within 60 days after receiving a notice of rejection. If
the department rejects the revised plan, the manufacturer or manufacturers that
submitted the plan or that would have been participating under the plan are considered
noncompliant with the requirements of this section.
B. A manufacturer that begins to sell or offer for sale in the State a covered drug after
the date that an approved plan is first implemented under subsection 6 shall, within 30
days after the manufacturer's initial sale or offer for sale in the State of that covered
drug, demonstrate to the department that it is participating in an existing stewardship
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 program under this section or submit a proposed plan consistent with subsection 3 for
a new stewardship program to the department for approval.
C. Prior to implementing an amendment to an approved plan, an operator shall submit
the proposed amendment to the department for review. If the amendment is not
substantive, such as the addition of or a change to a collection location or the addition
of a manufacturer to the stewardship program, approval by the department is not
needed, but the operator shall inform the department of the amendment within 14 days
of implementing the amendment. The department shall review plan amendments in
accordance with paragraphs A and B.
D. At any time, the department may require an operator to implement amendments to
its approved plan or to submit to an independent financial audit of its stewardship
program.
5. Costs. A manufacturer, individually or jointly with one or more manufacturers,
shall pay all costs associated with the implementation, administration and operation of the
manufacturer's stewardship program, including, but not limited to:
A. Costs of installing, managing and servicing collection receptacles at and collecting
covered drugs that are household pharmaceutical waste from participating authorized
collectors, transporting such covered drugs for disposal, disposing of such covered
drugs and providing mail-back envelopes;
B. Costs related to the development of, with input from authorized collectors and the
department, a readily recognizable, consistent design for collection receptacles, as well
as clear, standardized instructions for consumers regarding the use of collection
receptacles;
C. Costs incurred by the department in accordance with subsection 11 in the review of
submitted plans and plan amendments, the review of annual reports and the
administration and enforcement of this section; and
D. Costs associated with the stewardship program assessments required under this
section.
When 2 or more manufacturers participate in a stewardship program, or if multiple
stewardship programs exist, the costs of implementing, administering and operating the
program or programs must be fairly and reasonably allocated between each participating
manufacturer so that the share of the costs that is allocated to each manufacturer is
reasonably related to the revenue-based market share of covered drugs that the
manufacturer sells in the State.
6. Implementation of plan. A manufacturer or stewardship organization that
submitted a plan under subsection 3 that was approved by the department under subsection
4 shall implement that plan no later than 180 days after the date the plan was approved.
7. Confidential information. Proprietary information submitted to the department in
a drug take-back stewardship plan under this section, in an amendment to a p