An Act To Support Collection and Proper Disposal of Unwanted Drugs
Maine Legislature, Session 130, LD 0008
Committee: Environment and Natural Resources
Sponsors: CARNEY, HYMANSON
Amends: 22 MRSA §2700, 38 MRSA §1612, 38 MRSA §1776

Legislative Document
No. 8
S.P. 15
In Senate, January 13, 2021
An Act To Support Collection and Proper Disposal of Unwanted 
Drugs
Received by the Secretary of the Senate on January 11, 2021.  Referred to the Committee 
on Environment and Natural Resources pursuant to Joint Rule 308.2 and ordered printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator CARNEY of Cumberland.
Cosponsored by Representative HYMANSON of York.
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;
(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;
(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 or discarded drugs 
generated by a household.
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, 
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 will post on a 
publicly accessible website:
(1)  A list of authorized collectors, collection locations and the collection methods 
available at each collection location, updated as necessary;
(2)  General information regarding the purpose and scope of the stewardship 
program and the opportunities available to consumers under the program for the 
safe disposal of covered drugs that are household pharmaceutical waste; and
(3)  A statement that the stewardship program is 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;
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 
years of implementation and by 90% 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 
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, the costs of 
implementing, administering and operating the program 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 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 
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 plan or pursuant 
to the reporting requirements of this section that is identified by the submitter as proprietary 
information is confidential and must be handled by the department in the same manner as 
confidential information is handled under section 1310-B.
8.  Authorized collectors; collection locations.  This subsection governs the activities 
of authorized collectors and the operation of collection locations.
A.  A mandatory pharmacy collector shall participate in a stewardship program and 
shall provide for the safe collection of covered drugs that are household pharmaceutical 
waste under that program through the use of:
(1)  Mail-back envelopes made available to consumers of covered drugs upon 
request;
(2)  Collection receptacles; or
(3)  Any other method of collection that complies with applicable United States 
Department of Justice, Drug Enforcement Administration regulations under 21 
Code of Federal Regulations, Part 1300, 1301, 1304, 1305, 1307 or 1317 and that 
has been approved by the department as a method of collection for use in the 
stewardship program, except that the department may not approve for use in any 
stewardship program under this section a method of home disposal 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.
A mandatory pharmacy collector that is a pharmacy not located in the State that 
provides covered drugs to residents in the State by mail shall provide for the safe 
collection of covered drugs that are household pharmaceutical waste through the use 
of mail-back envelopes and shall ensure that consumers in the State purchasing covered 
drugs from the pharmacy are provided with information regarding the availability of 
such envelopes upon request and instructions regarding how the customer can request 
an envelope.
B.  An operator shall notify all authorized collectors that are not mandatory pharmacy 
collectors of the opportunity to serve on a voluntary basis as a collection location under 
the stewardship program and shall ensure that any such authorized collector that 
requests to participate in the program is added to the program within 90 days of the 
operator's receipt of the request.  A participating authorized collector that is not a 
mandatory pharmacy collector may use any of the collection methods described under 
paragraph A.
C.  The operator shall ensure that all collection receptacles located at a collection 
location under the stewardship program are emptied and serviced as often as necessary 
to avoid the receptacles reaching storage capacity and to ensure proper operation.
D.  A mandatory pharmacy collector participating in a stewardship program shall 
provide information on covered drug collection and safe drug disposal options to a 
consumer upon dispensing a covered drug, including the availability of mail-back 
envelopes upon request.  An authorized collector that is located in the State that is 
providing for the collection of covered drugs that are household pharmaceutical waste 
through the use of mail-back envelopes shall ensure that information regarding the 
availability of such envelopes upon request is prominently posted, displayed or 
otherwise provided to consumers purchasing covered drugs.
E.  As part of a stewardship program, all collection mechanisms, program information 
and other program services must be provided by the operator free of charge to 
authorized collectors, including, but not limited to, the installation, maintenance and 
emptying of collection receptacles; the provision of mail-back envelopes, educational 
materials, brochures and signage; and drug-disposal-specific surveillance.
F.  Collection of covered drugs that are household pharmaceutical waste at collection 
locations under a stewardship program must be made available to consumers free of 
charge.  An operator and an authorized collector may not charge a point-of-sale fee to 
consumers, a fee that could be passed on to consumers or any other fee relating to the 
collection and disposal of covered drugs that are household pharmaceutical waste.
9.  Education and outreach assessment.  During the 2nd and 3rd years of 
implementation of a stewardship program, and every 2 years after that 3rd year, the operator 
of the program shall fund an independent 3rd-party assessment of the effectiveness of the 
program's education and outreach efforts, including, but not limited to, progress achieving 
the consumer awareness goal described in subsection 3, paragraph J, subparagraph (1) and 
efforts under the program to discourage the use of improper disposal methods for covered 
drugs that are household pharmaceutical waste, as described in subsection 3, paragraph J, 
subparagraph (2).  The methods and scope of the assessment under this subsection must be 
developed with input from the department.  The operator shall implement changes as 
necessary to the stewardship program's education and outreach efforts if demonstrated by 
the results of the assessment.
10.  Annual stewardship program reporting.  Within 90 days after the first full year 
of implementation of a stewardship program, and annually thereafter, the operator of the 
program shall submit to the department a report describing the activities of the program 
during the prior calendar year, which must include, at a minimum:
A.  A list of manufacturers participating in the stewardship program, including contact 
information;
B.  The amount by weight of material collected under the stewardship program in the 
prior calendar year, including the amount by weight from each collection method used, 
both in total and by county;
C.  Details regarding the stewardship program's collection system, including a list of 
authorized collectors and associated collection locations with addresses; a list of 
locations where mail-back envelopes were provided under the program; a list of 
collection locations where collection receptacles were made available under the 
program; dates and locations of collection events held under the program; and a list of 
the transporters and disposal facilities used under the program for the transportation 
and disposal of collected covered drugs that are household pharmaceutical waste;
D.  Information regarding any safety or security issues encountered in the collection, 
transportation or disposal of covered drugs that are household pharmaceutical waste 
under the program during the prior calendar year and, if such issues occurred, a 
description of completed or anticipated changes to program policies, procedures or 
tracking mechanisms to address those issues;
E.  A description of the public education, outreach and evaluation activities 
implemented in accordance with the approved plan pursuant to subsection 3, paragraph 
I.  For the 2nd year and 3rd year of stewardship program implementation, and every 2 
years after that 3rd year, the report must include the results of the 3rd-party assessment 
required under subsection 9;
F.  A description of how packaging collected under the program was recycled, to the 
extent feasible;
G.  A description of the methods used under the stewardship program to collect, 
transport and dispose of covered drugs that are household pharmaceutical waste, 
including information regarding efforts by the operator to ensure that only covered 
drugs that are household pharmaceutical waste were collected, and how the methods 
are consistent with the federal hazardous waste regulations identified in subsection 3, 
paragraph F;
H.  A summary of the stewardship program's achievement of its performance goals as 
set forth in the approved plan pursuant to subsection 3, paragraph J.  If any performance 
goals were not achieved, the report must include a description of the efforts that will 
be made to achieve those goals the following year;
I.  An analysis of the convenience of the collection system under the stewardship 
program for people living in various regions of the State, as determined based on 
geographic information systems modeling;
J.  The total cost of implementing, administering and operating the stewardship 
program in the prior calendar year, which must include an accounting of the program's 
expenditures in the prior calendar year, as verified through an independent 3rd-party 
audit; and
K.  Any recommendations for changes to the stewardship program to improve the 
convenience of the collection system, to increase consumer awareness and education 
or to better evaluate program performance.
11.  Administration and enforcement; rulemaking; fees.  The department shall 
administer and enforce this section and may adopt rules as necessary to implement this 
section.  Rules adopted pursuant to this subsection are routine technical rules as defined in 
Title 5, chapter 375, subchapter 2-A.
The department shall charge a reasonable fee to be paid by a manufacturer or stewardship 
organization for review of a plan or amendments to an approved plan submitted under 
subsection 4.  The department may establish a reasonable annual fee to cover the 
department's actual costs for annual report review, oversight, administration and 
enforcement of a stewardship program, except that the fee may not exceed the greater of 
$100,000 per year and 1% of total stewardship program costs, as verified through the 
independent 3rd-party audit required under subsection 10, paragraph J.
12.  Private right of action.  A manufacturer or stewardship organization 
implementing an approved plan under this section that is in compliance with all applicable 
requirements of this section may bring a civil action against a manufacturer for damages 
when:
A.  The plaintiff manufacturer or stewardship organization has incurred more than 
$3,000 in actual, direct costs in collecting, handling and disposing of covered drugs 
that are household pharmaceutical waste sold or offered for sale in the State by a 
defendant manufacturer or manufacturers that are not in compliance with all applicable 
requirements of this section;
B.  The defendant manufacturer or manufacturers can be identified as the manufacturer 
or manufacturers of the covered drugs described in paragraph A from a brand or 
marking on the covered drugs or from other information available to the plaintiff 
manufacturer or stewardship organization;
C.  The plaintiff manufacturer or stewardship organization has submitted a 
reimbursement request for the costs described in paragraph A to the defendant 
manufacturer or manufacturers; and
D.  The plaintiff manufacturer or stewardship organization has not received 
reimbursement for the costs described in paragraph A within:
(1)  Sixty days after the request for reimbursement under paragraph C, if the 
plaintiff manufacturer or stewardship organization did not request an independent 
audit under subparagraph (2); or
(2)  Thirty days after completion of an independent audit, if the plaintiff 
manufacturer or stewardship organization requested an independent audit and the 
audit verified the validity of the reimbursement request.
As used in this subsection, "damages" means the actual, direct costs a plaintiff 
manufacturer or stewardship organization incurs in collecting, handling and disposing of 
covered drugs that are household pharmaceutical waste reasonably identified as having 
originated from a defendant manufacturer or manufacturers that are not in compliance with 
all applicable requirements of this section; punitive or exemplary damages not exceeding 
times those incurred costs; and the plaintiff manufacturer's or stewardship organization's 
attorney's fees and costs of bringing the action under this subsection.
13.  Annual report to Legislature.  The department shall annually report to the joint 
standing committee of the Legislature having jurisdiction over environment and natural 
resources matters on the status of stewardship programs established pursuant to this section 
and shall recommend amendments to the provisions of this section as necessary.  After 
reviewing the report under this subsection, the committee may report out legislation related 
to the report.  The report under this subsection may be included in the report required 
pursuant to section 1772, subsection 1.
14.  Preemption.  To ensure maximum effectiveness through uniform statewide 
application, the State intends to occupy the whole field of regulation of 
government-mandated, manufacturer-funded drug take-back, collection or disposal 
programs.  A local government may not adopt an ordinance mandating a 
manufacturer-funded drug take-back, collection or disposal program and any ordinance or 
regulation that violates this subsection is void and has no force or effect.
Sec. 3.  38 MRSA §1776, sub-§11, as enacted by PL 2013, c. 315, §7, is amended 
to read:
11.  Exceptions.  This section does not apply to products subject to section 1610, 1612, 
1665-A, 1665-B, 1672, 2165 or 2166.
Sec. 4. Submittal of drug take-back stewardship plan.  Within 180 days after 
the effective date of this Act, a manufacturer of a covered drug under the Maine Revised 
Statutes, Title 38, section 1612, individually or jointly with one or more manufacturers, or 
a drug take-back stewardship organization contracted by one or more manufacturers, shall 
submit to the Department of Environmental Protection for review a proposed drug take-
back stewardship plan that meets the requirements of Title 38, section 1612, subsection 3. 
SUMMARY
This bill provides for the establishment of drug take-back stewardship programs.   It 
requires certain drug manufacturers, as defined in the bill, to operate a drug take-back 
stewardship program to collect and dispose of certain drugs.