An Act To Support Collection and Proper Disposal of Unwanted Drugs
Maine Legislature, Session 129, LD 1460
Committee: Environment and Natural Resources
Sponsors: GRATWICK, HYMANSON, BLACK, CLAXTON, DAVIS, DILL, JACKSON, VITELLI, MADIGAN
Amends: 22 MRSA §2700, 38 MRSA §1611

Legislative Document
No. 1460
S.P. 445
In Senate, April 2, 2019
An Act To Support Collection and Proper Disposal of Unwanted 
Drugs
Reference to the Committee on Environment and Natural Resources suggested and ordered 
printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator GRATWICK of Penobscot.
Cosponsored by Representative HYMANSON of York and
Senators: BLACK of Franklin, CLAXTON of Androscoggin, DAVIS of Piscataquis, DILL of 
Penobscot, President JACKSON of Aroostook, SANBORN, L. of Cumberland, VITELLI of 
Sagadahoc, Representative: MADIGAN of Waterville.
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 1611.
Sec. 2.  38 MRSA §1611 is enacted to read:
§1611.  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 that is registered with the 
United States Department of Justice, Drug Enforcement Administration to collect 
controlled 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 not controlled 
substances.
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.  "Closed-shop pharmacy" means a pharmacy that purchases drugs for and 
dispenses drugs to a limited, institutional patient population.
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 prescription and nonprescription drugs, 
drugs in medical devices and combination products, brand and generic drugs and 
drugs for veterinary use.
(1)  "Covered drug" does not include:
(a)  Vitamins or supplements;
(b)  Herbal-based  remedies  and  homeopathic drugs, products or remedies;
(c)  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;
(d)  Pet pesticide products contained in pet collars, powders, shampoos, 
topical applications or other forms;
(e)  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;
(f)  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;
(g)  Emptied syringes or emptied medical devices or the component parts or 
accessories of those products or devices; and
(h)  Drugs that are used solely in a clinical setting.
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 drug take-back stewardship program.
F.  "Drug take-back stewardship plan" or "plan" means a plan designed by a 
manufacturer or drug take-back stewardship organization for the establishment of a 
drug take-back stewardship program.
G.  "Drug take-back stewardship program" or "stewardship program" means a system 
implemented for the collection, transportation and disposal of covered drugs in 
accordance with a drug take-back stewardship plan approved by the department under 
subsection 4.
H.  "Mandatory pharmacy collector" means a pharmacy registered with the Maine 
Board of Pharmacy that is part of a group of 10 or more establishments that conduct 
business under the same name or operate under a common ownership or management 
or pursuant to a franchise agreement with the same franchisor and a nonresident 
pharmacy registered with the Maine Board of Pharmacy that provides covered drugs 
to residents in the State by mail. "Mandatory pharmacy collector" does not include a 
closed-shop pharmacy.
I.  "Manufacturer" means an entity that:
(1)  Has legal ownership of the brand of a covered drug sold in or into the State;
(2)  Imports a covered drug branded by a person that meets the requirements of 
subparagraph (1) and has no physical presence in the United States; or
(3)  Sells a covered drug in the State at wholesale or retail, does not have legal 
ownership of the brand of the covered drug and elects to fulfill the 
responsibilities of the manufacturer for that covered drug.
J.  "Operator" means a manufacturer or drug take-back stewardship organization that 
implements and operates a drug take-back stewardship program.
2.  Drug take-back stewardship program.  A manufacturer shall:
A.  Individually or jointly with one or more manufacturers, operate a drug take-back 
stewardship program approved by the department;
B.  Enter into an agreement with a drug take-back stewardship organization to 
operate a drug take-back stewardship program; or
C.  Enter into an agreement with the department to operate a drug take-back 
stewardship program on behalf of the manufacturer.
3.  Submittal of drug take-back stewardship plan.  A manufacturer, 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 a proposed drug 
take-back stewardship plan.  The plan must, at a minimum, include:
A.  A certification that the drug take-back stewardship program will accept all 
covered drugs regardless of who produced them;
B.  Contact information for the person submitting the drug take-back stewardship 
plan with whom the department  shall  direct  all inquiries related to the plan and a 
listing of participating manufacturers with contact information for each participating 
manufacturer;
C.  A description of how the drug take-back stewardship program will provide free, 
convenient and ongoing collection of covered drugs to all persons seeking to dispose 
of covered drugs and how the collection will be geographically distributed in a way 
to ensure access in rural and underserved areas based on the use of geographic 
information modeling;
D.  A description of the collection methods to be used to ensure that covered drugs 
will be collected by authorized collectors;
E.  A listing of authorized collectors and collection sites;
F.  Information on how covered drugs will be safely and securely tracked and handled 
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, which requires 
disposal and destruction at a licensed waste disposal facility that renders drugs 
nonretrievable;
G.  A description of how the collection system will be designed and monitored to 
prevent tampering;
H.  A description of how the amount of covered drugs collected and disposed of will 
be measured;
I.  A description of the education and outreach materials that will be used to 
encourage consumer participation, including, but not limited to, messaging that is 
understood by a diverse audience, a publicly accessible website with information for 
both authorized collectors and consumers about the drug take-back stewardship 
program and printed materials for collection sites including brochures and signage.  
The education and outreach efforts must ensure that 60% of consumers are aware of 
the stewardship program after one year of stewardship program implementation, 70% 
after 2 years and 90% after 4 years;
J.  A description of the performance goals established to measure the success of the 
drug take-back stewardship program and a description of how the stewardship 
program will be designed to meet or exceed those goals; and
K.  Information on how the drug take-back stewardship program will be financed in 
accordance with subsection 5.
4.  Approval of drug take-back stewardship plan.  Within 20 business days after 
receipt of a proposed drug take-back stewardship plan under subsection 3, the department 
shall review the plan and approve, approve with conditions or deny the plan.  The 
department shall notify the submitter in writing of the department's determination and, if 
the plan is approved with conditions or denied, the notification must include the reasons 
for the determination.
A.  A manufacturer or drug take-back stewardship organization whose drug take-back 
stewardship plan is denied shall submit a revised plan to the department within 60 
days after receiving a notice of denial. If the department denies the subsequent 
proposal, the manufacturer or manufacturers participating in the proposed drug take-
back stewardship program are out of compliance with this section and subject to the 
enforcement provisions under this section. The department may hold a public hearing 
prior to making a decision to approve, approve with conditions or deny a proposed 
plan.
B.  A manufacturer who begins to offer a covered drug in the State after the effective 
date of this section shall provide to the department evidence of joining an existing 
drug take-back stewardship program or submit a proposed drug take-back 
stewardship plan within 30 days after the manufacturer's initial offer for sale of a 
covered drug.
C.  Prior to implementing a change to an approved drug take-back stewardship plan, 
an operator shall submit the proposed change to the department for review. If a 
change is not substantive, such as the addition of or a change to a collection site or 
the addition of a manufacturer to the drug take-back stewardship program, approval 
by the department is not needed, but the operator shall inform the department of the 
change within 14 days of implementing the change. The department shall review plan 
amendments in accordance with this section.
D.  At any time, the department may require changes to a drug take-back stewardship 
plan or implementation of a plan to meet the requirements of this subsection.
5.  Costs.  A manufacturer, individually or jointly with one or more manufacturers, 
shall pay all administrative and operational costs associated with the manufacturer's drug 
take-back stewardship program, including, but not limited to:
A.  The cost of collecting covered drugs from mandatory pharmacy collectors and 
authorized collectors, transporting covered drugs to disposal locations and disposing 
of covered drugs;
B.  Costs related to working with authorized collectors to develop a readily 
recognizable, consistent design of collection receptacles, as well as clear, 
standardized instructions for consumers on the use of collection receptacles.  The 
department may provide guidance to manufacturers on the development of the 
instructions and design;
C.  Costs incurred by the State in the administration and enforcement of the drug 
take-back stewardship program; and
D.  All costs associated with drug take-back stewardship program effectiveness and 
assessments under this section.
When more than one manufacturer participates in a drug take-back stewardship program, 
the costs of administration and enforcement must be fairly and reasonably allocated so 
that the portion of costs allocated to each manufacturer is reasonably related to the market 
share of covered drugs that manufacturer sells in the State.
Disposal of a covered drug under a drug take-back stewardship program must be free to 
consumers.  A manufacturer may not charge a point-of-sale fee to consumers, or a fee 
that could be passed on to consumers, to recoup the cost of implementing the stewardship 
program.
6.  Confidential information.  Proprietary information submitted to the department 
in a drug take-back stewardship plan, in an amendment to a plan or pursuant to 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.  As used in this subsection, "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.
7.  Audit.  The department may require an operator to submit an independent 
financial audit of a drug take-back stewardship program.
8.  Collection.  This subsection applies to authorized collectors, mandatory pharmacy 
collectors and collection sites.
A.  A mandatory pharmacy collector shall participate in each drug take-back 
stewardship program.  A mandatory pharmacy collector shall prominently display 
signage advertising covered drug collection to consumers and provide for the safe 
collection of covered drugs through:
(1)  On-site, publicly accessible and secure collection receptacles meeting federal 
standards;
(2)  Mail-back collection by prepaid envelopes as authorized by federal law and 
regulation; and
(3)  Other methods of collection approved by the United States Department of 
Justice, Drug Enforcement Administration.
B.  An operator shall notify all authorized collectors of the opportunity to serve as a 
collection site for the drug take-back stewardship program.  Except for mandatory 
pharmacy collectors, participation of an authorized collector is voluntary.
C.  A drug take-back stewardship program must include as a collection site each retail 
pharmacy and hospital or clinic with an on-site pharmacy and each law enforcement 
agency that volunteers to participate in the stewardship program without 
compensation and is an authorized collector.  An operator shall add the pharmacy, 
hospital, clinic or law enforcement agency as a collection site in the stewardship 
program no later than 90 days after the operator receives the offer to participate.
D.  Mandatory pharmacy collectors and authorized collectors for a drug take-back 
stewardship program shall provide information on covered drug collection and safe 
drug disposal options to a consumer upon dispensing a covered drug.
E.  As part of a drug take-back stewardship program, all collection requirements of 
mandatory pharmacy collectors and authorized collectors, including, but not limited 
to, collection receptacles, mail-back envelopes, educational materials and drug-
disposal-specific surveillance, must be provided by the operator free of charge to the 
collectors.
9.  Third-party outreach assessment.  Every 2 years, a drug take-back stewardship 
organization shall fund a 3rd-party assessment of the effectiveness of education and 
outreach efforts under the drug take-back stewardship program.  The methods and scope 
of the assessment must include input by the department.  The stewardship organization 
shall make changes to the education and outreach efforts based on the results of the 
assessment.
10.  Annual drug take-back stewardship program report.  Within 90 days after 
the first full year of implementation, and annually thereafter, an operator shall submit to 
the department a report describing the implementation of the drug take-back stewardship 
program during the previous calendar year.  The report must include at a minimum:
A.  A list of manufacturers participating in the drug take-back stewardship program, 
including current contact information;
B.  The amount by weight of covered drugs collected, including the amount by 
weight from each collection method used, both in total and by county;
C.  Details regarding the drug take-back stewardship program's collection system, 
including a list of collection sites with addresses; the number of mail-back envelopes 
provided; locations where mail-back envelopes were provided, if applicable; dates 
and locations of collection events held, if applicable; and the transporters and 
disposal facility or facilities used;
D.  Whether any safety or security problems occurred during collection, 
transportation or disposal of covered drugs and, if so, completed and anticipated 
changes to policies, procedures or tracking mechanisms to address the problem and 
improve safety and security;
E.  A description of the public education, outreach and evaluation activities 
implemented to ensure that 60% of consumers are aware of the drug take-back 
stewardship program after one year of stewardship program implementation, 70% 
after 2 years, and 90% after 4 years in accordance with subsection 3, paragraph I.  In 
order to evaluate whether the consumer awareness goals are reached, every 2 years 
the report must include the results of an assessment of the methods used for and 
effectiveness of education and outreach efforts pursuant to subsection 9;
F.  A description of how collected packaging was recycled to the extent feasible;
G.  A description of the methods used to collect, transport and dispose of covered 
drugs;
H.  A summary of the drug take-back stewardship program's degree of success in 
meeting goals for diversion rates, if applicable, and, if any goals have not been met, 
what effort will be made to achieve those goals the following year;
I.  An evaluation of the convenience of collection for people living in various regions 
of the State;
J.  The total cost of implementing the drug take-back stewardship program, including, 
but not limited to, the stewardship program's annual expenditures, as determined by 
an independent financial audit; and
K.  Any recommendations for changes to the drug take-back stewardship program to 
improve convenience of collection, consumer education and stewardship program 
evaluation.
11.  Administration.  The department shall charge a reasonable fee to be paid by a 
manufacturer or drug take-back stewardship organization for review of a drug take-back 
stewardship plan. The department may establish a reasonable annual fee to cover the 
actual costs for annual report review, oversight, administration and enforcement.  Fees 
established pursuant to this subsection may not exceed the greater of $100,000 per year 
and one percent of total drug take-back stewardship program costs as set forth in the 
independent financial auditing report under subsection 10, paragraph J.
12.  Private right of action.  A manufacturer or a drug take-back stewardship 
organization implementing an approved drug take-back stewardship plan in compliance 
with the requirements of this section may bring a civil action against another 
manufacturer or stewardship organization for damages when:
A.  The plaintiff manufacturer or drug take-back stewardship organization incurs 
more than $3,000 in actual direct costs in collecting, handling or disposing of covered 
drugs sold or offered for sale in the State by another manufacturer;
B.  The manufacturer from whom damages are sought can be identified as the 
manufacturer of the collected covered drugs from a brand or marking on the 
discarded covered drug or from other information available to the plaintiff 
manufacturer or drug take-back stewardship organization and does not operate a drug 
take-back stewardship program in the State;
C.  The plaintiff manufacturer or drug take-back stewardship organization submitted 
a reimbursement request to another manufacturer or stewardship organization; and
D.  The plaintiff manufacturer did not receive reimbursement within:
(1)  Sixty days after the request for reimbursement under paragraph C, if the 
plaintiff manufacturer or drug take-back stewardship organization did not request 
an independent audit under subparagraph (2); or
(2)  Thirty days after completion of an audit, if the plaintiff manufacturer or drug 
take-back stewardship organization requested an independent audit and the audit 
confirmed the validity of the reimbursement request.
A civil action under this subsection may be brought against an individual manufacturer 
only if that manufacturer is individually implementing its own drug take-back 
stewardship program.  A manufacturer participating in a stewardship program covering 
multiple manufacturers may not be sued individually for reimbursement. An action 
against a manufacturer participating in a stewardship program covering multiple 
manufacturers must be brought against the drug take-back stewardship organization 
implementing the stewardship program.
As used in this subsection, "damages" means the actual, direct costs a plaintiff 
manufacturer incurs in collecting, handling and disposing of covered drugs reasonably 
identified as having originated from a noncompliant manufacturer; punitive or exemplary 
damages not exceeding 3 times the costs incurred under this section; and the prevailing 
plaintiff manufacturer's attorney's fees and costs of bringing the action.
13. Violations.  A manufacturer that is not in compliance with this section is subject
to civil penalties under section 349.  The department shall list on its publicly accessible 
website manufacturers that are participating in an approved drug take-back stewardship 
program and manufacturers that have been identified as being noncompliant with this 
section. Each day in which a violation continues is a separate violation.
14.
Report to the Legislature.  The department, as a part of an annual product
stewardship report under section 1772, shall report to the joint standing committee of the 
Legislature having jurisdiction over natural resources matters on the status of drug take-
back stewardship programs established pursuant to this section and shall recommend 
modifications to the laws governing drug take-back stewardship programs the department 
determines necessary or appropriate.  The joint standing committee may report out a bill 
based on the recommendations.
15.
Rules.  The department shall 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.
Sec. 3.  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 1611, individually or jointly with one or more manufacturers, 
or a drug take-back organization contracted by one or more manufacturers shall submit to 
the Department of Environmental Protection a proposed drug take-back stewardship plan 
that meets, at a minimum, the requirements of Title 38, section 1611, 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.