An Act To Support Collection and Proper Disposal of Unwanted Drugs .
Maine Legislature, Session 124, LD 0821
Committee: Health and Human Services
Sponsors: PERRY, BEAUDOIN, CASAVANT, DUCHESNE, EBERLE, JONES, PINGREE, BARTLETT
Amends: 22 MRSA §2700, 38 MRSA §1611

FIRST PJ:GULAR SESSION=2009 
Legislative Document 
No. 821 
H.P.557 
House of Representatives, March 3,2009 
An Act To Support Collection and Proper Disposal of Unwanted 
Drugs 
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Reference to the Committee on Health and Human Services suggested and ordered printed. 
Presented by Representative PERRY of Calais. 
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/J1.I1l1LC~{ 
MILLICENT M~ MacFARLAND 
Clerk 
Cosponsored by Representatives: BEAUDOIN of Biddeford, CASAVANT of Biddeford, 
DUCHESNE of Hudson, EBERLE of South Portland, JONES of Mount Vernon, Speaker 
PINGREE of North Haven, Senators: BARTLETT of Cumberland, GOODALL ofSagadahoc. 
Printed on rccycbJ pilpl'r 
Be it enacted by the People of the State of Maine as follows: 
Sec. 1. 
MRSA §2700, sub-§5, as amended by PL 2005, c. 297, § 1 and 
affected by §3, is further amended to read: 
. 5. 
Unused fharmaceuticai Disposal Program Fund; funding. 
The Unused 
Pharmaceutical Disposal Program Fund, referred to in this chapter as "the fund," is 
established within the agency to be used by the director ofthe'agency to fund or assist in 
funding the program and Title 38, section 1611. Any balance in the fund does not lapse 
but is carried forward to be expended for the same purposes in succeeding fiscal years. 
The fund must be deposited with and maintained and administered by.the agency. The 
agency may accept funds into the fund from any non-General Fund source, including 
grants or contributions of money, fines and penalties imposed pursuant to Title 38, 
section 1611, subsection 9 or other things of value, that it determines necessary to carry 
out the purposes of this chapter. Money received by the agency to establish and maintain 
the program must be used for the expenses of administering this chapter and Title 38, 
section 1611. 
Sec. 2. 38 MRSA §1611 is enacted to read: 
§16H. Disposal of unwanted drugs 
After January 1, 2010, a manufacturer shall participate in a program for the disposal 
of unwanted drugs in accordance with this section. 
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1. Definitions. As used in this section, unless the context otherwise indicates, the 
following terms have the following meanings. 
A. "Agency" means the Maine Drug. Enforcement Agency under Title 25, section 
2955. 
B. "Covered drug" means any drug included in a manufacturer's program. 
C. "Drug" means: 
(1) An article recognized in the United States Pharmacopoeia and National 
Formulary or the Homeopathic Pharmacopoeia of the United States or any 
supplement of those pharmacopoeias; 
(2) A substance intended for use in the diagnosis, cure, mitigation, treatment or 
prevention of disease in humans or animals;' 
. 
(3) A substance, other than food, intended to affect the structure or any function 
of the body of humans or animals; or 
(4) A substance intended for use as a component of any substances specified in 
subparagraph (1), (2) or (3), but not including medical devices or their 
component parts or accessories. 
. 
"Drug" includes all prescription drugs and nonprescription over-the-counter drugs 
and veterinary drugs in any form, including pill, tablet, capsule, suppository, liquid, 
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cream, ointment, lotion, transdermal patch, powder or aerosol form and both name 
brand and generic drugs but does not include vitamins or herbal-based remedies. 
D. "Manufacturer" means a person or entity that: 
(1) Manufactures a covered drug or has legal ownership of the brand, brand 
name or co-brand under which a covered drug is sold; 
(2) Imports a covered drug manufactured by a person or entity that has no 
physical presence in fhe United States; or 
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(3) Sells at wholesale or retail 11 covered drug and does not have legal ownership 
of the brand or brand name, but that elects to fulfill the' manufacturer's 
responsibilities for that covered drug. 
E. "Reporting period" means a calendar year. 
F. 
"Residential source" includes single-family and multiple-family residences and, 
. locations where unwanted drugs may be found such as hospice facilities, nursing 
homes, boarding homes, schools, foster care facilities, day care facilities and other 
locations where either people or their pet animals, or both, reside on a temporary or 
permanent basis. "Residential source" does not include a pharmacy or a business or 
any other nonresidential source identified by the department. 
G. "Unwanted drug" means any covered drug from a residential source that its owner 
no longer wants or that has. been abandoned or discarded or is' intended to be 
discarded by the owner. 
.. Manufacturer responsibility. A manufacturer of covered drugs sold in the State 
shall participate in a program with other manufacturers of covered drugs, unless approved 
by the department to operate an independent program. The manufacturer shall: 
A. Except as otherwise provided in this subsection, submit to the depmiinent the 
manufacturer's proposed program to operate and finance the collection, tninspOliation 
and recycling or disposal of unwanted drugs either independently or in conjunction 
with other manufacturers; 
B. Pay all the administrative and operational costs associated with implementation of 
the program, including the cost of the collection, transportation, management and 
disposal of the unwanted drugs that are collected from residential sources and the 
recycling or disposal of the related packaging; 
C. Implement the program without charging a fee at the time of sale of the covered 
drugs or at the time the unwanted drugs are delivered or collected for disposal from 
residential sources; and 
. 
D. Operate the program as approved by the department and in accordance with this 
subsection and other applicable state and federal laws. 
The depaIiment may approve an independent program only if it meets all requirements of 
this section and accepts covered drugs from any manufacturer. 
After January 1, 2010, a manufacturer new to the State shall submit a proposed program 
to the department or join an approved program prior to initiating sales in. the State. 
3. Program requirements. The program required under subsection 2 must include 
at a minimum: 
A. A list of all manufacturers participating in the collection, handling and disposal 
proposed in the program and the manufacturers' contact information; 
B. Performance goals, including recovery goals for the first, 2nd and 3rd years of the 
program, expressed as pounds of unwanted drugs disposed ,of per capita and an 
explanation of how the recovery goals have been set to recover a significant 
percentage of unwanted drugs from residential' sources relative to the quantity of 
unwanted drugs that may be available for disposal; 
C. A description of a proposed collection system that, at a minimum, must include 
the use, of prepaid mailing envelopes addressed to the agency, unless other collection 
methods are approved by the United States Drug Enforcement Agency and the 
agency. The collection system must be convenient and adequate to serve the needs of 
residents in both urban and rural areas; and 
D. A handling and disposal system, including: 
(1) 
Identification of and contact information for hazardous waste disposal 
facilities and other entities to be used by the program to collect and destroy the 
unwanted drugs; 
(2) The policies and procedures to be followed by persons in charge of unwanted 
drugs collected pursuant to the program; 
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(3) A description of how the collected unwanted drugs are tracked through to 
final disposal and how safety and security is maintained; and 
(4) A description of the public education effort and communications strategy as 
required in subsection 5. 
4. Program review and approval. A program submitted to the department pursuant 
to subsectfon 2 must be approved by the department, with concurrence of the agency, 
before a manufacturer may engage in the collection of unwanted drugs from residential 
sources within the State. A manufacturer shall implement the program within 3 months 
of the program's approval unless "'e deIW-:,-"o-'t.ilPproves an extension of the 
implementation date. 
A. The department shall review each program in consultation with the agency. 
B. The depaJiment shall determine whether a program complies with this chapter. If 
the department is satisfied that a program complies, thedepaJiment shall issue an 
approval. If a program is rejected, the department shall provide the applicant with the 
reasons in writing for rejecting the program. The department inay also approve the 
program with modifications. 
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C. A manufacturer or the manufacturer's agent operating an approved program may 
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not make any substantive changes to the program without obtaining the department's . 
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prior written approval of the proposed changes, except that: 
(1) Additions and changes to the list of hazardous waste facilities and other 
entities under contract for drug collection or destruction may be made without the 
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depaliment's 'or agency's prior written approval.' 
The manufacturer or 
manufacturer's agent responsible for implementing the program must inform the 
depaliment and agency of such an addition or change 15 days prior to the 
effective date of the addition or change. 
If there is no objection by the 
depaliment or agency, the manufacturer may implement the addition or change; 
and 
(2) Additional manufacturers may participate in an approved program without 
the depaliment's and agency's prior written approval. 
The manufacturer or 
manufacturer's agent responsible for implementing the program must provide the 
depaliment with an updated manufacturer participant list within 15 days after a 
manufacturer begins participation in the program. 
D. If the department or agency determines that a program is not being operated in 
accordance with this section and rules adopted to implement this section, or if the 
department or agency determines that there is an imminent danger to the pubiic, the 
depaliment or agency may: 
(1) Amend the approval of the program by clarifying terms or conditions to 
ensure full implementation of the prografn; or 
(2) Suspend or cancel the approval of the program. 
At least 15 days prior to amending, suspending or canceling an approval, the 
department shall inform the manufacturer or the manufacturer's agent operating the 
program of the action and provide the manufacturer or the manufacturer's agent an 
opportunity to·respond. 
E. Notwithstanding paragraph D, if the department or agency determines that it is 
necessary in order to protect the public from imminent danger, the department or 
agency may immediately amend, suspend or cancel an approval without giving the 
manufacturer or the manufacturer's agent operating the program an opportunity to be 
heard, but must give that manufacturer or the manufacturer's agent an opportunity to 
be heard through proceedings consistent with Title 5, chapter 375, subchapter 4 
within 15 days after the date on which the depaliment or agency takes any of those 
actions. 
5. Education and ouil·each. A manufacturer must: 
A. Promote the use of a program and the proper disposal of unwanted drugs so that 
collection options are widely understood by customers, pharmacists, retailers of 
covered drugs and health care practitioners including doctors and other prescribers; 
B. Establish a toll-free telephone number and publicly accessible website where 
collection options are made available; and 
C. Provide educational and outreach materials describing where and how to return 
unwanted drugs. 
These materials must be provided to pharmacies, health care 
facilities and other interested parties at no cost. 
Pharmacies must make available to their customers the educational information and 
prepaid mailing envelopes supplied by the manufacturer or manufacturer's agent pursuant 
to subsection 3, paragraph C for unwant~d drug collection. 
6. Progress reports. By February 1, 2011, and by February 1st of each subsequent 
year, every manufacturer or manufacturer's agent who operates a program approved' under 
this section shall submit to the department and agency a written annual report, in a format 
prescribed by the department, covering the previous reporting period. The report must 
include: 
A. A list of manufacturers participating in a program; , 
B. The amount, by weight, of unwanted drugs collected from residential sources; 
C. Documentation verifying collection and disposal of the unwanted drugs; 
D. The hazardous waste disposal facilities used, the location of those facilities and 
the weight of unwanted drugs collected from residential sources and disposed of at 
, each facility; 
E. 
Whether policies and procedures for transporting and disposing of unwanted 
drugs, as established in the program, were followed during the reporting period and a 
description of noncompliance with those policies and procedures, if any; 
F. Whether any safety or security problems occurred during collection, transportation 
or disposal of {unwanted drugs during the reporting period and, if so, what changes 
are proposed for policies, procedures or tracking mechanisms to improve safety and 
security in the future; 
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'G. A description of the public education effort and communication strategy under 
subsection 5 implemented during the reporting period; 
H. A description of research, if any, regarding disposal techniques that provide 
superior protection to human health and the environment beyond that provided by 
current hazardous waste disposal techniques; 
I. How the program met the performance standards and recovery rates as established 
in the program or set by the department and agency and, if the program did not meet , 
those performance standards and recovery rates, what actions the manufacturer will 
take to alter the program to meet the performance standards and recovelY rates; and 
J. Any other informatiori that the department and agency may reasonably require. 
7. Drug disposal; rules. A manufacturer's program must provide for the disposal of 
all unwanted drugs from residential sources at a hazardous waste incinerator as defined in 
' section 1303-(:, subsection 15-A and licensed by the department. The department may 
adopt rules conceming approval of new disposal technology. Rules adopted pursuant to 
this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2-
A and must provide that: 
A. A manufacturer may petition the department for, and the department may grant 
approval to use, a disposal technology that provides superior environmental and 
human health· protection to that provided by a current hazardous waste disposal 
technology for drugs if that technology is proven and available. 
The proposed 
technology must provide equivalent protection in each, and superior protection in one 
or more, of: 
(1) The monitoring of any emissions or waste; 
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(2) Worker health and safety; 
'(3) Air, water or land emissions contributing to persistent, bioaccumulative and 
toxio pollution; and 
(4) The overall environment and human health; and 
B. The department must inform the agency of its determination under paragraph A 
and may grant the petition only if the agency concurs. 
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8. Performance standards. By June 2013, the department shall establish mandated 
performance standards and recovery rates for the 4th and subsequent program years. the 
department may require a manufacturer that does not meet the mandated' standards and 
rates to modify the manufacturer's program in order to achieve performance standards and 
improve recovery rates. Plan modifications require the department's approval before they 
may be implemented. 
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9. Fines and penalties. After January 1, 2010, a manufacturer ofa covered drug 
that is not in compliance with this section is subject to civil penalties under section 349. 
By June 1, 2010 the department shallliston its publicly accessible website manufacturers 
that are participating in an approved program and manufacturers that have been identified 
as being noncompliant with this section. All penalties and fines collected for violations 
of this section must be deposited into the Unused Pharmaceutical Disposal Program 
Fund, established under Title 22, section 2700. 
10. Report to the Legislature. By March 15, 2011 and by March 15th annually 
thereafter, the department, in consultation with the agency, shall report to the joint 
standing committees of the Legislature having jurisdiction over health matters and 
environmental matters' concerning the status of a program established pursuant to this 
section and shall recommend such modifications to the program as the department and 
agency may determine necessary or appropriate. 
11. Rules. The department may establish 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. Stakeholder group. The Department of Environmental Protection must 
convene a diverse stakeholder group that includes manufactUl:ers, law enforcement, health 
organizations and environmental groups to review and advise the department regarding 
. the development of the performance standards and recovery rates pursuant to the Maine 
Revised Statutes, Title 38, section 1611. 
SUMMARY 
This bill establishes a system to collect and safely dispose of unwanted drugs from 
households and other residential sources.