I 
112TH CONGRESS 
1ST SESSION H. R. 2939 
To provide for the disposal of drugs pursuant to national pharmaceutical 
stewardship programs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 15, 2011 
Ms. SLAUGHTER introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
Ways and Means, for a period to be subsequently determined by the 
Speaker, in each case for consideration of such provisions as fall within 
the jurisdiction of the committee concerned 
A BILL 
To provide for the disposal of drugs pursuant to national 
pharmaceutical stewardship programs, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pharmaceutical Stew-
ardship Act of 2011’’. 
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SEC. 2. NATIONAL PHARMACEUTICAL STEWARDSHIP PRO-
GRAMS. 
(a) REQUIRED PARTICIPATION.—Each manufacturer 
and brand owner of a drug marketed in the United States 
shall participate in— 
(1) the certified national pharmaceutical stew-
ardship program of the National Pharmaceutical 
Stewardship Organization; or 
(2) another certified national pharmaceutical 
stewardship program. 
(b) NATIONAL PHARMACEUTICAL STEWARDSHIP OR-
GANIZATION.— 
(1) ESTABLISHMENT.—There shall be estab-
lished in accordance with this section a nonprofit 
private corporation to be known as the National 
Pharmaceutical Stewardship Organization. The Or-
ganization shall not be an agency or instrumentality 
of the Federal Government, and officers, employees, 
and members of the board of the Organization shall 
not, by virtue of such service, be considered officers 
or employees of the Federal Government. 
(2) PURPOSE.—The purpose of the Organiza-
tion shall be to establish and, not later than 2 years 
after the date of the enactment of this Act, begin 
implementation of a certified national pharma-
ceutical stewardship program. 
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(3) BOARD OF DIRECTORS.—The Organization 
shall have a board of directors including representa-
tives of manufacturers and brand owners of drugs 
and public health stakeholders. The Administrator 
shall appoint the initial members of the board of di-
rectors. 
(4) BYLAWS.—The board of directors shall es-
tablish the general policies of the Organization for 
carrying out the purpose described in paragraph (2), 
including the establishment of the bylaws of the Or-
ganization. The board of directors shall ensure that 
the bylaws of the Organization include bylaws for 
the following: 
(A) Entering into contracts and agree-
ments with service providers and entities as 
necessary, useful, or convenient to provide all or 
portions of the national pharmaceutical stew-
ardship program of the Organization. 
(B) Taking any legal action necessary or 
proper for the recovery of an assessment for, on 
behalf of, or against manufacturers or brand 
owners of a drug participating in such program. 
(C) Performing such other functions as 
may be necessary or proper to carry out the 
purpose described in paragraph (2). 
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(D) Ensuring that the members of the 
board of directors serve without compensation, 
but are entitled to reimbursement (solely from 
the funds of the Organization) for expenses 
(other than meal or travel expenses) incurred in 
the discharge of their duties as members of the 
board of directors. 
(E) Ensuring that the Organization does 
not use any State or local government funds to 
carry out the purpose described in paragraph 
(2). 
(F) Allowing the Administrator— 
(i) to audit the activities of the Orga-
nization as the Administrator deems nec-
essary; and 
(ii) to access any facilities or property 
of the Organization as the Administrator 
deems necessary to conduct inspections or 
investigate complaints. 
(5) NONPROFIT STATUS.—In carrying out the 
purpose described in paragraph (2), the board of di-
rectors shall establish such policies and bylaws under 
paragraph (4) as may be necessary to ensure that 
the Organization maintains its status as an organi-
zation that— 
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(A) is described in subsection (c)(3) of sec-
tion 501 of the Internal Revenue Code of 1986; 
and 
(B) is, under subsection (a) of such sec-
tion, exempt from taxation. 
(6) CONTRIBUTIONS
TO
NATIONAL
PHARMA-
CEUTICAL
STEWARDSHIP
ORGANIZATION
NOT 
TREATED AS CHARITABLE CONTRIBUTIONS.—A con-
tribution by a manufacturer or brand owner of a 
drug to the Organization or the Organization’s na-
tional pharmaceutical stewardship program shall not 
be treated as a charitable contribution for purposes 
of section 170 of the Internal Revenue Code of 
1986. 
(7) ARTICLES
OF
INCORPORATION.—The Ad-
ministrator shall ensure that the initial articles of 
incorporation of the Organization are properly filed 
not later than 60 days after the date of the enact-
ment of this Act. 
(c) PROGRAM
REQUIREMENTS.—To be certified 
under subsection (f) or (g), a program shall meet each 
of the following: 
(1) The program is operated pursuant to an 
agreement among the manufacturers and brand 
owners of drugs participating in the program. 
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(2) Subject to subsection (d), the costs of the 
program are fully paid by such manufacturers and 
brand owners. 
(3) The program is developed with input from 
the public, including an opportunity for public com-
ment and at least one public hearing. 
(4) The program provides a system to facilitate 
the collection and disposal of any drug that— 
(A) is delivered to the program by an indi-
vidual in the United States; and 
(B) is household waste as defined under 
the implementing regulations of subtitle C of 
title II of the Solid Waste Disposal Act (42 
U.S.C. 6901 et seq.; commonly referred to as 
the ‘‘Resource Conservation and Recovery 
Act’’). 
(5) Collection and disposal of a drug through 
the program’s system (described in paragraph (4)) 
occurs in a manner that— 
(A) is safe and secure; 
(B) results in incineration of the drug in 
accordance with the hazardous waste inciner-
ation requirements under subtitle C of title II 
of the Solid Waste Disposal Act (42 U.S.C. 
6901 et seq.); 
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(C) protects patient information; 
(D) is accessible in every State, county, 
and city or town, including— 
(i) at least one collection site in every 
county of every State and one collection 
site in every city with a population of more 
than 10,000 individuals on an ongoing, 
year-round basis; or 
(ii) if collection is not feasible in a 
specific county or city, provision of prepaid 
mailing envelopes to individuals in such 
county or city for such collection and dis-
posal; and 
(E) in the case of a controlled substance, 
is consistent with section 302(g) of the Con-
trolled Substances Act (21 U.S.C. 822(g)). 
(6) The program shall not impose any fee on 
individuals for delivery or disposal of a drug through 
the program. 
(7) The program promotes the collection and 
disposal of drugs through the program. 
(8) The program ensures that options for col-
lection and disposal of drugs through the program 
are widely understood by customers, pharmacists, re-
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tailers, and health care practitioners including doc-
tors and other prescribers, including by— 
(A) maintaining a toll-free telephone num-
ber and a Web site publicizing such collection 
and disposal options; 
(B) preparing educational and outreach 
materials— 
(i) describing where and how to dis-
pose of drugs through the program; and 
(ii) addressing the risks of diversion 
of drugs and the importance of awareness 
about safe storage and disposal of drugs; 
and 
(C) providing such materials to phar-
macies, health care facilities, and other inter-
ested parties for dissemination. 
(9) The program— 
(A) annually evaluates the effectiveness of 
its educational and outreach activities under 
paragraph (7); and 
(B) at least every 4 years, includes in such 
evaluation— 
(i) the percentage of residents of the 
United States who are aware of the pro-
gram; and 
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(ii) the extent to which residents of 
the United States find the program to be 
convenient. 
(d) MECHANISM FOR TRANSFER OF COSTS AMONG 
MANUFACTURERS AND BRAND OWNERS.—To be certified 
under subsection (f) or (g), a program shall include a 
mechanism that— 
(1) provides for receiving and transferring 
funds among all certified national pharmaceutical 
stewardship programs in such amounts as may be 
necessary to ensure that the manufacturers and 
brand owners of drugs participating in such pro-
grams bear the costs of such programs in proportion 
to the market shares of their respective drugs; and 
(2) is specified in a written agreement among 
all manufacturers and brand owners of drugs. 
(e) PROGRAM REPORTING REQUIREMENTS.— 
(1) IN GENERAL.—To be certified under sub-
section (f) or (g), a program shall agree to submit 
a report to the Environmental Protection Agency by 
not later than January 1st of the first calendar year 
following such certification, and annually thereafter. 
(2) CONTENTS.—Each report submitted by a 
program under paragraph (1) shall describe the pro-
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gram’s activities during the preceding calendar year, 
including at a minimum— 
(A) a specification of the amount, by 
weight, of drugs collected through the program, 
including the amount by weight from each col-
lection method used; 
(B) an identification of any safety or secu-
rity problems which occurred during collection, 
transportation, or disposal of drugs during the 
preceding calendar year and a description of the 
changes which have or will be made to policies, 
procedures, or tracking mechanisms to alleviate 
any such problems and to improve safety and 
security in the future; 
(C) a description of the educational and 
outreach activities under subsection (c)(8); 
(D) a description of how collected pack-
aging was recycled to the extent feasible, in-
cluding the recycling facility or facilities used; 
and 
(E) the total expenditures of the program 
and a statement on whether the program fore-
sees a need for adjustment of the total annual 
cost responsibility under subsection (d) of man-
ufacturers and brand owners participating in 
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the program as a result of changes in volumes 
of collected drugs or other costs. 
(3) PROCEDURES.—The Administrator shall es-
tablish procedures for reporting under this sub-
section not later than the date that is one year after 
the date of the enactment of this Act. 
(4) PUBLIC AVAILABILITY.—The Administrator 
shall make each report submitted under this sub-
section available to the public. 
(f) CERTIFICATION OF NATIONAL PHARMACEUTICAL 
STEWARDSHIP ORGANIZATION’S PROGRAM.— 
(1) APPLICATION.—To seek certification of its 
program, the Organization shall submit an applica-
tion to the Administrator containing such informa-
tion as the Administrator may require. 
(2) CONSIDERATION
BY
ADMINISTRATOR.— 
Upon receipt of an application under paragraph (1), 
the Administrator— 
(A) shall consult with the Administrator of 
the Drug Enforcement Agency on the adequacy 
of the proposed program’s security measures 
for collection, transportation, and disposal of 
drugs, disposal systems, and mechanisms for 
secure tracking and handling; and 
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(B) within 90 days after receipt of the ap-
plication, shall— 
(i) certify the program if the Adminis-
trator determines it meets the require-
ments of this section; or 
(ii) reject the proposed program and 
provide a written explanation of the rea-
sons for such rejection. 
(3) RESPONSE
TO
REJECTION
OF
PROPOSED 
PROGRAM.—If the Administrator rejects the Organi-
zation’s 
proposed 
program 
under 
paragraph 
(2)(B)(ii), the rejection shall be treated as final 
agency action, and the Organization may— 
(A) revise its proposed program and sub-
mit a new application under paragraph (1); or 
(B) seek judicial review of the rejection not 
later than 60 days after receiving notice of the 
rejection. 
(4) SOLICITATION OF PUBLIC COMMENT TO IN-
FORM PROGRAM UPDATES.— 
(A) IN
GENERAL.—A certified national 
product stewardship program shall— 
(i) annually invite comments from 
health care facilities, health care practi-
tioners, pharmacists, State and local gov-
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ernments, law enforcement personnel, and 
citizens on their satisfaction with the serv-
ices provided by the program; 
(ii) compile and submit the informa-
tion received through such comments to 
the Administrator; and 
(iii) use such information in devel-
oping updates and changes to the program. 
(B) USE
BY
ADMINISTRATOR.—The Ad-
ministrator shall use information submitted 
under subparagraph (A)(ii) in reviewing pro-
posed updates and revisions to certified national 
pharmaceutical stewardship programs. 
(C) GUIDANCE.—The Administrator shall 
issue guidance on the process for complying 
with this paragraph. 
(5) TERM OF CERTIFICATION; UPDATES.—The 
term of a certification under paragraph (2)(B)(i) 
shall be not more than 4 years. Not less than every 
4 years, a new application, including any relevant 
updates to the certified national pharmaceutical 
stewardship program, shall be submitted under para-
graph (1) and approved under paragraph (2)(B)(i) 
in order for a program’s certification under this sub-
section to remain in effect. 
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(6) CHANGES TO CERTIFIED PROGRAM.— 
(A) IN GENERAL.—Before making any sig-
nificant change to its certified national pharma-
ceutical stewardship program, the Organization 
shall seek and obtain approval for the change 
from the Administrator. Not later than 15 days 
after submission of a request for a change 
under the preceding sentence, the Adminis-
trator shall approve the change or reject the 
change and provide a written explanation of the 
reasons for the rejection. 
(B) CHANGES
TO
COLLECTION
LOCA-
TIONS.—Not less than 15 days after making 
any change to a location for the collection of 
drugs through its certified national pharma-
ceutical stewardship program, the Organization 
shall inform the Administrator of the change. 
(7) SUBMISSION REQUIREMENTS.— 
(A) PUBLICATION.—Not later than 6 
months after the date of the enactment of this 
Act, the Administrator shall publish require-
ments for the submission of applications under 
paragraph (1) and requests for changes under 
paragraph (6), including requirements for the 
contents of such submissions. 
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(B) FAILURE TO PUBLISH.—If the Admin-
istrator fails to publish such requirements by 
the deadline specified in subparagraph (A), the 
requirements of this section applicable to manu-
facturers and brand owners of drugs shall none-
theless apply. 
(g) CERTIFICATION OF OTHER PROGRAMS.— 
(1) APPLICATION.—In lieu of participating in 
the certified national pharmaceutical stewardship 
program of the Organization, one or more manufac-
turers or brand owners of a drug may submit an ap-
plication to the Administrator seeking certification 
of a separate national pharmaceutical stewardship 
program. 
(2) GOVERNING
PROVISIONS.—The provisions 
of subsection (f) shall apply with respect to an appli-
cation for certification of a program under para-
graph (1) to the same extent and in the same man-
ner as such provisions apply to an application for 
certification of a program by the Organization under 
subsection (e), except as follows: 
(A) The reference to 90 days in subsection 
(f)(2)(B) (relating to the period of the Adminis-
trator’s review of an application) shall be treat-
ed as a reference to 120 days. 
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(B) If the Administrator rejects the pro-
posed program, in lieu of submitting a new ap-
plication under paragraph (1) or seeking judi-
cial review of the rejection, the manufacturers 
or brand owners may choose to participate in 
the certified national pharmaceutical steward-
ship program of the Organization. 
(C) The references to 4 years in subsection 
(f)(5) (relating to the term of certification and 
to submission of a new application) shall be 
treated as references to 3 years. 
(h) PROCESS TO CHANGE DISPOSAL MECHANISM.— 
(1) PETITIONS.—On petition by any person, the 
Administrator may authorize a national pharma-
ceutical stewardship program to use, in lieu of the 
disposal technologies otherwise required by sub-
section (c)(5)(B), one of more other disposal tech-
nologies described in paragraph (2). 
(2) REQUIRED LEVELS OF PROTECTION.—The 
Administrator may authorize the use of a disposal 
technology under paragraph (1) only if the tech-
nology— 
(A) is proven, available, and consistent 
with Federal and State legal requirements; and 
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(B) provides equivalent environmental and 
human health protection in each, and superior 
environmental and human health protection in 
one or more, of the following areas: 
(i) Monitoring of any emissions or 
waste. 
(ii) Worker health and safety. 
(iii) Air, water, or land emissions con-
tributing to persistent, bioaccumulative, 
and toxic pollution. 
(iv) Overall impact to the environment 
and human health. 
(i) SUSPENSION OF PROGRAM.— 
(1) IMMINENT
DANGER.—The Administrator 
may suspend, in whole or in part, the certification 
of any national pharmaceutical stewardship program 
if the Administrator determines that such action is 
necessary to protect the public from imminent dan-
ger. 
(2) FAILURE
TO
COMPLY.—If the Adminis-
trator determines that a national pharmaceutical 
stewardship is in violation of the requirements of 
this section, the Administrator— 
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(A) may issue a written warning to the 
program stating that the program is in violation 
of this section; and 
(B) if the program has not rectified each 
violation identified in such warning within 30 
days of receipt of such warning, may suspend, 
in whole or in part, the certification of the pro-
gram. 
(j) CIVIL PENALTIES.—Beginning on the date that 
is 2 years after the date of the enactment of this Act, 
a manufacturer or brand owner of a drug shall be liable 
for a civil penalty of not more than $50,000 for each cal-
endar day on which, as determined by the Administrator, 
the manufacturer or brand owner— 
(1) is not participating in a certified national 
pharmaceutical program; or 
(2) is in violation of its obligation to contribute 
to the costs of such a program under subsection 
(c)(2). 
(k) REGULATORY POWER.—The Administrator may 
adopt rules or guidance necessary to implement, admin-
ister, and enforce this section. The Administrator, in con-
sultation with the Secretary of Health and Human Serv-
ices, the Administrator of the Drug Enforcement Agency, 
the Director of National Drug Control Policy, and the 
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Commissioner of Food and Drugs, may include in such 
regulations or guidance any performance standards deter-
mined appropriate for implementing the program require-
ments specified in this section. 
(l) STATE, TRIBAL, AND LOCAL REGULATION.—This 
section does not preempt the authority of State, tribal, 
and local governments to impose more stringent require-
ments relating to the disposal of drugs. 
(m) REPORT
TO CONGRESS.—By December 31, 
2016, the Environmental Protection Agency shall report 
to the appropriate committees of the Congress concerning 
the status of the national pharmaceutical stewardship pro-
grams under this section, including any recommendations 
for changes to this section. 
(n) SEVERABILITY.—If any provision of this section 
or the application of such provision to any person or cir-
cumstance is held to be unconstitutional, the remainder 
of this section, and the application of the provisions of 
such remainder to any person or circumstance, shall not 
be affected thereby. 
(o) DEFINITIONS.—In this section: 
(1) The term ‘‘Administrator’’ means the Ad-
ministrator of the Environmental Protection Agency. 
(2) The term ‘‘board of directors’’ means the 
board of directors of the Organization. 
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(3) The term ‘‘brand owner’’, with respect to a 
drug, means the holder of an approved application 
for the drug under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355). 
(4) The term ‘‘certified national pharmaceutical 
stewardship program’’ means a national pharma-
ceutical stewardship program with a certification in 
effect under subsection (f) or (g). 
(5) The term ‘‘controlled substance’’ has the 
meaning given to such term in section 102 of the 
Controlled Substances Act (21 U.S.C. 802). 
(6) The term ‘‘drug’’ has the meaning given to 
such term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321) except that such 
term excludes any drug for which a take-back pro-
gram is in effect pursuant to a risk evaluation and 
mitigation strategy under section 505–1 of such Act 
(21 U.S.C. 355–1). 
(7) The term ‘‘Organization’’ means the Na-
tional Pharmaceutical Stewardship Organization es-
tablished in accordance with subsection (b). 
(p) FEES.—The Administrator may assess and col-
lect fees from manufacturers and brand owners of drugs 
to pay the administrative costs of carrying out this section. 
The Administrator shall allocate such fees among manu-
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