II 

111TH CONGRESS 

1ST SESSION S. 1336 

To amend the Controlled Substances Act to provide for disposal of controlled 

substances by ultimate users and care takers through State take-back 

disposal programs, to amend the Federal Food, Drug, and Cosmetic 

Act to prohibit recommendations on drug labels for disposal by flushing, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 24, 2009 

Mrs. MURRAY introduced the following bill; which was read twice and referred 

to the Committee on the Judiciary 

A BILL 

To amend the Controlled Substances Act to provide for disposal of controlled substances by ultimate users and care 

takers through State take-back disposal programs, to 

amend the Federal Food, Drug, and Cosmetic Act to 

prohibit recommendations on drug labels for disposal 

by flushing, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safe Drug Disposal 

5 Act of 2009’’. 


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1 SEC. 2. STATE TAKE-BACK DISPOSAL PROGRAMS. 

2 (a) IN GENERAL.—Part C of the Controlled Sub3 stances Act (21 U.S.C. 821 et seq.) is amended by adding 

4 at the end the following: 

5 ‘‘SEC. 312. STATE TAKE-BACK DISPOSAL PROGRAMS. 

6 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

7 date of the enactment of this section, the Attorney General 

8 shall promulgate regulations to authorize an ultimate user 

9 or care taker to dispose of a controlled substance in ac10 cordance with a State program described in subsection (b). 

11 ‘‘(b) STATE PROGRAMS.— 

12 ‘‘(1) MODELS; INDIVIDUALIZED PROGRAMS.— 

13 The regulations under subsection (a) shall— 

14 ‘‘(A) include 5 model State programs 

15 under which an ultimate user or care taker may 

16 dispose of an unused or partially used con17 trolled substance through delivery to a des18 ignated facility; and 

19 ‘‘(B) allow a State to work with the Attor20 ney General to devise an alternative program 

21 for such disposal that— 

22 ‘‘(i) best suits the State; and 

23 ‘‘(ii) as determined by the Attorney 

24 General, is consistent with this section. 

25 ‘‘(2) REQUIREMENTS.—Each program under 

26 paragraph (1) shall— 


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1 ‘‘(A) require a State to enact legislation as 

2 a prerequisite to adopting and implementing 

3 such program; 

4 ‘‘(B) protect the public safety; 

5 ‘‘(C) allow ultimate users and care takers 

6 to dispose of controlled substances through per7 sons other than law enforcement personnel; 

8 ‘‘(D) incorporate environmentally sound 

9 practices for disposing of controlled substances 

10 (by means other than flushing down a public or 

11 private wastewater treatment system or dis12 posing in a municipal solid waste landfill); 

13 ‘‘(E) be cost effective for the State; 

14 ‘‘(F) include convenient take-back options 

15 for urban and rural locations; and 

16 ‘‘(G) not restrict the funding which a State 

17 may use to implement the program. 

18 ‘‘(3) OTHER DRUGS AND BIOLOGICS.—A pro19 gram under paragraph (1) may, at the State’s op20 tion, apply to a drug or biological product other than 

21 a controlled substance to the same extent and in the 

22 same manner as such program applies to a con23 trolled substance. For purposes of this paragraph, 

24 the terms ‘drug’ and ‘biological product’ have the 

25 meanings given to those terms in section 201 of the 


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1 Federal Food, Drug, and Cosmetic Act and section 

2 351 of the Public Health Service Act, respectively. 

3 ‘‘(c) DEFINITION.—In this section, the term ‘care 

4 taker’— 

5 ‘‘(1) means a person responsible for taking care 

6 of one or more individuals or animals, including 

7 through provision of controlled substances; and 

8 ‘‘(2) may include a physician or other health 

9 care professional, a veterinarian, a long-term care 

10 facility, a nursing home, a hospital, a jail, or a 

11 school.’’. 

12 (b) GAO REPORT.—The Comptroller General of the 

13 United States shall— 

14 (1) collect data on the State take-back disposal 

15 programs implemented pursuant to section 312 of 

16 the Controlled Substances Act, as added by sub17 section (a); and 

18 (2) not less than every 4 years, submit findings 

19 and recommendations to the Congress regarding 

20 such programs. 

21 (c) CONFORMING AMENDMENT.—The table of con22 tents for the Comprehensive Drug Abuse Prevention and 

23 Control Act of 1970 (Public Law 91–513; 84 Stat. 1236) 

24 is amended by inserting after the item relating to section 

25 311 the following: 

‘‘Sec. 312. State take-back disposal programs.’’. 


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1 SEC. 3. NO LABELING RECOMMENDATIONS TO DISPOSE OF 

2 DRUGS AND BIOLOGICAL PRODUCTS BY 

3 FLUSHING. 

4 (a) DRUGS.—Section 505 of the Federal Food, Drug, 

5 and Cosmetic Act (21 U.S.C. 355) is amended by adding 

6 at the end the following: 

7 ‘‘(w) NO LABELING RECOMMENDATIONS TO DIS8 POSE BY FLUSHING.—In approving an application for a 

9 drug under this section, the Secretary shall ensure that 

10 the labeling for such drug does not include any rec11 ommendation or direction to dispose of the drug by means 

12 of a public or private wastewater treatment system, such 

13 as by flushing down the toilet.’’. 

14 (b) BIOLOGICAL PRODUCTS.—Section 351 of the 

15 Public Health Service Act (42 U.S.C. 262) is amended 

16 by adding at the end the following: 

17 ‘‘(k) NO LABELING RECOMMENDATIONS TO DISPOSE

18 BY FLUSHING.—In licensing any biological product under 

19 this section, the Secretary shall ensure that the labeling 

20 for such product does not include any recommendation or 

21 direction to dispose of the product by means of a public 

22 or private wastewater treatment system, such as by flush23 ing down the toilet.’’. 

24 (c) DRUGS AND BIOLOGICAL PRODUCTS ALREADY

25 MARKETED.— 


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1 (1) LABELING REVISION.—With respect to 

2 drugs and biological products that are legally mar3 keted under the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 321 et seq.) or part F of title III 

5 of the Public Health Service Act (42 U.S.C. 262 et 

6 seq.) as of the date of the enactment of this Act, the 

7 Secretary of Health and Human Services, acting 

8 through the Commissioner of Food and Drugs— 

9 (A) shall conduct a review of the labeling 

10 of such drugs and biological products; and 

11 (B) for any such labeling that includes a 

12 recommendation or direction to dispose of the 

13 drug or biological product by means of a public 

14 or private wastewater treatment system, such 

15 as by flushing down the toilet, shall order the 

16 labeling to be revised to exclude such rec17 ommendation or direction. 

18 (2) PENALTY.—Any drug or biological product 

19 whose labeling is in violation of an order issued 

20 under paragraph (1)(B) is deemed to be misbranded 

21 under section 502 of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 352). 

23 (3) EFFECTIVE DATE.—An order issued under 

24 paragraph (1)(B) shall take effect not later than 1 

25 year after the date of the enactment of this Act. 


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1 (4) DEFINITIONS.—In this subsection: 

2 (A) The term ‘‘biological product’’ has the 

3 meaning given such term in section 351 of the 

4 Public Health Service Act (42 U.S.C. 262). 

5 (B) The terms ‘‘drug’’ and ‘‘labeling’’ have 

6 the meanings given such terms in section 201 

7 of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 321). 

Æ 


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