I 

117TH CONGRESS 

1ST SESSION H. R. 1026 

To amend the Controlled Substances Act to require dispensers of certain 

opioids and opiates to affix on the container or package thereof a clear, 

concise warning that the opioid or opiate can cause dependence, addiction, and overdose, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 11, 2021 

Mr. STANTON introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

the Judiciary, 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 amend the Controlled Substances Act to require dispensers of certain opioids and opiates to affix on the 

container or package thereof a clear, concise warning 

that the opioid or opiate can cause dependence, addiction, and overdose, 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 ‘‘Lessening Addiction 

5 By Enhancing Labeling Opioids Act of 2021’’ or the 

6 ‘‘LABEL Opioids Act’’. 


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1 SEC. 2. LESSENING ADDICTION BY ENHANCING LABELING 

2 OF OPIOIDS. 

3 (a) IN GENERAL.—Section 305(c) of the Controlled 

4 Substances Act (21 U.S.C. 825(c)) is amended by striking 

5 ‘‘which shall provide that the label’’ and all that follows 

6 through the period and inserting the following: ‘‘which 

7 shall provide that— 

8 ‘‘(1) the label of a drug listed in schedule II, 

9 III, or IV shall, when dispensed to or for a patient, 

10 contain a clear, concise warning that it is a crime 

11 to transfer the drug to any person other than the 

12 patient; and 

13 ‘‘(2) the label of any container or package con14 taining an opioid or opiate listed in schedule II, III, 

15 IV, or V (other than a drug that is approved or au16 thorized by the Food and Drug Administration for 

17 the treatment of addiction or an opioid use disorder) 

18 shall, when dispensed to or for a patient, contain a 

19 clear, concise warning that the opioids or opiates 

20 dispensed can cause dependence, addiction, and 

21 overdose.’’; 

22 (b) PROHIBITED ACT.—Section 402(a)(3) of the 

23 Controlled Substances Act (21 U.S.C. 842(a)(3)) is 

24 amended after ‘‘distribute’’ by inserting ‘‘or dispense’’. 

25 (c) REGULATIONS.— 


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1 (1) REGULATIONS.—Not later than 1 year after 

2 the date of enactment of this Act, the Secretary of 

3 Health and Human Services shall prescribe final 

4 regulations to implement the amendments made by 

5 subsections (a) and (b), which regulations shall be 

6 effective beginning on the date that is 2 years after 

7 the date of enactment of this Act. 

8 (2) INTERIM RULES.—The Secretary of Health 

9 and Human Services may issue the regulations re10 quired under paragraph (1) by interim rule to the 

11 extent necessary to comply with the timing require12 ment in paragraph (1). 

13 (d) APPLICABILITY.—The amendment made by sub14 section (b) applies beginning on the date that is 2 years 

15 after the date of enactment of this Act. 

Æ 


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