Title: LABEL Opioids Act
Policy area: Crime and Law Enforcement

Summary:
Lessening Addiction By Enhancing Labeling Opioids Act of 2021 or the LABEL Opioids Act
This bill requires prescription opioids to contain a warning label specifying that the opioids may cause dependence, addiction, and overdose. A registrant (e.g., a pharmacist) who dispenses an opioid in violation of the labeling requirement is subject to penalties.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1026 Introduced in House (IH)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Lessening Addiction By Enhancing 
Labeling Opioids Act of 2021'' or the ``LABEL Opioids Act''.

SEC. 2. LESSENING ADDICTION BY ENHANCING LABELING OF OPIOIDS.

    (a) In General.--Section 305(c) of the Controlled Substances Act 
(21 U.S.C. 825(c)) is amended by striking ``which shall provide that 
the label'' and all that follows through the period and inserting the 
following: ``which shall provide that--
            ``(1) the label of a drug listed in schedule II, III, or IV 
        shall, when dispensed to or for a patient, contain a clear, 
        concise warning that it is a crime to transfer the drug to any 
        person other than the patient; and
            ``(2) the label of any container or package containing an 
        opioid or opiate listed in schedule II, III, IV, or V (other 
        than a drug that is approved or authorized by the Food and Drug 
        Administration for the treatment of addiction or an opioid use 
        disorder) shall, when dispensed to or for a patient, contain a 
        clear, concise warning that the opioids or opiates dispensed 
        can cause dependence, addiction, and overdose.'';
    (b) Prohibited Act.--Section 402(a)(3) of the Controlled Substances 
Act (21 U.S.C. 842(a)(3)) is amended after ``distribute'' by inserting 
``or dispense''.
    (c) Regulations.--
            (1) Regulations.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall prescribe final regulations to implement the 
        amendments made by subsections (a) and (b), which regulations 
        shall be effective beginning on the date that is 2 years after 
        the date of enactment of this Act.
            (2) Interim rules.--The Secretary of Health and Human 
        Services may issue the regulations required under paragraph (1) 
        by interim rule to the extent necessary to comply with the 
        timing requirement in paragraph (1).
    (d) Applicability.--The amendment made by subsection (b) applies 
beginning on the date that is 2 years after the date of enactment of 
this Act.
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