Title: LABEL Opioids Act of 2021
Policy area: Crime and Law Enforcement

Summary:
Lessening Addiction By Enhancing Labeling Opioids Act of 2021 or the LABEL Opioids Act of 2021
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]
[S. 2353 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2353

To amend the Controlled Substances Act to require dispensers of certain 
 opioids to affix on the container or package thereof a clear, concise 
warning that the opioid can cause dependence, addiction, and overdose, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 15, 2021

  Mr. Markey (for himself, Mr. Braun, and Mr. Manchin) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Controlled Substances Act to require dispensers of certain 
 opioids to affix on the container or package thereof a clear, concise 
warning that the opioid 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 of 2021''.

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 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 listed in schedule II, III, IV, or V (other than a drug 
        that is approved, or authorized for emergency use, 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 opioid 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 by inserting ``or dispense'' after 
``distribute''.
    (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 that paragraph.
    (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.
                                 <all>