[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2732 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 2732

 To amend the Controlled Substances Act to require warning labels for 
             prescription opioids, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 14, 2019

  Mr. Stanton (for himself and Mr. McAdams) 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 warning labels for 
             prescription opioids, 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 2019'' or the ``LABEL Opioids Act''.

SEC. 2. AMENDMENT.

    (a) In General.--Section 305(c) of the Controlled Substances Act 
(21 U.S.C. 825(c)) is amended--
            (1) by inserting ``(1)'' before ``The Secretary''; and
            (2) by adding at the end the following:
    ``(2) The label of any container or package containing an opioid or 
opiate listed in schedule II, III, IV, or V shall, when dispensed 
(other than administered) to or for a patient, contain a clear, concise 
warning, in a manner specified by the Secretary by regulation, that the 
opioids or opiates dispensed can cause dependence, addiction, and 
overdose.''.
    (b) Regulations.--
            (1) Regulations.--The Secretary of Health and Human 
        Services shall prescribe regulations under section 503(b) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) to 
        implement the amendment made by subsection (a) and such 
        regulations shall be effective not later than 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).
                                 <all>