[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3428 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3428

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


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                   IN THE SENATE OF THE UNITED STATES

                           September 12, 2018

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

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                                 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 2018'' 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 or III 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).
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