[Congressional Record Volume 164, Number 154 (Monday, September 17, 2018)]
[Senate]
[Page S6193]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 4017. Mr. MARKEY (for himself and Mr. Hatch) submitted an 
amendment intended to be proposed to amendment SA 4013 proposed by Mr. 
Alexander to the bill H.R. 6, to provide for opioid use disorder 
prevention, recovery, and treatment, and for other purposes; which was 
ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. LABELING OF PRESCRIPTION OPIOIDS.

       (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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