[Congressional Record Volume 165, Number 169 (Thursday, October 24, 2019)]
[Senate]
[Page S6165]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 1072. Mr. MARKEY (for himself, Mr. Braun, and Mr. Manchin) 
submitted an amendment intended to be proposed to amendment SA 948 
proposed by Mr. Shelby to the bill H.R. 3055, making appropriations for 
the Departments of Commerce and Justice, Science, and Related Agencies 
for the fiscal year ending September 30, 2020, and for other purposes; 
which was ordered to lie on the table; as follows:

       At the appropriate place in division B, insert the 
     following:

     SEC. __. OPIOID LABELING REQUIREMENTS.

       (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).
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