II 115th CONGRESS 2d Session S. 3428 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 A BILL To amend the Controlled Substances Act to require warning labels for prescription opioids, and for other purposes.

1. Short title This Act may be cited as the Lessening Addiction by Enhancing Labeling Opioids Act of 2018 or the LABEL Opioids Act . 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).