Section 1 Short title
This Act may be cited as the “Lessening Addiction By Enhancing Labeling Opioids Act of 2021” or the “LABEL Opioids Act of 2021”.
Lessening Addiction By Enhancing Labeling Opioids Act of 2021
A BILL
To amend the Controlled Substances Act to require dispensers of certain opioids to affix on the container or package thereof a clear, concise warning that the opioid can cause dependence, addiction, and overdose, and for other purposes.
Sec. 2 Lessening addiction by enhancing labeling of opioids
In general— Section 305(c) of the Controlled Substances Act (21 U.S.C. 825(c)) is amended by striking “which shall provide that the label” and all that follows and inserting the following:
“(1) the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient; and
“(2) the label of any container or package containing an opioid listed in schedule II, III, IV, or V (other than a drug that is approved, or authorized for emergency use, by the Food and Drug Administration for the treatment of addiction or an opioid use disorder) shall, when dispensed to or for a patient, contain a clear, concise warning that the opioid dispensed can cause dependence, addiction, and overdose.”
Prohibited act— Section 402(a)(3) of the Controlled Substances Act (21 U.S.C. 842(a)(3)) is amended by inserting “or dispense” after “distribute”.
Regulations—
Regulations— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall prescribe final regulations to implement the amendments made by subsections (a) and (b), which regulations shall be effective beginning on the date that is 2 years after the date of enactment of this Act.
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 that paragraph.
Applicability— The amendment made by subsection (b) applies beginning on the date that is 2 years after the date of enactment of this Act.