Sec. 8. Withdrawal of approval of certain opioids
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/bill/116/s/4242/is/section-8·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Notwithstanding any other provision of law, any ultra-high-dose opioid shall be considered a drug that presents an imminent hazard to the public health within the meaning of section 505(e) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(e) ), and the Secretary of Health and Human Services shall suspend the approval of such drug, in accordance with such section 505(e). In this section, the term ultra-high-dose opioid means an opioid drug for which the daily dosage provided for in the approved label exceeds the morphine milligram equivalents per day outlined in the report entitled CDC Guidelines for Prescribing Opioids for Chronic Pain , published by the Centers for Disease Control and Prevention in 2016 (or any successor document).
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Sec. 8
Withdrawal of approval of certain opioids
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