Code · BILL · 113th Congress · H.R. 5587 (Introduced in House) — To reduce opioid misuse and abuse. · Sec. 5

Sec. 5. FDA review of naloxone

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The Secretary, acting through the Commissioner of Food and Drugs, shall conduct a review of naloxone to consider whether naloxone should cease to be subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) and be available as an over-the-counter drug, in order to increase access to such drug.

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U.S. Code

Exemptions and consideration for certain drugs, devices, and biological products
§ 353

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Sec. 5

FDA review of naloxone

U.S.C.§ 353

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