Code · BILL · 114th Congress · H.R. 3677 (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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