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Code · BILL · 116th Congress · H.R. 3 (Placed on Calendar Senate) — To establish a fair price negotiation program, protect the Medicare program from excessive price increases, and estab... · Sec. 724

Sec. 724. Food and Drug Administration

235 words·~1 min read·/bill/116/hr/3/pcs/section-724

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The entirety of the funds made available pursuant to section 721(c)(3) shall be for the Commissioner of Food and Drugs, pursuant to applicable authorities in the Public Health Service Act ( 42 U.S.C. 201 et seq.) or the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) and other applicable law, to support widespread innovation in non-opioid and non-addictive medical products for pain treatment, access to opioid addiction treatments, appropriate use of approved opioids, and efforts to reduce illicit importation of opioids.
Such support may include the following: Facilitating the development of non-opioid and non-addictive pain treatments. Advancing guidance documents for sponsors of non-opioid pain products. Developing evidence to inform the potential for nonprescription overdose therapies. Examining expanded labeling indications for medication-assisted treatment. Conducting public education and outreach, including public workshops or public meetings, regarding the benefits of medication-assisted treatment, including all drugs approved by the Food and Drug Administration, and device treatment options approved or cleared by the Food and Drug Administration.
Exploring the expansion and possible mandatory nature of prescriber education regarding pain management and appropriate opioid prescribing through authorities under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ). Examining options to limit the duration of opioid prescriptions for acute pain, including through packaging options. Increasing staff and infrastructure capacity to inspect and analyze packages at international mail facilities and pursue criminal investigations.
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  • 21 USC 355–1
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Sec. 724
Food and Drug Administration
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