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Drug Shortage Compounding Patient Access Act of 2025

In committee: it can still change before the session ends.

US HR 5316 · House Bill · 119th Congress

Draft a letter
Stage
In committee
Started in
House
Sponsors
4
Latest action
Sep 11, 2025

What it does

Drug Shortage Compounding Patient Access Act of 2025 This bill relaxes certain requirements for the compounding of drugs facing shortages. Currently, subject to certain requirements, compounded drugs (i.e., drugs altered to meet patient needs) do not require Food and Drug Administration (FDA) approval. There are two general categories of compounding: (1) pharmacy compounding, wherein a licensed pharmacist or physician not registered with the FDA compounds in limited quantities for identified patients; and (2) bulk compounding, wherein an FDA-registered outsourcing facility compounds in bulk for use in medical facilities. The bill permits pharmacy compounding in limited quantities for an…

Official summary · Introduced in House · Sep 11, 2025

Titles and provisions can change as the bill moves.

Read the full textRead it on the official site

Where it stands

  1. Introduced (Done)

    Sep 11, 2025

  2. Committee (Current step)

    In committee · Sep 11, 2025

  3. Floor (Not started)

  4. Law (Not started)

What moved

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Who is involved

Sponsors

The lawmakers who put their names on it, lead sponsors first.

Where it goes next

While a bill can still move, the questions are about people and money.

Work with this bill

Drug Shortage Compounding Patient Access Act of 2025 | 52