GAP Supply Act
- Bill Number
- H.R. 7528
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-02-12: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-02-27T19:02:21Z
AI-Generated Summary
Purpose This legislation aims to strengthen the U.S. drug supply by allowing outsourcing facilities more flexibility to help address drug shortages. It modifies existing rules under the Federal Food, Drug, and Cosmetic Act so these facilities can continue producing and distributing certain compounded drugs for a limited time after a shortage is declared.
Key Provisions
- Amends section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b).
- Changes the timing requirement in subsection (a)(2)(A)(ii) from “at the time” a drug is in shortage to “within 180 calendar days.”
- Applies the same change to subsection (d)(2)(A).
- Creates a 180-day “tail period” during which outsourcing facilities may compound and distribute drugs that have entered shortage status.
Significant Changes to Existing Law
- Current law restricts outsourcing facilities to compounding drugs only at the exact moment they are listed as in shortage.
- The bill extends this window by up to 180 days, giving facilities additional time to ramp up production and supply the market.
- No other sections of the statute are altered.
Potential Impacts
- Government agencies: The Food and Drug Administration (FDA) would oversee the extended compounding period and monitor compliance with safety and quality standards.
- Citizens: Patients may experience fewer disruptions in access to critical medications during shortages.
- International relations: Minimal direct effect, though improved domestic supply could indirectly reduce reliance on foreign sources during crises.
Main Stakeholders Affected
- Outsourcing facilities (specialized compounding pharmacies).
- Drug manufacturers and distributors.
- The FDA and other federal health agencies.
- Healthcare providers and patients who rely on medications in short supply.
Notable Legal, Constitutional, or Political Implications
- The bill operates within Congress’s authority to regulate interstate commerce and drug safety.
- It does not raise new constitutional questions but refines an existing regulatory framework established by the 2013 Drug Quality and Security Act.
- The measure focuses on supply-chain resilience without altering core FDA approval or inspection powers.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Carter, Earl L. "Buddy" [R-GA-1]
Recent Actions
- 2026-02-12: Referred to the House Committee on Energy and Commerce.
- 2026-02-12: Introduced in House
- 2026-02-12: Introduced in House
Bill Versions
- Growing America’s Pharmaceutical Supply Act — issued 2026-02-12 — PDF (2 pages)