Drug Shortage Compounding & FDA Access

Current understanding

Federal policy on pharmacy and outsourcing-facility compounding during FDA-declared drug shortages, including Section 503A/503B rules under the FD&C Act. Proposed legislation would relax patient-specific prescription requirements, copy-drug limits, and post-shortage compounding windows to expand access when commercial supply is disrupted, and add manufacturer demand-surge reporting duties for life-sustaining drugs. Status: early-stage legislative activity.

Evidence log

• 2026-07-21 — Secure Drug Supply Chain Act of 2026: 2026 — Secure Drug Supply Chain Act of 2026 (S5043) introduced in the 119th Congress and referred to the Senate HELP Committee; bill text not yet available, but its stated focus on drug supply-chain security is adjacent to shortage-response and FDA access issues. (novelty: 2) (novelty: 2)
• 2025-12-09 — SAFE Drugs Act of 2025: 2025 — SAFE Drugs Act of 2025 (citation removed): Introduced bill would statutorily redefine ‘essentially a copy’ of a commercially available drug, raise the copy-drug limit to 20 per month, and impose annual reporting plus regular inspection requirements on certain compounders and outsourcing facilities. (novelty: 3) (novelty: 3)
• 2026-07-13 — Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments: 2026 — FDA proposed rule on drug establishment registration would let distributed manufacturing operations register as a single entity and align foreign establishment rules with the PREVENT Pandemics Act, indirectly affecting how manufacturing capacity is tracked during shortages. (novelty: 2)
• 2026-06-18 — Destruction of Hazardous Imports Act: 2026 — Destruction of Hazardous Imports Act (citation removed): Introduced bill would authorize FDA to destroy (rather than allow export of) refused imported drugs posing a significant public health concern, potentially affecting the disposition of substandard imported drug supply during shortage responses. (novelty: 3) (novelty: 3)
• 2026-05-20 — Revision of Applications for Manufacturing and Procurement Quotas: 2026 — DEA proposed rule to revise controlled substance manufacturing/procurement quota applications cites drug shortage prevention as a rationale, tying DEA quota administration to the broader federal drug shortage response. (novelty: 2)

Open questions

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