Drug Shortage Compounding Patient Access Act of 2025

This bill aims to help patients get needed medicines during drug shortages and urgent situations. It lets licensed pharmacists or physicians prepare small amounts of a needed medicine for quick use in hospitals or clinics, even without a prescription for a named patient, if the drug was on the FDA shortage list within the past 60 days and other safety steps are met. Those steps include trying first to obtain an FDA‑regulated outsourcing‑facility version of the drug, adding proper labels and beyond‑use dates, tracking which patients received the drug within 7 days, and reporting serious side effects to FDA within 15 days .

The bill also improves drug‑shortage reporting. Drug makers must alert FDA not only about supply cuts, but also about sudden spikes in demand, with notices sent early (6 months ahead when possible) or as soon as practicable. It defines what counts as a “shortage” and a “surge,” and makes clear that shortages of active ingredients count, too. Outsourcing facilities get more flexibility to make shortage drugs if the drug was on the shortage list at any time in the past 180 days, and FDA must post annual updates on which bulk drug ingredients are allowed for compounding. Compounded medicines must carry a clear label stating they are not FDA‑approved for general use.

• Who is affected:
  • Patients needing medicines during shortages; hospitals and clinics; pharmacists and physicians who compound medicines; outsourcing facilities; and drug manufacturers that report shortages .
• What changes:
  • Allows urgent hospital use of compounded drugs tied to recent FDA shortage listings, with strict labeling, record‑keeping, and side‑effect reporting rules.
  • Requires manufacturers to report surges in demand, not just supply cuts; clarifies “shortage” and “surge” definitions; includes active ingredient issues.
  • Lets outsourcing facilities compound shortage drugs if the shortage occurred within the past 180 days; requires yearly FDA updates on eligible bulk ingredients; adds a clear “not FDA‑approved” label for certain compounded drugs.
• When:
  • 60‑day look‑back for urgent hospital compounding; 7 days to send patient use records; 15 days to report adverse events; 6‑month advance notice (or as soon as practicable) for supply cuts; “as soon as practicable” for demand surges; 180‑day look‑back for outsourcing‑facility compounding tied to shortages .