H.R. 5316 — Drug Shortage Compounding Patient Access Act of 2025

This section amends section 503A(a) of the Federal Food, Drug, and Cosmetic Act to authorize licensed pharmacists or physicians to compound drug products in limited quantities for distribution to licensed prescribers for urgent administration to patients in hospitals or clinical settings—without an initial patient-specific prescription order—if (1) the drug appeared on FDA's drug shortage list under section 506E within the prior 60 days; (2) the prescriber certifies inability to obtain a comparable product from an outsourcing facility under section 503B; (3) the product is labeled with a beyond-use date per U.S. Pharmacopeia standards; (4) packaging is marked for urgent use only and requests patient records within 7 days of administration or discharge; (5) received records are linked to the order; and (6) adverse events are reported to FDA's MedWatch within 15 days. (As background, section 503A exempts traditional compounding by state-licensed pharmacies or physicians for individual patients from drug approval, labeling, and cGMP requirements to allow customized medications.) This section further revises section 503A(b)(2)—which excludes certain changes from the definition of a compounded drug "essentially a copy" of a commercial product—to also exclude drugs meeting the above shortage and documentation conditions.

This section expands manufacturer notification requirements to the FDA for critical drugs (i.e., life-supporting, life-sustaining, or used to prevent or treat debilitating diseases or conditions, including in emergencies)—previously limited to permanent discontinuances or interruptions likely to cause meaningful supply disruptions—to also cover surges in demand likely to lead to such disruptions. It revises notification timing to require at least six months' advance notice for discontinuances or interruptions (or as soon as practicable if impossible) and as soon as practicable for surges in demand; directs the FDA to distribute related information to additional entities, including outsourcing facilities; and adds or amends definitions of "drug shortage" (a period when U.S. demand exceeds supply, considering preparation or dispensing and reports from stakeholders) and "surge" (an increase in demand the manufacturer likely cannot meet without shortfall or delay).

This section modifies conditions for outsourcing facilities (i.e., registered facilities that compound drugs without certain FDA requirements such as new drug applications) to use bulk drug substances not on the FDA's clinical need list by allowing such use if the compounded drug appeared on the drug shortage list at any time during the 180-day period ending on the date of compounding, distribution, or dispensing (from at the time of such activities). It further directs the Secretary to make publicly available annual updates on the evaluation of bulk drug substances for the clinical need list.

This section amends section 503A of the Federal Food, Drug, and Cosmetic Act by (1) striking and replacing the labeling requirement in subsection (b)(3)(B) to require that compounded drug products be labeled “This medication has been compounded for dispensing to an individual patient and has not been approved by the Food and Drug Administration”; and (2) in subsection (b)(1)(A)(i)(I), revising the compliance standards for bulk drug substances to a United States Pharmacopoeia or National Formulary drug or dietary supplement monograph (from United States Pharmacopoeia or National Formulary monograph).