H.R. 7528 — GAP Supply Act

This section revises bulk drug substance requirements for registered outsourcing facilities (i.e., facilities authorized under the Federal Food, Drug, and Cosmetic Act to compound drugs in large quantities for hospitals and health care providers, exempt from certain new drug approval and labeling rules if conditions are met) by changing the condition that a drug compounded from such a substance appear on FDA's drug shortage list at the time of compounding, distribution, or dispensing to within 180 calendar days of such activities (from at the time). The revision applies to both (1) subsection (a)(2)(A)(ii), governing general exemptions from drug approval requirements, and (2) subsection (d)(2)(A), governing additional conditions for bulk drug use. (Thus, outsourcing facilities may compound and distribute drugs using bulk substances for 180 calendar days after removal from the shortage list.)