NCPA submitted comments to FDA’s Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. FDA is issuing this interim guidance stating that, until a substance has been evaluated and is identified in a final rule as being included or not included on the 503A bulks list, FDA does not intend to take action against a state-licensed pharmacy, federal facility, or licensed physician compounding a drug product using a bulk drug substance that is not a component of an FDA-approved drug product and that is not the subject of an applicable USP or NF monograph, provided that certain conditions are met.
NCPA supported this policy as it preserves patient access to compounds that have not yet been evaluated for inclusion or exclusion to the 503A bulks list. However, as FDA does not intend to categorize bulk drug substances that the public nominates for inclusion on the 503A bulks list on or after the date this guidance is finalized, NCPA asked that FDA maintain transparency of the revision of the 503A bulks list. We recommended that FDA publish on some cadence, say once a quarter, substances that are nominated and currently evaluated for inclusion on the 503A bulks list, with opportunity for comment. Public view and input into the nomination process is critical for patients and for the compounding pharmacists that serve them.
