December 10, 2021

Hospital compounding GFI “strikingly inconsistent,” APC tells FDA

In a comment letter submitted Monday, APC said FDA’s proposed grant of flexibility to hospital pharmacies related to the Food, Drug & Cosmetic Act’s prescription requirement is “strikingly inconsistent” with both the agency’s treatment of other state-licensed and -compliant 503A pharmacies and with the statute itself.

APC’s comment letter was submitted in response to FDA’s proposed Revised Draft Guidance for Industry: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.

From the letter:

APC strongly urges FDA to rescind both the revised hospital compounding GFI and the prescription requirement GFI (Docket No. FDA- 2016-D-0269) and issue a new GFI that implements 503A consistently between hospital and non-hospital pharmacies. The plain language of the statute makes no distinction for hospital pharmacies, and a new GFI should provide flexibility for providers and patients in both hospital and non-hospital clinical settings to access critical compounded drugs when needed in urgent medical situations but unavailable commercially or from an outsourcing facility.