Compounding and HCG
The issue
The statutory March 2020 reclassification of a number of substances as biologics has resulted in an interruption of care for many patients who relied on compounded versions of those substances. HCG may be the most prominent of those, despite the fact that is has a USP monograph.
APC has partnered with the Outsourcing Facilities Association to make that the case to FDA that the reclassification has created medication access issues for patients, and compounders should be allowed to compound HCG.
Resources and information
- Reed Smith Comment Letter to FDA (December 2020)
- APC Comment Letter on Implications of Reclassification on Compounding HCG (March 2021)
- Slide Deck: OFA-APC Listening Session Presentation to FDA (July 2021)
