APC: FDA to NABP: Biologics shouldn’t be compounded

May 21, 2021

FDA to NABP: Biologics shouldn’t be compounded

FDA has written to NABP expressing concern about biologics — like HCG, for instance — being compounded without a biologics license application (BLA) being filed.

Biologics, it points out, have been subject to licensure under the Public Health Service Act since March 2020, and “are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.”

The letter asks NABP to reach out to state pharmacy boards (which, presumably, will contact compounding pharmacies) to ensure everyone is clear about the legal situation: “federal law does not provide a legal pathway for marketing biological products that have been prepared outside the scope of an approved BLA.”

Your takeaway: Don’t compound biologics — including HCG — without a biologics license. Period. You can click here to read the FDA’s letter (PDF).