Making the case on HCG to FDA

Published July 23, 2021

On Tuesday, representatives of APC and the Outsourcing Facilities Association participated in a listening session with FDA staff about patient access issues created by the 2020 reclassification of certain substances as biologics — particularly HCG.

OFA director Lee Rosebush led the presentation, asking FDA to immediately clarify that “Deemed BLAs” may continue to be compounded pursuant to Section 503A and Section 503B of the Food, Drug & Cosmetic Act, and that FDA’s March 23, 2020, Notice to Compounders does not apply to pharmacies compounding transitioned products like HCG, which has a USP monograph.

APC members Tenille Davis of Civic Center Pharmacy in Scottsdale, Ariz., and Kim Keiffer of Empower Pharmacy in Houston, shared input with FDA on drug shortage and patient access issues the reclassification has created.

“Compounders have been compounding some of these drugs for nearly 50 years,” Rosebush said. “As of March 23, 2020, nothing in these drugs changed. HCG is the same drug that it was in 1973 when it was approved by the FDA. Patients should not suffer due to access issues resulting from an administrative conversion from an NDA to BLA.”

While FDA officials did ask questions in the listening session, they offered no comments or opinion on the presentation. “There’s no requirement that they respond or act on our request at all,” said APC CEO Scott Brunner, CAE. “So, as usual, it’s ‘wait and see’.”

View the APC/OFA July 20 Listening Session presentation slides here.