June 11, 2021
Help us gather shortage data on HCG
FDA has granted a request from APC and the Outsourcing Facilities Association for a listening session related to restrictions on compounding HCG that have resulted from the March 2020 reclassification of the drug as a biologic. That listening session is set for July 20.
Because HCG does have a drug monograph, the restriction creates a conflict of laws and stands to deprive some patients of an otherwise viable treatment option.
Between now and July 20, APC is gathering documentation of shortages or other interruptions in availability of HCG products from wholesalers and distributors. That documentation must come from compounding pharmacies and outsourcing facilities like yours. We’re speaking here not of your own internal documentation, but of documentation directly to you from the wholesaler or distributor, either in writing or via screen shots of the vendor’s software. Please scrub any examples you share with us to remove confidential pricing or other data.
In addition, note that we need ongoing documentation, not only a single point in time. Best to begin to collect the data, say, weekly, and share it with us prior to July 20.
APC will hold confidential all sources and senders of HCG shortage/unavailability data.
Send documentation to email@example.com, and mark it as “HCG shortage documentation.”