HCG and other NDA's reclassified by FDA as Biologic

Dear Friends of Compounding Pharmacies like Talon (and all others in the United States),

We rarely, if ever, have asked for your help. We've heard concerns from many of you about FDA's scheduled reclassification of some NDAs as biologics, set for March 23, 2020. We are asking you to take action against a recent reclassification of some NDA's including HCG.

How can you help? Glad you asked! I have provided downloadable letters including instructions on how to act (at the bottom of the letters).

Download Letter for Doctors/Providers

Download Letter for Patients

What is this all about? 

FDA's reclassification of several Section 505 drugs as biologics is set to take effect on March 23, 2020. Drugs reclassified as biologics may not be compounded without a biologics license, according to the FDA. Among the drugs to be reclassified is HCG. Because many Doctors, Compounders, and Patients may not be aware of that reclassification coming in the near future.

What will this mean for everyone?

Prices will go up for sure. Availability is likely to be decreased for several months until supply stabilizes. How much will it go up and how little supply will there be, only time will tell.

Other Resources:

  1. Preliminary list of drugs being reclassified
  2. Former FDA Commissioner Scott Gottlieb discusses the Biologics Price Competition and Innovation Act (BPCIA) that lead to this reclassification.
  3. FDA's GFI on mixing, diluting, or repackaging biologics, applying to 503A and 503B entities.

Please take action by February 12th!