By Matt Martin, PharmD, PCCA Clinical Compounding Pharmacist, and Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development

The FDA has provided a preliminary list of products that were originally approved as drug products, but that will be considered biologic products as of March 23, 2020.¹ Human chorionic gonadotropin, or HCG, is one of these drugs that will now be deemed a biologic product. This means that, starting on March 23, 2020, pharmacies will no longer be able to compound with HCG, and we will be retiring all PCCA formulas that include it at that time.

Background

“Drugs” are generally approved under Section 505 of the Food, Drug, & Cosmetic Act (FD&C Act) while “biologics” generally receive a biologics license under Section 351 of the Public Health Service Act (PHS Act). Traditional pharmacies compounding medications and dispensing them by prescription are considered 503A pharmacies under the FD&C Act. While Section 503A of the FD&C Act provides pharmacies some exemptions, it does not provide an exemption from requiring approval for a biologics license under Section 351 of the PHS Act — meaning that pharmacies cannot compound with biologic products.² You can read more about this framework in the FDA’s guidance document titled “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”

Potential Compounding Options

However, compounding is about attempting to solve the needs of patients through innovation in a partnership with the patient and their practitioner. For PCCA members with Clinical Services access, our team of pharmacists are ready to help examine formulations in our database and evaluate if they might be appropriate for patients.

With that in mind, we have a number of potential compounded formulations for compounders’ consideration if FDA-approved products do not meet the needs of their patients. When HCG had previously been part of a regimen for testosterone therapy, one option for men’s health is the use of anastrozole, as it will help the body continue to make testosterone to minimize the negative-feedback effects of testosterone therapy.^3,4,5

PCCA members with Clinical Services access can find a list of example formulas that include anastrozole and testosterone in a variety of dosage forms on our Members-Only Website. 

Matt Martin, PharmD, is a Clinical Compounding Pharmacist at PCCA. He joined the PCCA Clinical Services department in September 2014. Matt graduated from Morehead State University with a BS in Chemistry in 2002, and received his PharmD from the University of Kentucky College of Pharmacy in 2006. Prior to joining the PCCA team, Matt worked in compounding pharmacy for more than eight years, and has experience with both sterile and non-sterile preparations.  

Melissa Merrell Rhoads, PharmD, PCCA Director of Formulation Development, received her pharmacy degree from Mercer University in Atlanta, Georgia, in 1995. She currently is involved with and oversees the development and implementation of new formulas at PCCA. She had more than six years of compounding experience with pharmacies in Georgia and Florida prior to joining the PCCA staff in 2004. Her areas of interest include women’s health, veterinary and pain management compounding.

References
1.    U.S. Food & Drug Administration. (2019). Preliminary list of approved NDAs for biological products that will be deemed to be BLAs on March 23, 2020 [PDF File]. Retrieved from https://www.fda.gov/media/119229/download
2.    U.S. Food & Drug Administration. (2018). Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application: Guidance for industry [PDF File]. Retrieved from https://www.fda.gov/media/90986/download
3.    Charnow, J. A. (2013). Anastrozole improves testosterone therapy. Renal & Urology News. Retrieved from https://www.renalandurologynews.com/home/departments/mens-health-update/hypogonadism/anastrozole-improves-testosterone-therapy/
4.    DiGiorgio, L., & Sadeghi-Nejad, H. (2016). Off label therapies for testosterone replacement. Translational Andrology and Urology, 5(6), 588–849. https://dx.doi.org/10.21037%2Ftau.2016.08.15
5.    National Institute on Aging. (2018). Effects of aromatase inhibition versus testosterone in older men with low testosterone: Randomized-controlled trial. Retrieved from https://clinicaltrials.gov/ct2/show/NCT00104572
 

These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment.