The FDA Has Banned Compounded HCG— NuCare Pharmaceuticals Says Clinics Still Using It Could Face Serious Consequences

madman

Super Moderator
* In March 2020, Federal law changed so that compounding several types of biological products, including HCG, became illegal.1 After the Biologics License Application (BLA) transition period ended, it became illegal to manufacture or market compounded HCG in the U.S. without a BLA. The FDA and Congress have determined that compounded HCG raises patient safety concerns making it clear: compounded HCG is illegal.






The era of compounded HCG is officially over. One of the nation's leading suppliers of FDA-approved commercial HCG, NuCare Pharmaceuticals, shares what clinics and pharmacies need to know now.


ORANGE, Calif., Aug. 5, 2025 /PRNewswire/ -- Human Chorionic Gonadotropin (HCG) has long
been a staple in fertility and men's health treatments. It can play a vital role in stimulating ovulation in women, maintaining fertility and natural testosterone production in men. But despite its proven medical value, many clinics are unknowingly putting themselves at legal and regulatory risk.

In March 2020, Federal law changed so that compounding several types of biological products, including HCG, became illegal.1 After the Biologics License Application (BLA) transition period ended, it became illegal to manufacture or market compounded HCG in the U.S. without a BLA. The FDA and Congress have determined that compounded HCG raises patient safety concerns making it clear: compounded HCG is illegal.

Yet, some clinics still unknowingly source compounded versions believing they're compliant. They're not.

The potential consequences are serious—regulatory audits, patient liability, and penalties. Clinics using unapproved compounded HCG may also be jeopardizing patient health due to unknown or inconsistent manufacturing standards and questionable sterility. There are documented Class I recalls for compounded HCG from compounding pharmacies. A Class I recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.


That's where NuCare Pharmaceuticals steps in.

NuCare is one of the nation's leading suppliers of FDA-approved commercial HCG and other hormone treatment drugs for pharmacies, clinics, urologist, fertility specialists and men's health providers nationwide.

With demand for HCG surging and enforcement tightening, clinics need a reliable, compliant source they can trust. NuCare provides transparent, legal HCG supply options backed by FDA oversight, dependable inventory, and fast fulfillment.

If your clinic is still sourcing compounded HCG, or unsure about your current supply chain, it's time to make a change.

Protect your patients. Protect your practice. Choose legal HCG.
 
 

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Estradiol (E2)

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Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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