The FDA Has Banned Compounded HCG-- NuCare Pharmaceuticals Says Clinics Still Using It Could Face Serious Consequences
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.
Contact NuCare Pharmaceuticals today to switch to an FDA-approved supply.
NuCare Pharmaceuticals
622 W Katella Ave, Orange, CA 92867
[email protected]
(888) 569-8633
Disclaimer: This content, including all text and images, is for general informational purposes only. It has not been evaluated by the Food and Drug Administration, and is not intended for diagnosis or treatment, or to replace professional medical advice. You should consult your healthcare provider before using our products. Even when properly used under the direction of your healthcare provider, individual results may vary, and the effectiveness of our products may depend on a variety of factors, including but not limited to age, gender, overall health status, and lifestyle. Always read and follow the label instructions before using any of our products. NuCare Pharmaceuticals supplies FDA-approved products to licensed healthcare providers and pharmacies. Providers are responsible for ensuring compliance with applicable federal and state laws.
SOURCE NuCare Pharmaceuticals
Share this article