ORANGE, Calif. — NuCare Pharmaceuticals, a California-based supplier of FDA-licensed biologic medicines, is drawing attention to the continued production of compounded biologic products by some pharmacies despite a federal prohibition.
Under U.S. law, compounding pharmacies are not permitted to produce biologics such as human chorionic gonadotropin (HCG). The Food and Drug Administration (FDA) has issued repeated warnings stating that compounded biologics do not meet federal requirements and may present risks to patients. Still, according to NuCare, some pharmacies continue to make them, citing patient accessibility as a justification.
NuCare maintains that licensed, FDA-approved HCG is available in sufficient supply and that compounded versions bypass critical regulatory oversight. “This is not a gray area,” the company said in a statement. “Federal law clearly prohibits compounding of biologics, including HCG.”
The FDA has acknowledged challenges in enforcement, noting that inspections and warning letters can take time. When compounded biologics reach patients, concerns include variations in sterility, potency, and purity. FDA-approved biologics, by contrast, are subject to stringent manufacturing standards and continuous safety monitoring.
Patient Guidance
Patients receiving fertility treatment, hormone therapy, or men’s health protocols are advised to:
- Confirm that their HCG source is an FDA-licensed manufacturer.
- Verify supply chains with clinics, pharmacies, or telehealth providers.
- Report concerns or suspected violations through the FDA’s MedWatch program: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
NuCare’s Position
NuCare states that it offers legally compliant, FDA-licensed HCG and hormone therapies with consistent supply and safety standards. The company encourages clinics and pharmacies to ensure their sourcing complies with federal law to safeguard both patients and providers.
