ORANGE, Calif., Aug. 28, 2025 /PRNewswire/ -- Has a new breed of "Pharma Bros" emerged to undermine legitimate providers and potentially put patient safety at risk? They're not hedge fund traders or risk loving MedTech execs, but compounding pharmacies willing to ignore Federal Laws and FDA's very specific and very public warnings.

Despite a clear legal ban on compounded biologic products such as human chorionic gonadotropin (HCG), some pharmacies continue to produce them illegally. Their motive? The claim is often "patient accessibility." But there is no shortage of legitimate, licensed HCG. Thus, the likely real pursuit is profit, at the expense of regulatory compliance and, potentially, patient safety.

"Compounders know the law. They know compounded biologics are banned by the FDA. Yet many still make these drugs because the margins are just too good," said NuCare Pharmaceuticals, a California-based supplier of legally licensed HCG and other biological products. "This isn't a gray area—it's a black-and-white violation of federal law, and it may put patients at risk."

The FDA has repeatedly warned that compounding biologic products like HCG is illegal.¹ But enforcement often lags. By the time inspections are finished or warning letters are sent, compounders willing to take short cuts may have already pocketed millions. For them, a finger wag from the FDA is just another business expense. The real danger comes when patients are harmed. At that point, federal prosecutors may step in, and compounders risk massive civil lawsuits or even prison. Severe consequences, to be sure, but that may only come down after harm has occurred.

Compound pharmacists that produce biologic products like HCG know exactly what they are doing. They are choosing profits over patients.

Consumers Beware

When it comes to fertility treatment, hormone therapy, or men's health protocols, the source of medication is critical. Biologics aren't ordinary drugs. They are derived from living cells, highly complex, and because they are sterile injectables, must be made under the most demanding and consistent manufacturing conditions. Even the smallest variation in how they are made can drastically affect sterility, potency, purity, and safety.

FDA-licensed biologics are produced under rigorous quality oversight, with strict manufacturing controls and continuous monitoring for safety and quality. Illegally compounded biologics lack these safeguards, which patients take for granted. By bypassing FDA review and regulatory protections, they expose patients to unpredictable and potentially dangerous products.

Patients should take precautions

Ask your pharmacist or provider if your HCG was produced by an FDA-licensed commercial manufacturer.

Verify the source of your medicines. Clinics, pharmacies, and telehealth companies should only utilize HCG made by FDA-licensed manufacturers.

Report suspected violations to the FDA's MedWatch program: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

A Legal, Compliant Source

As non-compliant players put patients at risk, clinics and pharmacies should rely on suppliers that prioritize both patient access and safety. NuCare Pharmaceuticals is one of the nation's leading providers of FDA-licensed commercial HCG and hormone therapies. With dependable inventory, rapid fulfillment, and strict safety, quality, and compliance practices, NuCare delivers medicines that providers and patients can trust.

If your clinic is still sourcing compounded HCG, or if you're unsure about your current supply chain, it's time to make a change to legitimate, licensed HCG. Protect your patients. Protect your practice.

Contact NuCare Pharmaceuticals today to switch to an FDA-licensed supply.

NuCare Pharmaceuticals
622 W Katella Ave, Orange, CA 92867
Apply@NuCareRxUSA.com
(888) 569-8633

Source:
1. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020

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 and FDA-licensed products to healthcare providers and pharmacies. Providers are responsible for ensuring compliance with applicable federal and state laws.

 

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SOURCE NuCare Pharmaceuticals