FDA crackdown on compounded HCG prompts urgent compliance warning from NuCare Pharmaceuticals

NuCare Pharmaceuticals, a leading national supplier of FDA-approved Human Chorionic Gonadotropin (HCG), has issued a formal industry alert warning clinics, fertility centers, and men’s health providers of significant legal and regulatory risks tied to the ongoing use of compounded HCG. The company emphasized that as of the end of the Biologics License Application (BLA) transition period in March 2020, it is illegal to compound or distribute unlicensed HCG in the United States—a rule many clinics may still be unknowingly violating.

Why did the FDA ban compounded HCG?

The U.S. Food and Drug Administration (FDA) banned compounded HCG due to mounting concerns over sterility, manufacturing inconsistencies, and patient safety risks. The decision stemmed from a broader reclassification in which HCG and similar biological products came under stricter regulatory control under the Public Health Service Act, requiring a valid Biologics License Application (BLA) for legal distribution. Compounded biologics, including HCG, are now classified as biologic drugs and no longer permitted for compounding under Section 503A or 503B of the Federal Food, Drug, and Cosmetic Act unless specifically approved.

NuCare Pharmaceuticals, based in Orange, California, is leveraging this pivotal regulatory shift to clarify widespread industry confusion. According to company executives, many clinics are still inadvertently sourcing HCG from compounding pharmacies under the assumption that their supply chain remains compliant—a misconception that could result in steep penalties, patient harm, or both.

What is HCG and why is it used in clinics?

HCG is a hormone produced during pregnancy that is commonly used off-label in both women’s and men’s health treatments. In fertility care, it is administered to trigger ovulation. In men, it plays a central role in maintaining fertility and stimulating natural testosterone production, especially in the context of hormone replacement therapy (HRT). While its therapeutic applications are well-supported, NuCare underscored that only FDA-approved formulations of HCG are safe and legal to use under current regulations.

Clinics that continue using compounded versions are risking exposure to Class I recall events—an FDA classification that signals the most severe level of safety concern. Such recalls indicate that continued use of the product could result in serious adverse health outcomes or death. Compounded HCG has already been the subject of multiple recalls, further validating FDA warnings.

What risks do clinics face using compounded HCG?

The implications are multi-pronged. Legally, providers using unapproved compounded HCG are in violation of FDA regulations and subject to sanctions, fines, and compliance investigations. Operationally, practices may face supply disruptions or lose insurance coverage if found to be in breach of care standards. Clinically, patients may be exposed to contaminated or ineffective compounds due to the lack of standardized manufacturing controls in compounded drugs.

From a litigation standpoint, medical providers may be exposed to malpractice lawsuits in the event of patient injury. According to public records, some compounded HCG batches have lacked sterility assurance or were found to contain mismeasured dosages—raising red flags among both regulators and attorneys specializing in healthcare liability.

NuCare’s leadership emphasized that the compliance gap is not always due to negligence but rather a lack of awareness. “Clinics may believe their current supply chain is valid when, in fact, it hasn’t been audited or verified post-BLA transition,” said a NuCare compliance advisor in the statement. “The FDA has made it clear: compounded HCG is no longer legal. There are no exceptions.”

What solutions does NuCare Pharmaceuticals offer?

NuCare Pharmaceuticals offers clinics a reliable and compliant pathway forward. The company specializes in distributing FDA-approved HCG, among other hormone therapies, to licensed pharmacies, urologists, endocrinologists, and fertility providers across the U.S. With vertically integrated supply capabilities, NuCare claims to provide consistent inventory, rapid fulfillment, and full regulatory documentation to support BLA-compliant clinical practices.

The company operates under strict Good Manufacturing Practices (GMP) and collaborates directly with manufacturers of FDA-licensed HCG products. Its offering includes vial formats suitable for both fertility and men’s health clinics, alongside guidance on transitioning away from non-compliant compounded products.

NuCare also supports clinics in auditing their existing suppliers and offers consultation on navigating the BLA landscape, ensuring end-to-end transparency. “We’ve seen a surge in demand from clinics that are proactively removing compounded products from their formulary,” a NuCare spokesperson added. “Our goal is to be the trusted compliance partner clinics need in a highly regulated therapeutic space.”

Industry sentiment and regulatory environment tightening

Industry stakeholders note that the FDA has increased enforcement scrutiny around compounded biologics in recent years, following several adverse events linked to compounding pharmacies. This includes inspections, warning letters, and public safety communications targeted at products like HCG, compounded insulin, and growth hormones. The FDA’s compounding oversight group has explicitly advised providers to source biologics only from FDA-licensed manufacturers.

Market sentiment reflects increased wariness among providers. Healthcare risk managers are urging clinics to evaluate their vendors, with many seeking out third-party verification or switching to established pharmaceutical distributors. Insurers have also started adjusting malpractice underwriting criteria to reflect emerging risks in HRT and fertility segments, especially when compounded biologics are involved.

Although NuCare is privately held and does not disclose financials, it is regarded within the sector as a leading national distributor with strong reputational capital in fertility and hormone medicine supply chains. The company’s latest advisory has received widespread distribution among clinic networks, medical boards, and state health agencies, highlighting growing consensus on the need for strict compliance with FDA standards.

What’s next for clinics and the HCG market?

As federal enforcement expands and awareness improves, the market for compounded HCG is expected to shrink dramatically. Analysts anticipate a consolidation of supply channels around FDA-approved sources, particularly for high-risk therapies. Legal firms specializing in FDA law have advised clinics to document procurement chains and update protocols to ensure they can demonstrate compliance during potential audits.

NuCare is expected to expand its portfolio of FDA-licensed hormone therapies in the coming quarters, and clinics are likely to face increased pressure to verify supply legitimacy. This transition is part of a broader regulatory tightening that has impacted other biologics sectors as well, including compounded vaccines and gene therapies.

Some state boards of pharmacy have already begun issuing reminders to local compounding pharmacies to halt HCG production, and enforcement actions may escalate as complaints surface or adverse events occur. For clinics, the operational directive is clear: align with approved sources or risk serious consequences.

By eliminating compounded HCG from their practices and shifting toward regulated, licensed alternatives like those supplied by NuCare Pharmaceuticals, providers can reduce liability, improve patient safety, and stay ahead of a tightening compliance curve.