#USA #Orange, California #FDA #HCG #NuCare Pharmaceuticals

DOJ and FDA Highlight Dangers of Illegal HCG Sales

The Rising Concern of Unlawful Pharmacy Compounding

Recent prosecutions by the Department of Justice (DOJ) have shed light on a pressing public health issue linked to the illegal sale of human chorionic gonadotropin (HCG) in the United States. In Indiana and Florida, individuals Matthew Kawa and Jonathan Cosie admitted guilt to charges for importing unapproved HCG sourced from countries like India and China, then selling it through online platforms. While Kawa awaits his sentence, Cosie has already been sentenced to two years in prison, indicating an escalating crackdown on such illicit activities.

HCG is a compound that is derived from human biological material, heavily regulated by the FDA for specific medical conditions such as infertility treatments. The consequences of these prosecutions have intensified scrutiny over compounding pharmacies that, despite legal constraints, continue to sell unapproved HCG products via telehealth services and clinics. Since 2020, a federal law explicitly prohibited the compounding of certain biological products, including HCG, unless supported by an approved Biologics License Application (BLA). The rationale behind this legislation was concern over patient safety, as compounded HCG could potentially lead to severe health issues.

Many compounding pharmacies, similar to Kawa and Cosie, reportedly import bulk active pharmaceutical ingredients (APIs) of HCG, then utilize them to manufacture, label, and distribute unapproved products across the country, accumulating millions in illicit earnings. This practice constitutes a violation of various provisions of the Federal Food, Drug, and Cosmetic Act, which forbids the interstate trade of drugs that are misbranded or unapproved. Physicians prescribing these drugs also face potential legal repercussions as they hold the responsibility to ensure that any HCG they utilize is fully compliant with federal regulations.

Legal Actions and Continuing Concerns

The cases of Kawa and Cosie are just two instances among a series of prosecutions since the federal law was updated in 2020. This prompts questions about the legitimacy of pharmacy practices in light of increasing prosecutions of individual offenders compared to compounding pharmacies. According to a compliance professional from NuCare Pharmaceuticals, licensed pharmacies should not be immune to the law simply by virtue of holding a compounding license. The law remains unchanged regardless of how it is applied.

A senior official from the DOJ affirmed an ongoing commitment to collaborate with law enforcement to combat the distribution of misbranded drugs, including HCG. However, thus far, neither the FDA nor the DOJ has disclosed any enforcement actions against compounding pharmacies involved in illegal sales, raising critical questions about federal enforcement gaps that allow such practices to continue unpunished.

The FDA's own inspections, alongside ongoing litigation, highlight its awareness of state-licensed pharmacies still involved in compounding HCG, despite this practice being explicitly prohibited. This discrepancy in enforcement creates confusion and concern over why individuals receive harsh sentences while pharmacies engaging in similar misconduct face no visible consequences. Holding these businesses accountable may be essential to uphold the integrity of U.S. drug laws and patient safety.

The question looms: if enforcement actions are eventually pursued against compounding pharmacies compounding HCG, will regulatory bodies mandate the return of unlawful profits accrued from these illegal practices? Like the prosecutors' demands for Kawa and Cosie to forfeit their unlawful earnings, comparable standards should apply to pharmacies and physicians. If they knew that illicit profits would be reclaimed, compliance with patient safety laws might become a priority.

As an industry leader, NuCare Pharmaceuticals is urging federal authorities to address these pressing issues and ensure that corrective measures are taken to safeguard patient welfare while maintaining the robustness of U.S. drug regulations.

About NuCare Pharmaceuticals

NuCare Pharmaceuticals, Inc. is recognized as a leading provider of FDA-licensed HCG and hormone therapies in the country. The organization maintains stringent standards regarding safety, quality, and compliance to deliver reliable medications for healthcare providers and patients alike.