More News Malaysia

ORANGE, Calif., Dec. 4, 2025 /PRNewswire/ -- Recent Department of Justice (DOJ) prosecutions in Indiana and Florida for the illegal sale of human chorionic gonadotropin (HCG)¹ have renewed attention to a broader public health concern: many compounding pharmacies nationwide continue to engage in similar unlawful conduct.

In those cases, Matthew Kawa and Jonathan Cosie each pleaded guilty to importing unapproved HCG from India, China, and elsewhere and selling it online. Kawa's sentencing is pending, while Cosie was sentenced to two years in prison.

HCG is a biological drug derived from living human material and is heavily regulated by the FDA for the treatment of specific types of infertility and other medical conditions. These serious federal prosecutions have intensified scrutiny of compounding pharmacies that sell unapproved HCG through telehealth providers and clinics.

In March 2020, federal law changed to prohibit the compounding of certain biological products, including HCG, without an approved Biologics License Application (BLA).2 The FDA and Congress determined that compounded HCG poses patient safety risks and made it clear: compounding HCG for human use is illegal and can potentially lead to serious adverse events.

Reportedly, like Kawa and Cosie, many compounding pharmacies continue to import bulk HCG active pharmaceutical ingredient (API) from foreign sources and use it to compound, label, and distribute unapproved HCG products nationwide, potentially generating millions in illicit profits. Such conduct violates multiple provisions of the Federal Food, Drug, and Cosmetic Act that prohibit the interstate sale or receipt of drugs that are adulterated, misbranded, or unapproved.3 Physicians who prescribe these drugs and cause them to enter interstate commerce could also face liability under federal law, as it is their professional and legal responsibility to know that HCG requires a BLA and cannot be lawfully compounded.

The Kawa and Cosie cases are among several other HCG prosecutions brought since the 2020 change in the law.4 "If an individual can be prosecuted for selling unapproved HCG, licensed pharmacies should not be allowed to sell the same illegal drug simply because they hold a compounding license," said a NuCare compliance professional familiar with these cases. "The law doesn't change just because the seller hides behind the guise of 'compounding.'"

A senior DOJ official stated that the Department would "continue to work closely with our law enforcement partners to stop the distribution of misbranded HCG drugs and other misbranded drugs, including through criminal enforcement where appropriate." However, to date, neither the FDA nor DOJ has announced any matters brought against compounders for this activity.

These recent DOJ prosecutions raise serious questions about ongoing gaps in federal enforcement that continue to allow certain compounding pharmacies to sell unlawful biological drugs like HCG in plain sight.

Publicly available records from FDA inspections and ongoing litigation make it clear that FDA is aware that several state-licensed 503A pharmacies are still compounding and distributing HCG, an activity Congress explicitly prohibited in 2020. Why has it not undertaken any enforcement measures against this illegal activity?

The FDA and DOJ clearly deem this conduct serious enough to justify the resources spent investigating and prosecuting individuals. So why have individual actors been criminally prosecuted for importing or selling unapproved HCG, while licensed pharmacies currently engaging in similar conduct have faced no visible enforcement? A pharmacy license does not legitimize this activity or convert an unapproved biologic drug into a lawful drug product.

If the FDA eventually does bring enforcement actions against pharmacies that are illegally compounding HCG, will the government require disgorgement of the millions of dollars in unlawful proceeds generated from these unapproved biologics? In the recent DOJ prosecutions, both Kawa and Cosie were required to forfeit their profits from illegal HCG sales. Pharmacies and physicians engaged in the same conduct should be held to the same standard. If they knew that the financial gains from illegal drug sales would be clawed back, they might finally choose to follow the laws designed to protect patient safety.

Most importantly, how many patients have been exposed to unapproved, untested, and potentially unsafe biological drug products because laws aren't being uniformly enforced?

NuCare urges federal regulators to swiftly resolve these questions and to take any corrective action necessary to protect patients and uphold the integrity of U.S. drug laws.

About NuCare PharmaceuticalsNuCare Pharmaceuticals, Inc. is one of the nation's leading providers of FDA-licensed commercial HCG and hormone therapies. With uncompromising standards for safety, quality, and compliance, NuCare delivers medicines that healthcare providers and patients can trust.

NuCare Pharmaceuticals622 W Katella Ave, Orange, CA 92867[email protected](888) 569-8633

Source:1. United States v. Kawa et al., Case No. 3:25-cr-00091 (Indiana), prosecuted by Acting U.S. Attorney M. Scott Proctor and Assistant U.S. Attorney Luke N. Reilander.

United States v. Cosie, Case No. 3:23-cr-00057 (Florida), prosecuted by U.S. Attorney Roger Handberg and Assistant U.S. Attorneys David Mesrobian and Kelly Karase.

2. Notice to Compounders: Changes That Affect Compounding as of March 23, 2020, U.S. Food and Drug Administration.

3. 21 U.S.C. § 331(a)–(d) — Prohibited acts (U.S. Government Publishing Office, govinfo.gov).

4. United States v. Alberg, Case No. 1:20-cr-00362 (Colorado), prosecuted by U.S. Attorney Jason R. Dunn and Assistant U.S. Attorney Bryan David Fields.

United States v. Arona, Case No. 2:23-cr-00003 (Georgia), prosecuted by U.S. Attorney Ryan K. Buchanan, Director Amanda N. Liskamm, Senior Litigation Counsel Patrick R. Runkle, Assistant U.S. Attorney Jennifer Keen, and Trial Attorney Michael J. Wadden.

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.

SOURCE NuCare Pharmaceuticals

...