August 11, 2025: The FDA voices concern about sites that supply compounding ingredients
Major Stories
According to the U.S. Food and Drug Administration’s (FDA) annual Report on the State of Pharmaceutical Quality, active pharmaceutical ingredient (API) sites that solely supply compounding pharmacies are disproportionately high risk for regulatory action. These facilities only represent 18% of registered API manufacturers, but they drew 72% of the warning letters, import alerts, and regulatory meetings taken against API manufacturing sites over the last five years.
Domestic News
Cincinnati CBP and FDA seized 55,000 counterfeit pills and injectables in a week-long operation. A cybersecurity company reported on a rogue pharmacy network. Two men charged with importing unapproved pills from India. Pill press news in Florida and Mississippi.
Unapproved tirzepatide seized during the CBP/FDA operation (CBP)
In a week-long operation, Customs and Border Protection (CBP) in Cincinnati, Ohio, and the FDA intercepted almost 55,000 counterfeit injectables and pills on their way to 40 of 50 U.S. states and Washington, D.C. The medicines, which would have been valued at $3.53 million if they had been legitimate, included counterfeit semaglutide, retatrutide, and tirzepatide; cosmetic injectables; erectile dysfunction medication; contact lenses, and other prohibited items.
The FDA followed up a January 2025 inspection with a warning letter to California-based Oasis Medical, Inc. over violations of current good manufacturing practices and the distribution of contaminated eye drops.
Gen Digital issued a threat report about a single network of 5,000 fake pharmacy websites selling counterfeit or unregulated medications while harvesting buyers’ personal and financial data. Networks like these, which emerged in the early 2000s as rogue pharmacies, began to exploit patients turning to online sales to fill their prescriptions. A study in 2011 determined that just 30 criminal organizations controlled more than 54,000 fake drug-selling websites.
Two Rhode Island residents were charged with allegedly importing hundreds of thousands of sildenafil pills from India and repackaging them as all-natural dietary supplements for erectile dysfunction. The men sold them to a wholesale distributor, Noor Inc., which sold them to retail outlets in the Northeast.
Novo Nordisk filed 14 new lawsuits against the sale of compounded versions of semaglutide under what it called “the fake guise of personalization."
ProPublica reported that two people were hospitalized after receiving peptide injections at an anti-aging conference in Las Vegas, Nevada in July.
Hollywood, Florida, residents Josue David Balaguer, Marcos Geovanny Beltre Olivo, and Joel Medina were sentenced to a cumulative 330 months in prison for distributing counterfeit prescription pills made with methamphetamine, fentanyl, and nitazenes. A search in September 2024 yielded hundreds of thousands of pressed pills, a pill press, a packaging machine, and numerous mailing supplies.
Law enforcement in Mississippi followed up a pill press seizure in Columbus with the arrest of twelve alleged drug traffickers in Lowndes County.
PSM signed on to a letter supporting the Mississippi Board of Pharmacy’s proposed regulatory changes to address safety concerns created by pharmacies reselling compounded sterile drugs purchased from outsourcing facilities. Read it here.
Legislation
Representatives Blake Moore and Brad Schneider introduced a bill that would provide CBP with explicit authority to share relevant information with companies, carriers, and platforms when a shipment contains suspected counterfeit or pirated products.
Keep up with state legislation in the areas of pill presses, prescription drug affordability boards, and drug importation.
Patient safety issues in the GLP-1 space this week
Reddit, August 6, 2025
We agree with the first commenter on this Reddit post from August 6. When you buy non-FDA approved drugs from unknown sources, you can never be sure whether they were made or stored in safe conditions.
International News
More counterfeit Cialis and Viagra found in Canadian shops. Indian authorities seize thousands of doses of counterfeit antibiotics, painkillers, and steroids.
Counterfeit Cialis found in Ontario, August 2025 (CNW Group/Health Canada)
Health Canada announced the seizure of counterfeit Cialis and Viagra from stores in Toronto, Pickering, and Brantford, Ontario.
Northern Ireland’s Department of Health warned that residents had suffered adverse effects and hospitalizations after taking fake or unregulated weight loss medication they had purchased from unregulated sources.
Authorities in New Delhi, India, arrested six people who allegedly operated a counterfeit medicine scheme that manufactured fake drugs such as Ultracet and Augmentin under the labels of prominent pharmaceutical companies and sold them to unlicensed medical providers and medical stores. Raids of facilities involved in the operation yielded tens of thousands of counterfeit pills, 74 boxes of steroid injections, and over 1,000 tubes of prescription skin cream.