February 24, 2025: PSM report finds 80% of declared, unapproved semaglutide and tirzepatide slipped past customs over 17 months
Major Stories
A new PSM report shows that unregulated semaglutide and tirzepatide are slipping by FDA and CBP at the border. Semaglutide is no longer in shortage. Fake online pharmacies are still thriving.
PSM and George Karavetsos, former federal prosecutor and director of the U.S. Food and Drug Administration’s Office of Criminal Investigations, published an investigation into how much unauthorized semaglutide and tirzepatide is making its way into the country through legal importation channels. From September 2023 to January 2025, according to the FDA’s import dashboard and its database of registered drug manufacturers, authorities intercepted 18 percent of the 239 shipments of semaglutide and tirzepatide from foreign manufacturers with unregistered facilities. Many of these shipments were identified as ingredients for use in drug compounding, raising more flags about the safety profile of compounded drugs meant to replace FDA-approved Ozempic, Wegovy, Mounjaro and Zepbound.
However, the FDA announced on September 21 that injected semaglutide products were no longer in shortage. The agency declared that it would not enforce regulations barring compound pharmacies and outsourcing facilities from making copies of FDA-approved semaglutide injections until April 22 and May 22, respectively.
Click here to read the report and review the data.
A February 2025 Newsweek article examined the thriving market of fake online pharmacies selling dangerous black market and counterfeit medicines. PSM Executive Director Shabbir Safdar, one of the experts quoted in the article, addressed the enforcement challenges of shutting them down: “There is definitely more crime than there are resources to chase them. You can't arrest your way out of this problem. You can only make it harder for the criminals to do their job.”
Patient safety issues in the GLP-1 space this week
Attorneys general in 37 states and the District of Columbia asked the FDA to crackdown on bad actors endangering Americans by selling them counterfeit, unsafely compounded or research versions of the weight loss and diabetes drugs Mounjaro, Zepbound, Ozempic, and Wegovy.
Among others, AGs’ letter warned that dosing errors can result from patients formulating and injecting their own medicine, a risk that is readily observable in forums discussing these medicines.
The Arkansas State Board of Pharmacy suspended a Florida distributor’s license after it sold counterfeit Ozempic to an Arkansas pharmacy. The board was able to take quick action after an inspector using the National Association of Boards of Pharmacy (NABP)’s product verification technology, Pulse, rapidly confirmed that the product was counterfeit.
One of the compounding pharmacies making injectable tirzepatide for the telehealth provider Zappy Health relinquished its license on January 31. The Florida Department of Health filed a complaint against Ousia Pharmacy on December 5, claiming that the business was compounding without a sterile compounding license, improperly storing medicines that required refrigeration and failing to document drugs it dispensed.
Police in Pretoria, South Africa shut down an alleged drug syndicate selling counterfeit obesity treatments, steroids and other medications online. Images from the operation show boxes of “Izempic,” prefilled tirzepatide pens, and retatrutide, a drug that is still in clinical trials and not available publicly.
Screenshot from Reddit, February 2025
Domestic News
An Illinois company was fined for selling unapproved, imported surgical supplies. Two pharmacists were found guilty of diverting oxycodone pills to drug dealers. Kansas pharmacists rallied for PBM reform. Pill press news in Connecticut and Indiana.
Senators Amy Klobuchar and Chuck Grassley reintroduced the Safe and Affordable Drugs from Canada Act, which aims to lower drug costs for Americans by allowing them to import prescription drugs from Canada. Learn why importing Canadian medicine is not a viable policy solution.
Illinois-based Advanced Inventory Management, Inc. agreed to pay a $1 million fine to resolve a federal criminal investigation into its alleged selling of misbranded surgical supplies imported from overseas. The company admitted removing labels that said the products could not be sold in the U.S., marking them up, and making half a million dollars reselling them to U.S. customers.
Watch highlights from our May 2022 congressional briefing about Canadian drug importation
California-based Advoque Safeguard and its owners pleaded guilty to charges related to selling a hospital hundreds of thousands of substandard facemasks with false claims that they were N95s respirators during the earliest part of the COVID-19 epidemic.
A federal jury in Brooklyn, New York found pharmacists Yousef Ennab and Mohamed Hassan guilty of diverting over 1.2 million oxycodone pills from more than a dozen pharmacies in exchange for cash payments from drug traffickers who sold them on New York City streets. Six co-defendants in the case have pleaded guilty and are awaiting sentencing; a seventh has been sentenced to nine years in prison.
Kansas pharmacists held a day of advocacy at the state’s capitol in Topeka to push for restrictions on pharmacy benefit managers that they say are driving independent pharmacies out of business by paying them below cost.
The nationwide pressure on pharmacies has consequences: an article about pharmacy closures in Maine noted that 45% of Maine residents live in a pharmacy desert.
Daniel Pinos, an Ecuadorian dentist, received a year of probation for introducing misbranded drugs into interstate commerce. He treated patients in Pennsylvania even though he was not licensed in the U.S. and dispensed prescription drugs shipped from Ecuador. A colleague, Ecuadorian doctor Mauricio Sarmiento, pleaded guilty to the same crime in January.
Becton, Dickinson and Company announced the voluntary recall of one lot of the surgical skin antiseptic ChloraPrep Clear 1 mL due to fungal contamination that could cause serious systemic infection, sepsis, illness, and death.
Ethan Parker of Evansville, Indiana received a four-year federal prison sentence after pleading guilty to possession and distribution of a pill press. His co-defendant Joshua Harvey was sentenced to seven and a half years for conspiracy to distribute fentanyl. The pair sold fentanyl pills in and around Evansville between January and April 2022.
A federal jury in Connecticut found three New Haven residents guilty of trafficking narcotics, including fentanyl and methamphetamine pills disguised as legitimate prescription medication. Investigators seized large volumes of cocaine, fentanyl and methamphetamine in pill and powder form, four pill-press machines, an industrial mixer, firearms, and more than $200,000 in cash over the course of the investigation.
Law enforcement seized a pill press during a drug bust in Stamford, Connecticut.
International News
Canada warned about prescription drugs in more sexual enhancement products. Fake oncology drugs were seized in Turkey. Additional news in Ghana, India, Nigeria, Pakistan, Thailand, and Uzbekistan.
U.S. FDA also warns consumers about supplements that contain undeclared prescription medicines. Learn more.
Health Canada issued warnings about more than 30 sexual enhancement products that contained undeclared sildenafil and/or tadalafil. The products, which could pose serious health risks, were pulled from stores in New Brunswick, Ontario, and Quebec.
Turkey’s Interior Minister announced the seizure of five million counterfeit cancer medicines along with 100,000 empty medicine boxes, 32,000 brand labels, nine filling machines, and 350 kilograms of raw materials in Istanbul.
Nigeria’s NAFDAC has closed over 11,000 shops, shut down drug markets in Lagos, Aba and Onitsha, and arrested 40 individuals in a crackdown on the sale of counterfeit medicine inside its borders.
Counterfeit medicine seizures were also made in Ghana, India, Pakistan, Thailand, and Uzbekistan.