March 10, 2025: Patients transitioning from compounded diabetes / weight loss injections: Stick to licensed sources.
Major Stories
FDA’s shutdown of GLP-1 compounding could lead to a new era of risk for U.S. patients.
Last week, a federal judge ruled that compounders could not continue making tirzepatide injections while a lawsuit filed by Outsourcing Facilities Association (OFA) against the U.S. Food and Drug Administration (FDA) for removing the drug from the drug shortage list moved through the courts. A similar request in a parallel lawsuit involving semaglutide awaits the judge’s decision.
In response, FDA has clarified its timeline for enforcement against compounders making knockoffs of these diabetes and weight loss medicines: State-licensed compounding pharmacies must stop selling tirzepatide immediately and—unless OFA’s other injection request is dismissed earlier—may continue selling semaglutide until April 22, 2025. Federally-regulated outsourcing facilities may sell tirzepatide until March 19, 2025, and semaglutide until May 22, 2025.
As the compounding market for GLP-1s winds down, it is time to remind Americans: It may be tempting to seek risky replacements from online sources, but that’s dangerous. The FDA has seized counterfeit injections here in the U.S. Insulin pens relabeled as Ozempic have led to hospitalizations overseas and in the U.S. Individuals have reported near-death experiences from counterfeit glp-1s. A vendor sold Americans versions of semaglutide “for research purposes only,” assuring buyers they were the highest quality when he was actually selling them untested products he had imported from China. All medicines, and especially ones that you inject into your body, should be prescribed by a physician and purchased from a licensed U.S. pharmacy.
Vials of black market weight loss drugs seized by the Western Tennessee Drug Task Force, 2024
Patient safety issues in the GLP-1 space this week
Screenshot from Reddit
In this post, a Reddit user confers with 580 other subreddit members about boosting their glp-1 intake rather than seeking professional medical advice for both prescription use and dosage. On their own, this user is self-prescribing the maximum approved dose of tirzepatide and is also taking unregulated retatrutide, a drug that has not been approved for human use because it it still in clinical trials.
Domestic News
A Massachusetts bust yielded a pill press and dies to make over 50 different kinds of pills. More pill press news in Washington, Florida and Indiana.
A Lawrence, Massachusetts resident was arrested for allegedly distributing fentanyl and methamphetamine supplied by the Sinaloa Cartel. A February 2024 search of the defendant’s residence and alleged stash house yielded 16 kilograms of counterfeit pills; equipment, including a commercial pill press; over 50 pill dies to counterfeit Percoet, Xanax, Adderall and other drugs; kilogram quantities of illicit drugs; and firearms and ammunition.
Chandler Bennett of King County, Washington received a seven-year federal prison sentence for making and selling counterfeit fentanyl pills on the dark web. Law enforcement found weapons, two and a half kilograms of fentanyl-laced pills, fentanyl powder and three pill presses during a search of her RV and two storage spaces in 2024. Bennett’s partner Braiden F. Wilson was sentenced to eight years in prison on February 25.
Pill dies seized in Lawrence, February 2025. U.S. Attorneys Office of Massachusetts
Former Washington state resident Michael Slocumb was sentenced to 14 years in prison for his role in a drug trafficking ring that sold fentanyl pills, methamphetamine, and heroin in the Puget Sound region. Slocumb maintained a stash house in Shelton where law enforcement found two pill presses, 640,000 fentanyl pills, 13 kilograms of illicit drugs and $81,000 in cash when they searched it in December 2022.
Law enforcement in Hillsborough County, Florida and Indianapolis, Indiana also seized pill presses.
In California, the San Mateo County District Attorney’s Office announced that it is scheduling the trial of a Florida woman alleged to have performed illegal cosmetic injections that killed 34-year-old Christina Ashten Gourkani.
International News
Australia warned about counterfeit anti-choking devices. Counterfeit modafinil in Singapore.
Image from the MHRA's warning about fake anti-choking devices circulating in the U.K.
An article about the uphill battle Australia's Therapeutic Goods Administration faces when it tries to regulate brisk sales of unapproved and counterfeit medical devices used eBay sales of counterfeit LifeVac anti-choking devices as an example. Fake versions of the devices, which are not approved in the U.S., have also been found in the United Kingdom.
International news this week reflected efforts to deal with the problem of counterfeit drugs in their markets: In India, the Bengal Chemists & Druggists Association raised the alarm about a huge increase in the availability of counterfeit drugs. Coverage about drug shortages in Iraq suggested that as much as 35% of available medicine there was counterfeit or illegally imported. Somalia’s federal parliament is reviewing a law that would introduce strict licensing requirements for pharmaceutical imports, mandatory quality testing, and penalties for non-compliance.
Singapore’s Health Sciences Authority warned residents not to use unauthorised modafinil and armodafinil after nine individuals were hospitalized with serious skin reactions over the past year. Warning: This article contains graphic images of blistering and ulcers.