September 28, 2026: FDA warns compounding pharmacy for producing “inordinate amounts” of weight loss drugs for identical prescriptions
Major Stories
The FDA issued a warning letter to Empower Pharmacy, a Texas-based 503A compounding facility, for continuing to manufacture “inordinate amounts” of weight loss drugs that are essentially copies of brand-name products, which is no longer permitted now that shortages have resolved. The agency also said the inspection found that prescriber determinations of “significant difference” for the medications appeared to be repeated verbatim, which calls “the individualized nature of those determinations into question.” The facility was also found to have several violations of drug production standards that call into question its ability to maintain sterility.
PSM Executive Director Shabbir Imber Safdar called the letter “welcome and overdue,” while urging the FDA and Congress to take actions beyond the warning letter to ensure a safe drug supply for all Americans. In 2025, Empower Pharmacy was the subject of investigative articles by the Houston Chronicle and Endpoints News, which cited warning letters that the compounder used food-grade ingredients in injections and allegations from former employees that the company sourced ingredients from unvetted suppliers.
PSM recommends existing enforcement mechanisms and new policies to protect Americans from problems with the mass compounding of weight loss drugs in our Call to Action.
Domestic
Struggles for PBM reform in Arkansas and Iowa. Novel synthetic opioid linked to a rise in fake pill deaths. Texas man found guilty of selling unapproved and misbranded drugs.
Learn more about PBM regulations in our handout.
A dozen independent pharmacies in Arkansas are suing the pharmacy benefit manager (PBM) Express Scripts, alleging it regularly underpays pharmacies for the cost of filling a prescription. Last year, the state passed a law giving pharmacies the ability to file civil lawsuits against pharmacy middlemen if they are reimbursing a pharmacy less than it costs to fill the drugs. Since this law took effect, the 12 pharmacies allege Express Scripts has paid below the acquisition price tens of thousands of times.
Iowa attorneys are fighting to reinstate a law that would regulate PBMs after a lower court largely blocked it from taking effect. Senate File 383, signed into law in June 2025, is designed to limit anti-competitive practices of PBMs, including curbing pharmacy under-reimbursement.
A potent synthetic opioid called cychlorphine has been linked to a rise in poisoning deaths after appearing in counterfeit pills. Fentanyl test strips cannot detect cychlorphine, so people can unknowingly take the drug believing they are taking prescription medications such as Xanax or Percocet.
A federal jury found a Texas man guilty of illegally selling misbranded and unapproved drugs through websites and a Facebook group, sending more than 10,000 shipments to customers nationwide, collecting over $1.4 million. The substances, including products not approved for human use and illegally imported drugs, were sold without prescriptions with“research use only” labels to conceal their intended use by customers.
Forbes covered the story of a Montana woman who was hospitalized within an hour of injecting a popular black market peptide. The drug, which some claim has muscle-building benefits, caused a severe anaphylactic reaction, including lowering her heart rate to less than 20 beats per minute and causing her to stop breathing. She was flown by helicopter to a larger hospital to receive treatment and has regular cardiology appointments to monitor an irregular heartbeat caused by the reaction.
Pill Presses
A Michigan man has been convicted of crimes related to his involvement in a fentanyl pill stash house, where authorities found over 160,000 pills and a pill press. Following an undercover purchase of fentanyl, Florida authorities raided a home that is believed to be a drug lab with a pill press. The raid was part of a larger investigation into a website selling illegal drugs, which led to one arrest. Five people from Ohio and California were sentenced to up to 20 years in prison for their roles in smuggling controlled substances from California. After the drugs were transported to Ohio, one of the defendants purchased a pill press and over 55 pounds of binding powder to produce illicit pills.
Pill Press found in Michigan. (Photo: DOJ)
PSM in the news
Want a summary of this news straight to your inbox every week? Subscribe to our newsletter here!
In their coverage of the FDA's Empower Pharmacy warning letter, Washington Post Investigations and KING 5 cited the Partnership for Safe Medicines Executive Director Shabbir Imber Safdar’s press release calling the move “welcome and overdue.”
Regulators protecting patients in the news
Spectra Medical Devices is recalling certain sodium chloride flush ampules after quality issues at the manufacturer raised concerns that compromised sterility could expose patients to microorganisms, endotoxins, or foreign matter, potentially causing infections, systemic inflammatory responses, organ failure, or death.
International
International warnings about unsafe cosmetic injections. British regulators announce the sentencing of a man who falsified medical certifications. Canadian regulators warn about counterfeit laser hair removal machines.
Authorities in Ukraine, Montenegro, and Kuwait are warning about risks from counterfeit or improperly administered botulinum toxin products, highlighting the potential for serious patient harm from unregulated beauty injections. Ukraine has reported cases of botulism in three regions related to injections, including complications that can lead to respiratory failure, while several women in Montenegro were hospitalized after receiving suspected counterfeit Dysport. In Kuwait, authorities are working to prevent counterfeit Botox products flagged through an INTERPOL alert from entering the country.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) announced the sentencing of a man who supplied medical devices, including neonatal feeding pumps, with invalid CE markings. He received a suspended three-year prison sentence after convictions for fraudulently certifying devices used in UK hospitals.
Health Canada warned about counterfeit laser hair removal and therapy devices that were sold to clinics in Canada with falsified licences, potentially posing serious health risks due to unknown safety and effectiveness.
Portugal’s government is preparing legislation to create a specific criminal offense for selling counterfeit drugs, aiming to close a legal loophole that has allowed the practice to escape clear and adequate penalties.
Thai police uncovered a counterfeit cough and allergy medicine operation through two raids, seizing production equipment and materials for up to 100,000 bottles. Authorities continue to search for the network’s financier.
Recalled laser hair removal machines. (Photo: Health Canada)
Kenyan authorities issued a public alert after detecting fake Lucentis eye injections. One person was arrested in connection with the circulation of the counterfeit product. The affected batch numbers are 18862110 and 18802112. In India, authorities arrested two people in connection with a batch of suspected fake diabetes drugs. The Lipaglyn tablets bear the batch number IB00327A. Nigeria’s NAFDAC arraigned two men and a pharmaceutical firm over the alleged sale and distribution of counterfeit Coartem tablets, with laboratory testing finding no active ingredients in the malaria drugs.