August 17, 2026: Appeals court finds imported medications have “material, not theoretical” differences
Major Stories
The U.S. Court of Appeals for the Fourth Circuit upheld the preliminary injunction filed against alternative funding programs and related vendors, in a major win for Gilead Sciences' civil case. The Lanham Act lawsuit, filed in 2024, was filed after Gilead was notified of a Maryland patient receiving medications with label instructions in Turkish. It claims that several companies were participating in the illegal importation of HIV drugs.
The appeals court decision found that the difference between Gilead’s U.S. and international medications is “material, not theoretical.” The imported drug in the case did not include storage instructions or an FDA track-and-trace number, which can verify whether a drug is legitimate. In a statement, PSM executive director Shabbir Imber Safdar said, “You cannot import untraceable medicine with foreign-language labels, hand it to American patients, and call it equivalent to an FDA-approved medicine.”
Read more about AFP's here.
Peptides in the news
Retatrutide is at the center of six lawsuits filed by Eli Lilly, as the experimental drug was found at New York smoke shops and on Amazon. Researchers looked at social media advertising of peptides. Reporting on what a weight loss drug evaluation should look like.
Eli Lilly, which is conducting clinical trials of the investigational weight loss drug retatrutide, has filed six lawsuits against companies it says are illegally selling black market versions of its drug. Among the companies being sued are online sellers, med spas, and a compounding pharmacy, though the court documents do not mention whether the drugs the latter was selling were compounded. Any retatrutide that hasn’t been obtained through an Eli Lilly clinical trial is a black market drug.
Read more about the five major risks of taking untested peptides here.
After CBS News reported on illegal peptides being advertised and sold at New York bodegas, an independent testing laboratory found that four samples purchased at a Brooklyn smoke shop did not match reference samples and showed evidence of serious contamination. In addition to the experimental drug being found at bodegas and smoke shops, vials have been found listed on Amazon for $100-200.
This comes as a recent study found that only about 10% of videos promoting peptides on social media mentioned the serious side effects that could occur from the drugs, and 15% of the videos were from self-proclaimed medical experts. These medications are serious drugs, but because many popular peptides lack human clinical trial data, side effects and the treatment of side effects are not well documented.
Influencers have played a large role in the popularization of GLP-1 peptides, but their endorsements do not mean they are safe for everyone. The Medical Daily reported on this issue, giving readers guidance on what prescribers should be looking for to see if a patient is a good candidate for a drug. For many, an online questionnaire may not meet the standard of care, and baseline laboratory work, family history, and screening for disordered eating should be used in an evaluation.
Domestic
Canadian and American Pharmacists spoke out against drug importation programs. News about pill press prosecutions in Alabama, Maryland, and Massachusetts.
The Canadian Pharmacists Association and American Pharmacists Association issued a joint statement opposing the expansion of U.S. drug importation programs, after recent authorization in Colorado. The statement raises questions about pharmacist dispensing regulations, Canadian drug shortages, and patient continuity of care, among others.
A man in Massachusetts was sentenced to 21 years for operating a pill factory out of the basement of a residence, which was found to have two electric pill presses. In Maryland, three men were charged for their role in a drug conspiracy that led investigators to a pill press and meth pills in a residence. Authorities in Alabama investigated a drug operation that yielded a pill press and eight arrests.
A pill press seized in the Massachusetts case. Photo: DOJ
PSM in the news
In an editorial published in Real Clear Health, PSM Executive Director Shabbir Imber Safdar called out compounding pharmacies that continued producing semaglutide and tirzepatide beyond federally mandated phase-out deadlines after the FDA declared the semaglutide and tirzepatide shortages over. The piece highlights compliance failures, including a 503B facility that continued compounding tirzepatide for roughly a year after its deadline, an FDA-registered API supplier that sourced material from an unregistered third party, and Empower Pharmacy shipping medications made with ingredients from facilities that had never been FDA-registered or inspected. Safdar urges authorities to step up enforcement; without meaningful consequences, voluntary compliance is not enough to protect patients.
Regulators protecting patients in the news
Read FDA's April 2026 warning letter.
The FDA classified a Class II recall involving 162,111 vials of compounded semaglutide across 11 products after nylon/polyamide and silk/proteinaceous material particulate matter was found in the injections. The FDA issued the 503B facility a warning letter in April 2026 that documented white fiber-like particles and debris on the floor of an ISO-classified lab.
An Indian API manufacturer recalled sildenafil and tadalafil ingredients sold for compounding after an FDA inspection identified CGMP deviations. The Class II recall covers multiple lots and package sizes of APIs that were distributed nationwide in the U.S.
Fresenius Kabi issued two recalls; one for a lot of Tyenne (tocilizumab-aazg) injection after an internal investigation found glass particles in the drug. Tyenne is used for rheumatoid arthritis and severe or life-threatening cytokine release syndrome following CAR-T therapy. They also recalled one lot of morphine sulfate Injection because some syringes labeled as morphine may actually contain Dilaudid (hydromorphone).
Fresenius Kabi's recalled Tyenne Injection. (Photo: FDA)
Legislation
The Senate unanimously passed bipartisan legislation that would allow U.S. Customs and Border Protection to share suspected counterfeit shipments’ packing and shipping information with intellectual property rights holders, e-commerce platforms, and transportation carriers. The legislation is supported by several anti-counterfeiting and pharmaceutical safety organizations, including PSM, and now awaits consideration in the House.
Keep up with state legislation in the areas of pill presses, prescription drug affordability boards, drug importation, and med spas.
International
Authorities warned about Canadian med spas using unauthorized and counterfeit injections. Counterfeit drug alerts in Kenya and the Maldives.
Health Canada seized a range of unauthorized and counterfeit injectable health products from Dyosa Beauty & Wellness Lounge in Ontario, after the products were advertised for sale online. The products included Botox, injectable cosmetics, and counterfeit Juvéderm.
Kenya’s Pharmacy and Poisons Board warned about a falsified batch of emergency contraceptives (batch T34197R) in the country. Authorities have arrested two people as they investigate the counterfeit and its distribution network. The counterfeit products falsely identify Hungarian manufacturer Gedeon Richter as the producer and can be distinguished by differences in packaging, including a lack of the genuine product’s tamper-evident hot-melt seal, overly saturated orange coloring, an incorrect logo and mismatched fonts on the authentication panel, and errors in the patient leaflet.
Counterfeit Juvéderm Ultra 3. (Photo: Health Canada)
The Maldives Food and Drug Authority (MFDA) warned against a counterfeit batch of nivolumab, an injectable cancer treatment, identified as batch 8081399 and falsely attributed to Swords Laboratories Unlimited. The product was reportedly imported by a private individual, and the MFDA has prohibited its importation, sale, and use, although officials said it was not found in pharmacies. The warning follows a July 2026 World Health Organization alert about falsified Darzalex cancer medication in the Maldives and Mexico.
A Malaysian article warned that the rapid rise of GLP-1 drugs as a weight-loss solution is outpacing safeguards around their use. The authors focused on growing concerns about side effects, inadequate medical supervision, and the black-market sale of unapproved drugs such as retatrutide, which can carry risks of incorrect dosing, contamination, and counterfeit products. They called for stronger enforcement against illegal sellers, clearer safety standards for clinics providing GLP-1 injections, and better public education to ensure weight loss does not come at the expense of patient safety.