The escalating demand for weight loss medications such as Ozempic, Rybelsus, Wegovy, and Mounjaro, fueled by social media influence, has presented challenges for manufacturers struggling to meet the overwhelming market needs. Eli Lilly’s recent approval of Zepbound, a renamed version of Mounjaro for weight management, adds further strain to the already high demand. In response, Novo Nordisk, the producer of Ozempic, Wegovy, and Rybelsus, has intentionally delayed the release of new Wegovy starter doses to prioritize existing users amid limited availability and manufacturing constraints.
However, the surge in demand has led to the emergence of dubious versions of these drugs, raising concerns among healthcare professionals about the contents of these unauthorized alternatives. Online sellers are capitalizing on the opportunity, offering counterfeit Wegovy with questionable semaglutide content. Novo Nordisk has taken legal action against medical spas, weight loss clinics, and compounding pharmacies in the U.S., alleging the sale of unapproved versions of its drugs containing semaglutide variants not sanctioned by the FDA. (TIME contacted the compounding pharmacies named in the suits in Florida and Tennessee, but received no responses.)
Compounding pharmacies, operating in a legal gray area, have become a focal point in the weight loss drug market. Licensed and regulated by state pharmacy boards, these pharmacies are authorized to produce personalized drug versions tailored to individual patient needs. While they can modify ingredients to address allergies or improve taste, the FDA does not review these drugs for safety and efficacy, as they fall under Section 503A of the Federal Food, Drug, and Cosmetic Act.
Semaglutide, a key component of these weight loss drugs, is currently in short supply, leading compounding pharmacies to produce alternative versions. The FDA issued a warning on May 31, cautioning against the use of semaglutide salts by compounders, insisting on the base form for safety and efficacy. Some compounding pharmacists argue that semaglutide salts, when dissolved, yield the same end product and meet FDA criteria. This debate highlights the complexity surrounding compounded versions of weight loss drugs.
The demand for semaglutide-based weight loss drugs, known for their effectiveness in achieving substantial weight loss, has increased scrutiny on compounding pharmacies and their practices. Patients now face the challenge of verifying the legitimacy of facilities providing these medications.
Compounding pharmacists, who create these drugs without a standardized recipe, insist on the legitimacy of their products. They emphasize adherence to FDA-registered manufacturers for ingredients and rigorous testing by independent labs to ensure potency, sterility, and safety.
However, the responsibility for verifying the legitimacy of compounded drugs largely falls on patients. Compounding pharmacies are not required to proactively report testing results to state boards, leaving patients to rely on their own inquiries. Varying levels of state oversight contribute to inconsistencies in inspections and investigations, with some states conducting more rigorous checks than others.
Patients like Jess Holmes, who opted for a compounded version due to limited access to branded drugs, find themselves navigating a system reliant on self-vetting. Despite experiencing side effects, Holmes has lost weight and remains satisfied with her compounded semaglutide.
Compounding pharmacies are just one alternative source, and caution is urged against online retailers without proper licensing. The National Association of Boards of Pharmacy warns against illegitimate sites, emphasizing the need for prescriptions and raising awareness about warning signs such as unrealistically low prices and promises of swift delivery.
As the demand for compounded weight loss drugs continues to rise, the industry faces challenges in balancing accessibility, safety, and regulation. Compounding pharmacists express frustration with the surge in demand, highlighting the need for a nuanced approach to address the diverse health needs of patients seeking these medications.