Compounding pharmacies have increasingly been at the centre of safety concerns around the legitimacy and credibility of medications, especially obesity drugs. 鈥檚 semaglutide, for example, has been making headlines worldwide, increasingly becoming synonymous with prompting significant weight loss.
Compounding is the practice of customising medications for individual patients, and it is subject to specific US Food and Drug Administration (FDA) regulations. Amid recent news relating to safety concerns with compounding pharmacies, consumer concerns swirl as to whether the availability of obesity drugs via compounding pharmacies poses risks to patient health.
New regulatory rule under consideration
Safety processes and regulations apply to custom-made medicines, which differ from traditional pharmacies. Now, however, compounding pharmacies and the risk of counterfeit medications entering the US market are evolving against the backdrop of regulatory changes, sparking new restrictions.
Earlier this year, the FDA proposed a new rule to address challenges in compounding certain drug products. On 20 March, the US FDA issued a proposed update to the FD&C Act, which follows increased attention on compounding semaglutide and related products. If implemented, it establishes criteria for listing drug products or categories of drug products that present clear challenges for compounding pharmacies.
Drugs that appear on the accompanying lists may not be compounded under Section 503A or 503B. As part of the new rule, the FDA suggests six criteria it would examine before adding drugs to a list: formulation, dosage form, compounding process, delivery system, bioavailability, and testing.
Semaglutide drugs at the centre of action
The FDA originally approved semaglutide as Ozempic to treat type 2 diabetes in adults in 2017. Since then, its use has been extended to help manage weight loss, where the drug is marketed as Wegovy.
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By GlobalDataSemaglutide is part of a family of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. The class of medications mimics the GLP-1 hormone, which enters the gastrointestinal tract after eating. As part of its function, GLP-1 instructs the body to produce more insulin, lowering blood glucose. When the GLP-1 hormone exists in the body in higher amounts, the FDA states it can interact with areas of the brain that can decrease appetite and prompt a feeling of fullness.
There are currently three FDA-approved semaglutide products on the US market to aid weight loss and manage type 2 diabetes: Wegovy injection, Ozempic injection, and Rybelsus tablets.
On 8 March, the FDA also approved Wegovy to help lower the risk of cardiovascular death, heart attack and stroke in adults with heart disease who are obese or overweight.
Compounding concerns
Only available with a prescription, the FDA confirms there are no approved generic versions for the three medications. A drug may be compounded and therefore made available when there is a shortage of a particular medication. Since May 2023, Ozempic and Wegovy are listed on the FDA鈥檚 Drug Shortages list.聽
Compounding pharmacies may prepare a compounded version of one of these three approved drugs. However, this is only possible if they meet specific requirements detailed in the Federal Food, Drug, and Cosmetic (FD&C) Act. 鈥淧atients should not use a compounded drug if an approved drug is available to treat a patient,鈥� the FDA states.
Novo Nordisk鈥攖he company behind Ozempic, Rybelsus, and Wegovy鈥攃onfirms it does not directly or indirectly provide or sell bulk semaglutide to compounding pharmacies or any other entity that compounds semaglutide products.
鈥淲e cannot validate the safety or effectiveness of compounded products claiming to contain semaglutide that are not one of our own branded products,鈥� a spokesperson for Novo Nordisk told Pharmaceutical Technology. Novo Nordisk owns the registered trademarks for the FDA-approved Ozempic, Rybelsus and Wegovy drugs.
鈥淢edical spas, weight loss or medical clinics, and compounding pharmacies claiming to offer or sell compounded products claiming to contain 鈥榮emaglutide鈥� are sourcing their ingredients from entities other than Novo Nordisk,鈥� the spokesperson said.
Aware of the currently limited supply of certain drugs, the FDA urges patients to get their prescription drugs from state-licensed pharmacies in the US. In those cases, unlike counterfeit alternatives, the FDA and state authorities can ensure the quality of drug manufacturing, packaging, distribution, and labelling.
Some products marketed and sold as semaglutide may not be formulated with the same active ingredient as FDA-approved semaglutide products. Instead, they may be made from salt formulations. 鈥淧roducts containing these salts, such as semaglutide sodium and semaglutide acetate, are not safe and effective,鈥� the FDA says. On 27 April 2023, the FDA wrote to the National Association of Boards of Pharmacy detailing the agency鈥檚 concerns with using salt forms in compounded products. A few months later, the FDA sent additional letters to the National Association of Boards of Pharmacy and the Federation of State Medical Boards voicing similar worries.
Legal action against compounding
Novo Nordisk has taken legal action against compounded products claiming to include the drug semaglutide. In June 2023, the Danish multinational pharmaceutical company announced it was.
In November 2023, it revealed it was pursuing additional legal proceedings against two compounding pharmacies for selling adulterated and misbranded compounded drugs claiming to contain semaglutide. These claims brought its total proceedings to 12 legal actions, five of which were against compounding pharmacies.
Novo Nordisk confirmed that it had identified the presence of unknown impurities as high as 33%, which may pose potential safety risks to patients. The company also found lower levels of strength than labelled, including a sample with at least 19% less than what it claimed. The company states that this puts patients at risk of taking drug products that are less effective than expected based on their labeling.
Novo Nordisk also with information on compounded semaglutide. The company detailed that the FDA鈥檚 Adverse Event Reporting System (FAERS) database included 352 cases of adverse events associated with compounded 鈥渟emaglutide鈥� as of 31 December, 2023. Of those cases, 268 were classified as 鈥渟erious鈥� adverse events, 84 reported hospitalisation, and five involved deaths. It also stated that administration errors found patients had accidentally self-administered doses of compounded 鈥渟emaglutide鈥� that were up to ten times the intended amount.
Note: Paragraphs 1 and 2 have been updated to reflect the correct indicated name for semaglutide’s use as a weight loss treatment.
