{"id":630727,"date":"2024-12-12T14:51:26","date_gmt":"2024-12-12T19:51:26","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=630727"},"modified":"2025-02-28T15:00:58","modified_gmt":"2025-02-28T20:00:58","slug":"is-compounded-semaglutide-safe","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/is-compounded-semaglutide-safe\/","title":{"rendered":"Is compounded semaglutide safe?"},"content":{"rendered":"

Semaglutide has become a very popular drug that\u2019s in high demand in pharmacies everywhere and is currently also available from compounding pharmacies and online. But not all compounded semaglutide products are safe. In fact, the Food and Drug Administration (FDA) says consumers should exercise a lot of caution when considering using a compounded drug. In fact, compounded semaglutide may no longer be available for much longer. Here\u2019s what to know about buying semaglutide from a compounded pharmacy or online.<\/span><\/p>\n

What is semaglutide?<\/span><\/h2>\n

Semaglutide is the active ingredient in the popular diabetes medications <\/span>Ozempic<\/span><\/a> and <\/span>Rybelsus<\/span><\/a> and the weight-loss medication <\/span>Wegovy<\/span><\/a>. It\u2019s a <\/span>glucagon-like peptide-1 (GLP-1) receptor agonist<\/span><\/a>, which means it mimics a hormone the body naturally produces to regulate appetite and maintain healthy blood sugar levels.<\/span><\/p>\n

Ozempic is arguably the most popular semaglutide drug, not because of its FDA-approved use for treating Type 2 diabetes but because of the amount of weight people have lost while taking it. That has led to some people taking it <\/span>off-label<\/span><\/a> (for a non-FDA-approved use) for weight loss\u2014at least until the <\/span>FDA approved Wegovy<\/span><\/a> specifically for weight loss in 2021. The popularity of these drugs has led to <\/span>shortages<\/span><\/a>, which have opened up a market for compounded semaglutide.\u00a0<\/span><\/p>\n

What is compounded semaglutide?<\/span><\/h2>\n

A compounded drug is any formulation of a drug that has not been produced by its original manufacturer under an official generic or brand-name label. These drugs are often custom-made to accommodate the unique health needs of the person prescribed them. For example, if you are allergic to a nonessential ingredient in the usual manufactured formulation of a drug, you may be able to take a compounded formulation that is made without that ingredient. <\/span>According to the FDA<\/span><\/a>, compounded drugs need to be created by a licensed pharmacist or healthcare provider within the setting of a licensed pharmacy or other compounding facility.\u00a0<\/span><\/p>\n

Typically, the FDA doesn\u2019t allow compounding pharmacies to make a carbon copy of an existing, available drug. There needs to be some kind of modification or alteration made. But <\/span>if a drug is on the FDA\u2019s shortages list<\/span><\/a>, this restriction is often lifted to allow people to receive the medication they need. Because of periodic shortages, some compounding pharmacies have been able to create compounded semaglutide<\/span>\u2014until now. <\/span><\/p>\n

On Feb. 21, 2025, the FDA announced that the semaglutide shortage had ended. <\/span>The announcement<\/span><\/a> provided compounding pharmacies with a deadline to stop compounding, distributing, and dispensing semaglutide injection products that are copies of FDA-approved products (Ozempic, Wegovy, and Rybelsus). State-licensed pharmacies and physicians compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) have until April 22, 2025. Outsourcing facilities compounding under section 503B of the FD&C Act have until May 22, 2025.<\/span><\/p>\n

Difference between compounded semaglutide and Ozempic<\/span><\/h2>\n

Compounded semaglutide and Ozempic share the same active ingredient, but they aren\u2019t the exact same drug<\/a>. While <\/span>Ozempic<\/span><\/a>, <\/span>Wegovy<\/span><\/a>, and <\/span>Rybelsus<\/span><\/a> are all manufactured by Novo Nordisk, compounded semaglutide does not have a single manufacturer or formulation. Every compounding pharmacy makes its own version of the drug based on its access to any ingredients and equipment needed to produce it.<\/span><\/p>\n

RELATED:<\/strong> <\/span>Wegovy vs. Ozempic<\/span><\/a> \u2502 <\/span>Rybelsus vs. Ozempic<\/span><\/a><\/p>\n

According to <\/span>Michael Lahey<\/span><\/a>, MD, a physician with My Weight Loss Partner in Michigan, this difference between Ozempic and compounded semaglutide is crucial. Ozempic is not only FDA approved for the treatment of Type 2 diabetes and to reduce the risk of cardiovascular death or events such as stroke and heart attack in adults with Type 2 diabetes and cardiovascular disease, but it has also been fully tested for quality, safety, and efficacy. <\/span><\/p>\n

Compounded semaglutide can\u2019t be tested or FDA approved\u2014there are far too many unique formulations of it made in compounding pharmacies across the country. For example, some compounding pharmacies sell formulations of compounded semaglutide with B12, claiming that the vitamin may boost weight loss results. This has not been proven.\u00a0<\/span><\/p>\n

Risks of compounded semaglutide<\/span><\/h2>\n

Buying compounded semaglutide may seem like a beneficial way to get around frequent Ozempic and Wegovy drug shortages and the high cost of brand-name medications. Compounded semaglutide <\/span>can <\/span><\/i>be made safely and in accordance with state and federal drug laws. However, the lack of oversight and accountability for facilities producing compounded versions of drugs leaves consumers vulnerable to several risks. <\/span><\/p>\n

What the FDA says<\/span><\/h3>\n

The FDA acknowledges that compounded drugs are sometimes necessary but emphasizes that they should only be used cautiously and under the supervision of a healthcare provider since they do carry additional risks compared to brand-name and generic forms of drugs.\u00a0<\/span><\/p>\n

In July of 2024, the <\/span>FDA alerted consumers<\/span><\/a> to reports it had received about adverse reactions related to compounded semaglutide. Most of these involved dosing mistakes. For example, some types of compounded semaglutide come in a multi-dose vial that requires a person to measure the dose and inject themselves, and some people have accidentally taken excessive amounts of semaglutide in one dose, sometimes enough to qualify as an overdose.<\/span><\/p>\n

The FDA also warns healthcare providers and patients about other potential pitfalls with compounded semaglutide, including <\/span>concerns about the legitimacy of online compounding pharmacies<\/span><\/a>, the addition of unsafe ingredients, and even warnings about counterfeit versions of the drug.<\/span><\/p>\n

Quality concerns<\/span><\/h3>\n

By the time a drug is FDA approved, it has already undergone rigorous quality testing. But compounded semaglutide doesn\u2019t go through the same testing process, so many healthcare providers have concerns about the integrity of these drugs. Although compounding pharmacies are subject to federal quality standards and sometimes state-based oversight, including inspections, there\u2019s no guarantee that every pharmacy is always in compliance or producing safe, high-quality drugs.<\/span><\/p>\n

Dr. Lahey says some of the biggest overarching quality concerns with compounded semaglutide include:<\/span><\/p>\n