| Champaklal Maganlal Homeo Pharmacy Private Limited | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
| Krishiv Foods, LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | ||||
| H.E.A.L. Marketplace | Division of Human and Animal Food Operations East III | New Drug/Misbranded | ||||
| Sure-Biochem Laboratories, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| New England Life Care, Inc. dba Advanced Compounding Solutions | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products | ||||
| citypharma.us | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United Sta |
What is semaglutide?
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.
There are currently three FDA-approved semaglutide products:
All three medications are only available with a prescription, and there are no approved generic versions.
What is compounding?
Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved, and the agency does not verify the safety or effectiveness of compounded drugs.
Can semaglutide be compounded?
When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list.
Are there concerns with compounded semaglutide?
FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.
Additionally, FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded. On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms in compounded products.
What should patients know?
Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.
Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.
Purchasing medicine online from unregulated, unlicensed sources can expose patients to potentially unsafe products that have not undergone appropriate evaluation or approval, or do not meet quality standards. If you choose to use an online pharmacy, FDA’s BeSafeRx campaign resources and tools can assist in making safer, more informed decisions when purchasing prescription medicine online.
What should health care professionals know?
Health care professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide. FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.
Reporting issues to the FDA
FDA encourages health care professionals, patients, and compounders to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:
FDA warns patients about compounded versions of Novo Nordisk’s Ozempic, Wegovy
The U.S. Food and Drug Administration (FDA) and the European Union (EU) are announcing today their decision to expand the scope of the U.S.-EU Mutual Recognition Agreement (MRA) Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMP) to include inspections of veterinary pharmaceuticals (also called “animal drugs”). This MRA entered into force on November 1, 2017, but initially included only pharmaceuticals intended for human use. Today’s action to include animal drugs in the MRA is an important step in ensuring the safety and quality of animal drug products and will enhance efficiencies for the U.S. and EU regulatory systems.
An MRA is an agreement between two or more countries to recognize a specific process or procedure of the other country, and this is the first step toward strengthening use of each other’s animal drug inspection expertise and resources. The overall goal of the MRA is to produce greater efficiencies for both regulatory systems and provide a more practical means for both the FDA and the EU to oversee the facilities that manufacture animal drugs. By utilizing each other’s inspection reports and related information, an MRA can ultimately enable the FDA and the EU to avoid duplication of some animal drug inspections and enable regulators to devote more resources to other areas where there may be greater risk.
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| iSlim, LLC | Division of Pharmaceutical Quality Operations II | Unapproved New Drugs/Misbranded | ||||
| Pharmedica USA, LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Sorcerz.com | Center for Drug Evaluation and Research | CDER | Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet |
| EarthLab, Inc., dba Wise Woman Herbals | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded |
FDA is notifying consumers of certain products promoted for sexual enhancement that have been found to contain hidden ingredients and might pose a significant health risk:
Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
