{"id":630774,"date":"2024-12-19T10:46:30","date_gmt":"2024-12-19T15:46:30","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=630774"},"modified":"2025-10-07T14:18:43","modified_gmt":"2025-10-07T18:18:43","slug":"fda-compounded-glp-1-warning","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-compounded-glp-1-warning\/","title":{"rendered":"FDA issues warnings to GLP-1 compounders"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Originally approved to help people with Type 2 diabetes, the class of medications known as <\/span><a href=\"https:\/\/www.singlecare.com\/drug-classes\/glp-1-agonists\"><span style=\"font-weight: 400;\">GLP-1 agonists<\/span><\/a><span style=\"font-weight: 400;\"> and dual GIP\/GLP-1s\u00a0 quickly acquired a reputation for helping people shed stubborn pounds. As a result, <\/span><a href=\"https:\/\/www.uchicagomedicine.org\/forefront\/research-and-discoveries-articles\/research-on-glp-1-drugs\"><span style=\"font-weight: 400;\">the use of medications<\/span><\/a><span style=\"font-weight: 400;\"> like <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/ozempic\"><span style=\"font-weight: 400;\">Ozempic<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/wegovy\"><span style=\"font-weight: 400;\">Wegovy<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/zepbound\"><span style=\"font-weight: 400;\">Zepbound<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/rybelsus\"><span style=\"font-weight: 400;\">Rybelsus<\/span><\/a><span style=\"font-weight: 400;\">, and <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/mounjaro\"><span style=\"font-weight: 400;\">Mounjaro<\/span><\/a><span style=\"font-weight: 400;\"> has skyrocketed, as people turned to these medications to help them lose weight\u2014causing drug shortages and creating a market for compounded versions of these brand-name drugs.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">But the U.S. Food and Drug Administration (FDA) is sounding the alarm about the risks of using unapproved GLP-1s. Earlier this month, the FDA posted four warning letters to companies that have introduced unapproved GLP-1s, such as semaglutide, tirzepatide, and retatrutide, into interstate commerce.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The FDA also sent a <\/span><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/veronvy-694688-12102024\"><span style=\"font-weight: 400;\">warning letter<\/span><\/a><span style=\"font-weight: 400;\"> to the CEO of Veronvy, a company that has been selling unapproved and <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/general-device-labeling-requirements\/labeling-requirements-misbranding\"><span style=\"font-weight: 400;\">misbranded<\/span><\/a><span style=\"font-weight: 400;\"> oral GLP-1s on its website. The company was using a false or misleading label claiming that one of its products has been approved by the FDA.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">The concern over compounded GLP-1s<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Typically, compounding pharmacies are not allowed to make copies of FDA-approved medications. Rather, they create custom formulations if some sort of alteration is needed\u2014for example, if a patient requires a liquid version or a medication that\u2019s only available as a pill, or if a patient is allergic to a dye in a common prescription. However, when a drug is <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/ozempic-shortage\/\"><span style=\"font-weight: 400;\">in short supply<\/span><\/a><span style=\"font-weight: 400;\">, this restriction is lifted to help people access the medications they need. When demand for GLP-1s and GIP\/GLP-1s leaped past what the manufacturers could provide, compounded versions popped up in online pharmacies and brick-and-mortar stores, for the following drugs:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/ozempic\/what-is\"><span style=\"font-weight: 400;\">Ozempic (semaglutide)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/rybelsus\/what-is\"><span style=\"font-weight: 400;\">Rybelsus (semaglutide)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/wegovy\/what-is\"><span style=\"font-weight: 400;\">Wegovy (semaglutide)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/zepbound\/what-is\"><span style=\"font-weight: 400;\">Zepbound (tirzepatide)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.singlecare.com\/prescription\/mounjaro\/what-is\"><span style=\"font-weight: 400;\">Mounjaro (tirzepatide)<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Retatrutide (This drug is not FDA approved.)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">However, the FDA cautions that compounded drugs, while <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/human-drug-compounding\/compounding-when-drugs-are-fdas-drug-shortages-list?\"><span style=\"font-weight: 400;\">useful or even necessary in some situations<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss\"><span style=\"font-weight: 400;\">are not FDA-reviewed or approved<\/span><\/a><span style=\"font-weight: 400;\">, so the FDA cannot guarantee their safety, quality, or effectiveness.\u00a0<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/is-compounded-semaglutide-safe\/\"><b>Is compounded semaglutide safe?<\/b><\/a><\/p>\n<h2><span style=\"font-weight: 400;\">Warnings about unapproved GLP-1s<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Companies took advantage of the <\/span><a href=\"https:\/\/nabp.pharmacy\/news\/blog\/diabetes-drug-shortages-and-fake-ozempic\/\"><span style=\"font-weight: 400;\">surge in demand for GLP-1s<\/span><\/a><span style=\"font-weight: 400;\"> and began hawking illegal or even fake versions online\u2014often for prices much lower than the brand-name version. These compounded drugs may contain the wrong ingredient or no active ingredient at all, or they may contain too much or too little of the active ingredient. As a result, sometimes compounded semaglutide and compounded tirzepatide don\u2019t work, and sometimes they can cause adverse side effects, the National Association of Boards of Pharmacy has cautioned.\u00a0<\/span><\/p>\n<p><strong>RELATED: <a href=\"https:\/\/www.singlecare.com\/blog\/generic-glp-1\/\">Are there generic GLP-1 drugs?<\/a><\/strong><\/p>\n<h2><span style=\"font-weight: 400;\">Which companies are affected?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Due to the concern about the growing prevalence of unapproved GLP-1s on the market, the FDA issued warning letters to the following companies in December:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/links-2.govdelivery.com\/CL0\/https:%2F%2Fwww.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fwarning-letters%2Fxcel-research-llc-694608-12102024%3Futm_medium=email%26utm_source=govdelivery\/1\/01010193d6a341ec-a9e3d025-f148-4dc1-a643-8df54435f662-000000\/DpsIBQGX82V7sTn5YuKV8GW2t9Ww2TGuckKyRWyThcM=384\"><span style=\"font-weight: 400;\">Xcel Peptides<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/links-2.govdelivery.com\/CL0\/https:%2F%2Fwww.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fwarning-letters%2Fswisschems-695663-12102024%3Futm_medium=email%26utm_source=govdelivery\/1\/01010193d6a341ec-a9e3d025-f148-4dc1-a643-8df54435f662-000000\/h_1MgVnRA-klQj-WpBtjdc2s0qqbnRSKNVqNnC4l0OY=384\"><span style=\"font-weight: 400;\">Swisschems<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/links-2.govdelivery.com\/CL0\/https:%2F%2Fwww.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fwarning-letters%2Fsummit-research-peptides-695607-12102024%3Futm_medium=email%26utm_source=govdelivery\/1\/01010193d6a341ec-a9e3d025-f148-4dc1-a643-8df54435f662-000000\/OLEtmud9UiDod7UASUszcq6HEfIXc9l4qYD0pRYsbJ4=384\"><span style=\"font-weight: 400;\">Summit Research<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/links-2.govdelivery.com\/CL0\/https:%2F%2Fwww.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fwarning-letters%2Fprime-vitality-inc-dba-prime-peptides-695156-12102024%3Futm_medium=email%26utm_source=govdelivery\/1\/01010193d6a341ec-a9e3d025-f148-4dc1-a643-8df54435f662-000000\/s9vXoUqmGsfN5JuxyPoV3YbOaVFBXE2yjb6Qv0ykaIc=384\"><span style=\"font-weight: 400;\">Prime Peptides<\/span><\/a><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The FDA warned the companies about potential violations of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act), even with the companies claiming some of their GLP-1 products were currently for research purposes only. Despite the &#8220;for research purposes only&#8221; and &#8220;not for human consumption&#8221; labels, the FDA found evidence on the companies&#8217; websites suggesting that their compounded products were intended as drugs for human use, making the labels misleading or false.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What you can do<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Experts caution people to avoid buying products that haven\u2019t been specifically approved by the FDA. Unapproved or <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain\"><span style=\"font-weight: 400;\">counterfeit Ozempic<\/span><\/a><span style=\"font-weight: 400;\"> can pose potential harms that you might not expect. People who take semaglutide or tirzepatide should talk to their physicians if they are concerned about ongoing access to the medications that they need, rather than turning to a product that might not be safe. For example, there are both <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/ozempic-alternatives\/\"><span style=\"font-weight: 400;\">injectable and oral alternatives to Ozempic for people with Type 2 diabetes<\/span><\/a><span style=\"font-weight: 400;\"> that might work for you.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">If price is the issue, SingleCare coupons can help you save.<\/span><\/p>\n<p><a class=\"cta-button\" href=\"https:\/\/www.singlecare.com\/prescription\/ozempic\"><span style=\"font-weight: 400;\">Ozempic coupons<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a class=\"cta-button\" href=\"https:\/\/www.singlecare.com\/prescription\/rybelsus\"><span style=\"font-weight: 400;\">Rybelsus coupons<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a class=\"cta-button\" href=\"https:\/\/www.singlecare.com\/prescription\/wegovy\"><span style=\"font-weight: 400;\">Wegovy coupons<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a class=\"cta-button\" href=\"https:\/\/www.singlecare.com\/prescription\/mounjaro\"><span style=\"font-weight: 400;\">Mounjaro coupons<\/span><\/a><span style=\"font-weight: 400;\">,<\/span><a class=\"cta-button\" href=\"https:\/\/www.singlecare.com\/prescription\/zepbound\"><span style=\"font-weight: 400;\"> Zepbound coupons<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Originally approved to help people with Type 2 diabetes, the class of medications known as GLP-1 agonists and dual GIP\/GLP-1s\u00a0 quickly acquired a reputation for helping people shed stubborn pounds. As a result, the use of medications like Ozempic, Wegovy, Zepbound, Rybelsus, and Mounjaro has skyrocketed, as people turned to these medications to help them [&hellip;]<\/p>\n","protected":false},"author":135,"featured_media":630776,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[788,72,21067],"coauthors":[9482],"class_list":["post-630774","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-drug-safety","tag-fda","tag-glp-1-drugs","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA warns against compounded GLP-1 medications<\/title>\n<meta name=\"description\" content=\"The FDA issued warnings to makers of unapproved compounded semaglutide, 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