{"id":615956,"date":"2026-04-30T20:50:09","date_gmt":"2026-04-30T20:50:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/615956\/"},"modified":"2026-04-30T20:50:09","modified_gmt":"2026-04-30T20:50:09","slug":"fda-wants-to-limit-compounded-versions-of-weight-loss-drugs","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/615956\/","title":{"rendered":"FDA wants to limit compounded versions of weight loss drugs"},"content":{"rendered":"

The U.S. Food and Drug Administration on Thursday proposed excluding Novo Nordisk<\/a> and Eli Lilly\u2019s \u200cweight-loss drugs<\/a> from a key compounding list, potentially limiting large-scale production by outsourcing facilities.<\/p>\n

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If finalized, the move could impact telehealth firms that rely on outsourcing facilities to produce these drugs in bulk, while bolstering Novo and Lilly\u2019s efforts against unauthorized versions \u200bthat are eating into sales of their blockbuster treatments.<\/p>\n

The regulator said on Thursday it found no clinical \u2060need for outsourcing facilities to compound semaglutide, the active ingredient of Novo\u2019s Wegovy and Ozempic, and tirzepatide, \u200bsold as Zepbound and Mounjaro by Lilly, from bulk drug substances.<\/p>\n

The proposal also includes Novo\u2019s older molecule liraglutide. Lilly and \u200bNovo commended the FDA\u2019s confirmation that there is no clinical need to compound these drugs.<\/p>\n

\u201cThat means there is no basis for compounders to make tirzepatide knockoffs,\u201d a spokesperson for Lilly told Reuters.<\/p>\n

\u201cThe agency\u2019s notice today reaffirms that compounding is meant to \u200bbe a rare and limited exception to FDA\u2019s gold-standard drug approval framework,\u201d a Novo spokesperson said. Compounding, in which \u200bpharmacies mix ingredients for specialized medicines or to copy a drug but at different dosages, has flourished as Americans chase \u200cmore affordable \u2060options. <\/p>\n

It is legal in certain circumstances, such as a drug shortage or when prescribed by a physician to address patient side-effects.<\/p>\n

The FDA was reviewing nominations for the so-called 503B bulks list, which identifies drug ingredients that outsourcing facilities may use in compounding. Section 503B of the Federal Food, Drug, and Cosmetic Act allows FDA-regulated \u200boutsourcing facilities to produce compounded \u200bmedicines in bulk for \u2060healthcare providers, often without patient-specific prescriptions. <\/p>\n

Section 503A allows state\u2011licensed physicians and pharmacists to compound medicines for individual patients under state oversight.<\/p>\n

Many telehealth firms, including Hims & Hers, \u200boffer compounded medicines tailored to individual patients through 503A pharmacies, while also relying \u200bon 503B outsourcing \u2060facilities to produce them at scale.<\/p>\n

Most telehealth companies use 503A pharmacies to fill their personalized compounded doses, said Rosalie Hoyle, a research scientist at health consultancy Avalere, adding the exclusion from the 503B bulks list may not \u2060operationally impact \u200bcurrent compounding of GLP-1 drugs.<\/p>\n

The FDA has invited public comment on the \u200bproposal until June 29, before the agency issues its final decision.<\/p>\n","protected":false},"excerpt":{"rendered":"The U.S. Food and Drug Administration on Thursday proposed excluding Novo Nordisk and Eli Lilly\u2019s \u200cweight-loss drugs from…\n","protected":false},"author":2,"featured_media":615957,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[97,243],"class_list":["post-615956","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/615956","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=615956"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/615956\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/615957"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=615956"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=615956"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=615956"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}