The headquarters of the U.S. Food and Drug Administration in Silver Spring, Maryland, Nov. 4, 2009.<\/p>\n
Jason Reed | Reuters<\/p>\n
The \u2060Food and Drug \u2060Administration on Thursday proposed \u200bexcluding<\/a> the active ingredients in Novo Nordisk \u200c<\/a>and Eli Lilly<\/a>‘s blockbuster obesity and diabetes medications from the \u2060list \u2060of drugs that outsourcing facilities can use for \u200bcompounding in bulk. <\/p>\n If that proposal is finalized, the exclusion would likely limit the mass compounding \u2014 or the making of custom, often cheaper alternatives \u2014 of those medicines \u200bunless they appear on the FDA’s \u2060drug shortage \u2060list. The agency said it will consider public comments, which can be submitted until late June, before making a final decision. <\/p>\n The FDA finds “no clinical need” for outsourcing facilities to compound them from bulk drug substances, the agency said in a release. <\/p>\n The proposal includes semaglutide, the active ingredient in Novo’s obesity drug Wegovy and diabetes counterpart Ozempic, and tirzepatide, which is in Lilly’s weight loss injection Zepbound and diabetes shot Mounjaro. It also covers \u2060Novo’s older molecule liraglutide.<\/p>\n “When FDA-approved drugs are available, \u200boutsourcing facilities cannot lawfully \u200bcompound \u2060using bulk drug substances unless there is a clear clinical \u2060need,” \u200bFDA Commissioner Marty \u200bMakary said in the release. <\/p>\n The agency’s proposal specifically targets 503B outsourcing facilities, which manufacture compounded drugs in bulk with or without prescription and are largely regulated by FDA guidelines.\u00a0<\/p>\n The proposal does not impact 503A pharmacies, which make compounded drugs according to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA.\u00a0<\/p>\n Lilly and Novo have invested billions to ramp up manufacturing capacity over the last several years, which has helped alleviate supply constraints. The companies have also pursued efforts to make their branded medications more affordable to win over users who had flocked to cheaper compounded medications. <\/p>\n