There\u2019s been some question about the current state of FDA\u2019s enforcement when it comes to compounded tirzepatide copies.\u00a0<\/p>\n
At APC\u2019s request, FDA has reiterated that it does not plan to take action against any compounders who prepare copies of tirzepatide injection while the <\/strong>OFA v. FDA <\/em><\/strong>litigation continues. <\/strong>That includes 503A pharmacies and 503B outsourcing facilities. (You can read the original October letter to APC from FDA on this matter here<\/a>.)<\/p>\n What does this mean?<\/strong><\/p>\n This is nothing new. In simple terms, FDA does not plan to take action against compounders who prepare copies of tirzepatide injection, even though the drug has been removed from the shortage list \u2014 just as it stated in October<\/a>. This applies to situations where:<\/p>\n However, the FDA\u2019s enforcement discretion has limits. The agency can still take action if there are concerns about product quality or safety, so it\u2019s important for all compounders to maintain the highest standards.<\/p>\n For details, you can review the FDA\u2019s Declaratory Order<\/a> on this issue.<\/p>\n Questions? Contact APC\u2019s Tenille Davis at tenille@whizkid.com<\/a>\/a4pc<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"\n