{"id":10925,"date":"2024-10-18T00:53:18","date_gmt":"2024-10-18T04:53:18","guid":{"rendered":"https:\/\/a4pc.org\/?p=10925"},"modified":"2024-10-23T16:31:45","modified_gmt":"2024-10-23T20:31:45","slug":"breaking-fda-allows-renewed-compounding-of-tirzepatide-copies-for-now","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2024-10\/breaking-fda-allows-renewed-compounding-of-tirzepatide-copies-for-now\/","title":{"rendered":"BREAKING: FDA allows renewed compounding of tirzepatide copies \u2014 for now"},"content":{"rendered":"

FDA clarifies: <\/strong>Pharmacies may <\/strong>prepare copies of tirzepatide injection<\/strong><\/h3>\n

In a win for continued patient access to compounded versions of Eli Lilly\u2019s Mounjaro and Zepbound, FDA clarified today that pharmacies may continue to prepare copies of those FDA-approved drugs, at least for now.<\/p>\n

The news came in a late Thursday afternoon letter to APC<\/a> from FDA Office of Compounding Quality and Compliance Director Gail Bormel, who indicated that FDA will not take enforcement action against pharmacies that prepare copies of tirzepatide injection during a court-approved period in which the agency is reevaluating its October 2 decision resolving the formal shortage of that FDA-approved GLP-1 drug.<\/p>\n

Bormel\u2019s letter was a response to APC\u2019s emergency request last weekend<\/a> for just such a clarification from the agency. The uncertainty stemmed from FDA\u2019s response to a lawsuit filed against the agency by the Outsourcing Facilities Association and APC-member pharmacy Farmakeio. The lawsuit asserts that FDA was capricious in resolving the tirzepatide injection shortage, that it relied on incomplete data, and that it should have followed notice-and-comment rulemaking. On Friday, at FDA\u2019s request, the court remanded that decision back to the agency for reconsideration and indicated that enforcement action would not be taken against the plaintiffs in the case.<\/p>\n

Concerned about interruption of patients\u2019 drug therapy, APC had asked the agency to take a broader view and apply that \u201cenforcement discretion\u201d to all sterile compounding pharmacies that might prepare tirzepatide copies.<\/p>\n

\u201cFDA intends to treat compounders consistently at this time, meaning that FDA does not intend to take action against compounders for violations arising from the conditions above, for the same duration of time and subject to all the same limitations as described in FDA\u2019s motion and the court\u2019s order,\u201d Bormel said in the letter to APC\u2019s CEO Scott Brunner.<\/p>\n

\u201cThe abruptness of FDA\u2019s resolution of the tirzepatide injection shortage left thousands and thousands of patients stranded with a prescription that could no longer be filled \u2014 and no speedy means of transitioning to the FDA-approved drug,\u201d said APC\u2019s Brunner. \u201cFor those patients and their providers, today\u2019s clarification by FDA is wonderful news.<\/p>\n

\u201cI sincerely thank the agency for its responsiveness. I do want to make clear that what led to this outcome is the courage of the Outsourcing Facilities Association in challenging in court what was a too-hasty, poorly informed move by FDA to end the shortage in the first place. Patients may not know how this reversal came about, but we do, and it\u2019s thanks to OFA and Farmakeio.\u201d<\/p>\n

Brunner cautioned that FDA\u2019s clarification is not a checkered flag allowing unrestrained compounding of tirzepatide injection. \u201cJust because FDA says it will not take enforcement action during this period of time when it\u2019s re-evaluating its decision does not mean state boards of pharmacy will take the same approach. We would hope most states would follow FDA\u2019s lead, but we strongly urge pharmacies to check with their state board of pharmacy before they recommence compounding copies of tirzepatide injection.\u201d\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"

In a win for continued patient access to compounded versions of Eli Lilly\u2019s Mounjaro and Zepbound, FDA clarified today that pharmacies may continue to prepare copies of those FDA-approved drugs, at least for now.
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