We continue to hear from pharmacies that the FDA-approved tirzepatide drugs are not attainable from wholesalers in quantities needed to meet demand by patients transitioning from compounded to commercial versions of the drug. In the FDAs 12-page letter lifting the tirzepatide shortage, the agency asserted its authority to make its own decisions about shortages, responding to the compounder plaintiffs allegations that its process for resolving the shortage was a violation of the Administrative Procedure Act
Licensed 503A compounding pharmacies (used exclusively by PlexusDx) operate under rigorous federal oversight, including sterility testing, identity verification, and compounding accuracy audits
Within this framework, semaglutide is best considered an add-on therapy rather than a replacement for established treatments
If you have type 2 diabetes and semaglutide was prescribed for blood sugar management rather than weight loss, dosing modifications should be approached with extra caution
In contrast, standard dosing is approved by the FDA and supported by the various clinical trials, while microdosing is not FDA-approved
Biochim Biophys Acta 1830:34073413