National Law Review (Polsinelli PC) was explicit on April 22, 2026: removing a Category 2 bulk drug substance does not, on its own, authorize use of that substance in compounding or bring it within FDAs interim enforcement discretion policy for substances in Category 1. Even Category 1 substances are only under enforcement discretion, which is short of full authorization
Reconstituted peptides need refrigeration
One such medication, Ozempic, a popular GLP-1 receptor agonist, has become a significant topic of discussion, particularly concerning its administration
For instance, some studies have found that GLP-1RAs can cause or exacerbate muscle atrophy, leading to a decrease in muscle mass, this contradicts the hypothesis that GLP-1RAs have therapeutic potential in SIM (181,182)
Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial
Because many of these molecules cant be patented, pharmaceutical companies have little reason to fund those trials