Regulatory crossroad: The FDA is evaluating seven peptide substances for potential inclusion on the 503A Bulks List, determining their legal status for licensed compounders. Impact on patient care: ...

The FDA has proposed removing tirzepatide and semaglutide from its 503B bulk compounding list, a change that would bar outsourcing facilities from producing copies even during future shortages. The ...

Since 2022, four GLP-1 drugs, including those indicated for weight loss, have been on FDA’s drug shortage list due to extraordinarily high patient demand. The shortage has, in turn, resulted in ...

Pharmacists and doctors can make compounded medications by combining, mixing, or altering various ingredients to meet a specific need. But because these medications don’t have Food and Drug ...