Regulatory & FDA Updates

503A compounding pharmacies prepare medications for individual patients on a prescription and answer to state boards of pharmacy; 503B outsourcing facilities register with the FDA and batch preparations for clinics without patient names. This explainer covers which one fills your prescription, how to verify a pharmacy's license, and what "not FDA-approved" means for each.

What ketamine is, how compounded nasal spray differs from the FDA-approved esketamine product, and the risks the FDA identified in its 2022 alert.

Federal law limits when a compounding pharmacy may prepare a drug that is commercially available, and those limits turn on FDA's shortage list rather than on empty shelves. This page walks through where those lines fall, using the 2022 pediatric ibuprofen and acetaminophen scarcity as a worked example.

What epimedium is, how it differs in law and in evidence from sildenafil, and the FDA's documented problem with adulterated sexual enhancement supplements.