The Alliance for Pharmacy Compounding (APC) advocates for the responsible compounding and dispensing of “essentially copies” of FDA-approved drugs by compounding pharmacies when these drugs are listed as “currently in shortage” on the FDA Drug Shortage List, as permitted by FDA guidance. These best practices are specifically designed for 503A state-licensed compounding pharmacies. It is recommended that pharmacies seek legal counsel before compounding copies of FDA-approved drugs in shortage. APC does not guarantee that adherence to these best practices will protect a pharmacy from lawsuits, regulatory citations, or legal actions. Read More >