NCPA win: FDA issues temporary guidance for 503A compounding

NCPA April 20, 2020

On Monday, FDA released guidance stating it does not intend to take action against a 503A pharmacy for compounding a drug that is essentially a copy of a commercially available drug, or providing a drug to a hospital without obtaining a patient-specific prescription, if certain circumstances are met. This guidance is in direct response to a letter that NCPA, the Alliance for Pharmacy Compounding and the American Pharmacists Association sent to FDA asking them to issue guidance providing enforcement discretion for pharmacists to compound products that are "essentially a copy" of an FDA-approved drug that FDA identifies may be or is anticipated to be, in shortage during this public health emergency.