Does FDA want to prevent pharmacy compounding?
No. FDA believes that pharmacists engaging in traditional compounding provide a valuable medical service that is important to patient health. FDA has no interest in ending traditional pharmacy compounding. FDA regards traditional pharmacy compounding as the combining or altering of ingredients by a pharmacist, in response to a licensed practitioner’s prescription, to produce a drug tailored to an individual patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. Instead, FDA focuses on the subset of inappropriate compounding described in FDA’s Pharmacy Compounding CPG. The CPG is available on FDA’s pharmacy compounding web page.
