FAH sent comments on FDA’s draft guidance on hospital and health system drug compounding. The guidance updates a draft guidance proposed in 2016 and would set parameters on how hospital pharmacies compound drugs and distribute those across their systems. While the new guidance removed the 2016 proposed requirement that hospital systems only distribute compounded drugs within a 1-mile radius, the new draft guidance would only allow compounded drugs to be used within a 24-hour period of leaving the pharmacy.
FAH supported removal of the 1-mile requirement but opposed setting an arbitrary 24-hour limit on compounded drugs. FAH also urged FDA to replace the 24-hour requirement with guidelines established by the United States Pharmacopeia (USP) that set parameters related to “beyond-use dating (BUD)” to ensure the efficacy and safety of compounded drugs.
A copy of the letter can be found here.