Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The Parenteral Drug Association has reviewed the draft guidance, supports FDAs efforts to clarify GMP requirements for compounding pharmacies but has reservations regarding this guidance. Current available regulations are already in place to be utilized by this industry .The draft guidance has the potential to further confuse the current situation which has resulted in objectionable conditions and harm to patients. PDA recommends that FDA reconsider whether the draft guidance is needed or if existing GMPs (21cfr parts 210, 211) cannot be applied as is. Applying the same standard to compounding outsourcing facilities as applied to pharmaceutical manufacturers is imperative for parenteral products given the potential risks to patient safety. PDA is concerned that some of the reduced requirements could compromise product quality but we are most apprehensive about the noticeable relaxing of some of the sterility requirements included in the draft guidance.