503A & 503B Outsourcing Pharmacies

Drug compounding is the preparation of a medical formulation to meet the specific needs of a patient that cannot be met with commercially available products. This may be done for many reasons such as to change a delivery method, to avoid a non-active ingredient to which the patient is allergic, or to provide an exact dose that is not commercially available. Compounding may also be done for medically optional reasons, such as preference of flavor or texture, or dietary restrictions.

503A compounding pharmacies are those that compound according to prescriptions specific to a patient only for home use and in small batches. 503A’s are required by state boards of pharmacy to comply with USP 795, 797, USP 800, and other guidelines. 

503B compounding pharmacies may manufacture large batches with or without patient specific prescriptions with these medicines intended to be sold to and used within healthcare facilities. 503B’s are required by state boards of pharmacy and the US Food and Drug Administration to comply with USP 795, 797, USP 800, along with FDA cGMP guidelines. 

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