503A vs. 503B Compounding
Patient-Specific vs. Office-Use Compounding
503A and 503B are designations used by the Food and Drug Administration (FDA) to separate compounding facilities it federally regulates from those regulated primarily by state boards. The regulatory differences can be complex, but from a patient viewpoint, the distinctions can be simplified.
503A Pharmacies
503A pharmacies are traditional state-regulated compounding pharmacies that make individualized formulations, following a compounding prescription written for a specific patient by a specific prescriber. In other words, your provider writes your prescription and sends the prescription to our 503A pharmacy where we compound it specifically for you, exactly the way you and your provider want it. Once your medication is ready, we ship your prescription directly to you to use at your home.
Our pharmacy team compounds prescriptions from scratch. Standard pharmacies dispense medications manufactured by major drug companies in pre-determined dosage forms and quantities. Compounding gives your prescriber the flexibility to meet your individual medical needs. Our customizable approach to compounded medications allows us to concentrate creams to maximize ease of administration, tailor doses, and create dosage forms with combinations of active ingredients not available commercially. If you have sensitivities to fillers, we have options that accommodate a wide range of allergies.
503B Outsourcing Facility
503B outsourcing facilities are large-scale FDA-regulated facilities that manufacture in bulk. They compound drugs, but not for you individually. They manufacture large batches of medications to be sold to doctors’ offices, clinics, hospitals, and other health facilities for use on-site only. They do not sell products directly to you as a patient or sell medications that would be administered to you outside of a medical facility.
