Where do the names 503A and 503B come from?

They're sections of the Federal Food, Drug, and Cosmetic Act. Section 503B was added by the Drug Quality and Security Act in 2013, which created the outsourcing facility category. FDA's compounding pages explain both sections in more detail.

What is a 503A compounding pharmacy?

It's a licensed pharmacy, or a licensed physician, compounding drugs for an identified individual patient based on a valid prescription. When the conditions in section 503A are met, those drugs are exempt from some federal requirements that apply to manufactured drugs, including FDA approval. Day to day oversight comes mostly from the state board of pharmacy. In North Carolina that's the NC Board of Pharmacy.

What is a 503B outsourcing facility?

It's a facility that registers with FDA as an outsourcing facility. FDA says outsourcing facilities must comply with current good manufacturing practice (cGMP) requirements, are inspected by FDA on a risk based schedule and must report the products they compound to FDA. They can compound with or without prescriptions for individual patients, under the conditions in section 503B. FDA publishes a list of registered outsourcing facilities.

Are compounded drugs FDA approved?

No. FDA states that compounded drugs are not FDA approved, which means FDA doesn't verify their safety, effectiveness or quality before they're marketed. That's why clinics shouldn't describe a compounded product as FDA approved in any marketing.

What does this mean for how a clinic orders?

  • Prescription and compounded products are dispensed only against a valid prescription or order from a licensed practitioner.
  • Whether a clinic can keep compounded product on hand for office use depends on federal conditions and state law. Ask the pharmacy and check with your state board.
  • Product availability can vary by state.
  • Your licensed provider makes every clinical decision. Pharmacy type is a sourcing question, not a clinical one.

How can a clinic check a pharmacy or outsourcing facility?

  • Confirm the pharmacy's license with its state board of pharmacy, and any nonresident license your state requires.
  • For a 503B, check FDA's registered outsourcing facilities list.
  • Ask how the pharmacy documents each batch.
  • Make sure your clinic and each ordering practitioner are verified before the first order.

Through RevMed, products come from licensed, vetted pharmacy and laboratory partners, and clinics are verified by license and NPI before ordering. See how to choose a licensed supplier .