503B outsourcing facility

How is a 503B facility different from a 503A pharmacy?

Section 503B covers compounding within a facility that has elected to register with FDA as an outsourcing facility, by or under the direct supervision of a licensed pharmacist [1]. It is not required to be a licensed pharmacy, and unlike a 503A compounding pharmacy, it may or may not obtain a prescription for a named patient before compounding [1]. FDA, rather than a state board, is primarily responsible for overseeing and inspecting it on a risk-based schedule [2].

What rules must a 503B facility follow?

A 503B facility is exempt from standard drug labeling and premarket approval requirements, but not from FDA's manufacturing-quality (CGMP) rules [1]. It must submit adverse event reports to FDA, a condition 503A carries no equivalent of [1]. Its container labels must include required disclosures, such as the statement that the product is a compounded drug [1].

What can a 503B facility compound?

A 503B facility may not compound using a bulk drug substance unless that substance appears on FDA's 503B bulks list, or the finished drug is on FDA's drug shortage list at the time of compounding, distribution, and dispensing [3]. A 503A compounding pharmacy works under a different rule, tied to an identified patient's prescription.