FD&C Act Section 503B - Outsourcing Facilities

What it says

An outsourcing facility is a compounding facility that registers with FDA and can supply compounded drugs, including sterile drugs, without individual patient prescriptions. In return it can be exempt from certain requirements, such as FDA approval of the drug and adequate directions for use. To qualify, it must compound under the supervision of a licensed pharmacist, comply with current good manufacturing practice, follow the rules on permitted ingredients, and meet labeling, adverse event reporting and product reporting requirements.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• An outsourcing facility is held to manufacturing-level expectations. Compounded products are made under CGMP, so quality unit oversight, sterility assurance, cleaning, environmental control and record keeping all apply.
• Compounded drugs must be labeled as compounded, with the information the statute requires, and the facility must report the drugs it compounds to FDA on a regular schedule and report serious adverse events.
• This status is different from traditional pharmacy compounding. A facility that wants the benefits of outsourcing must meet the full set of conditions rather than choosing parts of them.

What FDA inspectors look for

• Whether aseptic processing, environmental monitoring, media fills and sterility and endotoxin testing demonstrate that sterile products are made under controlled conditions.
• Whether the quality unit has real authority to review records, investigate failures and reject products.
• Whether labeling, product reporting and adverse event reporting meet the statutory requirements.

Related regulations