21 CFR 601.2 - Biologics Licensing Procedures

What it says

21 CFR 601.2 establishes the procedural requirements for submitting a Biologics License Application, including required content addressing manufacturing methods, facilities and controls, and establishes that licenses remain in effect only as long as the establishment and product continue to comply with applicable requirements, subject to revocation for cause.

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

What it means in practice

• This regulation provides the specific procedural implementation of the statutory biologics licensing framework established under PHS Act Section 351, translating the statutory requirement into concrete application content and maintenance obligations.
• License maintenance is an ongoing obligation, not a one-time approval event, meaning continued compliance with applicable requirements is a condition of the license remaining valid, with revocation a genuine possibility for sustained noncompliance.
• Manufacturing method, facility and control information submitted as part of licensure becomes the specific baseline against which subsequent inspections and compliance assessments are made, connecting this procedural framework directly to ongoing GMP compliance expectations.

What FDA inspectors look for

• Whether current manufacturing practices continue to match what was described in the licensed application, since license validity depends on this ongoing consistency.
• Whether significant changes to manufacturing methods, facilities or controls have been properly assessed and, where required, submitted for supplemental approval before implementation.
• Whether the establishment continues to demonstrate the compliance posture that supported original licensure, on an ongoing basis rather than only at the point of initial approval.

Related regulations