- 21 CFR Part 600, titled Biological Products: General, is a key component of the U.S. Food and Drug Administration’s (FDA) regulatory framework that governs the manufacturing, quality control, and distribution of biological products. These products include vaccines, blood and blood components, allergenic extracts, cellular and gene therapies, and other biologics derived from living organisms. The regulation is administered by the FDA’s Center for Biologics Evaluation and Research (CBER) and establishes general provisions to ensure the safety, purity, and potency of biologics distributed in the United States.
- Part 600 serves as the foundational regulation for biologics, complementing more specific rules found in Parts 601 to 680. It begins by outlining definitions and general provisions, including terms like “biological product,” “manufacturer,” and “licensed establishment.” The regulation applies to all licensed manufacturers engaged in the production of biologics, whether for human or animal use, and lays the groundwork for the licensure process, facility oversight, and regulatory responsibilities.
- One of the central components of Part 600 is the requirement for manufacturers to have an active Biologics License Application (BLA), which is the regulatory equivalent of a New Drug Application (NDA) for biologics. A BLA must demonstrate that the product is safe, pure, and potent, and that the facility meets appropriate standards. The regulation also provides the FDA the authority to inspect establishments, review product and manufacturing data, and enforce compliance through licensure suspension, revocation, or legal action.
- Recordkeeping and reporting requirements are emphasized throughout Part 600. Manufacturers must maintain comprehensive records of production, quality control testing, distribution, and complaints. These records must be available for FDA inspection and retained for specified periods. Additionally, adverse event reporting is mandated under Part 600.80, requiring licensed manufacturers to submit postmarketing safety reports, including both serious and non-serious adverse experiences, in accordance with strict timelines and formats.
- Part 600 also includes specific provisions related to biological product dating (shelf life), labeling, and storage conditions. For instance, products must have expiration dating periods supported by stability data and must be stored under conditions that preserve their integrity. Environmental controls and cold chain requirements are especially important for sensitive biologics like vaccines or gene therapies, and manufacturers must ensure conditions are maintained from production through distribution.
- Another key feature is the requirement for adequate personnel, facilities, and equipment. Establishments must have properly trained staff, validated equipment, and controlled environments to prevent contamination and ensure product quality. This includes requirements for environmental monitoring, aseptic processing, and the prevention of cross-contamination between biological materials.
- In addition, Part 600 empowers the FDA to require product recalls, issue safety alerts, or impose special controls in the event of product defects or public health concerns. It supports broader FDA initiatives such as risk-based inspections, pharmacovigilance programs, and lot release protocols, where some biologics may require FDA testing and approval of each lot before distribution.
- In conclusion, 21 CFR Part 600 establishes the general regulatory framework for ensuring the safety and quality of biological products in the United States. It sets the stage for more detailed requirements found in subsequent parts and provides the FDA with the authority to license, monitor, and enforce standards for biologics manufacturers. Through its provisions for licensing, recordkeeping, reporting, and inspection, Part 600 plays a central role in maintaining public health and trust in complex biologic therapies.
