CFR section
21 CFR 640.120(a): Alternative procedures
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart L-Alternative Procedures
Key facts
| Citation | 21 CFR 640.120(a) |
|---|---|
| Section | Alternative procedures |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart L-Alternative Procedures |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (a) The Director, Center for Biologics Evaluation and Research, may issue an exception or alternative to any requirement in subchapter F of chapter I of title 21 of the Code of Federal Regulations regarding blood, blood components, or blood products. The Director may issue such an exception or alternative in response to: (1) A written request from an establishment. Licensed establishments must submit such requests in accordance with § 601.12 of this chapter; (2) An oral request from an… |
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