21 C.F.R. § 640.120 Alternative procedures.
Title 21 - Food and Drugs
(a) The Director, Center for Biologics Evaluation and Research, may approve 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. Requests for such exceptions or alternatives shall ordinarily be in writing. Licensed establishments shall submit such requests in accordance with §601.12 of this chapter. However, in limited circumstances, such requests may be made orally and permission may be given orally by the Director. Oral requests and approvals must be promptly followed by written requests and written approvals. (b) FDA will publish a list of approved alternative procedures and exceptions periodically in the [55 FR 10423, Mar. 21, 1990, as amended at 62 FR 39903, July 24, 1997]
Title 21: Food and Drugs
PART 640—ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
Subpart L—Alternative Procedures
§ 640.120 Alternative procedures.
