The FDA approves deviations from the regulations and publishes them annually. Each facility requesting a deviation must apply for it. Publication of the approved deviation does not allow adoption without prior approval from the FDA.
Sec. 640.120 Alternative procedures
(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 Federal Register.
