Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products.
Both licensed and unlicensed blood establishments must submit requests for an exception or alternative procedure to the requirements in Parts 600-680. Licensed establishments should submit the request in accordance with 21 CFR 601.12 and may reference our guidance document entitled: Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (November 2014).
Requests for such exceptions or alternative procedures should ordinarily be made in writing, 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.
It should be noted that requests for exceptions or alternate procedures includes specific circumstances and may require submission of supporting data unique to the circumstance. Publication of these approvals for a specific exception or alternative procedure does not necessarily mean that they can be generally applied to other manufacturers.