Under title 21 of the Code of Federal Regulations 640.120 (a), the Director, Center for Biologics Evaluation and Research, may issue an exception or alternative to any requirement in subchapter F (Biologics, Parts 600-680) of Chapter I (Food and Drug Administration, Department of Health and Human Services) 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 to the requirements in Parts 600-680. Licensed establishments must submit the request in accordance with 21 CFR 601.12 and may reference our guidance document entitled: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (December 2014).
Requests for such exceptions or alternative procedures should be made in writing; however, if there are difficult circumstances and submission of a written request is not feasible, such requests may be made orally, followed by a written request within 5 working days. If the Director issues an exception or alternative orally, the Director will follow up with a written notice.
It should be noted that requests for exceptions or alternatives to the regulations include specific circumstances and may require submission of supporting data unique to the circumstance. Publication of this list does not necessarily mean that the exceptions or alternatives can be generally applied to other manufacturers.