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.
Section 640.12027
Alternative procedures.
(a) The Director of the Center for Biologics Evaluation and Research may approve an exception or alternative to any requirement in
Subchapter F 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 establishment, if there are difficult circumstances and submission of a written request is not feasible. Establishments must follow up such oral request by submitting written requests within 5 working days.
(b) To respond to a public health need, the Director may issue a notice of exception or alternative to any requirement in Subchapter F regarding blood, blood components, or blood products, if a variance under this section is necessary to assure that blood, blood components, or blood products will be available in a specified location(s) to address an urgent and immediate need or to provide appropriate donor screening and testing.
(c) If the Director issues such an exception or alternative orally, the Director will follow up by issuing a written notice of the exception or alternative. The FDA will provide a list of approved exceptions and alternative procedures on the FDA Center for Biologics Evaluation and Research website.
