---
kind: "section"
citation: "21 C.F.R. § 640.120"
title: "21"
number: "640.120"
heading: "Alternative procedures."
url: "https://uscodex.org/cfr/21/640.120"
---

# §640.120. Alternative procedures.

- (a) The Director, Center for Biologics Evaluation and Research, may issue an exception or alternative to any requirement in subchapter F of [chapter I of title 21 of the Code of Federal Regulations](/cfr/21/chI.md) 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](/cfr/21/601.12.md) 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 under [paragraph (a)(1)](#a-1) of this section 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 of [chapter I of title 21 of the Code of Federal Regulations](/cfr/21/chI.md) 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 or locations to address an urgent and immediate need for blood, blood components, or blood products or to provide for 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. Periodically, FDA will provide a list of approved exceptions and alternative procedures on the FDA Center for Biologics Evaluation and Research Web site.

## Notes

### Amendments

[80 FR 29906, May 22, 2015]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.

### Source

Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.

### Amendments

[80 FR 29906, May 22, 2015]