---
kind: "section"
citation: "21 C.F.R. § 601.6"
title: "21"
number: "601.6"
heading: "Suspension of license."
url: "https://uscodex.org/cfr/21/601.6"
---

# §601.6. Suspension of license.

- (a) Whenever the Commissioner has reasonable grounds to believe that any of the grounds for revocation of a license exist and that by reason thereof there is a danger to health, the Commissioner may notify the licensed manufacturer that the biologics license is suspended and require that the licensed manufacturer do the following:
  - (1) Notify the selling agents and distributors to whom such product or products have been delivered of such suspension, and
  - (2) Furnish to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research, complete records of such deliveries and notice of suspension.
- (b) Upon suspension of a license, the Commissioner shall either:
  - (1) Proceed under the provisions of [§ 601.5(b)](/cfr/21/601.5.md?p=b) of this chapter to revoke the license, or
  - (2) If the licensed manufacturer agrees, hold revocation in abeyance pending resolution of the matters involved.

## Notes

### Amendments

[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]

### Authority

Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127.

### Source

Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.

### Amendments

[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]