---
kind: "range"
citation: "21 C.F.R. §§ 601.6–601.8"
title: "21"
from: "601.6"
to: "601.8"
count: 3
url: "https://uscodex.org/cfr/21/601.6..601.8"
---

# §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.

# §601.7. Procedure for hearings.

- (a) A notice of opportunity for hearing, notice of appearance and request for hearing, and grant or denial of hearing for a biological drug pursuant to this part, for which the exemption from the Federal Food, Drug, and Cosmetic Act in [§ 310.4](/cfr/21/310.4.md) of this chapter has been revoked, shall be subject to the provisions of [§ 314.200](/cfr/21/314.200.md) of this chapter except to the extent that the notice of opportunity for hearing on the matter issued pursuant to [§ 12.21(b)](/cfr/21/12.21.md?p=b) of this chapter specifically provides otherwise.
- (b) Hearings pursuant to [§§ 601.4 through 601.6](/cfr/21/601.4..601.6.md) shall be governed by [part 12](/cfr/21/part12.md) of this chapter.
- (c) When a license has been suspended pursuant to [§ 601.6](/cfr/21/601.6.md) and a hearing request has been granted, the hearing shall proceed on an expedited basis.

# §601.8. Publication of revocation.


The Commissioner, following revocation of a biologics license under [21 CFR 601.5(b)](/cfr/21/601.5.md?p=b), will publish a notice in the Federal Register with a statement of the specific grounds for the revocation.