0338 21cfr601 5 and 601 6 2007

Food and Drug Administration, HHS

§ 601.7
compliance is not demonstrated or
achieved and the licensed manufacturer does not waive the opportunity
for a hearing, the Commissioner shall
issue a notice of opportunity for hearing on the matter under § 12.21(b) of
this chapter.

§ 601.5 Revocation of license.
(a) A biologics license shall be revoked upon application of the manufacturer giving notice of intention to
discontinue the manufacture of all
products manufactured under such license or to discontinue the manufacture of a particular product for which a
license is held and waiving an opportunity for a hearing on the matter.
(b)(1) The Commissioner shall notify
the licensed manufacturer of the intention to revoke the biologics license,
setting forth the grounds for, and offering an opportunity for a hearing on the
proposed revocation if the Commissioner finds any of the following:
(i) Authorized Food and Drug Administration employees after reasonable
efforts have been unable to gain access
to an establishment or a location for
the purpose of carrying out the inspection required under § 600.21 of this chapter,
(ii) Manufacturing of products or of a
product has been discontinued to an extent that a meaningful inspection or
evaluation cannot be made,
(iii) The manufacturer has failed to
report a change as required by § 601.12
of this chapter,
(iv) The establishment or any location thereof, or the product for which
the license has been issued, fails to
conform to the applicable standards established in the license and in this
chapter designed to ensure the continued safety, purity, and potency of the
manufactured product,
(v) The establishment or the manufacturing methods have been so
changed as to require a new showing
that the establishment or product
meets the requirements established in
this chapter in order to protect the
public health, or
(vi) The licensed product is not safe
and effective for all of its intended uses
or is misbranded with respect to any
such use.
(2) Except as provided in § 601.6 of this
chapter, or in cases involving willfulness, the notification required in this
paragraph shall provide a reasonable
period for the licensed manufacturer to
demonstrate or achieve compliance
with the requirements of this chapter,
before proceedings will be instituted
for the revocation of the license. If

[64 FR 56451, Oct. 20, 1999]

§ 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) of this chapter to revoke the
license, or
(2) If the licensed manufacturer
agrees, hold revocation in abeyance
pending resolution of the matters involved.
[64 FR 56451, Oct. 20, 1999, as amended at 70
FR 14983, Mar. 24, 2005]

§ 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 of this chapter has
been revoked, shall be subject to the
provisions of § 314.200 of this chapter
except to the extent that the notice of
opportunity for hearing on the matter
issued pursuant to § 12.21(b) of this
chapter specifically provides otherwise.
(b) Hearings pursuant to §§ 601.4
through 601.6 shall be governed by part
12 of this chapter.

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