[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.36]

[Page 29-30]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1301.36  Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.

    (a) For any registration issued under section 303 of the Act (21 
U.S.C. 823), the Administrator may:
    (1) Suspend the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)) for any period of time.
    (2) Revoke the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)).
    (b) For any registration issued under section 1008 of the Act (21 
U.S.C. 958), the Administrator may:
    (1) Suspend the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) for any period of time.
    (2) Revoke the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) if he/she determines that such registration is 
inconsistent with the public interest as defined in section 1008 or with 
the United States obligations under international treaties, conventions, 
or protocols in effect on October 12, 1984.
    (c) The Administrator may limit the revocation or suspension of a 
registration to the particular controlled substance, or substances, with 
respect to which grounds for revocation or suspension exist.
    (d) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to 
Sec. 1301.37 and, if requested by the registrant, shall hold a hearing 
pursuant to Sec. 1301.41.
    (e) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he/she finds that there is an imminent 
danger to the public health or safety. If the Administrator so suspends, 
he/she shall serve with the order to show cause pursuant to Sec. 1301.37 
an order of immediate suspension which shall contain a statement of his 
findings regarding the danger to public health or safety.
    (f) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his/her 
Certificate of Registration, any order forms, and any import or export 
permits in his/her possession to the nearest office of the 
Administration. The suspension or revocation of a registration shall 
suspend or revoke any individual manufacturing or procurement quota 
fixed for the registrant pursuant to part 1303 of this chapter and any 
import or export permits issued to the registrant pursuant to part 1312 
of this chapter. Also, upon service of the order of the Administrator 
revoking or suspending registration, the registrant shall, as instructed 
by the Administrator:
    (1) Deliver all controlled substances in his/her possession to the 
nearest office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all controlled substances in his/her possession under seal 
as described in sections 304(f) or 1008(d)(6) of the Act (21 U.S.C. 
824(f) or 958(d)(6)).
    (g) In the event that revocation or suspension is limited to a 
particular controlled substance or substances, the registrant shall be 
given a new Certificate of Registration for all substances not affected 
by such revocation or suspension; no fee shall be required to be paid 
for the new Certificate of Registration. The registrant shall deliver 
the old Certificate of Registration and, if appropriate, any order forms 
in his/her possession to the nearest office of the Administration. The 
suspension or revocation of a registration, when limited to a particular 
basic class or classes of controlled substances, shall suspend or revoke 
any individual manufacturing or procurement quota fixed for the 
registrant for such class or classes pursuant to part 1303 of this 
chapter and any import or export permits issued to the registrant for 
such class or classes pursuant to part 1312 of this chapter. Also, upon 
service of the order of the Administrator revoking or suspending 
registration, the registrant

[[Page 30]]

shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular controlled 
substance or substances affected by the revocation or suspension which 
are in his/her possession; or
    (2) Place all of such substances under seal as described in sections 
304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)).
    (h) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator or 
dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under paragraph (e) of this section may 
request a hearing on the revocation or suspension of his/her 
registration at a time earlier than specified in the order to show cause 
pursuant to Sec. 1301.37. This request shall be granted by the 
Administrator, who shall fix a date for such hearing as early as 
reasonably possible.
    (i) In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so issues 
his/her order. The Administrator may extend any other existing 
registration under the circumstances contemplated in this section even 
though the registrant failed to apply for reregistration at least 45 
days before expiration of the existing registration, with or without 
request by the registrant, if the Administrator finds that such 
extension is not inconsistent with the public health and safety.

[62 FR 13955, Mar. 24, 1997]