[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.35]

[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. 1301.35  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration (DEA 
Form 223) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of sections 
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the 
issuance of registration or reregistration is not required, the 
Administrator shall deny the application. Before denying any 
application, the Administrator shall issue an order to show cause 
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold 
a hearing on the application pursuant to Sec. 1301.41.
    (b) If in response to a show cause order a hearing is requested by 
an applicant for registration or reregistration to manufacture in bulk a 
basic class of controlled substance listed in Schedule I or II, notice 
that a hearing has been requested shall be published in the Federal 
Register and shall be mailed simultaneously to the applicant and to all 
persons to whom notice of the application was mailed. Any person 
entitled to file comments or objections to the issuance of the proposed 
registration pursuant to Sec. 1301.33(a) may participate in the hearing 
by filing notice of appearance in accordance with Sec. 1301.43. Such 
persons shall have 30 days to file a notice of appearance after the date 
of publication of the notice of a request for a hearing in the Federal 
Register.

[[Page 30]]

    (c) The Certificate of Registration (DEA Form 223) shall contain the 
name, address, and registration number of the registrant, the activity 
authorized by the registration, the schedules and/or Administration 
Controlled Substances Code Number (as set forth in part 1308 of this 
chapter) of the controlled substances which the registrant is authorized 
to handle, the amount of fee paid (or exemption), and the expiration 
date of the registration. The registrant shall maintain the certificate 
of registration at the registered location in a readily retrievable 
manner and shall permit inspection of the certificate by any official, 
agent or employee of the Administration or of any Federal, State, or 
local agency engaged in enforcement of laws relating to controlled 
substances.

[62 FR 13954, Mar. 24, 1997]