[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1309.25]

[Page 104]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS--Table of Contents
 
Sec. 1309.25  Exemption of certain controlled substance registrants.

    (a) The requirement of registration is waived for any person who 
distributes a product containing a List I chemical that is regulated 
pursuant to Sec. 1310.01(b)(28)(i)(D), if that person is registered with 
the Administration to manufacture, distribute or dispense a controlled 
substance.
    (b) The requirement of registration is waived for any person who 
imports or exports a product containing a List I chemical that is 
regulated pursuant to Sec. 1310.01(b)(28)(i)(D), if that person is 
registered with the Administration to engage in the same activity with a 
controlled substance.
    (c) The Administrator may, upon finding that continuation of the 
waiver would not be in the public interest, suspend or revoke a person's 
waiver pursuant to the procedures set forth in Secs. 1309.43 through 
1309.46 and 1309.51 through 1309.57. In considering the revocation or 
suspension of a person's waiver, the Administrator shall also consider 
whether action to revoke or suspend the person's controlled substance 
registration pursuant to 21 U.S.C. 824 is warranted.
    (d) Any person exempted from the registration requirement under this 
section shall comply with the security requirements set forth in 
Sections 1309.71-1309.73 and the recordkeeping and reporting 
requirements set forth under Parts 1310 and 1313 of this chapter.

[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]

    Effective Date Note: At 67 FR 14860, Mar. 28, 2002, Sec. 1309.25 was 
revised, effective Apr. 29, 2002. For the convenience of the user, the 
revised text follows:

Sec. 1309.25  Temporary exemption from registration for chemical 
          registration applicants.

    (a) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a combination 
ephedrine product is temporarily exempted from the registration 
requirement, provided that the person submits a proper application for 
registration on or before July 12, 1997. The exemption will remain in 
effect for each person who has made such application until the 
Administration has approved or denied that application. This exemption 
applies only to registration; all other chemical control requirements 
set forth in this part 1309 and parts 1310, and 1313 of this chapter 
remain in full force and effect.
    (b) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export a 
pseudoephedrine or phenylpropanolamine drug product is temporarily 
exempted from the registration requirement, provided that the person 
submits a proper application for registration on or before October 3, 
1997. The exemption will remain in effect for each person who has made 
such application until the Administration has approved or denied that 
application. This exemption applies only to registration; all other 
chemical control requirements set forth in this part 1309 and parts 1310 
and 1313 of this chapter remain in full force and effect.