Code of Federal Regulations
Section 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.
(c) Each person required by sections 302 or 1007 of the Act 21
U.S.C. 822 or 957) to obtain a registration to manufacture or import
prescription drug products containing ephedrine, pseudoephedrine, or
phenylpropanolamine is temporarily exempted from the registration
requirement, provided that the person submits a proper application for
registration on or before March 3, 2010. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied the application. This exemption
applies only to registration; all other chemical control requirements
set forth in this part and parts 1310, 1313, and 1315 of this chapter
remain in full force and effect.
[67 FR 14860, Mar. 28, 2002, as amended at 75 FR 4982, Feb. 1, 2010]
NOTICE: This is an unofficial version. An official version of this publication may be obtained
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