[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: 21CFR1301.34]

[Page 27-29]
 
                         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. 1301.34  Application for importation of Schedule I and II substances.

    (a) In the case of an application for registration or reregistration 
to import

[[Page 28]]

a controlled substance listed in Schedule I or II, under the authority 
of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the 
Administrator shall, upon the filing of such application, publish in the 
Federal Register a notice naming the applicant and stating that such 
applicant has applied to be registered as an importer of a Schedule I or 
II controlled substance, which substance shall be identified. A copy of 
said notice shall be mailed simultaneously to each person registered as 
a bulk manufacturer of that controlled substance and to any other 
applicant therefor. Any such person may, within 30 days from the date of 
publication of the notice in the Federal Register, file written comments 
on or objections to the issuance of the proposed registration, and may, 
at the same time, file a written request for a hearing on the 
application pursuant to Sec. 1301.43. If a hearing is requested, the 
Administrator shall hold a hearing on the application in accordance with 
Sec. 1301.41. Notice of the hearing 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 such person 
may participate in the hearing by filing a notice of appearance in 
accordance with Sec. 1301.43 of this chapter. Notice of the hearing 
shall contain a summary of all comments and objections filed regarding 
the application and shall state the time and place for the hearing, 
which shall not be less than 30 days after the date of publication of 
such notice in the Federal Register. A hearing pursuant to this section 
may be consolidated with a hearing held pursuant to Sec. 1301.35 or 
Sec. 1301.36 of this part.
    (b) The Administrator shall register an applicant to import a 
controlled substance listed in Schedule I or II if he/she determines 
that such registration is consistent with the public interest and with 
U.S. obligations under international treaties, conventions, or protocols 
in effect on May 1, 1971. In determining the public interest, the 
following factors shall be considered:
    (1) Maintenance of effective controls against diversion of 
particular controlled substances and any controlled substance in 
Schedule I or II compounded therefrom into other than legitimate 
medical, scientific research, or industrial channels, by limiting the 
importation and bulk manufacture of such controlled substances to a 
number of establishments which can produce an adequate and uninterrupted 
supply of these substances under adequately competitive conditions for 
legitimate medical, scientific, research, and industrial purposes;
    (2) Compliance with applicable State and local law;
    (3) Promotion of technical advances in the art of manufacturing 
these substances and the development of new substances;
    (4) Prior conviction record of applicant under Federal and State 
laws relating to the manufacture, distribution, or dispensing of such 
substances;
    (5) Past experience in the manufacture of controlled substances, and 
the existence in the establishment of effective control against 
diversion;
    (6) That the applicant will be permitted to import only:
    (i) Such amounts of crude opium, poppy straw, concentrate of poppy 
straw, and coca leaves as the Administrator finds to be necessary to 
provide for medical, scientific, or other legitimate purposes; or
    (ii) Such amounts of any controlled substances listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States 
during an emergency in which domestic supplies of such substances are 
found by the Administrator to be inadequate; or
    (iii) Such amounts of any controlled substance listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for the 
medical, scientific, or other legitimate needs of the United States in 
any case in which the Administrator finds that competition among 
domestic manufacturers of the controlled substance is inadequate and 
will not be rendered adequate by the registration of additional 
manufacturers under section 303 of the Act (21 U.S.C. 823); or
    (iv) Such limited quantities of any controlled substance listed in 
Schedule I or II as the Administrator shall find

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to be necessary for scientific, analytical or research uses; and
    (7) Such other factors as may be relevant to and consistent with the 
public health and safety.
    (c) In determining whether the applicant can and will maintain 
effective controls against diversion within the meaning of paragraph (b) 
of this section, the Administrator shall consider among other factors:
    (1) Compliance with the security requirements set forth in 
Sec. Sec. 1301.71-1301.76; and
    (2) Employment of security procedures to guard against in-transit 
losses within and without the jurisdiction of the United States.
    (d) In determining whether competition among the domestic 
manufacturers of a controlled substance is adequate within the meaning 
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section 
1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator 
shall consider:
    (1) The extent of price rigidity in the light of changes in:
    (i) raw materials and other costs and
    (ii) conditions of supply and demand;
    (2) The extent of service and quality competition among the domestic 
manufacturers for shares of the domestic market including:
    (i) Shifts in market shares and
    (ii) Shifts in individual customers among domestic manufacturers;
    (3) The existence of substantial differentials between domestic 
prices and the higher of prices generally prevailing in foreign markets 
or the prices at which the applicant for registration to import is 
committed to undertake to provide such products in the domestic market 
in conformity with the Act. In determining the existence of substantial 
differentials hereunder, appropriate consideration should be given to 
any additional costs imposed on domestic manufacturers by the 
requirements of the Act and such other cost-related and other factors as 
the Administrator may deem relevant. In no event shall an importer's 
offering prices in the United States be considered if they are lower 
than those prevailing in the foreign market or markets from which the 
importer is obtaining his/her supply;
    (4) The existence of competitive restraints imposed upon domestic 
manufacturers by governmental regulations; and
    (5) Such other factors as may be relevant to the determinations 
required under this paragraph.
    (e) In considering the scope of the domestic market, consideration 
shall be given to substitute products which are reasonably 
interchangeable in terms of price, quality and use.
    (f) The fact that the number of existing manufacturers is small 
shall not demonstrate, in and of itself, that adequate competition among 
them does not exist.

[62 FR 13953, Mar. 24, 1997]