[Title 21 CFR 1311.42]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT]
[Part 1311 - REGISTRATION OF IMPORTERS AND EXPORTERS OF CONTROLLED SUBSTANCES]
[Sec. 1311.42 - Application for importation of Schedule I and II substances.]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
9
1996-04-01
1996-04-01
false
Application for importation of Schedule I and II substances.
1311.42
Sec. 1311.42
FOOD AND DRUGS
DRUG ENFORCEMENT
REGISTRATION OF IMPORTERS AND EXPORTERS OF CONTROLLED SUBSTANCES
Sec. 1311.42 Application for importation of Schedule I and II substances.
(a) In the case of an application for registration or reregistration
to import a controlled substance lhsted 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. 1301.54. If a hearing is requested, the
Administrator shall hold a hearing on the application in accordance with
Sec. 1301.54. 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. 1301.54 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 Secs. 1311.43 or
1311.44 of this part.
(b) The Administrator shall register an applicant to import a
controlled substance listed in Schedule I or II if he 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
[[Page 213]]
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 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), the Administrator shall consider among other factors:
(1) Compliance with the security requirements set forth in
Secs. 1301.71-1301.76 of this chapter; and
(2) Employment of security procedures to guard against in-transit
losses within and without of 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 (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 (i) domestic
prices and (ii) 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 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.
[[Page 214]]
(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.
[36 FR 7812, Apr. 24, 1971, as amended at 36 FR 18734, Sept. 21, 1971;
37 FR 15922, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 52 FR 17288, May 7, 1987]