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  <FDSYS>
    <CFRTITLE>21</CFRTITLE>
    <CFRTITLETEXT>Food and Drugs</CFRTITLETEXT>
    <VOL>9</VOL>
    <DATE>2005-04-01</DATE>
    <ORIGINALDATE>2005-04-01</ORIGINALDATE>
    <COVERONLY>false</COVERONLY>
    <TITLE>Application for bulk manufacture of Schedule I and II substances.</TITLE>
    <GRANULENUM>1301.33</GRANULENUM>
    <HEADING>Section 1301.33</HEADING>
    <ANCESTORS>
      <PARENT HEADING="Title 21" SEQ="3">Food and Drugs</PARENT>
      <PARENT HEADING="CHAPTER II" SEQ="2">DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE</PARENT>
      <PARENT HEADING="PART 1301" SEQ="1">REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES</PARENT>
      <PARENT HEADING="" SEQ="0">Action on Application for Registration: Revocation Or Suspension of Registration</PARENT>
    </ANCESTORS>
  </FDSYS>
  <SECTION>
    <SECTNO>§ 1301.33</SECTNO>
    <SUBJECT>Application for bulk manufacture of Schedule I and II substances.</SUBJECT>

    <P>(a) In the case of an application for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, the Administrator shall, upon the filing of such application, publish in the <E T="04">Federal Register</E> a notice naming the applicant and stating that such applicant has applied to be registered as a bulk manufacturer of a basic class of narcotic or nonnarcotic controlled substance, which class shall be identified. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of that basic class and to any other applicant therefor. Any such person may, within 60 days from the date of publication of the notice in the <E T="04">Federal Register,</E> file with the Administrator written comments on or objections to the issuance of the proposed registration.</P>
    <P>(b) In order to provide adequate competition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply.</P>
    <P>(c) This section shall not apply to the manufacture of basic classes of controlled substances listed in Schedules I or II as an incident to research or chemical analysis as authorized in § 1301.13(e)(1).</P>
    <CITA>[62 FR 13953, Mar. 24, 1997]</CITA>
  </SECTION>
</CFRGRANULE>
