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§1303.23. Procedure for fixing individual manufacturing quotas. — Inbound Citations

21 C.F.R. § 1303.23

Cited by 4 regulations in release Current.

Citations to 21 C.F.R. § 1303.23 as a whole

  • (1) All quantities of such class necessary to manufacture all quantities of other basic classes of controlled substances listed in Schedules I and II which the applicant is authorized to manufacture pursuant to § 1303.23; and
  • (a) For the purpose of determining individual manufacturing quotas pursuant to § 1303.23, each registered manufacturer shall be allowed as part of such quota an amount sufficient to maintain an inventory equal to:
    (1) For current manufacturers, 40 percent of their average estimated net disposal for the current calendar year and the last preceding calendar year; or
    (2) For new manufacturers, 40 percent of their reasonably estimated net disposal for the next calendar year as determined by the Administrator.
  • Any manufacturer assigned an individual manufacturing quota for any basic class of controlled substance listed in schedule I or II pursuant to § 1303.23 may at any time abandon their right to manufacture all or any part of such quota by filing a notice of such abandonment with the UN Reporting and Quota Section, Diversion Control Division, Drug Enforcement Administration in the online Quota Management System. The Administrator may, in his discretion, allocate such amount among the other manufacturers in proportion to their respective quotas.

Citations to §1303.23(b)

  • The Administrator may at any time reduce an individual manufacturing quota for a basic class of controlled substance listed in Schedule I or II which he has previously fixed in order to prevent the aggregate of the individual manufacturing quotas and import permits outstanding or to be granted from exceeding the aggregate production quota which has been established for that class pursuant of § 1303.11, as adjusted pursuant to § 1303.13. If a quota assigned to a new manufacturer pursuant to § 1303.23(b), or if a quota assigned to any manufacturer is increased pursuant to § 1303.24(c), or if an import permit issued to an importer pursuant to part 1312 of this chapter, causes the total quantity of a basic class to be manufactured and imported during the year to exceed the aggregate production quota which has been established for that class pursuant to § 1303.11, as adjusted pursuant to § 1303.13, the Administrator may proportionately reduce the individual manufacturing quotas and import permits of all other registrants to keep the aggregate production quota within the limits originally established, or, alternatively, the Administrator may reduce the individual manufacturing quota of any registrant whose quota is suspended pursuant to § 1303.24(b) or § 1301.36 of this chapter, or is abandoned pursuant to § 1303.27.