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§1315.23. Procedure for fixing individual manufacturing quotas. — Inbound Citations

21 C.F.R. § 1315.23

Cited by 6 regulations in release Current.

Citations to 21 C.F.R. § 1315.23 as a whole

  • (a) For the purpose of determining individual manufacturing quotas pursuant to § 1315.23, each registered manufacturer shall be allowed as part of such quota an amount sufficient to maintain an inventory:
    (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 a chemical pursuant to § 1315.23 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 the amount among the other manufacturers in proportion to their respective quotas.
  • (1) All quantities of the chemical necessary to manufacture products that the applicant is authorized to manufacture pursuant to § 1315.23; and
  • (1) All quantities of the chemical necessary to manufacture products that registered manufacturers are authorized to manufacture pursuant to § 1315.23; and
  • Any manufacturer assigned a procurement quota for a chemical pursuant to § 1315.23 may at any time abandon his 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 the amount among the other manufacturers in proportion to their respective quotas.

Citations to §1315.23(b)

  • The Administrator may at any time reduce an individual manufacturing quota for a chemical that he has previously fixed to prevent the aggregate of the individual manufacturing quotas and import quotas outstanding or to be granted from exceeding the assessment of annual needs that has been established for that chemical pursuant to § 1315.11, as adjusted pursuant to § 1315.13. If a quota assigned to a new manufacturer pursuant to § 1315.23(b), or if a quota assigned to any manufacturer is increased pursuant to § 1315.24(c), or if an import quota issued to an importer pursuant to § 1315.34, causes the total quantity of a chemical to be manufactured and imported during the year to exceed the assessment of annual needs that has been established for that chemical pursuant to § 1315.11, as adjusted pursuant to § 1315.13, the Administrator may proportionately reduce the individual manufacturing quotas and import quotas of all other registrants to keep the assessment of annual needs within the limits originally established, or, alternatively, the Administrator may reduce the individual manufacturing quota of any registrant whose quota is suspended pursuant to § 1315.24(b) or §§ 1301.36, 1309.43, 1309.44, or 1309.45 of this chapter or is abandoned pursuant to § 1315.27.