§826. Production quotas for controlled substances — Inbound Citations

Code of Federal Regulations Citations

Cited by 3 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 1303.01 — Scope of part 1303.

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  Procedures governing the establishment of production and manufacturing quotas on basic classes of controlled substances listed in schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826) are governed generally by that section and specifically by the sections of this part.

• 21 C.F.R. § 1303.31(a) — Hearings generally.

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  (a) In any case where the Administrator shall hold a hearing regarding the determination of an aggregate production quota pursuant to § 1303.11(c), or regarding the adjustment of an aggregate production quota pursuant to § 1303.13(c), the procedures for such hearing shall be governed generally by the rule making procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by section 306 of the Act (21 U.S.C. 826), by §§ 1303.32-1303.37, and by the procedures for administrative hearings under the Act set forth in §§ 1316.41-1316.67 of this chapter.

• 21 C.F.R. § 1315.01 — Scope.

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  This part specifies procedures governing the establishment of an assessment of annual needs, procurement and manufacturing quotas pursuant to section 306 of the Act (21 U.S.C. 826), and import quotas pursuant to section 1002 of the Act (21 U.S.C. 952) for ephedrine, pseudoephedrine, and phenylpropanolamine.

Citations to 21 U.S.C. § 826 as a whole

• 21 U.S.C. § 356c(e)(1)

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  (1) determine whether the notification pertains to a controlled substance subject to a production quota under section 826 of this title; and

• 21 U.S.C. § 356c(e)(2)(B)

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  (B) request that the Attorney General increase the aggregate and individual production quotas under section 826 of this title applicable to such controlled substance and any ingredient therein to a level the Secretary deems necessary to address a shortage of a controlled substance based on the best available market data; and

• 21 U.S.C. § 823(d)

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  (d) Registration granted under subsections (a) and (b) of this section shall not entitle a registrant to (1) manufacture or distribute controlled substances in schedule I or II other than those specified in the registration, or (2) manufacture any quantity of those controlled substances in excess of the quota assigned pursuant to section 826 of this title.

• 21 U.S.C. § 824(e)

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  (e) The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under section 826 of this title.

• 21 U.S.C. § 826a(3)

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  (3) identifies drugs containing a controlled substance subject to section 826 of this title when such a drug is determined by the Secretary to be in shortage.

• 21 U.S.C. § 842(b)(1)

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  (1) not expressly authorized by his registration and by a quota assigned to him pursuant to section 826 of this title; or

• 21 U.S.C. § 842(b)(2)

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  (2) in excess of a quota assigned to him pursuant to section 826 of this title.

Citations to §826(h)

• 21 U.S.C. § 826a(1)

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  (1) identifies the number of requests received under section 826(h) of this title (as added by section 1005 of this Act), the average review time for such requests, the number of requests granted and denied under such section, and, for each of the requests denied under such section, the basis for such denial;