§1301.36. Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order. — Inbound Citations

(a) In the case of an application for registration or reregistration to import a controlled substance listed 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 § 1301.43. If a hearing is requested, the Administrator shall hold a hearing on the application in accordance with § 1301.41. 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 § 1301.43 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 § 1301.35 or § 1301.36 of this part.

(a) The Administrator shall, on or before December 1 of each year, fix for and issue to each person who is registered to manufacture a basic class of controlled substance listed in Schedule I or II, and who applies for a manufacturing quota, an individual manufacturing quota authorizing that person to manufacture during the next calendar year a quantity of that basic class. The Administrator may establish an individual manufacturing quota in terms of pharmaceutical dosage-forms prepared from or containing the schedule I or II controlled substance, if they determine it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance. Any manufacturing quota fixed and issued by the Administrator shall be subject to his authority to reduce or limit it at a later date pursuant to § 1303.26 and to his authority to revoke or suspend it at any time pursuant to § 1301.36 of this chapter.

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.

(b) If requested by a person applying for or holding a procurement quota or an individual manufacturing quota, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the issuance, adjustment, suspension, or denial of such quota to such person, but the Administrator need not hold a hearing on the suspension of a quota pursuant to § 1301.36 of this chapter separate from a hearing on the suspension of registration pursuant to those sections.

If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser's registration) or is suspended or revoked under § 1301.36 of this chapter for all Schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused DEA Forms 222 to the Registration Section.

(d) An institutional practitioner that elects to conduct identity proofing and authorize the issuance of the authentication credential as provided in paragraphs (a) through (c) of this section must do so in a manner consistent with the institutional practitioner's general obligation to maintain effective controls against diversion. Failure to meet this obligation may result in remedial action consistent with § 1301.36 of this chapter.

The Administrator shall, on or before December 1 of each year, fix for and issue to each person registered to manufacture in bulk ephedrine, pseudoephedrine, or phenylpropanolamine who applies for a manufacturing quota an individual manufacturing quota authorizing that person to manufacture during the next calendar year a quantity of that chemical. Any manufacturing quota fixed and issued by the Administrator is subject to his authority to reduce or limit it at a later date pursuant to § 1315.26 and to his authority to revoke or suspend it at any time pursuant to §§ 1301.36, 1309.43, 1309.44, or 1309.45 of this chapter.

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.

(b) If requested by a person applying for or holding a procurement, import, or individual manufacturing quota, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the issuance, adjustment, suspension, or denial of the quota to the person, but the Administrator need not hold a hearing on suspension of a quota under § 1301.36 or § 1309.43 of this chapter separate from a hearing on the suspension of registration under that section.

The hearing will commence at the place and time designated in the order to show cause or notice of hearing published in the Federal Register (unless expedited pursuant to § 1301.36(h)) but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.