21 CFR 1315.34 - Obtaining an import quota.
(a) Any person who is registered to import ephedrine, pseudoephedrine, or phenylpropanolamine, or whose requirement of registration is waived pursuant to § 1309.24(c) of this chapter, and who desires to import during the next calendar year any ephedrine, pseudoephedrine, or phenylpropanolamine or drug products containing these chemicals, must apply on DEA Form 488 for an import quota for the chemical. A separate application must be made for each chemical desired to be imported.
(2) The name and address of a contact person and contact information (telephone number, fax number, e-mail address).
(5) For finished dosage forms, the official name, common or usual name, chemical name, or brand name, NDC number, and the authority to market the drug product under the Federal Food, Drug and Cosmetic Act of each form to be imported.
(i) Distribution/Sales—name, address, and registration number (if applicable) of each customer and the amount sold.
(c) For each form of the chemical (bulk or dosage unit), the applicant must state the quantity desired for import during the next calendar year.
(d) DEA Form 488 must be filed on or before April 1 of the year preceding the calendar year for which the import quota is being applied. Copies of DEA Form 488 may be obtained from the Office of Diversion Control Web site, and must be filed with the Drug & Chemical Evaluation Section. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.
(f) On or before July 1 of the year preceding the calendar year during which the quota shall be effective, the Administrator shall issue to each qualified applicant an import quota authorizing him to import:
(1) All quantities of the chemical necessary to manufacture products that registered manufacturers are authorized to manufacture pursuant to § 1315.23; and
(2) Such other quantities of the chemical that the applicant has applied to import and that are consistent with his past imports, the estimated medical, scientific, and industrial needs of the United States, the establishment and maintenance of reserve stocks, and the total quantity of the chemical that will be produced.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.