21 CFR 1315.22 - Procedure for applying for individual manufacturing quotas.
Any person who is registered to manufacture ephedrine, pseudoephedrine, or phenylpropanolamine and who desires to manufacture a quantity of the chemical must apply on DEA Form 189 for a manufacturing quota for the quantity of the chemical. Copies of DEA Form 189 may be obtained from the Office of Diversion Control Web site, and must be filed (on or before April 1 of the year preceding the calendar year for which the manufacturing quota is being applied) with the Drug & Chemical Evaluation Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. A separate application must be made for each chemical desired to be manufactured. The applicant must state the following:
(a) The name and DEA Chemical Code Number, as set forth in part 1310 of this chapter, of the chemical.
(4) The actual or estimated inventory allowance pursuant to § 1315.24; and
(2) Any additional factors that the applicant finds relevant to the fixing of the individual manufacturing quota, including any of the following:
(iii) The economic and physical availability of raw materials for use in manufacturing and for inventory purposes.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.