Source: https://www.deadiversion.usdoj.gov/21cfr/cfr/1315/subpart_c.htm
Timestamp: 2019-04-21 02:41:53+00:00

Document:
The Administrator shall, on or before July 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.
§1315.22 Procedure for applying for individual manufacturing quotas.
(a) The name and DEA Chemical Code Number, as set forth in part 1310 of this chapter, of the chemical.
(5) The actual or estimated inventory as of December 31.
(i) The trend of (and recent changes in) the applicant's and the national rates of net disposal.
(ii) The applicant's production cycle and current inventory position.
(iii) The economic and physical availability of raw materials for use in manufacturing and for inventory purposes.
(iv) Yield and stability problems.
(v) Potential disruptions to production (including possible labor strikes).
(vi) Recent unforeseen emergencies such as floods and fires.
§1315.23 Procedure for fixing individual manufacturing quotas.
(i) The trend of (and recent changes in) the national rate of net disposal.
(c) On or before March 1 of each year the Administrator shall adjust the individual manufacturing quota allocated for that year to each applicant in paragraph (a) of this section by the amount necessary to increase or reduce the actual inventory of the applicant to December 31 of the preceding year to his estimated inventory allowance for the current calendar year, pursuant to §1315.24.
(2) For new manufacturers, 50 percent of his reasonably estimated net disposal for the next calendar year as determined by the Administrator.
(b) During each calendar year each registered manufacturer shall be allowed to maintain an inventory of a chemical not exceeding 65 percent of his estimated net disposal of that chemical for that year, as determined at the time his quota for that year was determined. At any time the inventory of a chemical held by a manufacturer exceeds 65 percent of his estimated net disposal, his quota for that chemical is automatically suspended and shall remain suspended until his inventory is less than 60 percent of his estimated net disposal. The Administrator may, upon application and for good cause shown, permit a manufacturer whose quota is, or is likely to be, suspended under this paragraph to continue manufacturing and to accumulate an inventory in excess of 65 percent of his estimated net disposal, upon such conditions and within such limitations as the Administrator may find necessary or desirable.
(c) If, during a calendar year, a registrant has manufactured the entire quantity of a chemical allocated to him under an individual manufacturing quota, and his inventory of that chemical is less than 40 percent of his estimated net disposal of that chemical for that year, the Administrator may, upon application pursuant to §1315.25, increase the quota of such registrant sufficiently to allow restoration of the inventory to 50 percent of the estimated net disposal for that year.
§1315.25 Increase in individual manufacturing quotas.
(a) Any registrant who holds an individual manufacturing quota for a chemical may file with the Administrator an application on DEA Form 189 for an increase in the registrant's quota to meet the registrant's estimated net disposal, inventory, and other requirements during the remainder of that calendar year.
(b) The Administrator, in passing upon a registrant's application for an increase in the individual manufacturing quota, shall take into consideration any occurrences since the filing of the registrant's initial quota application that may require an increased manufacturing rate by the registrant during the balance of the calendar year. In passing upon the application the Administrator may also take into consideration the amount, if any, by which his determination of the total quantity for the chemical to be manufactured under §1315.11 exceeds the aggregate of all the individual manufacturing quotas for the chemical, and the equitable distribution of such excess among other registrants.
§1315.26 Reduction in individual manufacturing quotas.
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.
Any manufacturer assigned an individual manufacturing quota for a chemical pursuant to §1315.23 may at any time abandon his right to manufacture all or any part of the quota by filing with the UN Reporting & Quota Section, Diversion Control Division, Drug Enforcement Administration a written notice of the abandonment, stating the name and DEA Chemical Code Number, as set forth in part 1310 of this chapter, of the chemical and the amount which he has chosen not to manufacture. The Administrator may, in his discretion, allocate the amount among the other manufacturers in proportion to their respective quotas.

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