---
kind: "section"
citation: "21 C.F.R. § 1315.22"
title: "21"
number: "1315.22"
heading: "Procedure for applying for individual manufacturing quotas."
url: "https://uscodex.org/cfr/21/1315.22"
---

# §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 and shall state separately for each subcategory, as defined in [§ 1315.07](/cfr/21/1315.07.md), each quantity of such 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 UN Reporting & Quota Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in [§ 1321.01](/cfr/21/1321.01.md) 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.**
- (b) For the chemical in each of the current and preceding 2 calendar years,
  - (1) The authorized individual manufacturing quota, if any;
  - (2) The actual or estimated quantity manufactured;
  - (3) The actual or estimated net disposal;
  - (4) The actual or estimated inventory allowance pursuant to [§ 1315.24](/cfr/21/1315.24.md); and
  - (5) **The actual or estimated inventory as of December 31.**
- (c) For the chemical in the next calendar year,
  - (1) The desired individual manufacturing quota; and
  - (2) Any additional factors that the applicant finds relevant to the fixing of the individual manufacturing quota, including any of the following:
    - (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.**

## Notes

### Amendments

[72 FR 37448, July 10, 2007, as amended at 73 FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, 2010; 88 FR 60143, Aug. 31, 2023]

### Authority

Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.

### Source

Source: 72 FR 37448, July 10, 2007, unless otherwise noted.

### Amendments

[72 FR 37448, July 10, 2007, as amended at 73 FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9, 2010; 88 FR 60143, Aug. 31, 2023]