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Chemical Handler's Manual

SECTION VIII – QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE


This mailing address should be used for all reporting requirements described in this section.

Drug Enforcement Administration
Attn: UN Reporting and Quota Section/ODQ
8701 Morrissette Drive
Springfield, VA 22152


Background

Information regarding this subject may be found at 21 U.S.C. §§ 826 and 952, and 21 C.F.R. part 1315.

The Combat Methamphetamine Epidemic Act of 2005 (CMEA) amends the CSA to tighten controls on the manufacture, distribution, import, export, and retail sale of three List I chemicals: ephedrine, pseudoephedrine, and phenylpropanolamine, and drug products containing them. CMEA imposes the following changes:

  1. The DEA must establish an assessment of the annual needs for the estimated medical, scientific, research, and industrial needs of the U.S.; for lawful exports; and for the establishment and maintenance of reserve stocks. That assessment establishes an upper limit on the quantity of the chemicals and products containing the chemicals that can be produced in or imported into the U.S.
  2. Importers must obtain a quota to import the chemicals in bulk or contained in drug products.
  3. Bulk manufacturers must obtain a manufacturing quota to produce any of the three chemicals.
  4. Manufacturers who purchase the bulk chemicals to produce products must obtain a procurement quota before procuring any of the three chemicals.
  5. Manufacturers who package, repackage, label, or relabel must obtain a procurement quota before procuring any of the three chemicals.

Import Quotas

Information regarding this subject may be found at 21 U.S.C. § 952 and 21 C.F.R. §§ 1315.30, 1315.34, and 1315.36.

DEA registered importers must have an import quota issued by the DEA prior to submitting a DEA Form 486A for the importation of ephedrine, pseudoephedrine, and phenylpropanolamine.

Only DEA registered chemical importers may apply for an import quota for the three List I chemicals. A separate quota is required for each chemical. Each DEA registered importer that wishes to import ephedrine, pseudoephedrine, or phenylpropanolamine must follow the instructions http://www.deadiversion.usdoj.gov/quotas/488/488_instruct.htm to complete and file a DEA Form 488, Application for Import Quota, and its corresponding worksheet, DEA Form 488 (worksheet A, http://www.deadiversion.usdoj.gov/quotas/488/488_worksheeta.pdf each year for each chemical the importer wishes to import. Individual applications are required for importing either bulk chemical or finished dosage forms. The importer must provide on each application the following information:

  1. The applicant's name and DEA registration number.
  2. The name and address of a contact person and contact information (telephone number, fax number, email address).
  3. Name of the chemical and the DEA Chemical Code Number.
  4. Type of product (bulk or finished dosage forms).
  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.
  6. The amount requested expressed in terms of base.
  7. For the current and preceding two calendar years, expressed in terms of base:
    1. Distribution/Sales—name, address, and registration number (if applicable) of each customer and the amount sold.
    2. Inventory as of December 31 (each form—bulk, in-process, finished dosage form).
    3. Acquisition—imports.

For each form of the chemical (bulk or dosage unit), the applicant must state the quantity desired for import during the next calendar year.

Applications for individual import quotas must be filed on or before April 1 of the year preceding the year for which the quota is being applied.

Import quotas are issued on a calendar year basis and can only be used during the calendar year for which they were issued. Any person to whom an import quota has been issued may at any time request an increase in the quota quantity by applying to the DEA with a statement showing a need for the adjustment.

The DEA may approve the application if the DEA determines that the approval is necessary to provide for medical, scientific, or other legitimate purposes regarding the chemical.

Manufacturing Quotas

Information regarding this subject may be found at 21 U.S.C. § 826 and 21 C.F.R. §§ 1315.21, 1315.22, and 1315.25.

Each person registered to manufacture in bulk ephedrine, pseudoephedrine, or phenylpropanolamine must obtain an individual manufacturing quota before manufacturing may begin. An individual manufacturing quota represents the maximum amount of ephedrine, pseudoephedrine, or phenylpropanolamine a DEA registrant is authorized to manufacture in a calendar year. A separate quota is required for each chemical.

A manufacturer must complete and file a separate DEA Form 189, Application for Manufacturing Quota, for each chemical by April 1 of each year preceding the year for which quotas are being applied. For specific information required, please review 21 C.F.R. §§ 1315.21, 1315.22, 1315.25, and DEA Form 189. Manufacturing quotas are issued on a calendar year basis and can only be used during the calendar year for which they were issued. Requests for increases in manufacturing quotas can be made at any time so long as another DEA Form 189 is completed. Manufacturers may also abandon or reduce their quota by submitting a written notice to DEA.

The DEA may at any time reduce an individual manufacturing quota for a chemical that was 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.

Procurement Quotas

Information regarding this subject may be found at 21 U.S.C. § 826 and 21 C.F.R. §§ 1315.30 - 1315.33.

A DEA registered manufacturer of ephedrine, pseudoephedrine, or phenylpropanolamine must obtain an individual procurement quota before procuring any of these chemicals for dosage form manufacturing, packaging, repackaging, labeling, and relabeling activities. An individual procurement quota represents the maximum amount or quantity of ephedrine, pseudoephedrine, or phenylpropanolamine that a DEA registered manufacturer is authorized to procure in a calendar year. A separate quota is required for each chemical.

A manufacturer must complete and file a DEA Form 250, Application for Procurement Quota, by April 1 of the year preceding the calendar year for which the procurement quota is being applied. A separate application must be made for each chemical desired to be procured or used.

The applicant must state separately all of the following:

  1. A statement about the purpose(s) for the requested chemical and the quantity which will be used for each purpose during the next calendar year.
  2. For the current and preceding two years:
    1. Actual or estimated quantity used,
    2. Actual net disposals, and
    3. Actual inventory as of December 31 of each year; and
  3. If the purpose is to manufacture another chemical, the applicant must state the official name, common or usual name, chemical name, or brand name of the substance and the DEA Chemical Code Number; or
  4. If the purpose is to manufacture dosage forms, the applicant must state the official name, common or usual name, chemical name, or brand name of that dosage form. If the dosage form produced is a controlled substance listed in any schedule, the applicant must also state the schedule number and National Drug Code Number of the substance.

Manufacturers holding a procurement quota may request an adjustment of the quota by applying to the DEA with a statement showing the need for an adjustment.

Certification of Quotas

Information regarding this subject may be found at 21 C.F.R. § 1315.32.

Any person to whom a procurement quota has been issued must, at or before placing an order with another manufacturer or importer requiring the distribution of a quantity of the chemical, certify in writing to the other registrant that the quantity of ephedrine, pseudoephedrine, or phenylpropanolamine ordered does not exceed the person's unused and available procurement quota of the chemical for the current calendar year. The written certification must be executed by a person authorized to sign the registration application or by a person granted power of attorney to sign the certifications. A copy of such certification must be retained by the person procuring the ephedrine, pseudoephedrine, or phenylpropanolamine for two years from the date of the certification. Registrants must not fill an order from persons required to apply for a procurement quota unless the order is accompanied by a certification.

The certification must contain all of the following:

  1. The date of the certification.
  2. The name and address of the registrant to whom the certification is directed.
  3. A reference to the purchase order number to which the certification applies.
  4. The name of the person giving the order to which the certification applies.
  5. The name of the chemical to which the certification applies.
  6. A statement that the quantity (expressed in grams) of the requested chemical does not exceed the unused and available procurement quota of the chemical, issued to the person giving the order, for the current calendar year.
  7. The signature of the individual authorized to sign a certification.

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