Each year the United States sets the Aggregate Production Quotas (APQ) for Schedule I and II controlled substances and the Annual Assessment of Needs (AAN) for the Combat Methamphetamine Epidemic Act (CMEA) List I chemicals — ephedrine, pseudoephedrine, and phenylpropanolamine — which determine the annual quantities of controlled substances and List I chemicals available for national medical, scientific, and industrial use.
The following entities must apply for a quota:
- Manufacturers of Schedule I and II controlled substances.
- Manufacturers of the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
- Importers of the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Only those persons registered by the Drug Enforcement Administration to manufacture Schedule I or II controlled substances, or import or manufacture the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine, including drug products containing those List I chemicals, may submit applications for quotas.
Annual applications for quotas must be filed on or before the date indicated of the year preceding the calendar year for which the quota is being applied.
- DEA Form 189 for Manufacture Quotas must be filed on or before May 1.
- DEA Form 250 for Procurement Quotas must be filed on or before April 1.
- DEA Form 488 for Import Quotas must be filed on or before April 1.
Separate applications are required for each basic drug class requested. Registrants with new registrations or newly added drug codes may apply for quota at any time. Registrants may request adjustments to their current quotas at any time.