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:
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.
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.
Regulations governing controlled substance quotas are included in Title 21, Code of Federal Regulations, Part 1303. The regulations for List I chemicals quotas are contained in Title 21, Code of Federal Regulations, Part 1315. An electronic version of these regulations can be found on the Code of Federal Regulations (eCFR) - Title 21 Chapter II website.
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