Generic Perc/Norco launch update - DEA's quota process explained -
Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse, and dependence caused if abused— the lower the control schedule the more potential for abuse. The process to obtain approval from the Drug Enforcement Administration (DEA) for Schedule I-V controlled substances and List I chemicals licensing involves intricacy and a detailed timeline of approvals. This article will discuss the background of controlled substance applications and how to successfully work with the DEA.
The Quota Process
Every year the United States sets Aggregate Production Quotas (APQ) for Schedule I, Schedule II, and Pseudoephedrine, Ephedrine, and Phenylpropanolamine (PPA) substances. The quota is based on the Controlled Substance Act (CSA) number. List I chemicals are also included because of the Combat Methamphetamine Epidemic Act (CMEA). All bulk active pharmaceutical ingredient (API) manufacturers that produce controlled drug substance API, manufacturers and packagers of Schedule I and II controlled substances, and manufacturers and importers of Pseudoephedrine, Ephedrine, and PPA must apply for quota. The request and approval/denial of quota can take six to eight weeks to process and bulk manufacture API can take six to nine months to process. This is important to consider when forecasting project timelines.
Quota requests have deadlines due for the next year’s forecast for manufacturing and packaging by April 1 of each year with DEA response by mid-December. Bulk API manufacturing quota requests should be made before May 1 of each year with the DEA response expected by mid-December as well. Keep in mind that the earlier the quota is requested the better. (Quota Applications, 2018)
Manufacturers assigned to individual manufacturing quota may abandon their right to manufacture quota at any time by filing with written notice via DEA website.
The notice should include:
o Name of the controlled substance code number (CSA #)
o The amount chosen to be relinquished before the calendar year ends
The administrator may allocate the amount amended to the other manufacturers in proportion to their respective quotas. For the DEA, a registration is required to import and export controlled substances and controlled reference standards to and from abroad.
The approval process consists of eight steps that must be adhered to in order to file successfully. When partnering with a contract development and manufacturing organization (CDMO), it is important to select one that has vast knowledge and experience with filing controlled substance licenses with the DEA. Involve the DEA expert from the start to protect your product from delays and to fully understand the timelines needed for approval.
