The Drug Enforcement Administration (DEA) announced that the manufacturing of almost every Schedule II opiate and opioid medication will be reduced by ≥25% in 2017. The Final Order has been published in the Federal Register.
The Final Order includes the Aggregate Production Quota (APQ), defined as the total amount of a controlled substance necessary to meet the estimated medical, scientific, research, industrial, and export needs for the year and the maintenance of reserve stocks. The APQ serves to provide adequate and uninterrupted supply for legitimate medical need of >250 Schedule I and II controlled substances that have abuse potential while limiting the amounts to prevent diversion.
According to sales data from IMS Health, the demand for these opioids, represented by prescriptions written by DEA-registered practitioners, has decreased. The 2017 APQ has been decreased accordingly for oxycodone, hydrocodone, fentanyl, hydromorphone, morphine, and others. Some medications such as hydrocodone will be available at 66% of last year’s level. The general reduction is a result of removing the 25% buffer that was added to the APQ year from 2013-2016 to prevent shortages.
When the APQ is set, the DEA allocates individual quotas to companies that apply for it.
For more information visit FederalRegister.gov.