DEA Tightens Opioid Manufacturing Restrictions

The US Drug Enforcement Administration (DEA) has reduced the amount of opioid controlled substances that may be manufactured in the United States in 2017.

Under a Final Order being published in the Federal Register tomorrow, the DEA is reducing the amount of almost every Schedule II opiate and opioid medication by 25% or more next year. For instance, hydrocodone manufacturing in 2017 will be 66% of last year’s level.

The 2017 Aggregate Production Quota (APQ) established by the Final Order will reduce manufacturing of oxycodone, hydrocodone, fentanyl, hydromorphone, morphine, and other opioid medications. The APQ is the total amount of controlled substance necessary to meet the estimated medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks.

Sales data obtained from IMS Health has shown a decreased demand for these opioid medications. Opioid demand is determined by the amount of prescriptions written by DEA-registered practitioners.

The manufacturing reductions come amid growing concerns about opioid abuse and increasing opioid-related deaths. The CDC issued guidelines earlier this year recommending reducing prescription medications for chronic pain in an effort to combat the misuse of opioids. However, much of the reduction for 2017 is attributed to the elimination of a 25% buffer that was added to the APQ annually in 2013 through 2016 to guard against drug shortages.

The DEA’s APQ system is intended to provide for the adequate and uninterrupted supply for legitimate medical need of Schedule I and II controlled substances, as well as limiting the amount available to prevent diversion. Annual APQs are established for more than 250 Schedule I and II controlled substances.

Once the APQ is set, the DEA allocates individual manufacturing and procurement quotas to companies that apply for it. The DEA can revise a company’s quota any time during the year due to increased sales or exports, new manufacturers entering the market, new product development, or product recalls.