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From Health Law Daily, August 20, 2018

Manufacturing quotas for opioids proposed at 10% reduction for 2019

By Patricia K. Ruiz, J.D.

The Drug Enforcement Agency (DEA) proposed reducing manufacturing quotas by an average of 10 percent for the six most frequently misused opioids. The reduced quotas come as a result of the Trump Administration’s "Safe Prescribing Plan," which seeks to cut nationwide opioid prescription fills by one-third in three years (Notice, 83 FR 42164, August 20, 2018).

Quotas for 2019. For 2019, the DEA proposed to reduce more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. The quotas detailed in the DEA’s proposal represent the quantities of the specified chemicals to be manufactured in the U.S. during the year to provide for the estimated medical, scientific, research, and industrial needs of the U.S.; lawful export requirements; and the establishment and maintenance of reserved stocks. The quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine but not imports of controlled substances for use in industrial processes. The DEA will accept comments on its proposal through September 19, 2019.

Setting of annual quotas. Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. § 826) requires the Attorney General (AG) to establish aggregate production quotas for each basic class of controlled substances listed in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine. The AG delegated the function to the DEA. In setting annual aggregate production quotas, the DEA considers data from sources including FDA estimates of legitimate need, estimates of retail consumption based on prescriptions dispensed, manufactures’ disposition history and forecasts, data from the DEA’s system for tracking controlled substance transactions, and past quota histories.

In 2018, the DEA issued a final rule (83 FR 32784) amending its regulations to improve its ability when setting annual opioid production limits to consider the likelihood of whether a drug can be diverted for abuse, as well as any relevant information obtained from HHS and from the states. The 2019 aggregate quotas proposed were determined with consideration of these factors.

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