The DEA announced that is suggesting a significant drop in the number of opioids the United States can produce in 2018.
In a notice published in the Federal Register, the DEA is proposing a 20% reduction in prescribed schedule II opioid painkillers. This class includes oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine, and fentanyl. This reduction only affects drug manufacturing in the United States, not on the imports of controlled substances for industrial processes.
“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said Acting Administrator Chuck Rosenberg in a press release. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”
The DEA is proposing quotas for many schedule I and II drugs, leaving enough to meet the “legitimate medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks.” The DEA looks at statistics like the amount of each drug disposed in the last three years, the current inventory of each drug, and projected demand to determine the minimum necessary amount of each drug. The DEA sets a quota for more than 250 drugs annually.
“The purpose of quotas,” said the DEA statement, “is to provide for an adequate and uninterrupted supply for legitimate medical need of schedule I and schedule II controlled substances, which have a high potential for abuse, while limiting the amounts available to prevent diversion.”
The exact quotas are still not set, and are pending a review and commenting period. Comments can be submitted through the Federal eRulemaking Portal. After the final quotas are established, the DEA will allocate individual quotas to manufacturers. Those individual quotas can be changed at any time during the year to respond to an unexpected increase in demand.