By Ed Coghlan.
The Drug Enforcement Administration wants to be able to give companies quotas for the controlled substances that they produce. The DEA has a published a proposed rule change to direct the Administrator to issue procurement quotas for manufacturers.
The public comment period opened on Friday (April 19) and will last until May 4. Some pain advocacy groups are developing strategies to add the voice of the pain patients—many of whom depend on opioids to help manage their pain–to this discussion.
In addition to procurement quotas, the DEA says it wants to make other improvements in the “regulatory system for the production, manufacturing and procurement of controlled substances”.
The new rule would, if approved, require applicants for procurement quotas to state what basic class of controlled substance is needed, the purpose or purposes for which the class is desired, the quantity desired for each purpose during the next calendar year, and the quantities used and estimated to be used for each purpose during the current and preceding two calendar years.
If the applicant’s purpose is to manufacture another basic class of controlled substance, the applicant also must state the quantity of the other basic class that the applicant has applied to manufacture, and the quantity of the first basic class necessary to manufacture a specified quantity of the second basic class.
For more on the rule change and the address to either mail comments or directions on how to submit them online, you can go here.
This is the latest attempt by the DEA to ratchet up the pressure on the opioid supply in the country.
Earlier this month, the DEA announced it has reached an agreement with Attorneys General from 46 states, Puerto Rico, and the District of Columbia to share prescription drug information with one another in order to aid investigations. DEA’s Automation of Reports and Consolidated Orders System (ARCOS) system collects some 80 million transaction reports every year from manufacturers and distributors of prescription drugs.
Last month, the DEA said it will add 250 task force officers and dozens of additional analysts to areas across America where the opioid crisis is at its worst. DEA task forces act as a force multiplier in carrying out DEA’s mission through coordination and cooperation with federal, state, and local law enforcement agencies in the U.S.