On April 19, 2018, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM) proposing various changes to DEA’s process for setting Aggregate Production Quotas (APQ) and Individual Procurement Quotas (IPQ). Here are some of the more significant “changes” proposed in the NPRM:
Aggregate Production Quotas
- DEA must consider the diversion of a particular class of drugs when setting APQ;
- DEA must also consider information from HHS, FDA, CDC, CMA, and state information when setting APQ;
- DEA must consider diversion as one of the factors for adjusting APQ;
- Allows for a hearing, if requested, and necessary to resolve issues related to a state’s objection to changes in APQ.