The DEA recently informed manufacturers that, effective immediately, applications for procurement quotas for commercial manufacturing of a schedule II-controlled substance will be calculated on a semi-annual basis, except for injectable drug products containing schedule II-controlled substances, which will be calculated on an annual basis. In December 2023, the DEA announced that drug manufacturers would be required to apply for quota allotments quarterly. According to STAT, DEA’s December 2023 announcement of quarterly allotments was an attempt to prevent shortages and hoarding from manufacturers that resulted from annual allotments. However, as manufacturers had a difficult time producing smaller amounts of drugs in quarterly allotments, this change backfired. The DEA will continue to require regular reporting, which is, at a minimum, quarterly.
NCPA
