25 Oct 2019
Proposal to Revise Controlled Substances Regulations Under Consideration
The U.S. Drug Enforcement Administration is seeking input by 23 December on a proposal to revise its existing regulations that manage the quotas for controlled substances (including fentanyl, oxycodone, hydrocodone, oxymorphone or hydromorphone) as well as list I chemicals ephedrine, pseudoephedrine and phenylpropanolamine held by DEA-registered manufacturers. The DEA states that this rule would apply to importers of list 1 chemicals as well as bulk and dosage-form manufacturers.
Among other things, this proposed rule would make the following changes:
- define import quotas and other types of quotas;
- formalise the current reporting practice for abandoning quota;
- provide that both manufacturers and distributors are required to obtain certification of a buyer’s quota;
- reduce the allowable individual inventory held by both bulk and dosage-form manufacturers of controlled substances in schedules I and II and list 1 chemicals;
- formalise the practice of use-specific subcategories for individual manufacturing and procurement quotas, including for commercial sales, transfer, product development, replacement, and packaging and labelling; and
- modify deadlines for fixing or establishing the different types of quotas to allow more time for processing and communicating with applicants.
According to a DEA press release, the proposal would further limit excess quantities of medications that might be vulnerable to diversion for illicit distribution and use. The agency states that the quota reductions are “based on rates of overdose deaths and abuse, the overall public health impact related to specific controlled substances and may include other factors as appropriate.”