The Drug Enforcement Administration is proposing to revise its existing regulations that manage the quotas for controlled substances and 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
- formalize 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
- formalize the practice of use-specific subcategories for individual manufacturing and
procurement quotas, including for commercial sales, transfer, product development, replacement, and packaging and labeling
- modify deadlines for fixing or establishing the different types of quotas to allow more time for processing and communicating with applicants
Comments on this rule are due by Dec. 23.
Copyright © 2023 Sandler, Travis & Rosenberg, P.A.; WorldTrade Interactive, Inc. All rights reserved.