Background

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.

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