Management of Quotas for Controlled Substances and List I Chemicals

The Drug Enforcement Administration (DEA) proposes to revise existing regulations that manage the quotas for controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, held by DEA-registered manufacturers. This rule is being proposed to: Define the types of quotas, update the method to abandon quota, clarify the current language to ensure that both manufacturers and distributors are required to obtain certification of a buyer's quota, reduce overall inventories, formalize the existing practice of use-specific subcategories for individual manufacturing and procurement quotas, and modify existing deadlines to fix/issue quotas. The DEA is also amending certain regulations to implement updates to the Controlled Substances Act made by the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act. The DEA emphasizes that all of these revisions and amendments would apply to both bulk and dosage-form manufacturers, as well as importers of the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The changes are necessary to reduce the potential for diversion, and would align regulations with current manufacturing business practices.