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The Drug Enforcement Administration (DEA) proposes to revise existing regulations that manage the quotas for schedule I and II controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, to be utilized by DEA-registered manufacturers. This rule is being proposed to: restructure DEA's manufacturing and procurement quota regulations for more clarity and consistency; clarify which use-specific subcategories for quotas should be used for controlled substances that will be sold domestically and controlled substances that will be exported and revise the applications for individual manufacturing and procurement quota. These revisions would apply to both bulk and dosage-form manufacturers. The changes are necessary to ensure clarity, provide transparency into the manufacturing process, and to ensure enough schedule I and II controlled substances and three List I chemicals are available in America to meet estimated scientific, medical, lawful export, and inventory needs.

The DEA Diversion Control Division hosted a Supply Chain Conference April 30 May 2, 2024 in Little Rock, Arkansas.  This conference offered DEA registered Manufacturers, Distributors, Pharmacists, Importers or Exporters the opportunity to meet, share information and discuss concerns.  The conference provided a venue in which representatives from the supply chain industry, their affiliated associations, and DEA engaged in discussions concerning existing federal regulations, issues requiring regulatory changes (to include recent changes to quotas), clarification of DEA policy, and the development of initiatives to reduce diversion of pharmaceutical controlled substances while ensuring an adequate and uninterrupted supply.  This has become an annual conference hosted by DEA.