Revision of Applications for Manufacturing and Procurement Quotas NPRM

Fresenius Kabi USA, LLC opposes the proposed rule because it increases administrative complexity, reduces manufacturing flexibility, and risks exacerbating drug shortages. The company argues that the new subcategories and data requirements create significant compliance costs without improving the quota allocation process.

Premier Inc., a healthcare improvement company and supply chain leader, supports the DEA's proposed revisions but argues that the current quota system is insufficient to address drug shortages. They advocate for a more flexible, demand-driven quota process, the creation of a Chief Pharmacy Officer within the DEA, and better coordination between API and finished-dose manufacturers to ensure patient access to critical medications.

The American Pharmacists Association (APhA) supports the DEA's proposal to improve visibility into manufacturing timelines and distinguish between domestic and export markets to prevent drug shortages. However, they urge the DEA to also address downstream supply chain constraints, specifically requesting that the agency work with distributors to ensure that diversion-prevention measures do not inadvertently restrict access to medications for legitimate patients, such as those in hospice care.

The End Drug Shortages Alliance (EDSA) opposes the finalization of the NPRM, requesting a deferral to allow for further stakeholder engagement and evaluation of current quota policies. They argue that the proposed rigid quota categories and additional reporting requirements may reduce operational flexibility and exacerbate drug shortages for essential Schedule II medications.

The Association for Accessible Medicine (AAM) opposes the proposed rule, arguing that the expansion of quota subcategories and reporting requirements will increase administrative complexity and reduce manufacturer flexibility, potentially exacerbating drug shortages. They urge the DEA to defer the rule, address underlying structural issues like staffing and processing delays, and adopt more collaborative, data-driven reforms to improve supply chain resilience.

Amneal Pharmaceuticals supports the DEA's proposed rule to improve transparency and address drug shortages but recommends several specific improvements. They advocate for reinstating annual quota submissions, establishing definitive processing timelines, creating an expedited resubmission pathway, and prioritizing quota allocation for API manufacturers.

Johnson & Johnson supports the DEA's efforts to modernize quota administration and improve supply-chain visibility. They advocate for specific improvements including transparent performance metrics, expedited review pathways for urgent matters, and more granular data sharing to ensure patient access and commercial continuity.

A concerned citizen and prescription medication user opposes the proposed rule because it prioritizes manufacturing volume over product quality assurance for Schedule II CNS stimulants. The commenter argues that accelerated production has led to measurable degradation in medication quality and urges the DEA to mandate batch consistency data, pharmacological profiling, and patient-reported quality feedback in the final rule.

The commenter, representing a business in the pharmaceutical manufacturing sector, argues that the proposed changes to quota applications will not be successful in meeting the DEA's goals. They suggest alternative methods for tracking domestic vs. international usage and request specific revisions to quota timing and production cycle time definitions to better prevent drug shortages.

Health policy economists from The Brookings Institution oppose the proposed rule, arguing that collecting more production-cycle data without addressing the underlying complexity and delays of the quota system will not reduce drug shortages. They contend that the new data may be used to tighten the system rather than build resilience and recommend reforms such as allowing quota rollover and moving toward single annual allocations.