Revision of Applications for Manufacturing and Procurement Quotas NPRM

The commenter, a private individual suffering from ADHD, argues that current regulatory oversight of ADHD medications is failing to ensure drug efficacy and quality. They advocate for stricter manufacturing standards, continuous dissolution surveillance, and periodic bioequivalence re-verification to ensure patients receive effective medication.

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.

An individual patient expresses that their medication (Adderall XR) has become less effective recently, causing significant personal hardship. They are requesting that the agency "do something to fix this problem," which supports the proposed action to revise manufacturing and procurement quotas to ensure consistent medication availability and quality.

The commenter, an ADHD patient, supports the revision of manufacturing and procurement quotas to address medication shortages and quality issues. They advocate for earlier publication of 2027 quotas, adjustments to allow for methodical manufacturing, and the establishment of generous ordering limits for pharmacies.

The commenter, a long-term patient of Adderall XR, argues that prescription amphetamine medications have become inconsistent and less effective over time. They urge the DEA to investigate manufacturing processes and conduct independent testing to ensure medications reliably deliver the expected therapeutic effects.

An individual with ADHD reports a significant decline in the quality and consistency of Adderall medications, leading to a decrease in their ability to work and maintain their quality of life. They urge the agency to investigate potential issues at the manufacturing level regarding chemical composition and measurement systems.

The commenter expresses personal frustration regarding the efficacy and side effects of their Adderall prescription and alleges that the medication's formula has been changed without notice. The comment does not take a specific position on the proposed revision of manufacturing and procurement quotas.

An individual who experiences diminished effects from generic Vyvanse medications argues that the current bioequivalency standards for generics are too low. They support the proposed action to revise manufacturing and procurement quotas to ensure cleaner and more effective medication alternatives.