Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies; Guidance for Industry; Availability

FDA, Please find attached comments from the Association for Accessible Medicines (AAM) and its members regarding the FDA's "Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act" and the related document, "DSCSA Standards for Interoperable Data Exchange." AAM and its members appreciate the opportunity to provide our comments to the FDA regarding issues contained in these two procedural guidance documents. We thank you in advance for your consideration of these comments. Scott Kuzner, Ph.D. Senior Director, Sciences and Regulatory Affairs