National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

The American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA) are pleased to submit comments on the proposed rule entitled "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers." APhA is the only organization advancing the entire pharmacy profession. Our expert staff and strong volunteer leadership, including many experienced pharmacists, allow us to deliver vital leadership to help pharmacists, pharmaceutical scientists, student pharmacists, and pharmacy technicians find success and satisfaction in their work while advocating for changes that benefit them, their patients, and their communities. NASPA is dedicated to enhancing the success of state pharmacy associations in their efforts to advance the profession of pharmacy. NASPA's membership is comprised of state pharmacy associations and over 70 other stakeholder organizations. NASPA promotes leadership, sharing, learning, and policy exchange among its members and pharmacy leaders nationwide. APhA and NASPA strongly support the purpose and goals of the Drug Supply Chain Security Act (DSCSA) to enhance the safety and security of the pharmaceutical distribution supply chain and agrees that uniform national standards for licensure of wholesale drug distributors is a critical component to achieve the goals. APhA and NASPA appreciates FDA's efforts in developing guidance, standards, and other information to assist pharmacists and pharmacies in complying with DSCSA's requirements. APhA and NASPA members are particularly interested in these standards because if dispensers' activities and actions fall outside the activities excluded from the definition of wholesale distribution in section 503(e)(4) of the Food, Drug, and Cosmetic Act (FD&C Act), then they would be considered wholesale distributors and would need to be licensed as such. Please, see our full comments on the exemptions. APhA and NASPA appreciates FDA's ongoing efforts in developing guidance, standards, and other information to assist pharmacists and pharmacies in complying with DSCSA's requirements. We look forward to continuing to support FDA's efforts and working to improve the safety and security of the drug supply chain.