DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information; Availability

Margaret A. Hamburg, M.D. Commissioner of Food and Drugs Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dear Commissioner Hamburg: Re: FDA Docket FDA-2014-D-1981 DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information The National Association of Chain Drug Stores (NACDS) thanks the Food and Drug Administration for the opportunity to submit our comments on the DSCSA Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information. NACDS represents traditional drug stores and supermarkets and mass merchants with pharmacies. Chains operate more than 40,000 pharmacies, and NACDS 125 chain member companies include regional chains, with a minimum of four stores, and national companies. Chains employ more than 3.8 million individuals, including 175,000 pharmacists. They fill over 2.7 billion prescriptions yearly, and help patients use medicines correctly and safely, while offering innovative services that improve patient health and healthcare affordability. NACDS members also include more than 800 supplier partners and nearly 40 international members representing 13 countries. For more information, visit www.NACDS.org. Our full comments have been submitted electronically via upload into the docket. Sincerely, Diane Darvey, Pharm.D., J.D. Director Government Affairs and Public Policy