The U.S. Drug Supply Chain Security Act (DSCSA), enacted November 2013, represents Title II of the Drug Quality and Security Act (H.R. 3204). This federal law establishes a national standard for drug security that overrides state regulations and mandates a complete prescription drug traceability system that encompasses the full supply chain range, from pharmaceutical manufacturer to dispenser, for pharmaceuticals distributed in the United States. The law includes complex regulations related to drug tracing, verification and serialization.
Purpose: According to estimates by the World Health Organization, 1 to 10 percent of drugs sold universally are counterfeit, with rates as high as 50 percent in some countries. The primary intent of the DSCSA legislation is to verify products, improve detection of potential counterfeits and facilitate product recalls.
Stakeholders: The list of stakeholders involved in this initiative is broad, ranging from the FDA, state officials and international regulatory counterparts to pharmaceutical manufacturers, repackagers, wholesale distributors, third-party logistics providers (3PLs) and dispensers.
A dispenser is defined as any entity that dispenses prescription products to patients. This includes retail and hospital pharmacies, the focus of this document, as well as any person authorized by law to dispense or administer prescription drugs, and a group of chain pharmacies or affiliated warehouses or distribution centers of such entities as long as the pharmacy chain group or warehouse or distribution center does not act as a wholesale distributor.
Responsibilities of Dispensers: Following is a summary of the key requirements for dispensers:
- Track/Receive Lot Level Compliance Data – ability to receive lot-level Transaction History (TH), Transaction Information (TI) and Transaction Statement (TS) for every product purchased.
- “T3” Compliance Data Verification – ability to verify “T3” compliance data against products shipped to them by suppliers, including being able to quarantine any product deemed suspect or questionable.
- “T3” Compliance Data Storage – ability to store compliance information associated with all shipments received for at least six years from shipment receipt date.
Retrieve and respond to requests for information – ability to retrieve compliance data requested by the FDA or similar regulatory body within two business days.
Timeline – Major Implementation Phases: A key note related to DSCSA deadlines is the recent four-month extension the FDA gave pharmacies to comply with track and trace requirements. Originally set for July 1, 2015, this date has been moved to November 1, 2015 (see below).
Following is a full list of key dates associated with the DSCSA timeline:
- January 2015 – wholesale drug distributors must report licensing status and contact information to FDA; dispensers may buy drugs only from companies that are DSCSA-authorized.
- November 2015 – dispensers must begin receiving and providing TI, TH and TS from suppliers when they buy or sell prescription drugs (excludes dispensing to patients).
- November 2017 – manufacturers must place a unique product identifier (2D DataMatrix barcode, NDC, Serial Number, Lot Number, Expiration Date) on certain prescription drug packages.
- November 2018 – re-packagers must place a unique product identifier on certain prescription drug packages.
- November 2019 – wholesalers can trade only products with product identifiers.
- November 2020 – dispensers can trade only products with product identifiers.
- November 2023 – serialization phase with enhanced system, package level requirements for the interoperable, electronic tracing of products.
For the most recent timeline published by the FDA: Drug Supply Chain Security Act (DSCSA) Implementation Plan
Dispenser Compliance Guidelines and Tips:
- Verify that pharmaceutical suppliers are currently able to provide drug traceability records.
- Ask your suppliers for a written agreement stating they will maintain drug traceability records for at least six years and provide electronic access to those records upon request.
- Request that your suppliers keep you updated on any DSCSA changes or additional requirements.
According to our research, most DSCSA software solutions on the market address the pharmaceutical companies. The only vendor we were able to identify that offers a dispenser solution related to DSCSA compliance is TraceLink, Inc., which offers the TraceLink Dispenser DSCSA transaction history management system. Some venders offering DSCSA compliant solutions are TraceLink, LSPediA, and RX Transparent.
DSCSA is a complex law, and this article does not attempt to address every nuance. Following are links to additional resources and information related to the DSCSA: