Pharma track and trace: the next 10 years
Drug Quality and Security Act's timetables for FDA, manufacturers, wholesalers, dispensers and 3PLs
Title II of the Drug Quality and Security Act (DQSA), passed in November 2013, is unusually detailed in its specified actions and deadlines compared to much federal legislation; usually, a law is passed with general goals and dates, and then the appropriate regulatory agencies develop specific regulations and timetables. But the entire dynamic of DQSA—the end product of a decade or more of Congressional bills, hearings, prior law and litigation—was an unusual exercise in law-making. To make a reasonably effective track-and-trace system function across the pharmaceutical supply chain, a cascade of actions need to be successfully completed; first at manufacturers and their agents (including repackagers and third-party logistics firms [3PLs]), then wholesalers, then dispensers, including hospitals. Merely to get these parties to the same table was an accomplishment for the Pharmaceutical Distribution Security Alliance, the lobbying group that interacted most broadly with Congress on the bill’s gestation.
Will all this come to pass? Others reasonably ask, why will it take so long? Still up in the air are many decisions that FDA will have to make in expanding its oversight and control of pharmaceutical distribution. Fasten your seatbelts; it’s going to be a bumpy ride.
FDA
Implementation Date
Publish guidance on identifying suspect product and notification termination
May 26, 2014
Gather stakeholder comments in a public docket on standards for interoperable exchange of transaction information, transaction history, and transaction statements
September 28, 2014
Publish draft guidance outlining standards for interoperable exchange of transaction information, transaction history, and transaction statements
November 27, 2014
Hold first of five required public meetings on unit level tracing, interoperable exchange of transaction information, and protection of confidential commercial information
November 27, 2014*
Establish database of authorized wholesale distributors
January 1, 2015
Publish guidance establishing processes for covered entities to request a waiver and for FDA to determine exceptions and exemptions
November 27, 2015
Finalize guidance specifying circumstances in which products not labeled with a product identifier that are in the pharmaceutical distribution supply chain are exempt from requirements
November 27, 2015
Establish by regulation the standards for wholesale distributor licensing
November 27, 2015
Establish by regulation the standards for third-party logistics provider licensing
November 27, 2015
Issue final guidance documents on unit level tracing and interoperable exchange of transaction information
May 27, 2016*
Receive feasibility assessment of dispensers with 25 or fewer full-time employees conducting electronic tracing of products at package level
May 27, 2022
Publish for final comment the feasibility assessment of dispensers with 25 or fewer full-time employees conducting electronic tracing of products at package level
June 26, 2022
Hold public meeting for stakeholder views on feasibility assessment
November 23, 2022
*Earliest date for an FDA public meeting; regulations will follow.
Manufacturers
Implementation Date
Product tracing and recordkeeping requirements
January 1, 2015
Authorized trading partners only
January 1, 2015
Verification systems in place
January 1, 2015
Electronic format requirement
November 27, 2017
Product identifier requirement
November 27, 2017
Verification of suspect product at the package level
November 27, 2017
Verification on request of whether identifier on a product corresponds to manufacturer’s product identifier
November 27, 2017
Verification of saleable returned product
November 27, 2017
Electronic tracing of product at package level
November 27, 2023
Responses to requests for information from FDA and federal/state officials within 24 hours
November 27, 2023
Sunset of requirements relating to provision and receipt of transaction history and verification of saleable returned product
November 27, 2023
Wholesale distributors
Implementation Date
Product tracing and recordkeeping requirements
January 1, 2015
Authorized trading partners only
January 1, 2015
Verification systems in place
January 1, 2015
Reporting obligations to FDA begin
January 1, 2015
May no longer accept returned product from dispensers and repackagers unless wholesale distributor can associate the returned product with its transaction information and transaction statement
November 27, 2019
May disclose transaction information, transaction history, or transaction statement to subsequent purchaser pursuant to written agreement
November 27, 2019
Product identifier required for all transactions
November 27, 2019
Verification of suspect product at the package level
November 27, 2019
Verification of saleable returned product
November 27, 2019
Electronic tracing of product at package level
November 27, 2023
Responses to requests for information from FDA and federal/state officials within 24 hours
November 27, 2023
Sunset of requirements relating to provision and receipt of transaction history, verification of saleable returned product, and confidentiality of lot level information in transaction information
November 27, 2023
Repackagers
Implementation Date
Product tracing and recordkeeping requirements
January 1, 2015
Authorized trading partners only
January 1, 2015
Verification systems in place
January 1, 2015
Product identifier requirement
November 27, 2018
Verification of suspect product at the package level
November 27, 2018
Verification on request of whether identifier on a product corresponds to repackager’s product identifier
November 27, 2018
Verification of saleable returned product
November 27, 2018
Electronic tracing of product at package level
November 27, 2023
Responses to requests for information from FDA and federal/state officials within 24 hours
November 27, 2023
Sunset of requirements relating to provision and receipt of transaction history and verification of saleable returned product
November 27, 2023
Third-party logistics providers
Implementation Date
Reporting obligations to FDA begin
November 27, 2014
