Pharma track and trace: the next 10 years

Nicholas Basta

Pharmaceutical Commerce, Pharmaceutical Commerce - March/April 2014,

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Publish draft guidance outlining standards for interoperable exchange of transaction information, transaction history, and transaction statements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