DSCSA Timeline

For Implementing the Drug Supply Chain Security Act

DSCSA Timeline

2013

November 27, 2013
The 113th Congress of the United States enacts the Drug Supply Chain Security Act

2014

May 26th, 2014
The FDA draft guidance on suspect product and terminating notifications

November 27th, 2014
Standards published for Transaction Information (TI), Transaction History, (TH) and Transaction Statement (TS) [Collectively T3]

Third Party Logistics (3PL) licensure reporting begins

2015

January 1st, 2015
Trading partners must be authorized. Manufacturers must
print lot numbers of packaging
for all prescription drugs

Manufacturers send and Wholesale Distributors receive T3 and begin direct purchase statement

Wholesale distribution licensure reporting begins

FDA establishes publicly available database of wholesale distributors

July 1st, 2015
Dispensers begin providing T3 information to trading partners

November 27th, 2015
National standards for Wholesale Distributor licensure issued

National standards issued for 3PLs

Waiver guidance issued for exchange of T3

Standards issued for exceptions to Product Identifier requirements

Standards issued for grandfathering product

2016

March 1st, 2016
T3 enforcement discretion ends

2017

November 27th, 2017
Manufacturers serialize product

Manufacturers verify Standardized Numerical Identifiers (SNI)

T3 transmitted electronically

Federal distributor licensure regulations effective

2018

November 27th, 2018
Repackagers serialize product

Repackagers associate & verify SNI

2019

October 23rd, 2019
FDA delays enforcement of salable returns requirements by 1yr for Wholesale Distributors

November 27th, 2019
Wholesale Distributors receive and distribute serialized products 

Wholesale Distributors verify SNI, including returns

2020

October 23rd, 2020
FDA delays enforcement of salable returns requirements by 3 years for Wholesaler Distributors and Dispensers

November 27th, 2020
Dispensers receive and ship serialized data

Dispensers verify SNI

2023

August 30th, 2023
The FDA announced a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) set to go into effect on Nov. 27, 2023.

November 27th, 2023
Full interoperable electronic
unit-level traceability for all stakeholders

Dispensers only receive & ship/dispense serialized products

Dispensers verify Product Identifiers, including SNIs

Trust.med provides pharmaceutical manufacturers a cost effective way to exchange TI data, verify products, facilitate tracing requests, and issue recall notifications to dispensers.

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