DSCSA Timeline

For Implementing the Drug Supply Chain Security Act


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


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The FDA draft guidance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


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


March 1st, 2016
T3 enforcement discretion ends


November 27th, 2017
Manufacturers serialize product

Manufacturers verify Standardized Numerical Identifiers (SNI)

T3 transmitted electronically

Federal distributor licensure regulations effective


November 27th, 2018
Repackagers serialize product

Repackagers associate and
verify SNI


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


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


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
and ship/dispense
serialized products

Dispensers verify Product Identifiers, including SNIs

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