DSCSA Timeline
For Implementing the Drug Supply Chain Security Act
2013
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The FDA draft guidance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 and
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
and ship/dispense
serialized products
Dispensers verify Product Identifiers, including SNIs
DataX
Drop-Ship Data Routing
