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The FDA draft guidance on suspect product and terminating notifications
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
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 & verify SNI
October 23rd, 2019
FDA delays enforcement of salable returns requirements by 1yr for Wholesale Distributors
October 23rd, 2020
FDA delays enforcement of salable returns requirements by 3 years for Wholesaler Distributors and Dispensers
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
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
July 1st, 2015
Dispensers begin providing T3 information to trading partners
November 27th, 2019
Wholesale Distributors receive and distribute serialized products
Wholesale Distributors verify SNI, including returns
November 27th, 2020
Dispensers receive and ship serialized data
Dispensers verify SNI
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
Trust.med provides pharmaceutical manufacturers a cost effective way to exchange TI data, verify products, facilitate tracing requests, and issue recall notifications to dispensers.
DSCSA Timeline
For Implementing the Drug Supply Chain Security Act
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
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