DSCSA Timeline

For Implementing the Drug Supply Chain Security Act

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November 27, 2013
The 113th Congress of the United States enacts 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The FDA draft guidance on suspect product and terminating notifications

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The FDA draft guidance on suspect product and terminating notifications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

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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

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March 1st, 2016
T3 enforcement discretion ends

 

March 1st, 2016
T3 enforcement discretion ends

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November 27th, 2017
Manufacturers serialize product

Manufacturers verify Standardized Numerical Identifiers (SNI)

T3 transmitted electronically

Federal distributor licensure regulations effective

November 27th, 2017
Manufacturers serialize product

Manufacturers verify Standardized Numerical Identifiers (SNI)

T3 transmitted electronically

Federal distributor licensure regulations effective

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November 27th, 2018
Repackagers serialize product

Repackagers associate & verify SNI

November 27th, 2018
Repackagers serialize product

Repackagers associate & verify SNI

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

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

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

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

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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, 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

DSCSA Requirements and Resources

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