Publication

The Drug Supply Chain Security Act Timeline

On November 18, Congress passed the Drug Supply Chain Security Act (DSCSA or the Act), as Title II of the Drug Quality and Security Act (H.R. 3204).  The DSCSA creates new sections in the Federal Food, Drug, and Cosmetic Act (FDCA), outlining product tracing and verification requirements for entities in the drug supply chain, from the manufacturer to the dispenser; establishing a unit-level, interoperable, electronic product tracing system; and establishing licensing requirements and standards for wholesale distributors and third-party logistics providers.  The Act complements the drug supply chain provisions enacted in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA).  Those provisions required drug facilities to register with the Food and Drug Administration (FDA) and obtain a Unique Facility Identifier, to be included in an electronic database maintained by FDA. 

Below is the implementation timeline of the Act’s provisions.  

Implementation Timeline

2013 November Date of statutory enactment

 
2014 May (Tracing System) Deadline for FDA guidance on identifying suspect products and terminating notifications

 
2014 November (3PLPs) Begin reporting license and facility information

(Tracing System) Earliest date for the first FDA public meeting

 
2015 January 1 Deadline to partner with authorized partners only

Deadline to begin product tracing

Deadline to establish verification systems

(Wholesalers & 3PLPs) Begin licensing requirement

(Wholesalers) Begin reporting license and facility information

(FDA) Deadline to establish a database of authorized wholesalers

 
2015 November (FDA) Deadline for guidance on grandfathering products without a product identifier

(FDA) Deadline for guidance outlining standards for the licensing of wholesaler distributors and 3PLPs

(FDA) Deadline for guidance regarding waivers, exceptions, and exemptions

 
2017 November (Manufacturers) Deadline for electronic tracing

(Manufacturers) Deadline to begin affixing product identifiers to each package and homogenous case of product

(Manufacturers) Deadline to package-level verification capability

 
2018 November (Repackagers) Deadline to begin affixing product identifiers and handling only products that have product identifiers

(Repackagers) Begin package-level verification capability

 
2019 November (Wholesalers) Begin voluntary disclosing of transaction information to purchaser

(Wholesalers) Begin product identifier requirement for all transactions

(Wholesalers) Begin package-level product verification capability

 
2020 November (Dispensers) Deadline to handle only products with product identifiers

(Dispensers) Begin lot-number product verification capability

(Dispensers) Begin product identifier verification capability

 
2022 May (Tracing System) Deadline for a consulting firm’s assessment of the feasibility of the tracing system for small dispensers

 
2023 November (Tracing System) Begin interoperable, unit-level, electronic tracing

(Tracing System) Sunset previous tracing requirements

(Tracing System) All responses to state and federal officials must be made within 24 hours