drug supply chain and security act

The Drug Supply Chain Security Act (DSCSA)

The act called the ‘Drug Supply Chain Security Act (DSCSA)’ is the second title of the Drug Quality Security Act (DQSA) that was enacted by the US Congress on November 27, 2013. The main objective behind DSCSA has been the adoption of operational measures and building an interoperable single solution to identify and trace prescription drugs that fall under the scope of DSCSA. 

Moreover, the DSCSA also has provisions to establish standardized procedures for national Pharmaceutical Industry licenses for all Pharma Supply Chain Partners like Wholesale Distributors, Third-Party Logistics Providers, and other Intermediaries. 

USFDA vision behind the Drug Supply Chain and Security Act (DSCSA)

The core vision behind DSCSA is to build a highly transparent and accountable system. The system is envisioned to help USFDA enhance the ability to protect the consumer from exposure to ineffective, stolen, counterfeit, and contaminated drugs that are otherwise harmful if consumed. Every year there is a lot of loss of life and commercial board and in terms of loss of profit and hampered brand reputation to global pharmaceutical manufacturers. 

Drug counterfeiting is one of the major driving forces behind the drafting and enactment of the drug supply chain security act (DSCSA). It is seen as a countermeasure against the counterfeiting that has led to USFDA envisioning a highly transparent, real-time system. The system creates a complete track and trace routine of all medicines that are introduced in a genuine Pharma Supply Chain. It facilitates figuring out stolen, counterfeit, or less effective drugs that were introduced into the Supply Chain and had a high chance of reaching the consumers. 

The end-vision is to achieve complete visibility of the Pharma Supply Chain with ultimate tracking and tracing capabilities to eliminate the drug counterfeits by 2023. 

Milestones

The Drug Supply Chain Security Act has identified the accountable Pharma Supply Chain Partners that need to be a part of the single-spine, electronic, interoperable system. The system hosts real-time transactions of medicine lots as they are transferred from one supply chain partner to another. For successful implementation of the same, the USFDA has preset annual deadlines corresponding to several roles and responsibilities. It is mandatory for each Pharma Supply Chain Partner who wishes to operate within the US Pharmaceutical Market. 

Defined Deadlines

January 1, 2015 – Manufacturers

All the medicines that are introduced into the Pharma supply chain by manufacturers on/after January 1, 2015, should have a lot number printed on the packaging of Rx drugs. 

November 27, 2017 – Manufacturers

The deadline wines US-based pharmaceutical manufacturers to print GTIN, Serial Number, Lot Number, Expiry Date (in a human-readable format), and GST Datamatrix. 

NOTE: This deadline has been revised to November 2018 for serialization requirement enforcement. 

November 27, 2018 – Repackagers

The date binds drug Repackagers for serialization of repackaged medicines. It is compulsory to do it before passing the lots further into the supply chain. 

November 27, 2019 – Wholesalers

The sellers need to be completely compliant with the serialization, authentication, and verification requirements. This deadline demanded the wholesalers to register themselves on electronic systems to initiate and acknowledge drug lot transactions in real-time. 

November 27, 2020– Dispensers

The deadline holds 3PL Partners, and that dispenses to abide by the requirements of Digital Track and Trace capability is on our singles five digital solutions for the growth and dictation and verification

November 27, 2023: Complete Pharma Supply Chain under the Drug Supply Chain Security Act

2023 is the year by which the USFDA has directed the full implementation of Track and Trace enabled interoperable electronic system or Software real-time transaction system. USFDA looks to achieve outright unit-level traceability Including aggregation through the supply chain and complete transaction management and data fetching.