Understanding the Drug Supply Chain Security Act (DSCSA): Origins and Purpose

The Drug Supply Chain Security Act (DSCSA) passed in November 2013 is a landmark legislation aimed at making the American pharmaceutical supply chain safer. Specifically, it endeavors to minimize the entry of counterfeit, stolen, contaminated or otherwise harmful drugs into the regular supply chain to guarantee patient safety.

 

Objective and Scope of DSCSA

The DSCSA requires prescribing drugs to be traceable through the US supply chain. For this purpose, manufacturers, repackagers, wholesale distributors and dispensers are supposed to have robust verification and tracking processes. By November 2024, the act will mandate an electronic system that can identify and trace specific prescription drug packages.

 

Major Provisions of DSCSA:

1.         Product Identification: A unique product identifier on a package level must be attached to every drug.
2.         Product Tracing: From manufacturer through dispenser operation change Ownership Company should provide transaction information.
3.         Product Verification: Wholesalers and dispensers should verify their unique identifiers as genuine so as not to be engaged in illegal product distribution.
4.         Detection and Response: The DSCSA provides for procedures on suspicious drug detection and prevention from reaching patients.
5.         Notification: Any entity that discovers an illegitimate or suspect product should inform other stakeholders including the FDA.

 

Why was DSCSA Introduced?

The introduction of the federal law became indispensable due to concerns about the integrity of the drug supply chain in the USA. A number of high-profile cases involving fake or adulterated medicines had exposed weaknesses inherent in the current system thereby necessitating stronger controls and better mechanisms for monitoring them.

 

The legislation sought to address several key issues:

•           Prevent Counterfeiting: Counterfeit drugs pose significant risks to patient safety and public health with stringent tracing requirements being provided by DSCSA which ensures that only genuine drugs get into circulation.
•           Enhance Transparency: By putting up a common system for tracking medicines across America, DSCSA has improved transparency, making it easier to identify any supply chain issues and fix them promptly.
•           Improve Response Times: In a drug recall or security breach scenario, the DSCSA’s framework supports rapid identification and removal of affected products thus minimizing patient risk.

 

Conclusion

The DSCSA is a major leap forward in protecting the US pharmaceutical supply line. This regulation must be followed as law by all players including wholesale pharmacy companies. Drugzone and other wholesale pharmacy in the USA providers are taking proactive steps and adopting DSCSA guidelines to guarantee the integrity and safety of their drugs. As it continues its rollout, the DSCSA pledges to increase security, visibility, and trust in the pharmaceutical sector for patients ultimately resulting in receiving safe and effective medications.

FAQs

Q: What is the main objective of DSCSA?
A: The major objective of the DSCSA is to improve drug supply chain security by enhancing traceability of prescription drugs so as to reduce counterfeiting, stealing or adulteration of drugs that are being sold in the market.

Q: Who needs to follow the DSCSA?
A: Manufacturers, wholesalers, repackers and pharmacies within the pharmaceutical supply chain must adhere to the requirements of this act. 
 

Article Author

Binu .B RPH

President

With more than 20 years of experience in the pharmaceutical wholesale sector, I have Founded and managed several companies, including a pharmaceutical wholesale company, a compounding/retail pharmacy,and many more. As the president of Drugzone Pharmaceuticals Inc., I develop new business and maintain existing business relationships.