What You Need To Know About DSCSA

Melissa Brodsky

Photo of scattered pills to represent DSCSA. The Workd logo in the lower left corner

What is the DSCSA

The Drug Supply Chain Security Act was created in 2013 and enforced to roll out over ten years, with 2023 being the deadline. The purpose of the DSCSA was to be able to track certain prescription medications throughout the nation electronically. It affects pharma supply from all angles; manufacturing, wholesale, distribution, logistics, and sales to trace the journey of the drug, from origination to consumer. 

There are three main goals the DSCSA means to accomplish within ten years:

  • Verification: The legitimacy of certain medications have to be verified across all stages of its production to distribution.
  • Detectability: Illegal drugs entering the marketplace need to be more easily identified.
  • Recall: Drug recalls should be made easier and more effective. 

The primary purpose of the DSCSA’s creation was to prevent illegitimate and recalled drugs from saturating the US marketplace and keep consumers safe.

What is Drug Pedigree?

The Food and Drug Administration defines drug pedigree as “a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.”  Essentially, a drug pedigree is a record of distribution from the manufacturer through the pharmacy to protect patients from the potential of contaminated and counterfeit drugs. 

Pedigree elements include:

  • The lot number
  • The potency of the medication
  • The expiration date
  • The drug and electronic codes
  • The manufacturer name
  • The name of the distributor, wholesaler, or supplier/pharmacy 
  • The unique identifier of the product

Be Ready For The Full 2023 Rollout of the DSCSA

To protect the public from medications that may be harmful, whether they are illegal, expired, counterfeit, or any other possible scenario, guidelines were created. By 2023, the FDA will actively enforce these guidelines. It’s essential to be aware of and compliant with these guidelines wherever you fall in the supply chain.  

Here are some ways to be fully prepared for the DSCSA when 2023 comes: 

  • Report your licensing to the FDA annually
  • Know how to handle those questionable products
  • Make sure your supply chain partners are aware and compliant as well 
  • Only work with authorized manufacturers, distributors, logistics, and dispensers

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Where Can I Learn More Info About The DSCSA?

There is a lot to know when it comes to the DSCSA. Googling the DSCSA brings up hours of extraordinarily detailed and informational reading. It’s an excellent way to familiarize yourself if you haven’t already. 

The HDA Conference in San Diego in March 2020, will have numerous sessions covering all types of pharma distribution topics, with a heavy emphasis on the DSCSA. It’s the perfect opportunity to not only learn about DSCSA but also to stay on top of other pharma industry-related topics.  

Every day throughout the three-day conference, there will be many sessions related to the DSCSA:

  • DSCSA FDA Activity Update, which will be led by Tish E. Paul, Principal, Olsson Frank Weeda Terman Matz PC
  • DSCSA Saleable Return Verification Industry update, led by Justine M. B. Freisleben, Vice President, Industry Relations, Healthcare Distribution Alliance, and Scott A. Mooney, Vice President, Distribution Operations, McKesson Corporation.
  • The Current EDI Initiatives And Future Solutions by Tim Stearns, Senior B2B E-Commerce Analyst, Baxter Healthcare
  • Intro to the DSCSA by Brian P. Waldman, Esq. MBA, Partner, Arent Fox LLP
  • Traceability Dispenser Panel led by expert panel Ronald N. Bone, HDA Consultant, Ronald N. Bone Consulting LLC, Scott T. Hatakeyama, Director – Buy to Pay, Kaiser Permanente, Leon Nevers, Director, Procurement and Business Development, H-E-B.

The HDA is adding more sessions and speakers, and most are related to the DSCSA. For more information, visit the HDA website

As a pharma distribution company, you need to be aware of and ready for the DSCSA in 2023. 

References:

https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies

https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

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