Compliance With the Drug Supply Chain Security Act (DSCSA)

Many pharmacists have been asking HCC for pharmacy consulting regarding compliance with the Drug Supply Chain Security Act (DSCSA). The DSCSA is intended to create a national system for tracking prescription drugs from their manufacture to dispensing by pharmacists. Each stage of the supply chain has specific requirements to assure that drugs distributed are safe and contain the active ingredients on the label. The law is also a step to help prevent diversion and counterfeiting.

However, this new regulation, which outlines a 10-year plan to establish a standard system for electronic tracking and tracing of prescription drugs does not just affect manufacturers, repackagers and distributors. The law also will affect pharmacists who dispense the medications, according to the Pew Charitable Trust. Pharmacists must comply with applicable traceability requirements by July 1, 2015. Pharmacists are obviously the last step in the pharmaceutical distribution chain, but our role in making sure that medicines are safely dispensed to patients is critical.

According to the Pew Charitable Trust, pharmacists will be required to:

  • Only engage in sales transactions with appropriately licensed or registered partners
  • Provide transaction information, including transaction history and a transaction statement
  • Quarantine and investigate suspected products (i.e., counterfeit, diverted or otherwise unsafe products)
  • Identify and remove illegitimate products and notify the FDA and trading partners if they suspect products are counterfeit, diverted or otherwise unsafe
  • Dispense encoded products with a unique product identifier, which can be used to verify its legitimacy
  • Verify the product identifier, standardized numerical identifier (SNI) for any suspect products
  • Participate in the electronic package-level traceability system.

If you have questions regarding compliance with the Drug Supply Chain Security Act (DSCSA) or virtually any area of your pharmacy business or practice, we urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all areas of your business. Call us today at 800-642-1652 for a free consultation today!

Bob Miller
1/18/2015


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