New DSCSA Provider Requirements starting in November

Created October 21, 2020 By MDScripts

Article Summary

[Delayed until 2023] Information regarding two new DSCSA medication serialization requirements that will take effect for Dispensers on November 27, 2020.

Please review our Previous Article on DSCSA Regulations for additional background information on what DSCSA is and how it impacts drug supply-chain and dispensing.

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10/23/2020 UPDATE: FDA Releases Guidance that Wholesaler and Provider Verification Requirements will be delayed until November 27, 2023.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser

 - Below information no longer applies to providers, but will be left in place to educate providers on requirements that will be required in the future.

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DSCSA Background

The Drug Supply Chain and Security Act (Title II, Drug Quality and Security Act, 2013) addresses risks in the pharmaceutical distribution supply chain by establishing a national system that allows stakeholders and regulators to trace each package of product. The serialization and traceability requirements will be phased in over 10 years (2013-2023). The law requires all sectors in the supply chain, manufacturers, repackagers, wholesale distributors, and dispensers to participate.

Two New Requirements for Dispensers that become effective on November 27, 2020 2023

1. Accept only serialized products: Dispensers may engage in transactions only of products encoded with a unique product identifier (PIs), which will be used to verify a drug's legitimacy and enable product tracing in the event of a recall or identification of a suspect product.

2. Verify unique product identifier of suspect products at package level: Dispensers must verify the product identifier, which includes the standardized numerical identifier, or SNI, for products they suspect are potentially counterfeit, diverted, or otherwise unsafe at the package level for at least three packages or 10 percent of suspect products, whichever is greater.

FAQ

Additional Information:

DSCSA Law Link: https://www.govinfo.gov/conten...

FDA Grandfathering Policy for Packages and Homogeneous Cases of Product Without a Product Identifier,Guidance Link: https://www.fda.gov/media/1095...

This information is being provided for informational purposes and is not intended to be construed as legal advise. Please consult your legal or regulatory counsel if you have specific questions relating to how DSCSA requirements may impact your practice. If you have specific questions about how the medications you purchase and dispense may be impacted, please contact your medication supplier. 

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What you need to know about DSCSA Medication Serialization