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Pedigree

Verification systems

It is expected that, in compliance with the modifications to the DSCSA, trading partners will develop secure electronic systems to verify the status of a pharmaceutical product and create processes to ensure that appropriate quarantine, investigation, and reporting requirements are met if a product is determined to be illegitimate or suspect.

Concerns over improper pharmaceutical products entering commerce are not new. However, it does appear that the new mandates increase the attention required to protect the public and impose requirements on supply-chain stakeholders to assist in identification of improper pharmaceutical products.

Draft guidance

In an effort to provide specific recommendations, FDA recently published its draft “Guidance for Industry Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The agency has requested that comments to the draft be submitted by August 11, 2014.

In the document, FDA identified numerous scenarios that should lead to scrutiny regarding the authenticity of pharmaceutical products. While not all inclusive, the specific examples provided in the guidance document are a helpful demonstration of how FDA views the issues.

All Proven Rx Sales Suppliers Are Pedigree Compliant

  • Pharmacy: DSCSA July 1st, 2015 Checklist

    Through our website, you have direct access to Transaction Pedigree information via Electronic Web Portal, Invoice/Pedigree Request Combo at Point of Sale, or Directly Requesting Transaction History up to six years from point of sale from each Supplier.

  • Supplier: DSCSA July 1st, 2015 Checklist

    Each supplier will maintain point of sale transaction information, supply chain history, and transaction statements on behalf of Purchaser and provide access to documentation for up to six years after point of sale.

ADDITIONAL INFORMATION

What You Need To Know

Title II of the Drug Quality and Security Act is composed of the Drug Supply Chain Security Act (DSCSA). The DSCSA modified Section 582 of the Federal Food, Drug, and Cosmetic Act to require pharmaceutical manufacturers, repackagers, wholesale distributors, and drug dispensers who are not practitioners to notify FDA and certain trading partners of products that are identified as illegitimate within 24 hours of making such determination.

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