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Standards Compliance

Achieving Compliance

Ineffective, contaminated, adulterated, counterfeit, or recalled food, medical devices, and pharmaceuticals can cause injury or death. Around the world, new regulations will increase supply integrity and ensure safety and security in the supply chain.

In the United States, the FDA Drug Supply Chain and Security Act (DSCSA) requires pharmaceutical manufacturers to implement item-level serialization for all prescription products by November 27, 2017. Shortly thereafter supply chain participants will share serialized event information with each change in ownership.

What’s New?

Compliance with DSCSA will enable the verification of unique drug-product identifiers at the package level, and enhance detection and notification of illegitimate products in the prescription drug supply chain.

Changes are required by key constituents in the production, distribution, and dispensing of drug products. Adherence to DSCSA and industry guidelines requires changes to product identification, electronic information exchange, regulatory reporting, susceptibility monitoring, and suspect product investigation.

The amount of information exchanged among trading partners will increase dramatically. All trading partners must exchange information electronically, by regulation. New systems to manage the serialized-information lifecycle are essential. However, defining, installing, verifying, and successfully deploying serialized information systems can be challenging.

Moving Forward

Manufacturers, distributors, and dispensers handling prescription drugs in the United States, must establish supply integrity; meet the market requirements for product packaging, labeling and information exchange, as established by industry and trading partners; and adhere to federal and international regulatory requirements.

Since 2006, BrandSure has successfully managed more than 35 serialization-focused engagements, many of them facilitating federal and state regulatory compliance. BrandSure is a member and alliance partner of GS1 US and contributed to the authoring of DSCSA and Traceability Implementation Guidelines.

BrandSure will quickly assess gaps in process and technology to deliver actionable compliance strategies and project plans.

Contact Us.

  • Compliance assessment
  • Supply Integrity strategy
  • Actionable roadmap