The Aim of DSCSA Compliance Laws

In September 2018, the U.S. Food and Drug Administration (FDA) has finalized two extremely important guidance documents in order to clarify one important thing: DSCSA issues with product identifier Q&A and DSCSA enforcement exemptions.

Since the agency received tons of questions related to the Drug Supply Chain Security Act (DSCSA), they deemed it necessary to shed some light on the issues of compliance obligations for pharmaceutical trading partners.

The moment the DSCSA became effective with its compliance requirements and obligations, it became clear that there has been a lot of confusion related to homogenous cases of product and compliance obligations for packages that aren’t properly labeled with a product identifier but are regularly distributed across the distribution supply chain.

Since the FDA made a decision to delay the DSCSA compliance laws until November 27, 2018, they felt the need to issue these important guidance documents so that manufacturers can clearly understand their obligations and imprint of affix product identifiers. This enforcement of the manufacturer requirement is known as serialization.

The Two DSCSA Guidances

The two DSCSA guidances are: “Product Identifier Requirements Under the Drug Supply Chain Security Act— Compliance Policy”, and “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier”.

The first one is about the confirmation that the serialization deadline has been extended and will finalize in July 2017 along with draft guidance which relates to the FDA’s intention to take legal actions against all who do not imprint or affix a product identifier to each homogenous case and package of product before the deadline on November 27, 2018.

With it, the FDA also announced a one-year delay in their enforcement of this particular DSCSA requirement.

The other guidance is referring to the finalization of November 2017 draft guidance, which is meant to share a clear clarification on the eligibility of homogenous case or package of the product that hasn’t been labeled with a proper product identifier, for an FDA enforcement exemption under the DSCSA.

This exemption enforcement is valid only if a particular product was repackaged by the repackager or the product was packaged by the manufacturer before November 27, 2018. Based on the specific types of trading partners, this DSCSA requirement sets out related exemptions for:

  • Manufacturers
  • Wholesale distributors
  • Dispensers
  • Repackagers

Trading partners will be exempted from DSCSA requirements at every level in the supply chain, according to the grandfathering guidance.

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