The implementation of the Drug Supply Chain Security Act has been postponed until November 2024, granting pharmacies an additional year to prepare for compliance with the law’s drug distribution security requirements. Originally passed in 2013, the full enforcement was initially slated for a decade later. However, in response to advocacy from pharmacy organizations requesting more time, the FDA extended the deadline to November 27, 2024.
This delay encompasses several key provisions, notably the interoperable electronic package-level product tracing requirements, as stated by the FDA. The FDA acknowledges that the extra time is necessary for further development and refinement of appropriate systems and processes to enable interoperable electronic tracing at the package level. This extension aims to achieve robust supply chain security under the Drug Supply Chain Security Act while ensuring uninterrupted patient access to prescription drugs.
The Drug Supply Chain Security Act, enacted in 2013, mandates security measures for entities within the pharmaceutical supply chain to prevent counterfeit and illegitimate drugs from entering the market. One critical measure is the electronic tracking of prescription drug movements at the package level.
For the past decade, trading partners, primarily manufacturers, wholesale distributors, dispensers, and repackagers, have fulfilled their tracking obligations primarily through paper records. However, starting on November 27, 2023, the DSCSA will require trading partners to handle documentation about products and ownership electronically. The FDA is providing a one-year stabilization period, which concludes on November 27, 2024, to facilitate the transition to these electronic tracing requirements.
During this stabilization period, trading partners will need to implement, troubleshoot, and refine their electronic interoperable systems. Simultaneously, they will be permitted to continue using paper documentation for product and ownership records. Trading partners must also complete the development and validation of interoperable systems and processes, manage products and data, and ensure a smooth supply chain with continued product availability to patients.
The FDA has introduced two new guidelines:
- Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies: This guidance outlines the FDA’s compliance policies concerning the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act.
- Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies: This guidance explains the FDA’s compliance policies related to the requirements for wholesale distributors and dispensers to verify a product’s product identifier under certain circumstances as per sections 582(c)(4) and 582(d)(4) of the FD&C Act.
Additionally, the FDA has issued a final guidance document titled “Enhanced Drug Distribution
Security at the Package Level Under the Drug Supply Chain Security Act,” which provides updated information on the requirements for electronic tracing of prescription drugs at the package level. You can find links to all these guidance documents through the following links.
- Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies
- Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies
- Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act