FDA is announcing two compliance policy guidances establishing a one-year stabilization period to accommodate additional time that trading partners in the pharmaceutical supply chain may need to adhere to Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level.
Under the DSCSA, trading partners – primarily manufacturers, wholesale distributors, dispensers, and repackagers – are subject to certain requirements for enhanced drug distribution security. The DSCSA, enacted in 2013, outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S. Currently, these entities can choose to provide such information either electronically or in paper format.
These DSCSA requirements are scheduled to change on November 27, 2023, and will include requiring trading partners to provide, receive and maintain documentation about products and ownership only electronically. The stabilization period will accommodate an additional year, until November 27, 2024, to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems.
FDA expects trading partners to use this stabilization period to build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients. This period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA.
The two compliance policy guidances FDA issued are:
- an immediately-in-effect compliance policy guidance, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies. This guidance describes FDA’s compliance policies regarding enforcement of requirements for enhanced drug distribution security requirements under section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- a revised final compliance policy guidance, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies. This guidance describes FDA’s compliance policies regarding enforcement of requirements for wholesale distributors and dispensers to verify a product’s product identifier in certain circumstances under sections 582(c)(4) and 582(d)(4) of the FD&C Act.
Additionally, on August 30, FDA announced a final guidance, Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act. The updates address comments on a June 2021 draft guidance of the same name, including clarifying terms and recommendations such as operational processes related to aggregation, reconciliation, and responding to verification requests.
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