[August 30, 2023] FDA is announcing two compliance policy guidances establishing a 1-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. The DSCSA requires trading partners to provide, receive and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser as the drugs are distributed in the U.S. supply chain. Currently, these entities can choose to provide such information either electronically or in paper format.
Those 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. The stabilization period is intended to avoid disruption to the supply chain and ensure continued patient access to drug products as trading partners work to fully implement the enhanced drug security requirements.
“FDA is committed to successful implementation of interoperable systems required under the DSCSA,” said Leigh Verbois, director of CDER’s Office of Drug Security, Integrity and Response. “We have heard concerns about supply chain readiness, and we believe that some flexibility will support successful implementation and lead to a stronger and safer drug supply chain.”
As explained in the guidance, FDA does not intend to enforce the enhanced drug distribution security requirements under section 582(g)(1) of the the Federal Food, Drug, and Cosmetic (FD&C) Act during this stabilization period to help trading partners transition to full implementation. Additionally, FDA does not intend to enforce section 582(g)(1)(B) of the FD&C Act with respect to drug product that is introduced in a transaction into commerce by the product’s manufacturer or repackager before November 27, 2024, and for subsequent transactions of such product through the product’s expiry.
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 compliance policies support trading partners’ use of current methods to exchange and store documentation about products and their chain of ownership, investigate and report suspect or illegitimate product, and handle saleable returns.
The two 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 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.