Manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA within 24-hours after determining a product is illegitimate.
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.
- September 5, 2023 - DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry
- August 30, 2023 - Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product — Compliance Policies (read the announcement here)
- August 30, 2023 - Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
- August 25, 2023 - Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies (read the announcement here)
- August 10, 2023 - Federal Register Notice: Development of Small Dispensers Assessment Under the Drug Supply Chain Security Act; Request for Comments
- Read an overview of key supply chain requirements: What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)?
- Read the law Drug Supply Chain Security Act
- Find a list of DSCSA policy documents
- Get involved with DSCSA issues through FDA’s public meetings
- Find more information through webinars on various requirements
- View resources for state officials
- Browse answers to questions on product tracing requirements
- Learn about the DSCSA Pilot Project Program
- Decision tree graphic: Should this drug package or case have a product identifier under the DSCSA?
- Understand the public health emergencies and DSCSA requirements
If you have questions related to wholesale distributor and third-party logistics provider requirements, email us WDD3PLRequirements@fda.hhs.gov.
If you have other DSCSA-related questions, such as those related to product tracing information, waivers, exceptions and exemptions, and trading partner requirements, email us at firstname.lastname@example.org.