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 23, Immediate-in-Effect Guidance Announced: Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry
- September 20, Updated: Product Tracing Requirements Frequently Asked Questions
- August 18, Updated: Notify FDA of Illegitimate Products
- July 2022 – Two guidances announced: DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, Revised Draft Guidance and Identifying Trading Partners Under the Drug Supply Chain Security Act, Revised Draft Guidance
- DSCSA presentation at FDA’s Regulatory for Industry Conference
- Extension of comment period to September 6, 2022 for the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
- Verify Wholesale Drug Distributor Licenses
- Read the law Drug Supply Chain Security Act.
- Find a list of DCSCA policy documents.
- Read the key provisions of the law.
- 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 email@example.com.