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 build an electronic, interoperable system 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. The system 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.
- Extension of Comment Period on Enhanced Drug Distribution Security under DSCSA, Draft Guidance, until 9/2/2021
- FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain
- Federal Register notice reopening of comment period until 6/22/2021
- Public meeting: Drug Supply Chain Security Act pilot project program and enhanced drug distribution security
- Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency
- Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies When Investigating a Suspect or Illegitimate Product—Compliance Policies
- DSCSA Pilot Project Program
- Decision tree graphic: Should this drug package or case have a product identifier under the DSCSA?
- FDA advances policies related to bolstering security of drug products in the U.S. supply chain
- Public Health Emergencies and DSCSA Requirements
Law and Policies
Read the Drug Supply Chain Security Act. Find a list of DCSCA policy documents and FDA’s implementation plan. Additionally, read the key provisions of the law and find out if you are ready for DSCSA’s requirements.
Reporting and Notification Requirements
The DSCSA requires wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA
Additionally, to further enhance the security of the drug supply chain, manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA and other trading partners within 24 hours after determining a product is illegitimate. See frequently asked questions for more information about filling out Form FDA 3911 for a drug notification.
Resources and Information
Get involved with DSCSA issues through FDA’s public meetings. Find more information through webinars on various requirements, resources for state officials, and answers to questions on product tracing requirements.
How to Submit Inquiries
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.