Drug Supply Chain Security Act
Title II of the Drug Quality and Security Act (Pub. L. 113-54, 2013), codified at FD&C Act §§581–585. It builds an interoperable, electronic, package-level system for tracing prescription drugs through the US supply chain, and defines who may be a trading partner at all.
Manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers handling prescription drugs in the US supply chain.
- 01Exchange of transaction information and transaction statements in an interoperable electronic form
- 02Trading only with authorised trading partners, verified and documented
- 03Systems and processes to investigate suspect product and notify FDA and trading partners for illegitimate product
- 04Product identifiers applied at package and homogeneous case level, and verifiable
DSCSA (FD&C Act §§581–585): frequently asked questions
Quick answers to common questions about DSCSA (FD&C Act §§581–585).
What is DSCSA (FD&C Act §§581–585)?
DSCSA (FD&C Act §§581–585) — Drug Supply Chain Security Act — is a statute issued by the Food and Drug Administration (United States). Title II of the Drug Quality and Security Act (Pub. L. 113-54, 2013), codified at FD&C Act §§581–585. It builds an interoperable, electronic, package-level system for tracing prescription drugs through the US supply chain, and defines who may be a trading partner at all.
Who does DSCSA (FD&C Act §§581–585) apply to?
Manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers handling prescription drugs in the US supply chain.
What are the key requirements of DSCSA (FD&C Act §§581–585)?
FDA DSCSA (FD&C Act §§581–585) requires, among other things: Exchange of transaction information and transaction statements in an interoperable electronic form; Trading only with authorised trading partners, verified and documented; Systems and processes to investigate suspect product and notify FDA and trading partners for illegitimate product; Product identifiers applied at package and homogeneous case level, and verifiable.
When was DSCSA (FD&C Act §§581–585) last updated?
The current version of DSCSA (FD&C Act §§581–585) dates from November 2023.
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