DSCSA (Drug Supply Chain Security Act)
The Drug Supply Chain Security Act (DSCSA) is a 2013 federal law that establishes a national system for tracking and tracing prescription drug products through the U.S. pharmaceutical supply chain to protect consumers from counterfeit, stolen, contaminated, or harmful drugs.
Exam Tip
DSCSA = drug supply chain tracking. Know TI (transaction information) and TS (transaction statement); the TH (transaction history) requirement ended November 27, 2023. Suspect = may be bad, Illegitimate = confirmed bad. NEW to 2026 PTCE under Federal Requirements.
What Is the DSCSA?
The Drug Supply Chain Security Act (DSCSA), signed into law in 2013 as part of the Drug Quality and Security Act, creates a uniform, electronic, interoperable system to trace prescription drugs through the U.S. supply chain. It replaces the previous patchwork of state drug pedigree laws with a single national standard.
DSCSA Requirements
| Requirement | Description |
|---|---|
| Transaction Information (TI) | Drug name, strength, dosage form, NDC, container size, number of containers, lot number, transaction date, shipment date, names/addresses of parties |
| Transaction History (TH) | Record of each prior transaction going back to the manufacturer; FDA says the requirement to provide and receive it effectively ended on November 27, 2023 |
| Transaction Statement (TS) | Statement by the seller that it is authorized, received the product from an authorized person and received TI and TS from the prior owner, has systems to comply with verification requirements, and did not knowingly ship a suspect or illegitimate product |
Key DSCSA Concepts
| Concept | Description |
|---|---|
| Product Tracing | Ability to trace drug product through supply chain using TI and TS |
| Product Verification | Process to verify product at the package level using its unique identifier |
| Suspect Product | Product that may be counterfeit, diverted, stolen, fraudulent, or unfit |
| Illegitimate Product | Confirmed counterfeit, diverted, stolen, or intentionally adulterated product |
| Product Identifier | Standardized barcode (2D data matrix) with NDC, serial number, lot number, and expiration date |
Who Must Comply
| Entity | Responsibilities |
|---|---|
| Manufacturers | Serialize products, provide TI/TS, respond to verification requests |
| Wholesale Distributors | Pass along TI/TS, verify suspect products, maintain records |
| Dispensers (Pharmacies) | Receive TI/TS before accepting ownership, identify suspect/illegitimate products, quarantine and report |
| Repackagers | Serialize repackaged products, maintain records |
DSCSA and the 2026 PTCE
Starting January 2026, DSCSA content is included on the PTCE under the Federal Requirements domain (18.75%). Key topics include:
- Transaction documentation (TI and TS; the TH requirement ended November 27, 2023)
- Suspect and illegitimate product handling
- Product identifier and verification requirements
- Roles and responsibilities of supply chain entities
Exam Alert
DSCSA is NEW to the 2026 PTCE. Know the two transaction documents exchanged today (TI and TS; FDA says the transaction history requirement effectively ended on November 27, 2023), the difference between suspect and illegitimate products, and that pharmacies must not accept ownership of a product without TI and TS. This falls under the Federal Requirements domain (18.75%).
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NDC Number (National Drug Code)
The NDC (National Drug Code) is a unique 10-digit, 3-segment numeric identifier assigned to each medication product in the United States, identifying the labeler, product, and package size.
Lot Number
A lot number is a unique identifier assigned by a drug manufacturer to a specific batch of medication produced at the same time and under the same conditions, used for tracking, quality control, and recall purposes.
FDA Drug Recall Classifications
FDA drug recall classifications are a three-tier system (Class I, II, and III) that categorizes product recalls based on the severity of the health hazard posed by the defective or potentially harmful product.
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