2.2 Drug Supply Chain Security Act (DSCSA)
Key Takeaways
DSCSA establishes a national track-and-trace system for prescription drugs to prevent counterfeit medications from entering the supply chain.
The FDA stabilization period for interoperable electronic tracing ended November 27, 2024; pharmacy technicians must understand verification requirements.
Transaction documentation includes Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS).
Pharmacies must verify product identifiers within 24 hours of receiving suspect or illegitimate products.
Serialization requires unique identifiers: NDC, serial number, lot number, and expiration date on each saleable unit.
Quick Answer: DSCSA creates a national track-and-trace system for prescription drugs. Pharmacies must verify product identifiers, maintain transaction records (TI, TH, TS), and report suspect/illegitimate products. This is NEW content for the 2026 PTCE — the Federal Requirements domain increased from 12.5% to 18.75% primarily due to DSCSA.
The Drug Supply Chain Security Act (DSCSA) establishes requirements for an interoperable, electronic system to identify and trace prescription drugs distributed in the United States.
Why DSCSA Matters
- Prevents counterfeit drugs from entering the legitimate supply chain
- Enables rapid identification of suspect or recalled products
- Creates accountability at every step: manufacturer → wholesaler → dispenser (pharmacy)
- Protects patients from receiving dangerous counterfeit medications
Key DSCSA Terminology
| Term | Definition |
|---|---|
| Product Identifier | Unique combination of NDC, serial number, lot number, and expiration date |
| Serialization | Assigning a unique serial number to each individual saleable unit |
| Transaction Information (TI) | Details about a specific drug transaction (product name, strength, dosage form, NDC, container size, number of containers, lot number, transaction date, shipment date, parties involved) |
| Transaction History (TH) | A statement that the previous owner(s) passed on TI |
| Transaction Statement (TS) | Written statement confirming regulatory compliance |
| Suspect Product | A product that may be counterfeit, diverted, stolen, intentionally adulterated, or appear otherwise unfit |
| Illegitimate Product | A product confirmed to be counterfeit, diverted, stolen, or intentionally adulterated |
The 3 T's: Transaction Documentation
When receiving prescription drugs, pharmacies must obtain documentation known as the 3 T's:
| Document | What It Contains |
|---|---|
| Transaction Information (TI) | Product details: drug name, NDC, strength, lot number, quantity, transaction date, names of trading partners |
| Transaction History (TH) | Chain of custody information showing previous owners passed along complete TI |
| Transaction Statement (TS) | Attestation that the product was handled properly and is not suspect or illegitimate |
Retention Requirement: Pharmacies must retain transaction documentation for 6 years after the transaction.
Product Identifier Requirements
Each saleable unit must have a 2D data matrix barcode containing:
- NDC (National Drug Code) — identifies the drug product
- Serial Number — unique to each individual unit
- Lot Number — identifies the manufacturing batch
- Expiration Date — when the product expires
Pharmacy Verification Requirements
When Receiving Products
- Verify the product identifier (scan the 2D barcode)
- Ensure transaction documentation (TI, TH, TS) accompanies the shipment
- Check for signs of tampering or suspect characteristics
Suspect Product Handling
When a pharmacy identifies a suspect product:
- Quarantine the product immediately
- Notify the trading partner within 24 hours
- Investigate with trading partner assistance
- Determine if product is illegitimate
Illegitimate Product Handling
When a product is confirmed illegitimate:
- Quarantine (do not dispense or sell)
- Notify FDA and trading partners within 24 hours
- Cooperate with any investigation
- Dispose of product according to FDA guidance
DSCSA Timeline and 2026 Requirements
| Milestone | Requirement |
|---|---|
| November 27, 2024 | FDA stabilization period for electronic tracing ends |
| 2026 | PTCE now tests DSCSA compliance knowledge |
Exemptions from DSCSA
Certain products are exempt from DSCSA requirements:
- Blood and blood components
- Radioactive drugs and biologics
- Imaging drugs
- Certain IV solutions
- Medical gases
- Homeopathic products
- Drugs compounded by pharmacies (for individual patient use)
What are the "3 T's" of DSCSA transaction documentation that pharmacies must receive when obtaining prescription drugs?
Transaction Information, Transaction History, Transaction Statement
Tracking Number, Temperature Log, Transaction Receipt
Trade Agreement, Transfer Documentation, Testing Certificate
Traceability Information, Technical Specifications, Transaction Log
A pharmacy technician notices a shipment of medication has a product identifier that cannot be verified. Within what timeframe must the pharmacy notify its trading partner about this suspect product?
Immediately (within 1 hour)
Within 24 hours
Within 72 hours
Within 7 business days
What information is encoded in the 2D data matrix barcode required on prescription drug packages under DSCSA?
Manufacturer name, price, pharmacy name, and dispensing instructions
Patient name, prescriber DEA number, fill date, and quantity
NDC, serial number, lot number, and expiration date
Drug interactions, storage requirements, and recall status
Sections you finish are checked off in the contents.