The Drug Supply Chain Security Act (DSCSA)

What is the primary purpose of the Drug Supply Chain Security Act (DSCSA)?

To build an electronic, interoperable system to track and trace prescription drugs at the single-package level from the manufacturer to the pharmacy shelf (preventing counterfeit or contaminated drugs).

How long must a pharmacy retain DSCSA transaction documentation (TI and TS data)?

6 years

What common pharmacy products are exempt from DSCSA tracking?

• Over-the-Counter (OTC) drugs

• Animal/Veterinary drugs

• Compounded medications

• Medical gases (e.g., oxygen)

• Standard IV fluids (e.g., Normal Saline bags)

What are the components of DSCSA product tracing documentation?

• TI (Transaction Information)

• TS (Transaction Statement)

What information is included in the TI (Transaction Information)?

Specific drug details: Name, strength, dosage form, NDC, lot number, container size, transaction date, and the names/addresses of who transferred it.

What is a TS (Transaction Statement)?

An electronic affirmation from the seller stating they are authorized, received the product legally, and didn't alter the tracing data.

What is a Suspect Product under DSCSA?

A medication you have reason to believe is potentially counterfeit, diverted, stolen, altered, or otherwise unfit for distribution (e.g., misspelled labels, missing barcodes, weird packaging).

What is an Illegitimate Product under DSCSA?

A medication where there is credible evidence confirming that it is actually counterfeit, stolen, contaminated, or dangerous.

If a technician identifies a suspect or illegitimate product in the pharmacy, what is the immediate first step?

Quarantine the product (isolate it in a secure, separate area) and alert the pharmacist. Never put it on the shelves or dispense it.

How long does a pharmacy have to notify the FDA and trading partners if a drug is confirmed to be illegitimate?

Within 24 hours

What tool does the DSCSA rely on for single-unit tracking?

2D Data Matrix Barcodes (the small, square pixelated grids on manufacturer labels).

What four pieces of data are embedded within a manufacturer's 2D Data Matrix Barcode?

• GTIN (Global Trade Item Number, which includes the NDC)

• Lot Number

• Expiration Date

• Unique Serial Number