PTCB Guide to the DSCSA Act.

Federal Requirements Outline – DSCSA Act and the PTCB Exam.

The 2026 PTCB exam brings with it some new topics untested on previous versions of the exam.

One of these topics is the DSCSA act. Up to this point, the act has not been examinable material on the PTCB test. But effective January 2026, pharmacy technicians will be required to know about the key provisions of the act – what it intends to achieve, and how it impacts the practice of pharmacy.

Note that pharmacy technicians are not required to read the act in full, nor learn about every provision and clause of the act. Instead, technicians are required to have a broad understanding of the key purpose and functions of the act. This includes knowing details about how long documentation must be kept by pharmacies etc., for example.

To help you prepare for this topic of the 2026 test, we put together a Q & A style approach that covers many of the key details technicians need to know. Later, we review sample PTCB questions to give you an idea of the type and style of questions asked on this topic of your exam.

What is the DSCSA act?

The Drug Supply Chain Security Act (DSCSA) is a federal law designed to strengthen the safety and integrity of the prescription drug supply chain.

• It establishes a national system for tracing prescription drugs as they move from manufacturers to wholesalers, pharmacies, and finally to patients.
• Under the DSCSA, trading partners must verify product legitimacy, detect and quarantine suspect or illegitimate drugs, maintain transaction documentation, and meet specific licensing and reporting requirements.

The goal is to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the market, ensuring that patients receive safe and authentic prescription drugs.

When and why was the DSCSA act passed?

The DSCSA act was passed in 2013 as part of the Drug Quality and Security Act.

It was created in response to safety incidents involving counterfeit, stolen, contaminated, or diverted prescription drugs, aiming to protect patients by ensuring product authenticity.

The law requires manufacturers, wholesalers, re-packagers, and pharmacies to exchange standardized transaction data, use product serialization, and meet stricter licensing requirements.

Its core purpose is to create a secure, interoperable, end-to-end system that improves the detection and removal of dangerous or illegitimate drugs from the supply chain.

Who must comply with the act?

All participants in the prescription drug supply chain must comply with the DSCSA.

This includes:

• Manufacturers
• Repackagers
• Wholesale distributors
• Third-party logistics providers (3PLs)
• Pharmacies

Each of whom must follow the act’s tracing, verification, and product-serialization requirements.

How long must pharmacies keep DSCSA documentation?

Pharmacies must keep DSCSA documentation for at least 6 years.

This includes:

• Transaction Information (TI)
• Transaction History (TH)
• Transaction Statements (TS)

For each prescription drug transfer in the supply chain.

Pharmacies must be able to retrieve this documentation during inspections or audits to demonstrate proper traceability and compliance.

Are over-the-counter drugs included under DSCSA?

No.

Over-the-counter (OTC) drugs are not covered under the act because the law applies only to prescription drugs in finished form.

Pharmacies, wholesalers, and manufacturers are therefore not required to exchange or maintain Transaction Information (TI), Transaction History (TH), or Transaction Statements (TS) for OTC products.

How quickly must illegitimate products be reported to the FDA?

Illegitimate or suspect products must be reported to the FDA within 24 hours of determining that they pose a potential risk.

Pharmacies and supply-chain partners must also notify immediate trading partners within the same timeframe.

What is the definition of an illegitimate product?

Under the DSCSA, an illegitimate product is a prescription drug that is either:

• Counterfeit
• Diverted
• Stolen
• Intentionally adulterated
• Appears to be otherwise unfit for distribution
• An altered product that poses a serious risk to patient safety.

This includes products with altered labeling, missing or mismatched serial numbers, or evidence of tampering.

Why is the DSCSA act relevant to pharmacy technicians?

The DSCSA is highly relevant to pharmacy technicians because they play a direct role in receiving, verifying, documenting, and storing prescription drug supply-chain records.

Pharmacy technicians must check product identifiers, ensure Transaction Information/History/Statements are present, and help resolve or escalate suspect-product issues.

Their accuracy and compliance help maintain drug safety, prevent counterfeit prescription drugs from entering the pharmacy, and keep the pharmacy in full regulatory compliance.

PTCB Exam Style Questions.

By now, you will have covered a lot of key detail about the act that gets tested on the exam.

But it’s always worth putting that detail into practice, to show what type and style of questions get asked on the PTCB exam. Below, we put together three sample exam-style questions on the DSCSA act. Have a go and then review each of your answers with the explanations you can find in the section directly below.

Question 1.

Which of the following products is covered under the DSCSA?

a. OTC drugs

b. prescription drugs only

c. veterinary medicines

d. both OTC drugs and prescription drugs

Question 2.

How long must a pharmacy retain transaction documentation under the DSCSA?

a. 6 months

b. 1 year

c. 6 years

d. 10 years

Question 3.

Under the DSCSA, which situation requires quarantine and investigation for potential illegitimate products?

a. a prescription drug nearing its expiration date

b. a shipment with missing or altered product identifiers

c. a drug dispensed without a child-resistant cap

d. a prescription drug returned to stock after patient refusal

Answer Explanations.

Question 1: b) Prescription drugs only

The DSCSA only covers prescription drugs. It does not include OTC medicines or dietary supplements.

Question 2: c) 6 years

Pharmacies are required to retain DSCSA documentation for 6-years.

Question 3: b) A shipment with missing or altered product identifiers

Under the DSCSA, a shipment with missing or altered product identifiers must be quarantined and/or investigated.

DSCSA Act Cheat Sheet.

Throughout this guide, we reviewed many of the key details that pharmacy technicians are required to know for their 2026 pharmacy technician exam. Whilst this guide doesn’t intend to be exhaustive, it does inform much of the broad information that will get tested.

In review, we learned:

• Purpose of the act: to establish a national system to track and trace prescription drugs through the supply chain, reducing counterfeit, stolen, contaminated, or otherwise illegitimate products.
• Year passed: enacted in 2013 as part of the Drug Quality and Security Act (DQSA).
• Who must comply: manufacturers, re-packagers, wholesale distributors, third-party logistics providers, and dispensers (including pharmacies).
• Products covered: prescription drugs in finished dosage form.
  Not covered: OTC drugs, medical devices, APIs, blood products, IV fluids, imaging agents, and veterinary drugs.
• Transaction Documentation Required:
• – Transaction information (TI) – drug name, NDC, lot number, strength, dosage form, container size, number of containers, transaction date, shipment date, and trading partner info.
• – Transaction history (TH) – chain of custody back to the manufacturer (phase being phased out).
• – Transaction statement (TS) – attesting that the seller complies with DSCSA.
• Record retention: pharmacies must keep DSCSA records for 6 years.
• Product verification: pharmacies must be able to verify product identifiers (serialized barcodes) and investigate suspicious products.
• Illegitimate product definition: a drug that is counterfeit, diverted, stolen, contaminated, tampered with, or lacks proper labelling — or has evidence suggesting it could cause serious adverse health consequences.
• Reporting time requirement: suspected or confirmed illegitimate products must be reported to the FDA and trading partners within 24 hours.
• Pharmacy technician relevance: pharmacy technicians often help receive inventory, check DSCSA compliance, maintain records, quarantine suspect products, and support pharmacists during investigations.

By keeping this information fresh in your mind, you are now well-equipped to tackle most questions that will appear on this new topic of the PTCB exam.

Hope you found this week’s PTCB guide to the DSCSA act helpful!

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