Unit 12: DSCSA Act

A pharmacy technician receives a shipment of prescription drugs. What is the PRIMARY purpose of the DSCSA in this situation?
A. Ensure correct dosing
B. Track and trace drug movement
C. Reduce drug prices
D. Improve insurance billing

B
(DSCSA creates a system to track and trace prescription drugs through the supply chain )

A contaminated drug batch was discovered nationwide. Which DSCSA function allows tracing it back to its source?
A. Serialization
B. Transaction History
C. FDA reporting
D. Quarantine

B
(TH shows full chain of custody)

A pharmacy receives drugs without documentation. Which DSCSA rule is being violated?
A. Serialization requirement
B. Product verification
C. 3T documentation requirement
D. Controlled substance law

C
(TI, TH, TS must accompany transfers)

Which of the following drugs IS covered under DSCSA?
A. OTC ibuprofen
B. Veterinary antibiotics
C. Prescription insulin
D. Blood products

C
(DSCSA applies to prescription human drugs only)

Which product is EXEMPT from DSCSA requirements?
A. Injectable antibiotic
B. Oral chemotherapy drug
C. OTC cough syrup
D. Biologic prescription drug

C. OTC cough syrup

A technician notices mismatched lot numbers on a drug bottle. What should they suspect?
A. Proper labeling
B. Illegitimate product
C. Expired product
D. Controlled substance issue

B. Illegitimate product

Which of the following BEST defines an illegitimate product?
A. Expired medication
B. High-cost drug
C. Counterfeit or contaminated drug
D. Generic drug

C. Counterfeit or contaminated drug

A shipment appears tampered with. What is the FIRST action?
A. Dispense quickly
B. Return to shelf
C. Quarantine product
D. Ignore

C. Quarantine product

A confirmed counterfeit drug is identified. When must the FDA be notified?
A. 7 days
B. 72 hours
C. 24 hours
D. 1 week

C. 24 hours

A technician checks product name, NDC, lot number, and shipment date. What are they reviewing?
A. Transaction Statement
B. Transaction History
C. Transaction Information
D. Product identifier

C. Transaction Information

Which document shows EVERY previous owner of a drug?
A. TI
B. TH
C. TS
D. NDC

B. TH

A seller certifies the drug is legitimate and from authorized sources. What document is this?
A. TI
B. TH
C. TS
D. DEA form

C. TS

Which statement is TRUE about Transaction History (TH) today?
A. Required forever
B. Being phased out with electronic systems
C. Not used at all
D. Only used for controlled substances

B. Being phased out with electronic systems

How long must pharmacies keep DSCSA records?
A. 1 year
B. 3 years
C. 6 years
D. 10 years

C. 6 years

A drug package includes NDC, serial number, lot number, and expiration date. This is called:
A. Product identifier
B. Transaction data
C. DEA code
D. Barcode label

A. Product identifier

What is the MAIN purpose of serialization?
A. Speed up dispensing
B. Prevent counterfeit drugs
C. Lower costs
D. Improve labeling

B. Prevent counterfeit drugs

Who is responsible for assigning serial numbers?
A. Pharmacies
B. FDA
C. Manufacturers
D. Technicians

C. Manufacturers

A technician scans a barcode to verify authenticity. This is an example of:
A. Quarantine
B. Serialization use
C. Diversion
D. Billing

B. Serialization use

A pharmacy must know where a drug came from and where it went next. This is called:
A. Verification
B. Tracking
C. Dispensing
D. Auditing

B. Tracking

Which describes tracing?
A. Counting inventory
B. Following drug ownership history
C. Dispensing medication
D. Storing drugs

B. Following drug ownership history

A pharmacy buys drugs from an unlicensed supplier. This violates:
A. Quarantine rules
B. Authorized trading partner requirement
C. Serialization
D. DEA law

B. Authorized trading partner requirement

A suspect drug is found. What must happen immediately?
A. Dispense it
B. Quarantine it
C. Destroy it
D. Return to shelf

B. Quarantine it

What does quarantine mean in DSCSA?
A. Dispense quickly
B. Separate from inventory
C. Return to supplier
D. Discount drug

B. Separate from inventory

After confirming an illegitimate product, what must also occur besides FDA reporting?
A. Ignore it
B. Notify trading partners
C. Sell at discount
D. Repackage

B. Notify trading partners

A technician pockets opioid tablets during inventory. This is:
A. Dispensing error
B. Drug diversion
C. Documentation error
D. Counterfeit

B. Drug diversion

Which drugs are MOST commonly diverted?
A. Antibiotics
B. Vitamins
C. Controlled substances
D. OTC drugs

C. Controlled substances

A nurse replaces opioid with saline. What risk does this create?
A. Overdose
B. Contamination and ineffective treatment
C. Faster healing
D. None

B. Contamination and ineffective treatment

A pharmacy receives serialized drugs but does NOT verify identifiers when requested. This violates:
A. Tracking
B. Verification requirements
C. Storage rules
D. Pricing laws

B. Verification requirements

Which situation REQUIRES DSCSA documentation?
A. Patient picking up medication
B. Transfer of ownership between wholesaler and pharmacy
C. Drug counseling
D. OTC sale

B. Transfer of ownership between wholesaler and pharmacy

Which is NOT part of a product identifier?
A. NDC
B. Serial number
C. Lot number
D. Manufacturer address

D. Manufacturer address

A technician notices duplicate serial numbers on two packages. This suggests:
A. Normal variation
B. Counterfeit risk
C. Expired drug
D. Billing issue

B. Counterfeit risk

Which best describes the “electronic interoperable system”?
A. Paper logs only
B. Nationwide digital tracking system
C. Insurance billing system
D. Pharmacy database only

B. Nationwide digital tracking system

A drug is suspected but not confirmed illegitimate. It should be classified as:
A. Safe
B. Expired
C. Suspect product
D. Verified product

C. Suspect product

Which action is INCORRECT under DSCSA?
A. Buying from licensed wholesaler
B. Keeping records 6 years
C. Ignoring minor discrepancies
D. Quarantining suspect drugs

C. Ignoring minor discrepancies

A pharmacy receives a drug shipment with complete product details (NDC, lot, quantity, dates), but no statement verifying legitimacy. What is missing?
A. Transaction Information
B. Transaction History
C. Transaction Statement
D. Product Identifier

C
(TS = legal attestation of legitimacy — very commonly tested confusion)

A technician is reviewing a document that lists EVERY previous owner of a drug back to the manufacturer. Which document is this?
A. TI
B. TH
C. TS
D. SNI

B
(TH = full chain — but note it's being phased out → test trap)

Which scenario BEST represents Transaction Information (TI)?
A. A signed statement of compliance
B. A record of all prior owners
C. Product details like NDC, lot, shipment date
D. Barcode scan result

C. Product details like NDC, lot, shipment date

A pharmacist says: “We no longer rely on full transaction history because of the electronic system.” What concept is this referring to?
A. Serialization
B. TH phase-out
C. Quarantine
D. Diversion

B. TH phase-out

A system allows a pharmacy to follow a drug backward through each owner. This is:
A. Tracking
B. Tracing
C. Serialization
D. Verification

B
(Tracing = backward)

A pharmacy documents where a drug came from and where it is going next. This is:
A. Tracking
B. Tracing
C. Serialization
D. Quarantine

A
(Tracking = forward + movement awareness)

Each drug package has a unique number + barcode used to verify authenticity. This is:
A. Tracking
B. Tracing
C. Serialization
D. Documentation

C. Serialization

A technician scans a 2D barcode to confirm a drug’s identity. What DSCSA function is being used?
A. Tracing
B. Tracking
C. Serialization
D. Quarantine

C. Serialization

A drug has damaged packaging and mismatched identifiers, but is NOT yet confirmed fake. It is classified as:
A. Illegitimate
B. Counterfeit
C. Suspect
D. Expired

C
(Suspect = not confirmed yet)

A manufacturer confirms a drug is counterfeit. It is now:
A. Suspect
B. Illegitimate
C. Expired
D. Verified

B. Illegitimate

Which action is REQUIRED for a suspect product?
A. Report to FDA immediately
B. Quarantine and investigate
C. Destroy immediately
D. Dispense carefully

B. Quarantine and investigate

Which action is REQUIRED ONLY after confirmation of illegitimacy?
A. Quarantine
B. Investigation
C. FDA notification within 24 hours
D. Barcode scan

C. FDA notification within 24 hours

A technician suspects a drug is counterfeit. What is the FIRST step?
A. Notify FDA
B. Quarantine product
C. Return to supplier
D. Dispense quickly

B. Quarantine product

A confirmed illegitimate product must be reported within:
A. Immediately
B. 24 hours
C. 72 hours
D. 1 week

B. 24 hours

Which is ALSO required after confirming an illegitimate product?
A. Ignore it
B. Notify trading partners
C. Sell at discount
D. Repackage

B. Notify trading partners

A pharmacy buys drugs from an online vendor without verifying licensure. This violates:
A. Serialization rules
B. Authorized trading partner requirement
C. TI documentation
D. DEA law

B. Authorized trading partner requirement

Which is an authorized trading partner?
A. Licensed wholesaler
B. Random online seller
C. Patient
D. Insurance company

A. Licensed wholesaler

Which item REQUIRES DSCSA tracking?
A. OTC allergy medication
B. Prescription antibiotic
C. Blood product
D. Medical device

B. Prescription antibiotic

Which item does NOT require DSCSA compliance?
A. Injectable biologic
B. Oral chemotherapy
C. OTC pain reliever
D. Specialty prescription drug

C. OTC pain reliever

Which is NOT part of a product identifier?
A. NDC
B. Serial number
C. Lot number
D. Pharmacy address

D. Pharmacy address

Which combination correctly represents a product identifier?
A. NDC + price + manufacturer
B. NDC + serial + lot + expiration
C. Lot + quantity + invoice
D. Serial + address + dosage

B. NDC + serial + lot + expiration

Why are duplicate serial numbers a red flag?
A. Pricing issue
B. Counterfeit risk
C. Expired drug
D. Storage problem

B. Counterfeit risk

A technician notices small but consistent shortages of opioids during inventory. What is the MOST likely concern?
A. Documentation error
B. Drug diversion
C. Expired medication
D. Serialization issue

B. Drug diversion

A technician receives a drug without TI, TH, or TS. What should they do?
A. Accept shipment
B. Quarantine shipment
C. Dispense carefully
D. Ignore

B. Quarantine shipment

A technician accidentally places a suspect drug back on the shelf. What DSCSA principle was violated?
A. Tracking
B. Quarantine requirement
C. Serialization
D. Documentation

B. Quarantine requirement

Which sequence is CORRECT when handling a suspicious drug?
A. Report → quarantine → investigate
B. Quarantine → investigate → report if confirmed
C. Investigate → dispense → report
D. Dispense → quarantine → report

B. Quarantine → investigate → report if confirmed

Which is the BEST summary of DSCSA?
A. Controls drug pricing
B. Tracks and verifies prescription drugs to prevent harm
C. Regulates insurance
D. Approves medications

B. Tracks and verifies prescription drugs to prevent harm