CSP Regulatory Compliance 2 — Questions and Answers
Question 1: Under the DSCSA, which data elements make up the product identifier on a prescription drug package?
- NDC, serial number, lot number, and expiration date (Correct answer)
- NDC, manufacturer name, and wholesaler ID
- Lot number, ship date, and dispenser license number
- Serial number, price, and DEA schedule
Correct answer: NDC, serial number, lot number, and expiration date
The DSCSA product identifier includes the NDC, a unique serial number, lot number, and expiration date, encoded in a 2D data matrix barcode.
Question 2: A specialty pharmacy determines that a product it received is illegitimate under the DSCSA. Within what time frame must it notify FDA and affected trading partners?
- Within 7 days
- Within 24 hours (Correct answer)
- Within 72 hours
- Within 30 days
Correct answer: Within 24 hours
Once a product is determined illegitimate, FDA and trading partners must be notified within 24 hours, typically using FDA Form 3911.
Question 3: How long must a dispenser keep DSCSA transaction information, history, and statements?
- 2 years
- 3 years
- 6 years (Correct answer)
- 10 years
Correct answer: 6 years
The DSCSA requires trading partners to retain transaction documentation for at least 6 years from the date of the transaction.
Question 4: Which component of a REMS program may require pharmacies to be specially certified before dispensing a drug?
- Medication Guide
- Communication plan
- Implementation system
- Elements to Assure Safe Use (ETASU) (Correct answer)
Correct answer: Elements to Assure Safe Use (ETASU)
ETASU can require prescriber and pharmacy certification, documentation of safe-use conditions, and patient monitoring or enrollment.
Question 5: Under the 2023 revision of USP <797>, what is the maximum beyond-use date for a Category 1 compounded sterile preparation stored in a refrigerator?
- 24 hours (Correct answer)
- 12 hours
- 4 days
- 9 days
Correct answer: 24 hours
Category 1 CSPs have a BUD of no more than 12 hours at controlled room temperature or 24 hours refrigerated.
Question 6: Under USP <800>, how often must an entity review its Assessment of Risk for hazardous drugs it chooses not to handle with all containment requirements?
- Every 6 months
- At least every 12 months (Correct answer)
- Every 3 years
- Only when the NIOSH list is updated
Correct answer: At least every 12 months
USP <800> requires the Assessment of Risk to be reviewed at least every 12 months and documented.
Question 7: A theft of Schedule II drugs is discovered at a specialty pharmacy. What must happen first under DEA rules?
- File DEA Form 41 within 30 days
- Notify the state board only
- Notify the DEA Field Division Office in writing within one business day of discovery (Correct answer)
- Wait until the biennial inventory to reconcile
Correct answer: Notify the DEA Field Division Office in writing within one business day of discovery
Registrants must notify DEA in writing within one business day of discovering a significant theft or loss, then complete DEA Form 106.
