CSPT Labeling and Documentation 4 — Questions and Answers
Question 1: Which regulatory body requires that CSP labels include a statement indicating the preparation is a compounded preparation and not FDA-approved?
- DEA
- USP
- State Board of Pharmacy (Correct answer)
- The Joint Commission
Correct answer: State Board of Pharmacy
State Boards of Pharmacy require labeling that identifies a preparation as compounded and not commercially manufactured or FDA-approved.
Question 2: When a CSP is prepared in multiple containers from one compounding record, what must appear on each individual container label?
- Only the lot number
- The compounder's name and dispensing date only
- All required label elements including lot number, BUD, and strength (Correct answer)
- A cross-reference to the master formula sheet only
Correct answer: All required label elements including lot number, BUD, and strength
Each individual container must bear a complete label with all required elements so it can stand alone as a fully identified preparation.
Question 3: A pharmacist accidentally omits the administration route from a CSP label for an IV preparation. What is the most significant patient safety risk?
- The medication may be stored at the wrong temperature
- The medication could be administered via the wrong route, causing serious harm (Correct answer)
- The insurance claim may be rejected
- The BUD calculation may be incorrect
Correct answer: The medication could be administered via the wrong route, causing serious harm
Omitting the route of administration from an IV label risks wrong-route administration, which can be fatal (e.g., intrathecal vs. IV).
Question 4: According to USP <797>, what information must be documented in the compounding record that is NOT required on the patient label?
- Drug name and strength
- Quantity dispensed
- Identity and quantity of each component used (Correct answer)
- Patient name
Correct answer: Identity and quantity of each component used
The compounding record must document each individual component's identity and quantity, whereas the patient label shows only the final preparation's name and strength.
Question 5: A CSP label reads 'Vancomycin 1 g/250 mL NS.' A nurse asks what concentration this represents in mg/mL. What is the correct answer?
- 0.4 mg/mL
- 4 mg/mL (Correct answer)
- 40 mg/mL
- 400 mg/mL
Correct answer: 4 mg/mL
1 g = 1,000 mg divided by 250 mL equals 4 mg/mL.
Question 6: Which document serves as the primary accountability record linking each batch of CSPs to its raw materials, equipment used, and personnel involved?
- Patient medication administration record (MAR)
- Master formula record
- Batch compounding record (Correct answer)
- Pharmacy dispensing log
Correct answer: Batch compounding record
The batch compounding record documents lot-specific details including raw materials, equipment, environmental conditions, and responsible personnel for each production run.
Question 7: When a CSP requires light protection, how should this be communicated to the end user?
- Verbal counseling only
- An auxiliary label such as 'Protect from Light' on the container (Correct answer)
- A note in the electronic health record only
- It is not required to communicate this to the user
Correct answer: An auxiliary label such as 'Protect from Light' on the container
An auxiliary label affixed to the container is the standard method to alert healthcare providers and patients of light-sensitive storage requirements.
CSPT Labeling and Documentation 4
Which regulatory body requires that CSP labels include a statement indicating the preparation is a compounded preparation and not FDA-approved?