Labeling and Documentation Flashcards
7 cards from real CSPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Labeling and Documentation flashcards as text
Which regulatory body requires that CSP labels include a statement indicating the preparation is a compounded preparation and not FDA-approved?
Answer: State Board of Pharmacy
State Boards of Pharmacy require labeling that identifies a preparation as compounded and not commercially manufactured or FDA-approved.
When a CSP is prepared in multiple containers from one compounding record, what must appear on each individual container label?
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.
A pharmacist accidentally omits the administration route from a CSP label for an IV preparation. What is the most significant patient safety risk?
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).
According to USP , what information must be documented in the compounding record that is NOT required on the patient label?
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.
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?
Answer: 4 mg/mL
1 g = 1,000 mg divided by 250 mL equals 4 mg/mL.
Which document serves as the primary accountability record linking each batch of CSPs to its raw materials, equipment used, and personnel involved?
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.
When a CSP requires light protection, how should this be communicated to the end user?
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.