Labeling and Documentation Flashcards

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.