Question

question 115

which of the following information should a pharmacy technician include on the label for a compounded sterile product?

manufacturers name
lot number
base solution
providers name

Explanation:

Analyze labeling requirements for compounded sterile products (CSPs)

Using the Sterile Compounding and USP 797 Regulations knowledge points

According to USP Chapter <797> and standard pharmacy practice guidelines, the label of a compounded sterile product (CSP) must contain specific information to ensure patient safety and proper administration. This includes:

• Patient name and identification (for patient-specific CSPs)
• Names and amounts/concentrations of all active ingredients
• Name and volume of the base solution (diluent)
• Beyond-use date (BUD) and time
• Storage conditions
• Route of administration
• Initials of the compounding personnel

Evaluate the given options

• Manufacturer's name: This is found on commercial product labels, not on a custom compounded sterile product label.
• Lot number: While recorded in the compounding log, it is not a standard requirement on the final patient-specific CSP label unless prepared in batches.
• Base solution: The name and volume of the base solution (e.g., 0.9% Sodium Chloride, 5% Dextrose) must be clearly indicated on the label so the clinician knows what the drug is dissolved in.
• Provider's name: While required on a prescription, it is not a mandatory element on the immediate CSP container label itself compared to the critical clinical components of the mixture.

Answer:

• Manufacturer's name
• Lot number
• Base solution (Correct answer)
• Provider's name