Question

question 86

a pharmacy technician is performing non-sterile compounding and should identify that which of the following documents is required to be maintained for each compounded preparation?

patients insurance card copy
a material safety data sheet for the final product only
a compounding record that includes ingredients, quantities, lot numbers, and beyond-use date
a copy of the pharmacists license

Explanation:

Identify compounding documentation requirements

Using the Nonsterile Compounding and USP 795 Regulations knowledge points

• USP Chapter <795> governs nonsterile compounding standards.
• For each individual compounded preparation, a Compounding Record (CR) must be created and maintained.
• The compounding record serves as the specific log of the actual preparation process, detailing the ingredients used, their exact quantities, manufacturer lot numbers, expiration dates, and the assigned beyond-use date (BUD).

Evaluate the given options

• Patient's insurance card copy: This is a billing document, not a compounding-specific quality control record.
• A material safety data sheet for the final product only: Safety Data Sheets (SDSs) are kept for hazardous bulk ingredients, not created for each individual compounded preparation.
• A compounding record that includes ingredients, quantities, lot numbers, and beyond-use date: This matches the USP <795> requirement for documenting each unique compounded preparation.
• A copy of the pharmacist's license: This is kept in personnel files, not for each individual compounded preparation.

Answer:

• Patient's insurance card copy
• A material safety data sheet for the final product only
• A compounding record that includes ingredients, quantities, lot numbers, and beyond-use date (Correct answer)
• A copy of the pharmacist's license