APC APC Compounding and Dispensing Practices 1 — Questions and Answers
Question 1: According to APC standards, which is the most critical step when verifying a compounded preparation before dispensing?
- Checking the color of the final preparation
- Confirming identity, purity, potency, and sterility (for sterile compounds) against the master formula (Correct answer)
- Counting the number of capsules prepared
- Verifying that the label font size meets requirements
Correct answer: Confirming identity, purity, potency, and sterility (for sterile compounds) against the master formula
APC quality standards require pharmacists to verify that compounded products meet the master formula specifications for identity, purity, potency, and sterility to ensure patient safety.
Question 2: When compounding a sterile preparation, the USP chapter that governs the process in Australian-aligned practice is:
- USP <795>
- USP <797> (Correct answer)
- USP <800>
- USP <1151>
Correct answer: USP <797>
USP <797> establishes standards for sterile pharmaceutical compounding including environmental controls, beyond-use dating, and personnel requirements.
Question 3: A pharmacist receives a prescription for a pediatric oral suspension of a drug not commercially available in liquid form. The FIRST step should be to:
- Begin compounding immediately using any available formula
- Verify the prescription, check a validated compounding formula, and confirm stability data (Correct answer)
- Dispense the tablet form with crushing instructions
- Refer the patient to a hospital pharmacy without further action
Correct answer: Verify the prescription, check a validated compounding formula, and confirm stability data
APC standards require verification of the prescription and use of a validated formula with documented stability data before compounding any preparation for patient use.
Question 4: Beyond-use dates (BUDs) for compounded preparations are assigned based on:
- The expiry date of the longest-dated ingredient used
- Stability studies, formulation type, and storage conditions per compounding standards (Correct answer)
- The prescriber's preference noted on the prescription
- Manufacturer guidelines for the commercially available equivalent
Correct answer: Stability studies, formulation type, and storage conditions per compounding standards
BUDs must be based on available stability data, the nature of the preparation, and storage conditions as outlined in compounding standards such as USP <795> and <797>.
Question 5: When dispensing a Schedule 8 (controlled) substance in Australia, the pharmacist must:
- Dispense without additional documentation if the prescription appears valid
- Record the dispensing in the appropriate controlled drugs register and verify the prescription's authenticity (Correct answer)
- Contact the prescriber only if the quantity seems excessive
- Allow a pharmacy technician to dispense independently without pharmacist verification
Correct answer: Record the dispensing in the appropriate controlled drugs register and verify the prescription's authenticity
Schedule 8 substances require mandatory entry in the controlled drugs register and verification of prescription authenticity as part of Australian pharmaceutical regulatory requirements.
Question 6: The primary purpose of a master formula record in compounding is to:
- Record patient counseling notes
- Provide a standardized reproducible procedure ensuring consistency and quality across all batches (Correct answer)
- List the cost of ingredients for billing purposes
- Track which pharmacy technician prepared the compound
Correct answer: Provide a standardized reproducible procedure ensuring consistency and quality across all batches
A master formula record documents the standardized procedure, ingredients, quantities, and quality parameters necessary to ensure consistent, safe, and reproducible compounded preparations.
APC APC Compounding and Dispensing Practices 1
According to APC standards, which is the most critical step when verifying a compounded preparation before dispensing?