ExCPT Sterile and Non-Sterile Compounding Questions and Answers — Questions and Answers
Question 1: A pharmacy technician is preparing a non-aqueous topical cream by mixing two commercially available ointments. According to USP Chapter <795>, what is the maximum beyond-use date (BUD) that can be assigned to this compounded preparation when stored at room temperature?
- 14 days
- 30 days
- 90 days
- 6 months (Correct answer)
Correct answer: 6 months
According to USP Chapter <795> guidelines for non-sterile compounding, the default BUD for non-aqueous formulations (like ointments and creams made from commercial products) is the earliest expiration date of any active pharmaceutical ingredient (API) or 6 months, whichever is earlier.
Question 2: When compounding a sterile preparation, which of the following actions is performed first in the garbing process before entering the cleanroom's buffer area?
- Donning sterile gloves
- Washing hands and forearms
- Putting on a hair cover and face mask (Correct answer)
- Donning a non-shedding gown
Correct answer: Putting on a hair cover and face mask
The correct garbing sequence, from dirtiest to cleanest, requires applying shoe covers, then a hair cover, beard cover (if applicable), and a face mask before proceeding to hand hygiene and donning a gown. This minimizes contamination of cleaner items.
Question 3: A technician is compounding a hazardous drug (HD) intravenously. Which type of Primary Engineering Control (PEC) is required to ensure both product sterility and personnel safety?
- Laminar Airflow Workbench (LAFW)
- Compounding Aseptic Isolator (CAI)
- Class II Biological Safety Cabinet (BSC) (Correct answer)
- A HEPA filter in the general pharmacy
Correct answer: Class II Biological Safety Cabinet (BSC)
A Class II Biological Safety Cabinet (BSC) is required for compounding sterile hazardous drugs. It provides a sterile environment for the product while using negative pressure and HEPA-filtered exhaust to protect the compounder and the environment from exposure to the hazardous drug.
Question 4: What is the primary purpose of using a filter needle when withdrawing medication from a glass ampule?
- To sterilize the medication
- To prevent glass particles from being introduced into the final preparation (Correct answer)
- To measure the volume of the liquid more accurately
- To vent the ampule and prevent pressure buildup
Correct answer: To prevent glass particles from being introduced into the final preparation
When a glass ampule is broken, microscopic glass shards can fall into the solution. A filter needle is specifically designed to trap these particles as the medication is withdrawn, ensuring the final sterile product is free from glass contamination.
Question 5: A pharmacy technician is preparing a magic mouthwash that contains several liquid ingredients. Which piece of equipment is most appropriate for accurately measuring 25 mL of a low-viscosity liquid for this non-sterile compound?
- A conical graduate
- A beaker
- A graduated cylinder (Correct answer)
- An oral syringe
Correct answer: A graduated cylinder
For measuring liquids in non-sterile compounding, a graduated cylinder provides greater accuracy than a conical graduate or a beaker. An oral syringe is also accurate but is typically used for smaller volumes or for direct administration. A graduated cylinder is the standard tool for this volume.
Question 6: Which of the following best describes the difference between a manufacturer's expiration date and a compound's beyond-use date (BUD)?
- They are interchangeable terms for the same concept.
- The expiration date applies to sterile products, while the BUD applies to non-sterile products.
- The expiration date is determined by the drug manufacturer based on stability testing, while the BUD is assigned by the pharmacy for a specific compounded preparation. (Correct answer)
- The BUD is always longer than the manufacturer's expiration date.
Correct answer: The expiration date is determined by the drug manufacturer based on stability testing, while the BUD is assigned by the pharmacy for a specific compounded preparation.
A manufacturer's expiration date is based on extensive stability testing of a specific, sealed commercial product. A beyond-use date (BUD) is assigned to a compounded preparation by the pharmacy and is determined by factors like the date of compounding, ingredients used, and USP guidelines to ensure safety and potency for a custom-made product.
ExCPT Sterile and Non-Sterile Compounding Questions and Answers
A pharmacy technician is preparing a non-aqueous topical cream by mixing two commercially available ointments.
According to USP Chapter , what is the maximum beyond-use date (BUD) that can be assigned to this compounded preparation when stored at room temperature?