MCC Beyond-Use Dating and Stability 1 — Questions and Answers
Question 1: According to USP <795>, what is the maximum beyond-use date (BUD) for a nonaqueous compounded preparation when no stability data is available (Category 1)?
- 14 days
- 90 days
- 180 days (Correct answer)
- 365 days
Correct answer: 180 days
USP <795> allows up to 180 days for Category 1 nonaqueous formulations when no supporting stability data is available, as these formulations are inherently more stable without water.
Question 2: What is the primary purpose of assigning a beyond-use date to a compounded preparation?
- To comply with state pharmacy board requirements only
- To ensure the preparation maintains acceptable potency, quality, and purity until use (Correct answer)
- To limit the pharmacist's liability for product failures
- To synchronize with the expiration date of raw ingredients
Correct answer: To ensure the preparation maintains acceptable potency, quality, and purity until use
BUDs are assigned to ensure compounded preparations remain safe and effective with acceptable potency, quality, and purity throughout their intended use period.
Question 3: According to USP <797>, what is the maximum BUD for a Category 1 compounded sterile preparation (CSP) stored at controlled room temperature?
- 12 hours (Correct answer)
- 24 hours
- 48 hours
- 72 hours
Correct answer: 12 hours
Category 1 CSPs have the most conservative BUD of 12 hours at controlled room temperature per USP <797>, due to minimal sterility assurance requirements.
Question 4: Which of the following factors does NOT directly affect the stability of a compounded preparation?
- pH of the formulation
- Packaging and container type
- Color of the compounding hood (Correct answer)
- Storage temperature
Correct answer: Color of the compounding hood
The color of the compounding hood has no effect on product stability; pH, container type, and storage temperature are all critical determinants of preparation stability.
Question 5: What type of chemical degradation occurs when a drug molecule reacts with water molecules in the formulation?
- Photolysis
- Oxidation
- Hydrolysis (Correct answer)
- Thermolysis
Correct answer: Hydrolysis
Hydrolysis is the cleavage of a chemical bond by reaction with water and is one of the most common degradation pathways for drugs in aqueous formulations.
Question 6: Which storage condition is most commonly used to extend the BUD of water-containing compounded preparations?
- Elevated temperature (40°C)
- Refrigeration (2–8°C) (Correct answer)
- Freezing (−20°C or below)
- Room temperature with desiccants
Correct answer: Refrigeration (2–8°C)
Refrigeration at 2–8°C slows microbial growth and reduces the rate of chemical degradation, allowing longer BUDs for water-containing preparations.
Question 7: When a compounded preparation is made from a commercially manufactured drug product, how does the source product's expiration date affect the BUD assignment?
- The BUD cannot exceed the expiration date of the source manufactured product (Correct answer)
- The BUD defaults to 6 months regardless of the source product's date
- The source product's expiration date is irrelevant to the BUD
- The BUD must be at least 1 year from the date of compounding
Correct answer: The BUD cannot exceed the expiration date of the source manufactured product
The BUD of a preparation derived from a manufactured drug product cannot exceed the expiration date of that product, as the ingredient quality is already time-limited by the manufacturer.
MCC Beyond-Use Dating and Stability 1
According to USP , what is the maximum beyond-use date (BUD) for a nonaqueous compounded preparation when no stability data is available (Category 1)?