NAPLEX USP 795 Practice Questions with Answers

Mastering USP 795 standards is essential for passing the pharmacy board exams and ensuring patient safety in nonsterile compounding. This guide provides comprehensive NAPLEX USP 795 Practice Questions with Answers to help you navigate the complexities of beyond-use dating, stability, and facility requirements. For a broader overview of clinical topics, you may also explore our NAPLEX Prep hub, which covers everything from calculations to pharmacotherapy.

Concept Explanation

USP Chapter <795> provides the national standards for nonsterile compounding to ensure the quality, safety, and efficacy of compounded preparations. These standards apply to all healthcare settings where nonsterile preparations are made, including community pharmacies, hospitals, and clinics. The core of USP 795 involves categorizing compounding into three levels of complexity: Simple, Moderate, and Complex. Simple compounding involves preparations with a USP monograph or those following a peer-reviewed article with specific quantities and procedures. Moderate compounding requires special calculations or procedures, such as making a suppository or a cream from scratch where stability data is unavailable. Complex compounding involves specialized training, facilities, or equipment, such as transdermal patches or extended-release tablets.

A critical component of USP 795 is the determination of Beyond-Use Dates (BUD). Unlike expiration dates provided by manufacturers, a BUD is the date after which a compounded preparation must not be used. According to the United States Pharmacopeia, if there is no stability data available, default BUDs are assigned based on the dosage form and the presence of water. For example, non-preserved aqueous dosage forms (like an oral suspension) generally have a BUD of 14 days when stored under refrigeration. In contrast, non-aqueous formulations (like an ointment or capsule) can have a BUD of up to 180 days. Understanding these limits is vital for clinical safety, much like managing drug interactions in NAPLEX Anticoagulation Practice Questions.

Solved Examples

1. Problem: A pharmacist is compounding a topical cream containing hydrocortisone powder and a commercially available moisturizing base. The base contains water. What is the default BUD if no stability data is found?
   Solution:
   1. Identify the dosage form: Topical cream (Aqueous).
   2. Determine the USP 795 default for preserved aqueous topicals/semisolids: 30 days.
   3. Verify storage: Room temperature is typical for creams.
   4. Final Answer: The BUD is 30 days.
2. Problem: Calculate the amount of active ingredient needed for 60 capsules, each containing 25 mg of Drug X. The pharmacist decides to make enough for 65 capsules to account for powder loss.
   Solution:
   1. Set up the calculation: $$\text{Total Weight} = 65 \text{ capsules} \times 25 \text{ mg/capsule}$$
   2. Perform the multiplication: $$65 \times 25 = 1625 \text{ mg}$$
   3. Convert to grams if necessary: $$\frac{1625 \text{ mg}}{1000} = 1.625 \text{ g}$$
   4. Final Answer: 1.625 grams of Drug X.
3. Problem: A pharmacist is preparing an oral solution by dissolving a tablet in purified water. What is the maximum BUD?
   Solution:
   1. Identify the dosage form: Oral aqueous liquid.
   2. Check USP 795 defaults: For water-containing oral formulations, the BUD is 14 days.
   3. Check storage: Must be stored in a refrigerator.
   4. Final Answer: 14 days (refrigerated).

Practice Questions

Test your knowledge with these NAPLEX-style questions. If you find these challenging, you can use our AI Question Generator to create more tailored practice sets.

1. A pharmacist compounds a non-aqueous ointment using white petrolatum and mineral oil. What is the maximum BUD for this preparation if stored at room temperature?
2. Which of the following would be classified as "Moderate" compounding under USP 795: mixing two commercially available creams, or compounding a troche for which there is no stability data?
3. According to USP 795, how often must personnel involved in nonsterile compounding undergo competency evaluation?

4. A pharmacy is compounding a 1% progesterone aqueous oral suspension. The progesterone powder has an expiration date of 2 years from now. The purified water and suspending vehicle expire in 1 year. What is the BUD?
5. Describe the requirement for a "designated person" in a compounding facility according to USP 795.
6. A pharmacist is preparing a batch of 100 suppositories. If each suppository requires 2 grams of cocoa butter base, and the displacement factor of the drug is negligible, how much base is needed if a 10% overage is prepared?
7. What is the minimum frequency for cleaning and sanitizing the work surfaces in a nonsterile compounding area?
8. True or False: USP 795 standards apply to the administration of a medication to a single patient by a nurse in a hospital setting.
9. A compounded preparation is found to have a pH of 4.5. If the stability of the active ingredient is significantly compromised at a pH below 5, what action should the pharmacist take regarding the BUD?
10. When using a balance to weigh 50 mg of a potent drug, the sensitivity requirement is 6 mg. What is the percentage of error if the minimum weighable quantity is not met? Use the formula: $$\text{Error} = \frac{ \text{Sensitivity Requirement}}{ \text{Quantity Weighed}} \times 100$$

Answers & Explanations

1. 180 Days: For non-aqueous formulations (like an ointment with no water), the maximum BUD is 180 days when stored at controlled room temperature.
2. Compounding a troche: This is Moderate because it requires special knowledge or calculations for which stability data is not readily available. Mixing two commercial creams is typically Simple.
3. Every 12 months: Personnel must demonstrate competency initially and at least every 12 months thereafter.
4. 14 Days (Refrigerated): For water-containing oral formulations, the BUD is 14 days under refrigeration. The expiration dates of the individual ingredients are longer, but the 14-day rule for aqueous oral liquids takes precedence.
5. Responsibility: USP 795 requires each facility to have one or more designated persons responsible for the performance and operation of the compounding facility and personnel.
6. 220 grams: $$100 \text{ suppositories} \times 2 \text{ g/suppository} = 200 \text{ g}$$. Adding 10% overage: $$200 \times 1.10 = 220 \text{ g}$$.
7. At the beginning and end of each shift: Surfaces must also be cleaned after spills and when surface contamination is known or suspected.
8. False: USP 795 applies to compounding, not to the administration of medication. Administration is governed by other clinical protocols, similar to those found in NAPLEX Infectious Disease Practice Questions.
9. Shorten the BUD: If the preparation is unstable, the pharmacist must assign a shorter BUD than the USP default to ensure the preparation remains potent and safe until the BUD.
10. 12%: Using the provided formula: $$\frac{6 \text{ mg}}{50 \text{ mg}} \times 100 = 12\%$$. This exceeds the standard 5% error limit commonly used in pharmacy.

1. What is the default BUD for a water-containing topical semi-solid (e.g., a cream) according to USP 795?

• A14 days refrigerated
• B30 days
• C90 days
• D180 days

Frequently Asked Questions

What is the difference between USP 795 and USP 797?

USP 795 sets the standards for nonsterile compounding, such as creams and oral liquids, while USP 797 governs sterile compounding, including IV bags and eye drops. The main difference lies in the environmental controls and microbial risk assessments required for sterile preparations.

Can a BUD exceed the expiration date of an ingredient?

No, the beyond-use date of a compounded preparation can never exceed the earliest expiration date of any individual component used in the formulation. Pharmacists must always check the manufacturer's labels for all active and inactive ingredients before assigning a BUD.

What qualifies as "Simple" compounding?

Simple compounding involves following a specific USP monograph or a manufacturer's instructions for reconstituting a product. It generally involves straightforward mixing of ingredients with known stability and safety profiles.

Are flavoring agents considered active ingredients?

Flavoring agents are considered inactive ingredients or excipients used to improve patient compliance. However, their addition must be documented, and they must not interfere with the stability or efficacy of the active pharmaceutical ingredient.

How should nonsterile compounding records be maintained?

Compounding records, including Master Formulation Records and Compounding Records for each specific batch, must be kept for a period defined by state law, often 2 to 3 years. These records must be easily retrievable for inspection by regulatory bodies like the FDA or State Boards of Pharmacy.

What is the role of a Master Formulation Record?

The Master Formulation Record serves as the "recipe" for a compounded preparation, ensuring consistency and quality across different batches. It includes the ingredients, specific instructions, equipment needed, and quality control procedures for a specific formulation.