Nonsterile Preparations - NAPLEX

1. What is the USP definition of controlled room temperature for storage labeling purposes?

   $20$–$25\,^{\circ}\text{C}$ with permitted excursions per USP. USP defines this range to maintain stability, allowing brief excursions to 15–30°C for real-world conditions.

2. What is the primary purpose of a levigating agent in compounding a suspension or ointment?

   Reduce particle size and improve dispersion by forming a paste. Levigation minimizes agglomeration and ensures homogeneous mixing in semisolid or liquid preparations.

3. What is the USP default BUD for a nonaqueous nonsterile preparation at controlled room temperature?

   Not later than $6$ months or earliest ingredient expiration, whichever is earlier. For nonaqueous formulations, USP <795> sets this BUD to limit degradation while considering ingredient stability.

4. What does USP define as a nonsterile preparation in compounding practice?

   A compounded preparation not required to be sterile. Nonsterile preparations are compounded drugs intended for routes where sterility is not necessary, such as oral or topical use.

5. Which type of levigation is preferred for an oleaginous ointment base?

   Levigate with a mineral oil or other oil-miscible agent. Oil-miscible agents like mineral oil ensure compatibility and even dispersion in hydrophobic bases.

6. What is the USP default BUD for a water-containing oral nonsterile preparation when refrigerated?

   Not later than $14$ days when stored at $2$–$8\,^{\circ}\text{C}$. Refrigeration slows microbial growth in water-containing orals, justifying the 14-day BUD per USP <795>.

7. Identify the correct method to prepare a solution when the drug is freely soluble in the vehicle.

   Dissolve drug directly in vehicle, then QS to final volume. Direct dissolution ensures uniform distribution when the drug dissolves easily without additional steps.

8. Identify the correct USP default BUD category for an anhydrous ointment (no water) stored at room temperature.

   Nonaqueous preparation: BUD not later than $6$ months. Anhydrous ointments lack water, reducing microbial risk, so USP <795> allows up to 6 months at room temperature.

9. What is the USP term for ingredients used to compound that meet USP–NF standards?

   Compounding components. Compounding components are official USP-NF substances or approved ingredients ensuring quality and safety in preparations.

10. What is the primary purpose of a compounding record (CR) for a specific batch?

    Document the actual ingredients, steps, and results for that batch. A CR records specifics of each compounding event to verify compliance, traceability, and quality for that preparation.

11. State the formula to calculate percent strength $\%\,w/v$ for a solution.

    $\%\,w/v=\frac{\text{g solute}}{\text{mL solution}}\times 100$. This formula expresses concentration as grams of solute per 100 mL of solution for liquid preparations.

12. Which USP chapter primarily governs nonsterile compounding standards?

    USP <795>. USP <795> outlines standards for personnel, facilities, documentation, and quality assurance in nonsterile compounding.

13. What volume is needed to provide a $150\,\text{mg}$ dose from a $25\,\text{mg/mL}$ solution?

    $6\,\text{mL}$. Divide dose by concentration to find volume: $150 / 25 = 6$ mL for accurate administration.

14. What is the USP compounding category for nonsterile preparations (CSP vs nonsterile)?

    Nonsterile compounding (not a CSP). USP categorizes preparations not requiring sterility as nonsterile compounding, distinct from CSPs which must be sterile under <797>.

15. Which dosage form is most appropriate for a patient who cannot swallow tablets and needs flexible dosing?

    Oral liquid (solution or suspension). Oral liquids allow dose adjustment and ease of administration for patients with swallowing difficulties.

16. State the formula to calculate percent strength $\%\,w/w$ for a preparation.

    $\%\,w/w=\frac{\text{g solute}}{\text{g preparation}}\times 100$. This formula calculates weight-based concentration for solids or semisolids using total preparation weight.

17. What is the primary purpose of a master formulation record (MFR) in nonsterile compounding?

    Standardized recipe and instructions for a compounded preparation. An MFR ensures consistency by detailing ingredients, equipment, procedures, and expected yield for repeated compounding.

18. What is the concentration in $\text{mg/mL}$ of a $2\%\,w/v$ solution?

    $20\,\text{mg/mL}$. 2% w/v means 2 g per 100 mL, equivalent to 20 mg per mL by unit conversion.

19. Identify the correct method to prepare a suspension from a poorly soluble drug powder.

    Levigate with a suitable agent, then incorporate vehicle gradually. Levigation creates a smooth paste to suspend insoluble particles evenly before adding the vehicle.

20. Which mixing technique is preferred to incorporate small amounts of a potent drug into a large powder mass?

    Geometric dilution. Geometric dilution progressively mixes equal volumes to achieve uniform distribution of potent substances.

21. What is the best practice meaning of "QS" in a nonsterile compounding formula?

    Quantity sufficient to make the final volume or weight. QS indicates adding enough vehicle to reach the desired total volume or weight for accurate concentration.

22. How many grams of drug are needed to prepare $120\,\text{mL}$ of a $1\%\,w/v$ solution?

    $1.2\,\text{g}$. 1% w/v is 1 g per 100 mL, so for 120 mL, scale proportionally to determine drug amount.

23. Which label element identifies the end of intended use for a compounded nonsterile preparation?

    Beyond-use date (BUD). BUD indicates the date after which the preparation should not be used, based on stability and microbial risk.

24. Which USP chapter provides guidance for pharmaceutical compounding quality assurance?

    USP <1163>. USP <1163> focuses on quality assurance programs, including process validation and stability testing for compounded preparations.

25. What is the USP default BUD for a water-containing topical/dermal/mucosal nonsterile preparation?

    Not later than $30$ days. Topical water-containing preparations have higher microbial risk, so USP <795> limits BUD to 30 days at room temperature.

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