Pharmacy compounding is the art and science of creating personalized medications for patients with unique needs not met by commercially available products. This practice ranges from preparing customized non-sterile dosage forms to complex sterile preparations. For PharmD students, a deep understanding of the scope of compounding and the rigorous standards set by USP chapters is fundamental for ensuring the quality, safety, and efficacy of these patient-specific preparations.
1. According to USP <795> standards, what is the primary purpose of a Master Formulation Record?
- To document the specific ingredients and steps used for a single prescription fill.
- To serve as a detailed, official “recipe” or set of instructions for a specific compounded preparation.
- To log the daily temperature of the compounding room.
- To detail the training qualifications of the compounding pharmacist.
Answer: To serve as a detailed, official “recipe” or set of instructions for a specific compounded preparation.
2. Which USP chapter provides standards for the compounding of non-sterile preparations?
- USP <797>
- USP <800>
- USP <795>
- USP <825>
Answer: USP <795>
3. The “triad relationship” in traditional pharmacy compounding refers to the connection between the:
- Pharmacist, Technician, and Patient
- Patient, Prescriber, and Pharmacist
- Drug, Excipient, and Container
- FDA, State Board of Pharmacy, and DEA
Answer: Patient, Prescriber, and Pharmacist
4. What is the primary purpose of USP General Chapter <800>?
- To set standards for sterile compounding
- To describe good manufacturing practices for drug companies
- To provide standards for handling hazardous drugs to protect personnel, patients, and the environment
- To outline labeling requirements for over-the-counter products
Answer: To provide standards for handling hazardous drugs to protect personnel, patients, and the environment
5. A laminar air flow workbench (LAFW) provides what type of environment for sterile compounding?
- An ISO Class 8 environment
- A negative pressure environment
- An ISO Class 5 environment
- A containment segregated compounding area
Answer: An ISO Class 5 environment
6. The Beyond-Use Date (BUD) for a non-aqueous formulation, like an ointment, packaged in an ointment jar is typically:
- 14 days when stored at controlled cold temperatures
- 30 days
- Not longer than the time remaining until the earliest expiration date of any active ingredient, or 6 months, whichever is earlier
- 1 year
Answer: Not longer than the time remaining until the earliest expiration date of any active ingredient, or 6 months, whichever is earlier
7. A key legal distinction between pharmacy compounding and drug manufacturing is that compounding is performed:
- For bulk sale to other pharmacies
- In anticipation of receiving a large number of prescriptions
- Based on a prescription for an individual patient
- To create a direct copy of a commercially available product
Answer: Based on a prescription for an individual patient
8. Which engineering control is required for compounding sterile hazardous drugs?
- A horizontal laminar air flow workbench
- A Containment Primary Engineering Control (C-PEC), such as a Class II Biological Safety Cabinet
- A positive pressure cleanroom
- A standard compounding counter
Answer: A Containment Primary Engineering Control (C-PEC), such as a Class II Biological Safety Cabinet
9. The document that details all the steps and ingredients for a specific, single preparation for a given patient is the:
- Master Formulation Record
- Standard Operating Procedure (SOP)
- Safety Data Sheet (SDS)
- Compounding Record
Answer: Compounding Record
10. What is a common reason for compounding a medication for a pediatric patient?
- To create a dose or concentration that is not commercially available
- To make the medication less effective
- To add ingredients the child is allergic to
- To practice compounding skills without a prescription
Answer: To create a dose or concentration that is not commercially available
11. Aseptic technique is a set of procedures designed to:
- Ensure the final product is the correct color
- Prevent microbial contamination of sterile products
- Calibrate the electronic balance
- Document compounding errors
Answer: Prevent microbial contamination of sterile products
12. According to USP <797>, compounding personnel must successfully pass which test to demonstrate proper aseptic technique?
- A written exam on pharmacy law
- A media-fill test
- A physical fitness test
- A basic mathematics test
Answer: A media-fill test
13. A Containment Secondary Engineering Control (C-SEC) room used for hazardous drug compounding must have:
- Positive air pressure relative to adjacent areas
- At least 30 air changes per hour (ACPH)
- Negative air pressure relative to adjacent areas
- No air ventilation system
Answer: Negative air pressure relative to a_d_jacent areas
14. Geometric dilution is a technique used in compounding to:
- Ensure the even distribution of a small amount of a potent substance in a larger amount of diluent
- Measure the volume of a liquid accurately
- Determine the beyond-use date of a preparation
- Sterilize compounding equipment
Answer: To ensure the even distribution of a small amount of a potent substance in a larger amount of diluent
15. Which of the following is a key piece of personal protective equipment (PPE) required by USP <800> when handling hazardous drugs?
- A standard cloth mask
- A single pair of non-chemotherapy rated gloves
- Two pairs of chemotherapy-rated gloves
- A standard lab coat
Answer: Two pairs of chemotherapy-rated gloves
16. The “scope of compounding practice” includes preparing medications for which of the following populations?
- Pediatric patients
- Geriatric patients
- Veterinary patients
- All of the above
Answer: All of the above
17. The primary purpose of a “buffer area” (or cleanroom) in sterile compounding is to:
- Provide a space for personnel to de-gown
- House the Primary Engineering Control (PEC) in an ISO Class 7 environment
- Store bulk drug ingredients at room temperature
- Be a general storage area for compounded products
Answer: To house the Primary Engineering Control (PEC) in an ISO Class 7 environment
18. What is the BUD for a water-containing oral formulation (like a suspension) when stored at controlled cold temperatures?
- Not later than 24 hours
- Not later than 14 days
- Not later than 30 days
- Not later than 6 months
Answer: Not later than 14 days
19. Section 503A of the Food, Drug, and Cosmetic Act applies to:
- Traditional pharmacy compounding for specific patients
- Large-scale drug manufacturing
- Outsourcing facilities
- Over-the-counter drug sales
Answer: Traditional pharmacy compounding for specific patients
20. A primary engineering control (PEC) creates the critical ISO Class 5 environment. Which of the following is NOT a PEC?
- Laminar Airflow Workbench (LAFW)
- Biological Safety Cabinet (BSC)
- Compounding Aseptic Isolator (CAI)
- The ante-room sink
Answer: The ante-room sink
21. In compounding, trituration is the process of:
- Reducing the particle size of a solid by grinding it in a mortar
- Mixing two or more liquids together
- Melting a solid base for a suppository
- Measuring the volume of a liquid in a graduated cylinder
Answer: Reducing the particle size of a solid by grinding it in a mortar
22. Which dosage form would be prepared as a sterile compound?
- An oral capsule
- A topical ointment
- An ophthalmic (eye) drop
- A rectal suppository
Answer: An ophthalmic (eye) drop
23. The NIOSH list is a resource used by pharmacies to identify:
- Expired medications
- Hazardous drugs
- State-specific pharmacy laws
- Commercially available drug shortages
Answer: Hazardous drugs
24. The garbing process for sterile compounding requires applying PPE in which general order?
- From dirtiest to cleanest items
- In any order the compounder prefers
- From cleanest to dirtiest items, moving from the head down
- Gloves should always be put on first
Answer: From cleanest to dirtiest items, moving from the head down
25. Levigation is the process of:
- Incorporating a solid into an ointment by first wetting it with a small amount of liquid
- Dissolving a solid into a solvent
- Filtering a liquid to remove particulates
- Adding flavor to an oral liquid
Answer: Incorporating a solid into an ointment by first wetting it with a small amount of liquid
26. The Drug Quality and Security Act (DQSA) created which new category of compounder?
- Section 503A Traditional Pharmacies
- Section 503B Outsourcing Facilities
- Section 501c Non-profit Pharmacies
- Section 401a Research Pharmacies
Answer: Section 503B Outsourcing Facilities
27. What is the minimum frequency for cleaning and disinfecting the surfaces inside a sterile compounding PEC?
- Once per week
- At the beginning of each shift, before each batch, and every 30 minutes during compounding
- Once per month
- Only when a spill occurs
Answer: At the beginning of each shift, before each batch, and every 30 minutes during compounding
28. Why might a pharmacist compound a “dye-free” version of a medication?
- The patient has an allergy to a coloring agent in the commercial product
- The patient prefers a different color
- To make the medication more potent
- To extend the expiration date of the medication
Answer: The patient has an allergy to a coloring agent in the commercial product
29. What does “aseptic” literally mean?
- Clean
- Free from disease-causing microorganisms
- Related to aesthetics
- Pressurized
Answer: Free from disease-causing microorganisms
30. The “first air” in a laminar flow workbench is:
- The air that first enters the room
- The unfiltered air directly in front of the HEPA filter
- The air that is closest to the operator
- The air exiting the HEPA filter that is essentially particle-free
Answer: The air exiting the HEPA filter that is essentially particle-free
31. Which of the following is a valid reason to compound a drug?
- The patient needs a therapeutic equivalent of a manufactured product because it is cheaper
- The prescriber wants to create a new chemical entity
- The patient cannot swallow a tablet and requires a liquid formulation that is not available
- The pharmacy wants to make large batches of a product to sell to other pharmacies
Answer: The patient cannot swallow a tablet and requires a liquid formulation that is not available
32. A Class III (Class A) torsion balance requires the use of:
- A power outlet for operation
- A computer for digital readouts
- A set of calibrated weights
- A magnetic stirrer
Answer: A set of calibrated weights
33. What is the primary role of the state boards of pharmacy in regulating compounding?
- They are the primary regulators of day-to-day pharmacy practice and traditional compounding
- They only regulate drug manufacturers
- They have no authority over compounding pharmacies
- They only regulate outsourcing facilities
Answer: They are the primary regulators of day-to-day pharmacy practice and traditional compounding
34. Compounding for “palliative care” or “hospice” often involves creating:
- Standard dosage forms for common illnesses
- Unique combinations or dosage forms to manage complex symptoms like severe pain or nausea
- Veterinary-specific formulations
- High-dose vitamin supplements
Answer: Unique combinations or dosage forms to manage complex symptoms like severe pain or nausea
35. A HEPA filter is designed to remove at least 99.97% of airborne particles of what size?
- 10 microns and larger
- 1 micron and larger
- 0.3 microns and larger
- 0.1 microns and larger
Answer: 0.3 microns and larger
36. The Beyond-Use Date (BUD) is determined from the date the preparation is:
- Manufactured by a drug company
- Compounded by the pharmacy
- Prescribed by the doctor
- Dispensed to the patient
Answer: Compounded by the pharmacy
37. Which of the following must be included on the label of a compounded prescription?
- The phrase “This is a compounded preparation”
- The cost of the ingredients
- The name of the technician who assisted
- The logo of the drug manufacturer
Answer: The phrase “This is a compounded preparation”
38. The use of a closed system drug-transfer device (CSTD) is recommended by USP <800> for:
- Administering hazardous drugs
- Preparing oral suspensions
- Measuring the pH of a solution
- Calibrating an electronic balance
Answer: Administering hazardous drugs
39. Compounding a medication for a veterinary patient often requires:
- Using ingredients toxic to humans
- Creating species-appropriate doses and palatable dosage forms
- Ignoring the veterinarian’s prescription
- Using non-pharmaceutical grade ingredients
Answer: Creating species-appropriate doses and palatable dosage forms
40. A low-risk level sterile preparation involves compounding with no more than how many commercial sterile products?
- One
- Two
- Three
- Five
Answer: Three
41. The “ante-area” in a sterile compounding facility is the space where:
- Sterile preparations are compounded
- Personnel hand washing and garbing occurs
- The PEC is located
- Finished products are stored under refrigeration
Answer: Personnel hand washing and garbing occurs
42. Which dosage form is an example of a dispersion?
- A saline solution
- A sugar syrup
- A suspension
- An alcohol tincture
Answer: A suspension
43. A pharmacist is required to counsel a patient on a compounded prescription to ensure:
- The patient understands its specific use, storage, and BUD
- The pharmacy can charge a counseling fee
- The patient knows how to manufacture the drug at home
- The patient will not sue the pharmacy
Answer: The patient understands its specific use, storage, and BUD
44. What is a key quality assurance step in compounding?
- The pharmacist performing a final check of the preparation and the compounding record
- Having the patient sign a waiver for all potential errors
- Skipping the documentation to save time
- Allowing the technician to give final approval
Answer: The pharmacist performing a final check of the preparation and the compounding record
45. Outsourcing facilities under 503B are primarily intended to:
- Compound for specific patients based on individual prescriptions
- Compound large batches of sterile products that may be sold to hospitals without a prescription
- Only compound non-sterile preparations
- Act as wholesale drug distributors
Answer: Compound large batches of sterile products that may be sold to hospitals without a prescription
46. When preparing a hazardous drug, all manipulation should be performed in a manner that:
- Maximizes the potential for aerosolization
- Minimizes the generation of particles and aerosols
- Allows for direct contact with the skin
- Does not require any special ventilation
Answer: Minimizes the generation of particles and aerosols
47. A key component of Standard Operating Procedures (SOPs) is to:
- Provide a list of recommended restaurants for lunch
- Ensure consistency and quality in all compounding-related tasks
- Be a record of every prescription ever filled
- Be a flexible guideline that can be ignored if necessary
Answer: Ensure consistency and quality in all compounding-related tasks
48. Why would a pharmacist need to compound a topical cream for a patient with a dermatological condition?
- To combine multiple active ingredients into one preparation
- To provide a non-standard strength of a medication
- To omit an excipient that the patient is allergic to
- All of the above
Answer: All of the above
49. Total parenteral nutrition (TPN) is considered what risk level of sterile compounding?
- Low-risk
- Medium-risk
- High-risk
- It is not considered a sterile compound
Answer: Medium-risk
50. The ultimate responsibility for the quality and safety of any compounded preparation rests with the:
- Compounding technician
- Prescriber
- Patient
- Compounding pharmacist
Answer: Compounding pharmacist
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com