Pharmacy Compounding 3 — Questions and Answers
Question 1: Which USP chapter governs sterile compounding in pharmacies?
- USP <795>
- USP <797> (Correct answer)
- USP <800>
- USP <1151>
Correct answer: USP <797>
USP <797> provides standards for compounding sterile preparations, including cleanroom classification and beyond-use dating.
Question 2: An ISO 5 environment is required for which step during sterile compounding?
- Labeling the final product
- Cleaning the anteroom
- Critical site manipulation during compounding (Correct answer)
- Donning PPE in the buffer room
Correct answer: Critical site manipulation during compounding
Critical site manipulations (e.g., needle insertion into a vial) must occur in an ISO 5 environment to prevent contamination.
Question 3: Which type of ointment base is most appropriate when the goal is to maximize drug penetration through the skin?
- Hydrocarbon (oleaginous) base (Correct answer)
- Absorption base
- Water-removable (o/w emulsion) base
- Water-soluble base
Correct answer: Hydrocarbon (oleaginous) base
Hydrocarbon bases such as petrolatum provide occlusion, which maximizes skin hydration and enhances drug penetration.
Question 4: A prescription requires compounding a suppository. Which base melts at body temperature and is most commonly used for rectal suppositories?
- Polyethylene glycol (PEG)
- Cocoa butter (theobroma oil) (Correct answer)
- Glycerin-gelatin base
- Hydroxypropyl methylcellulose
Correct answer: Cocoa butter (theobroma oil)
Cocoa butter melts at 30–36°C (close to body temperature) making it the classic fatty base for rectal suppositories.
Question 5: When compounding a solution, which factor most directly affects the rate of dissolution of a solid drug?
- Color of the container
- Particle size of the drug (Correct answer)
- Humidity of the compounding area
- Atmospheric pressure
Correct answer: Particle size of the drug
Smaller particle size increases surface area, greatly accelerating the rate of drug dissolution.
Question 6: Section 503A of the FDCA exempts compounding pharmacies from FDA approval requirements provided they compound:
- In large batches for office use only
- Based on valid prescriptions for individual identified patients (Correct answer)
- Only OTC drug ingredients
- Only veterinary preparations
Correct answer: Based on valid prescriptions for individual identified patients
503A exemptions apply when a licensed pharmacist compounds based on a valid prescription for an individually identified patient.
Question 7: Which physicochemical property determines whether a drug can be incorporated into a water-soluble suppository base like PEG?
- Molecular weight only
- Melting point of the drug
- Drug solubility in the base (Correct answer)
- Color and taste of the drug
Correct answer: Drug solubility in the base
A drug must be soluble in the PEG base to be uniformly incorporated; insoluble drugs require suspension techniques.
Pharmacy Compounding 3
Which USP chapter governs sterile compounding in pharmacies?