Compounding Flashcards

Which USP chapter governs sterile compounding in pharmacies?

Answer: USP

USP provides standards for compounding sterile preparations, including cleanroom classification and beyond-use dating.

An ISO 5 environment is required for which step during sterile compounding?

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.

Which type of ointment base is most appropriate when the goal is to maximize drug penetration through the skin?

Answer: Hydrocarbon (oleaginous) base

Hydrocarbon bases such as petrolatum provide occlusion, which maximizes skin hydration and enhances drug penetration.

A prescription requires compounding a suppository. Which base melts at body temperature and is most commonly used for rectal suppositories?

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.

When compounding a solution, which factor most directly affects the rate of dissolution of a solid drug?

Answer: Particle size of the drug

Smaller particle size increases surface area, greatly accelerating the rate of drug dissolution.

Section 503A of the FDCA exempts compounding pharmacies from FDA approval requirements provided they compound:

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.

Which physicochemical property determines whether a drug can be incorporated into a water-soluble suppository base like PEG?

Answer: Drug solubility in the base

A drug must be soluble in the PEG base to be uniformly incorporated; insoluble drugs require suspension techniques.