Compounding

Q: What is compounding?

A: The process of preparing personalized medications by mixing ingredients in the exact strength and dosage form required for a patient.

What is the USP (United States Pharmacopeia)?

An official compendium that sets standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. Ensures quality, purity, strength, and consistency.

What is the NF (National Formulary)?

can refer to an official book of drug standards or a list of medicines approved for reimbursement by a national healthcare system or insurance plan. Also An official compendium that provides standards for excipients (inactive substances like binders, fillers, preservatives). Published together with USP as USP–NF.

What is USP–NF?

A combined publication of the United States Pharmacopeia (USP) and National Formulary (NF). Together, USP–NF provides official quality standards for drugs and ingredients in the U.S.

Q: Why might a patient need compounded medication?

A: To avoid allergens, make unavailable strengths/forms, create liquids for those who can’t swallow pills, or replace discontinued drugs.

Q: What is sterile compounding?

A: Preparing medications free from bacteria/microorganisms (e.g., injections, IV meds, eyedrops); governed by USP 797.

Q: What is non-sterile compounding?

A: Preparing meds that don’t need a sterile environment (e.g., creams, ointments, oral meds); governed by USP 795.

Q: What factors must be considered in compounding?

A: Cost-effectiveness, availability, solubility, stability, and dosage form of ingredients.

Q: What are key reference guides for compounding?

A: Remington’s Pharmaceutical Sciences, Merck Manual, Trissel’s Stability of Compounded Formulations, USP–NF.

Q: What do USP 797 and USP 795 cover?

A: USP 797 → sterile compounding; USP 795 → non-sterile compounding.

Q: What is the role of the Pharmacy Compounding Accreditation Board?

A: Provides voluntary quality accreditation to ensure safe, high-quality compounding practices.

Q: What are SOPs in compounding?

A: Written step-by-step procedures for tasks like maintenance, calibration, training, prep, packaging, and storage.

Q: What must SOP documentation include?

A: SOP number, effective date, author, purpose, scope, equipment, materials, procedure, forms, authorization signature.

Q: Why is documentation important in compounding?

A: Ensures safety, consistency, traceability, and accountability.

: How should the compounding workplace be set up?

A: Separate, clean, uncluttered area; tools/surfaces cleaned with 70% isopropyl alcohol before and after use.

Q: Example: How would a technician prepare a compounded eczema cream?

A: Obtain formula → gather ingredients → weigh/verify → mix → package/label → final check.