Pharmaceutical Compounding Terminology

Compounding

Preparation of customized medications for individual patients.

Beyond-Use Date (BUD)

Date after which a compounded preparation should not be used.

USP <795>

USP chapter governing nonsterile compounding.

USP <797>

USP chapter governing sterile compounding.

USP <800>

USP chapter governing hazardous drug handling.

503A Pharmacy

Traditional compounding pharmacy serving individual patients.

503B Outsourcing Facility

FDA-regulated facility that compounds medications on a larger scale.

Quality Assurance (QA)

Activities designed to prevent quality problems.

Quality Control (QC)

Activities used to detect and evaluate quality problems.

Formulation Record

Master recipe describing how a preparation should be compounded.

Compounding Record

Record documenting what actually occurred during compounding

Expiration Date

The manufacturer-assigned date indicating how long a product is expected to remain safe, stable, and effective.

Lot Number

Unique identifier assigned to a batch of ingredients or products.

Strength

Amount of drug present per dosage unit or volume.

Potency

Amount of drug needed to produce a specific effect.

Concentration

Amount of drug relative to the total preparation.

Stability

Ability of a preparation to maintain quality over time.

Compatibility

Ability of ingredients to coexist without undesirable interactions.

Preparation

A compounded medication is called a preparation.

Product

A commercially manufactured medication is called a product.

Validation

Documented evidence that a process consistently produces the intended result.

Verification

Confirmation that a specific step, calculation, or process was completed correctly.