Nonsterile Compounding

Compounding equipment used to weigh ingredients

Torsion or electronic balance (must be Class A)

Compounding equipment used to reduce particle size by grinding

Mortar and pestle

Compounding equipment used to measure the volume of liquids

Graduated cylinder

Compounding equipment used as a surface for preparing semi-solid dosage forms

Ointment slab or ointment paper

Active pharmaceutical ingredient

The substance used in the compounding of a drug product that will display pharmacologic activity to treat, mitigate, cure, prevent or diagnose disease

Compounding Facility

Separate area within a pharmacy used for compounding

Geometric dilution

Using equal amounts of ingredients, during each step of compounding, repeatedly, until the entire amount of compound is prepared

Inactive ingredients

Substance required to compound a dosage form that are not intended to exert a pharmacological affect. Also called an excipient.

Levigate

To incorporate a solid into an ointment

Meniscus

The top of a liquid that is being measured in a graduated cylinder. Concave in shape: measurement should be read at the bottom of the meniscus

Triturate

To reduce particle size by grinding in the mortar and pestle

Vehicle

A component for internal or external use that is used as a carrier or diluent in which liquids, semi solids, or solids are dissolved or suspended

Master formulation record

Guidance document that should be created prior to preparing a specific compound for the first time.

• Should contain thorough details on the compounding process

  • Ingredients, calculations, steps, equipment, etc.

• Compound product info

  • Name, strength, dosage, form, stability, BUD, etc.

• Labeling and quality control

Compounding record

Should be maintained and logged each time a compound is prepared. Should include the master formulation record, reference number, all details on the products used (NDC, Lot number, expiration dates), Personnel involved in compounding, checking, and quality control, BUD, labeling, and quality control results.

Three categories of nonsterile compounds per USP General Chapter <795>

• Simple - Prepared from a USP monograph, a peer-reviewed journal, or per manufacturer labeling that contains specific information on ingredients, quantities, processes, stability, and beyond-use dating

• Moderate - Making a preparation that requires special calculations or procedures to determine quantities of components, or lacking stability data

• Complex - Making a preparation that requires special training, environment, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes

Compounding of solutions

Are generally prepared from a combination of compatible solutions or other ingredients that mix homogenously into a vehicle. May require heating to dissolve particles

Compounding of suspensions

Insoluble solid dosage forms (tablets, powders, granules, etc.) can be compounded into a suspension

Solid substance is levigated in a mortar and pestle, wetted to form a paste, and transferred from the mortar by combining with small amounts of the suspension vehicle until all remnants of the paste are emptied into the compound container

Compounding of emulsions

Mixtures of oil, water, and an emulsifying agent Generally requires the use of special blending or homogenizing equipment

Compounding of ointments

Made by incorporating other ingredients/dosage forms into a base

Can be done in a mortar and pestle, or more commonly with a spatula on an ointment slab or paper

Compounding of creams

Made by separating ingredients into "lipid" and "aqueous" categories, heating them separately above their melting points, then mixing them together continuously as they cool

Compounding of gels or jellies

Involve incorporation into a "gelling agent", typically by either heating ingredients or altering their pH

Compounding of Capsules

Can be prepared by hand or with special capsule-packing equipment

Compounding of Tablets

Require packing/compressing equipment to prepare the molded dosage form. This process can also be used for lozenges, troches, and other molded dosage forms

Compounding of suppositories

Can be compounding using one of two methods:

• Molding - ingredients are incorporated into a melted base and poured into a suppository mold to cool

• Hand-rolling and shaping - ingredients are incorporated into a semi-solid base, and hand molded or rolled into suppository shape