Guidelines for Compounding Practices

Compounding is an integral part of pharmacy practice andis essential to the provision of health defined in several ways; one definition in Chapter 795 ofthe United States Pharmacopeia(USP795) is as follows:The preparation, mixing, assembling, altering, pack-aging, and labeling of a drug, drug-delivery device,or device in accordance with a licensed practi-tioner s prescription, medication order, or initiativebased on the practitioner patient pharmacist com-pounder relationship in the course of professionalpractice. Compounding includes the following: Preparation of drug dosage forms for bothhuman and animal patients, Preparation of drugs or devices in anticipationof prescription drug orders, on the basis of rou-tine, regularly observed prescribing patterns, Reconstitution or manipulation of commercialproducts that may require the addition of one ormore ingredients, Preparation of drugs or devices for the purposesof, or as an incident to, research (clinical or academic), teaching, or chemical analysis, and Preparation of drugs and devices for pre-scriber s office use where permitted by federaland state can be as simple as the addition of a liquid to a manufactured drug pow-der or as complex as the preparation of a multicomponent parenteral nutrition solution.

Guidelines for Compounding Practices 3 Regulatory Framework In general, professions such as medicine and pharmacy are established as legal entities

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