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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

2 The Art, Science, and Technology of Pharmaceutical Compounding bar above more fully defines compounding and manufacturing and provides guidelines for differentiating the two activities.

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