Guidelines for Compounding Practices（复合实践指南）.pdf

Chapter 1 Guidelines for Compounding Practices CHAPTER AT A GLANCE Compounding is an integral part of pharmacy practice and is essential to the provision of health care.1 Compounding Regulatory Framework is defined in several ways; one definition in Chapter 795 of Unapproved Drugs the United States Pharmacopeia (USP 795) is as follows: Certification and Accreditation The preparation, mixing, assembling, altering, pack- Compounding Facility aging, and labeling of a drug, drug-delivery device, and Equipment or device in accordance with a licensed practi- Personnel tioner’s prescription, medication order, or initiative Ingredient Standards based on the practitioner–patient–pharmacist–com- The Compounding Process pounder relationship in the course of professional Continuous Quality practice. Compounding includes the following: Improvement Packaging, Storage, and Labeling Preparation of drug dosage forms for both Quality Control human and animal patients, Stability, Expiration, and Preparation of drugs or devices in anticipation Beyond-Use Dating of prescription drug orders, on the basis of rou- Records and Reports tine, regularly observed prescribing patterns, Patient Counseling Reconstitution or manipulation of commercial Disposing of Expired products that may require the addition of