A TREATISE OF PRESCRIPTION INCOMPATIBILITIES IN PHARMACY
1 LAWS, REGULATIONS, STANDARDS, AND GUIDELINES FOR COMPOUNDING PRACTICES 2 COMPOUNDING INGREDIENT CONSIDERATIONS 3 COMPOUNDING WITH HAZARDOUS DRUGS FACILITIES, EQUIPMENT, AND SUPPLIES 5 RECORDS AND RECORD KEEPING 6 STABILITY OF COMPOUNDED PREPARATIONS 7 PHARMACEUTICAL COMPOUNDING CALCULATIONS 8 QUALITY CONTROL 9 FLAVORS, SWEETENERS, AND COLORS 10 PRESERVATION, STERILIZATION, AND DEPYROGENATION 11 POWDERS AND GRANULES CONTENTS 12 CAPSULES 13 TABLETS 14 LOZENGES, TROCHES, AND FILMS 15 SUPPOSITORIES AND INSERTS 16 STICKS 17 SOLUTIONS 18 SUSPENSIONS 19 EMULSIONS 20 FOAMS 21 OINTMENTS, CREAMS, AND PASTES 22 GELS 23 OPHTHALMIC, OTIC, AND NASAL PREPARATIONS 24 INHALATION PREPARATIONS 25 PARENTERAL PREPARATIONS 26 BIOTECHNOLOGY, NANOTECHNOLOGY, AND PHARMACOGENOMICS 27 SPECIAL POPULATIONS AND PREPARATIONS 28 COMPOUNDING WITH SPECIAL INGREDIENTS 29 VETERINARY PHARMACEUTICALS 30 COMPOUNDING FOR CLINICAL AND INVESTIGATIONAL STUDIES 31 COSMETICS FOR SPECIAL POPULATIONS AND FOR USE AS VEHICLES 32 COMPOUNDING FOR TERRORIST ATTACKS AND NATURAL DISASTERS 33 PHARMACEUTICAL COMPOUNDING ERRORS LAWS, REGULATIONS, STANDARDS, AND GUIDELINES FOR COMPOUNDING PRACTICES CHAPTER AND THE DEFINITIONS IN THE DRUG QUALITY AND SECURITY ACT (H R 3204, 113TH CONG , 2013) COMPOUNDING CAN BE AS SIMPLE AS THE ADDITION OF A LIQUID TO A MANUFACTURED DRUG POWDER OR AS COMPLEX AS THE PREPARATION OF A MULTICOMPONENT PARENTERAL NUTRITION SOLUTION IN GENERAL, COMPOUNDING DIFFERS FROM MANUFAC TURING IN THAT COMPOUNDING INVOLVES A SPECIFIC PRACTITIONER– PATIENT–PHARMACIST RELATIONSHIP, THE PREPARATION OF A RELA TIVELY SMALL QUANTITY OF MEDICATION, AND DIFFERENT CONDI TIONS OF SALE (I E , SPECIFIC PRESCRIPTION ORDERS) THE SECTION, “DISTINGUISHING COMPOUNDING FROM MANUFACTURING,” LATER IN THIS CHAPTER, MORE FULLY DEFINES COMPOUNDING AND MANU FACTURING AND PROVIDES GUIDELINES FOR DIFFERENTIATING THE TWO ACTIVITIES A PHARMACIST IS RESPONSIBLE FOR COMPOUNDING PREP ARATIONS OF ACCEPTABLE STRENGTH, QUALITY, AND PURITY, WITH APPROPRIATE PACKAGING AND LABELING IN ACCORDANCE WITH GOOD PHARMACY PRACTICES, OFFICIAL STANDARDS, AND CURRENT SCIENTIFIC PRINCIPLES PHARMACISTS SHOULD CONTINUALLY EXPAND THEIR COMPOUNDING KNOWLEDGE BY PARTICIPATING IN SEMINARS, STUDYING CURRENT LITERATURE, AND CONSULTING WITH COLLEAGUES CHAPTER AT A GLANCE REGULATORY FRAMEWORK UNAPPROVED DRUGS DISTINGUISHING COMPOUNDING FROM MANUFACTURING FDA MODERNIZATION ACT OF EVENTS LEADING UP TO THE DRUG QUALITY AND SECURITY ACT H R 3204: DRUG QUALITY AND SECURITY ACT UNITED STATES PHARMACOPEIA CERTIFICATION AND ACCREDITATION COMPOUNDING PERSONNEL COMPOUNDING PROCESS PACKAGING, STORAGE, AND LABELING OFFICE-USE COMPOUNDING REFERENCE LIBRARY