June 2018 / USP Compounding Compendium Contents 3. Introduction USP Compounding Compendium... 9

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1 June 2018 / USP Compounding Compendium Contents 3 Contents Introduction USP Compounding Compendium... 9 Section 1 Mission and Preface General Notices and Requirements Admissions and Annotated List of Changes Section Pharmaceutical Compounding Nonsterile Preparations Pharmaceutical Compounding Sterile Preparations Hazardous Drugs Handling in Healthcare Settings Pharmaceutical Calculations in Pharmacy Practice Quality Assurance in Pharmaceutical Compounding Compounding for Phase I Investigational Studies Prescription Balances and Volumetric Apparatus Used in Compounding Section 3 1 Injections and Implanted Drug Products (Parenterals) Product Quality Tests Labeling Prescription Container Labeling Volumetric Apparatus Balances Antimicrobial Effectiveness Testing Biological Indicators Resistance Performance Tests Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms Sterility Tests Bacterial Endotoxins Test Pyrogen Test Elastomeric Closures for Injections Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders Performance Quality Tests Propellants Topical Aerosols Leak Rate Chromatography Packaging and Storage Requirements Containers Glass Plastic Packaging Systems and Their Materials of Construction Plastic Materials of Construction Plastic Packaging Systems for Pharmaceutical Use Containers Performance Testing Deliverable Volume Density of Solids Distilling Range Loss on Drying

2 4 Contents June 2018 / USP Compounding Compendium 741 Melting Range or Temperature Osmolality and Osmolarity Particulate Matter in Injections Particulate Matter in Ophthalmic Solutions ph Powder Fineness Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses Refractive Index Specific Gravity Uniformity of Dosage Units Viscosity Capillary Methods Cleaning Glass Apparatus Physical Environments That Promote Safe Medication Use Disinfectants and Antiseptics Good Storage and Distribution Practices for Drug Products Storage and Transportation of Investigational Drug Products Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use Microbiological Control and Monitoring of Aseptic Processing Environments Packaging and Repackaging Single-Unit Containers Pharmaceutical Dosage Forms Good Packaging Practices Good Repackaging Practices Stability Considerations in Dispensing Practice Good Distribution Practices for Bulk Pharmaceutical Excipients Sterility Assurance Depyrogenation Dry Heat Depyrogenation Depyrogenation by Filtration Endotoxin Indicators for Depyrogenation Sterilization of Compendial Articles Steam Sterilization by Direct Contact Moist Heat Sterilization of Aqueous Liquids Monitoring of Bioburden Sterilizing Filtration of Liquids Biological Indicators for Sterilization Liquid-Phase Sterilization Gaseous Sterilization Dry Heat Sterilization Physicochemical Integrators and Indicators for Sterilization Radiation Sterilization Vapor Phase Sterilization New Sterilization Methods Sterilization-in-Place Water for Pharmaceutical Purposes Weighing on an Analytical Balance Written Prescription Drug Information Guidelines Section 4 Acacia Syrup Acetazolamide Compounded Oral Suspension

3 June 2018 / USP Compounding Compendium Contents 5 Diluted Acetic Acid Acetylcysteine Compounded Solution Diluted Alcohol Allopurinol Compounded Oral Suspension Alprazolam Compounded Oral Suspension Aluminum Acetate Topical Solution Aluminum Subacetate Topical Solution Amiodarone Hydrochloride Compounded Oral Suspension Amlodipine Compounded Oral Suspension Anticoagulant Citrate Dextrose Solution Anticoagulant Citrate Phosphate Dextrose Solution Anticoagulant Citrate Phosphate Dextrose Adenine Solution Anticoagulant Sodium Citrate Solution Aromatic Elixir Ascorbic Acid Compounded Oral Solution Atenolol Compounded Oral Suspension Atenolol Compounded Oral Suspension, Veterinary Atenolol Compounded Oral Solution Azathioprine Compounded Oral Suspension Baclofen Compounded Oral Suspension Beclomethasone Dipropionate Compounded Oral Solution Belladonna Tincture Benazepril Hydrochloride Compounded Oral Suspension, Veterinary Bentonite Magma Compound Benzaldehyde Elixir Benzethonium Chloride Tincture Compound Benzoin Tincture Benzyl Benzoate Lotion Bethanechol Chloride Compounded Oral Solution Bethanechol Chloride Compounded Oral Suspension Biotin Compounded Oral Suspension Milk of Bismuth Buprenorphine Compounded Buccal Solution, Veterinary Calamine Topical Suspension Phenolated Calamine Topical Suspension Calcium Hydroxide Topical Solution Camphor Spirit Captopril Compounded Oral Solution Captopril Compounded Oral Suspension Carbol-Fuchsin Topical Solution Compound Cardamom Tincture Aromatic Cascara Fluidextract Cefazolin Ophthalmic Solution Cherry Juice Cherry Syrup Chloroquine Phosphate Compounded Oral Suspension Chocolate Syrup Cisapride Compounded Injection, Veterinary Cisapride Compounded Oral Suspension, Veterinary Compound Clioquinol Topical Powder Clomipramine Hydrochloride Compounded Oral Suspension, Veterinary Clonazepam Compounded Oral Suspension

4 6 Contents June 2018 / USP Compounding Compendium Clopidogrel Compounded Oral Suspension Coal Tar Ointment Coal Tar Topical Solution Cocaine and Tetracaine Hydrochlorides and Epinephrine Topical Solution Codeine Phosphate Compounded Oral Solution Collodion Flexible Collodion Cyclophosphamide Compounded Oral Suspension Cyclosporine Compounded Ophthalmic Solution, Veterinary Dapsone Compounded Oral Suspension Dexamethasone Sodium Phosphate Compounded Injection Diltiazem Hydrochloride Compounded Oral Solution Diltiazem Hydrochloride Compounded Oral Suspension Dipyridamole Compounded Oral Suspension Dolasetron Mesylate Compounded Oral Solution Dolasetron Mesylate Compounded Oral Suspension Doxycycline Compounded Oral Suspension, Veterinary Enalapril Maleate Compounded Oral Suspension Enalapril Maleate Compounded Oral Suspension, Veterinary Enrofloxacin Compounded Oral Suspension, Veterinary Ethambutol Hydrochloride Compounded Oral Suspension Famciclovir Compounded Oral Suspension Ferrous Sulfate Syrup Flecainide Acetate Compounded Oral Suspension Flucytosine Compounded Oral Suspension Folic Acid Compounded Oral Solution Ganciclovir Compounded Oral Suspension Granisetron Hydrochloride Compounded Oral Suspension Green Soap Green Soap Tincture Anticoagulant Heparin Solution Hydralazine Hydrochloride Compounded Oral Solution Hydrochloric Acid Compounded Injection Diluted Hydrochloric Acid Ichthammol Ointment Indomethacin Compounded Topical Gel Iodine Topical Solution Strong Iodine Solution Iodine Tincture Strong Iodine Tincture Ipecac Oral Solution Isradipine Compounded Oral Suspension Ivermectin Compounded Oral Solution, Veterinary Ketoconazole Compounded Oral Suspension Labetalol Hydrochloride Compounded Oral Suspension Lamotrigine Compounded Oral Suspension Lansoprazole Compounded Oral Suspension Leflunomide Compounded Oral Suspension Lemon Tincture Leucovorin Calcium Compounded Oral Suspension Licorice Fluidextract Lisinopril Compounded Oral Suspension

5 June 2018 / USP Compounding Compendium Contents 7 Magnesium Citrate Oral Solution Marbofloxacin Compounded Oral Suspension, Veterinary Methylene Blue Injection, Veterinary Metolazone Compounded Oral Suspension Metoprolol Tartrate Compounded Oral Solution Metoprolol Tartrate Compounded Oral Suspension Metronidazole Benzoate Compounded Oral Suspension Miconazole Compounded Ophthalmic Solution Mineral Oil Emulsion Mirtazapine Compounded Oral Suspension, Veterinary Morphine Sulfate Compounded Injection Morphine Sulfate Compounded Suppositories Myrrh Topical Solution Naratriptan Compounded Oral Suspension Nitromersol Topical Solution Hydrophilic Ointment White Ointment Yellow Ointment Omeprazole Oral Suspension Ondansetron Compounded Topical Gel Ondansetron Compounded Oral Suspension Opium Tincture Vehicle for Oral Solution Vehicle for Oral Solution, Sugar Free Vehicle for Oral Suspension Compound Orange Spirit Sweet Orange Peel Tincture Orange Syrup Pantoprazole Oral Suspension Paregoric Pentoxifylline Compounded Oral Suspension Peppermint Spirit Pergolide Compounded Oral Suspension, Veterinary Hydrophilic Petrolatum Phenobarbital Compounded Oral Suspension Phenoxybenzamine Hydrochloride Compounded Oral Suspension Diluted Phosphoric Acid Piroxicam Compounded Oral Suspension Piroxicam Compounded Cream Polyethylene Glycol Ointment Potassium Bromide Compounded Oral Solution, Veterinary Potassium Phosphates Compounded Injection Prazosin Hydrochloride Compounded Oral Suspension Prednisolone Compounded Oral Suspension, Veterinary Prednisolone Sodium Phosphate Compounded Oral Solution Progesterone Compounded Vaginal Inserts Propylthiouracil Compounded Oral Suspension Pyrazinamide Compounded Oral Suspension Pyrimethamine Compounded Oral Suspension Quinidine Sulfate Compounded Oral Suspension Compound Resorcinol Ointment Rifabutin Compounded Oral Suspension

6 8 Contents June 2018 / USP Compounding Compendium Rifampin Compounded Oral Suspension Ringer s Injection Rose Water Ointment Salicylic Acid Collodion Selegiline Hydrochloride Compounded Topical Gel Senna Fluidextract Senna Oral Solution Sildenafil Compounded Oral Suspension Sodium Bicarbonate Compounded Injection Sodium Bromide Compounded Injection, Veterinary Sodium Bromide Compounded Oral Solution, Veterinary Sodium Hypochlorite Compounded Topical Solution Sodium Phenylbutyrate Compounded Oral Suspension Sodium Phosphates Compounded Injection Sotalol Hydrochloride Compounded Oral Suspension Spironolactone Compounded Oral Suspension Spironolactone Compounded Oral Suspension, Veterinary Spironolactone and Hydrochlorothiazide Compounded Oral Suspension Sulfur Ointment Sumatriptan Compounded Oral Suspension Suspension Structured Vehicle Sugar-Free Suspension Structured Vehicle Syrup Tacrolimus Compounded Oral Suspension Tadalafil Compounded Oral Suspension Temozolomide Compounded Oral Suspension Terbinafine Compounded Oral Suspension Terbutaline Sulfate Compounded Oral Suspension Tetracycline Hydrochloride Compounded Oral Suspension Theophylline Compounded Oral Suspension Tiagabine Hydrochloride Compounded Oral Suspension Tolu Balsam Syrup Tolu Balsam Tincture Topiramate Compounded Oral Suspension Tramadol Hydrochloride Compounded Oral Suspension Tramadol Hydrochloride and Acetaminophen Compounded Oral Suspension Tramadol Hydrochloride Compounded Oral Suspension, Veterinary Urea Compounded Irrigation Ursodiol Compounded Oral Suspension Valacyclovir Compounded Oral Suspension Vanilla Tincture Verapamil Hydrochloride Compounded Oral Solution Verapamil Hydrochloride Compounded Oral Suspension Voriconazole Compounded Ophthalmic Solution, Veterinary Sterile Water for Injection Xanthan Gum Solution Zinc Oxide Ointment Zinc Oxide Paste Zinc Oxide and Salicylic Acid Paste Zinc Sulfide Topical Suspension Zonisamide Compounded Oral Suspension