June 2018 / USP Compounding Compendium Contents 3 Contents Introduction USP Compounding Compendium... 9 Section 1 Mission and Preface... 12 General Notices and Requirements... 17 Admissions and Annotated List of Changes... 29 Section 2 795 Pharmaceutical Compounding Nonsterile Preparations... 31 797 Pharmaceutical Compounding Sterile Preparations... 39 800 Hazardous Drugs Handling in Healthcare Settings... 84 1160 Pharmaceutical Calculations in Pharmacy Practice... 103 1163 Quality Assurance in Pharmaceutical Compounding... 126 1168 Compounding for Phase I Investigational Studies... 133 1176 Prescription Balances and Volumetric Apparatus Used in Compounding... 142 Section 3 1 Injections and Implanted Drug Products (Parenterals) Product Quality Tests... 150 7 Labeling... 156 17 Prescription Container Labeling... 162 31 Volumetric Apparatus... 165 41 Balances... 166 51 Antimicrobial Effectiveness Testing... 167 55 Biological Indicators Resistance Performance Tests... 170 61 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests... 173 62 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms... 179 71 Sterility Tests... 186 85 Bacterial Endotoxins Test... 194 151 Pyrogen Test... 200 381 Elastomeric Closures for Injections... 202 601 Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders Performance Quality Tests... 208 602 Propellants... 233 603 Topical Aerosols... 234 604 Leak Rate... 235 621 Chromatography... 235 659 Packaging and Storage Requirements... 247 660 Containers Glass... 253 661 Plastic Packaging Systems and Their Materials of Construction... 260 661.1 Plastic Materials of Construction... 267 661.2 Plastic Packaging Systems for Pharmaceutical Use... 288 671 Containers Performance Testing... 293 698 Deliverable Volume... 300 699 Density of Solids... 303 721 Distilling Range... 305 731 Loss on Drying... 306
4 Contents June 2018 / USP Compounding Compendium 741 Melting Range or Temperature... 307 785 Osmolality and Osmolarity... 310 788 Particulate Matter in Injections... 312 789 Particulate Matter in Ophthalmic Solutions... 316 791 ph... 317 811 Powder Fineness... 321 823 Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses... 322 831 Refractive Index... 332 841 Specific Gravity... 332 905 Uniformity of Dosage Units... 334 911 Viscosity Capillary Methods... 337 1051 Cleaning Glass Apparatus... 339 1066 Physical Environments That Promote Safe Medication Use... 340 1072 Disinfectants and Antiseptics... 352 1079 Good Storage and Distribution Practices for Drug Products... 357 1079.1 Storage and Transportation of Investigational Drug Products... 367 1111 Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use... 371 1116 Microbiological Control and Monitoring of Aseptic Processing Environments... 372 1136 Packaging and Repackaging Single-Unit Containers... 385 1151 Pharmaceutical Dosage Forms... 396 1177 Good Packaging Practices... 422 1178 Good Repackaging Practices... 425 1191 Stability Considerations in Dispensing Practice... 427 1197 Good Distribution Practices for Bulk Pharmaceutical Excipients... 433 1211 Sterility Assurance... 455 1228 Depyrogenation... 465 1228.1 Dry Heat Depyrogenation... 469 1228.3 Depyrogenation by Filtration... 473 1228.5 Endotoxin Indicators for Depyrogenation... 477 1229 Sterilization of Compendial Articles... 481 1229.1 Steam Sterilization by Direct Contact... 487 1229.2 Moist Heat Sterilization of Aqueous Liquids... 490 1229.3 Monitoring of Bioburden... 495 1229.4 Sterilizing Filtration of Liquids... 498 1229.5 Biological Indicators for Sterilization... 505 1229.6 Liquid-Phase Sterilization... 508 1229.7 Gaseous Sterilization... 511 1229.8 Dry Heat Sterilization... 514 1229.9 Physicochemical Integrators and Indicators for Sterilization... 517 1229.10 Radiation Sterilization... 517 1229.11 Vapor Phase Sterilization... 521 1229.12 New Sterilization Methods... 523 1229.13 Sterilization-in-Place... 523 1231 Water for Pharmaceutical Purposes... 525 1251 Weighing on an Analytical Balance... 563 1265 Written Prescription Drug Information Guidelines... 569 Section 4 Acacia Syrup... 572 Acetazolamide Compounded Oral Suspension... 572
June 2018 / USP Compounding Compendium Contents 5 Diluted Acetic Acid... 572 Acetylcysteine Compounded Solution... 573 Diluted Alcohol... 574 Allopurinol Compounded Oral Suspension... 574 Alprazolam Compounded Oral Suspension... 574 Aluminum Acetate Topical Solution... 575 Aluminum Subacetate Topical Solution... 576 Amiodarone Hydrochloride Compounded Oral Suspension... 576 Amlodipine Compounded Oral Suspension... 577 Anticoagulant Citrate Dextrose Solution... 577 Anticoagulant Citrate Phosphate Dextrose Solution... 579 Anticoagulant Citrate Phosphate Dextrose Adenine Solution... 580 Anticoagulant Sodium Citrate Solution... 582 Aromatic Elixir... 582 Ascorbic Acid Compounded Oral Solution... 583 Atenolol Compounded Oral Suspension... 583 Atenolol Compounded Oral Suspension, Veterinary... 584 Atenolol Compounded Oral Solution... 585 Azathioprine Compounded Oral Suspension... 585 Baclofen Compounded Oral Suspension... 586 Beclomethasone Dipropionate Compounded Oral Solution... 586 Belladonna Tincture... 587 Benazepril Hydrochloride Compounded Oral Suspension, Veterinary... 587 Bentonite Magma... 588 Compound Benzaldehyde Elixir... 588 Benzethonium Chloride Tincture... 588 Compound Benzoin Tincture... 589 Benzyl Benzoate Lotion... 589 Bethanechol Chloride Compounded Oral Solution... 590 Bethanechol Chloride Compounded Oral Suspension... 590 Biotin Compounded Oral Suspension... 591 Milk of Bismuth... 592 Buprenorphine Compounded Buccal Solution, Veterinary... 592 Calamine Topical Suspension... 593 Phenolated Calamine Topical Suspension... 593 Calcium Hydroxide Topical Solution... 593 Camphor Spirit... 594 Captopril Compounded Oral Solution... 594 Captopril Compounded Oral Suspension... 594 Carbol-Fuchsin Topical Solution... 595 Compound Cardamom Tincture... 595 Aromatic Cascara Fluidextract... 595 Cefazolin Ophthalmic Solution... 596 Cherry Juice... 597 Cherry Syrup... 597 Chloroquine Phosphate Compounded Oral Suspension... 598 Chocolate Syrup... 598 Cisapride Compounded Injection, Veterinary... 598 Cisapride Compounded Oral Suspension, Veterinary... 599 Compound Clioquinol Topical Powder... 600 Clomipramine Hydrochloride Compounded Oral Suspension, Veterinary... 600 Clonazepam Compounded Oral Suspension... 601
6 Contents June 2018 / USP Compounding Compendium Clopidogrel Compounded Oral Suspension... 602 Coal Tar Ointment... 602 Coal Tar Topical Solution... 603 Cocaine and Tetracaine Hydrochlorides and Epinephrine Topical Solution... 603 Codeine Phosphate Compounded Oral Solution... 604 Collodion... 605 Flexible Collodion... 605 Cyclophosphamide Compounded Oral Suspension... 606 Cyclosporine Compounded Ophthalmic Solution, Veterinary... 607 Dapsone Compounded Oral Suspension... 607 Dexamethasone Sodium Phosphate Compounded Injection... 608 Diltiazem Hydrochloride Compounded Oral Solution... 609 Diltiazem Hydrochloride Compounded Oral Suspension... 610 Dipyridamole Compounded Oral Suspension... 610 Dolasetron Mesylate Compounded Oral Solution... 611 Dolasetron Mesylate Compounded Oral Suspension... 611 Doxycycline Compounded Oral Suspension, Veterinary... 612 Enalapril Maleate Compounded Oral Suspension... 613 Enalapril Maleate Compounded Oral Suspension, Veterinary... 614 Enrofloxacin Compounded Oral Suspension, Veterinary... 614 Ethambutol Hydrochloride Compounded Oral Suspension... 615 Famciclovir Compounded Oral Suspension... 616 Ferrous Sulfate Syrup... 617 Flecainide Acetate Compounded Oral Suspension... 617 Flucytosine Compounded Oral Suspension... 618 Folic Acid Compounded Oral Solution... 618 Ganciclovir Compounded Oral Suspension... 619 Granisetron Hydrochloride Compounded Oral Suspension... 620 Green Soap... 620 Green Soap Tincture... 621 Anticoagulant Heparin Solution... 621 Hydralazine Hydrochloride Compounded Oral Solution... 622 Hydrochloric Acid Compounded Injection... 623 Diluted Hydrochloric Acid... 623 Ichthammol Ointment... 624 Indomethacin Compounded Topical Gel... 624 Iodine Topical Solution... 624 Strong Iodine Solution... 625 Iodine Tincture... 625 Strong Iodine Tincture... 626 Ipecac Oral Solution... 626 Isradipine Compounded Oral Suspension... 627 Ivermectin Compounded Oral Solution, Veterinary... 628 Ketoconazole Compounded Oral Suspension... 629 Labetalol Hydrochloride Compounded Oral Suspension... 629 Lamotrigine Compounded Oral Suspension... 630 Lansoprazole Compounded Oral Suspension... 630 Leflunomide Compounded Oral Suspension... 631 Lemon Tincture... 632 Leucovorin Calcium Compounded Oral Suspension... 632 Licorice Fluidextract... 633 Lisinopril Compounded Oral Suspension... 633
June 2018 / USP Compounding Compendium Contents 7 Magnesium Citrate Oral Solution... 634 Marbofloxacin Compounded Oral Suspension, Veterinary... 635 Methylene Blue Injection, Veterinary... 636 Metolazone Compounded Oral Suspension... 636 Metoprolol Tartrate Compounded Oral Solution... 637 Metoprolol Tartrate Compounded Oral Suspension... 638 Metronidazole Benzoate Compounded Oral Suspension... 638 Miconazole Compounded Ophthalmic Solution... 639 Mineral Oil Emulsion... 640 Mirtazapine Compounded Oral Suspension, Veterinary... 640 Morphine Sulfate Compounded Injection... 641 Morphine Sulfate Compounded Suppositories... 641 Myrrh Topical Solution... 642 Naratriptan Compounded Oral Suspension... 643 Nitromersol Topical Solution... 643 Hydrophilic Ointment... 644 White Ointment... 644 Yellow Ointment... 644 Omeprazole Oral Suspension... 644 Ondansetron Compounded Topical Gel... 645 Ondansetron Compounded Oral Suspension... 646 Opium Tincture... 646 Vehicle for Oral Solution... 647 Vehicle for Oral Solution, Sugar Free... 647 Vehicle for Oral Suspension... 647 Compound Orange Spirit... 648 Sweet Orange Peel Tincture... 648 Orange Syrup... 648 Pantoprazole Oral Suspension... 649 Paregoric... 649 Pentoxifylline Compounded Oral Suspension... 650 Peppermint Spirit... 651 Pergolide Compounded Oral Suspension, Veterinary... 651 Hydrophilic Petrolatum... 652 Phenobarbital Compounded Oral Suspension... 652 Phenoxybenzamine Hydrochloride Compounded Oral Suspension... 653 Diluted Phosphoric Acid... 653 Piroxicam Compounded Oral Suspension... 654 Piroxicam Compounded Cream... 655 Polyethylene Glycol Ointment... 655 Potassium Bromide Compounded Oral Solution, Veterinary... 656 Potassium Phosphates Compounded Injection... 656 Prazosin Hydrochloride Compounded Oral Suspension... 657 Prednisolone Compounded Oral Suspension, Veterinary... 658 Prednisolone Sodium Phosphate Compounded Oral Solution... 659 Progesterone Compounded Vaginal Inserts... 659 Propylthiouracil Compounded Oral Suspension... 660 Pyrazinamide Compounded Oral Suspension... 661 Pyrimethamine Compounded Oral Suspension... 662 Quinidine Sulfate Compounded Oral Suspension... 662 Compound Resorcinol Ointment... 663 Rifabutin Compounded Oral Suspension... 663
8 Contents June 2018 / USP Compounding Compendium Rifampin Compounded Oral Suspension... 664 Ringer s Injection... 665 Rose Water Ointment... 666 Salicylic Acid Collodion... 667 Selegiline Hydrochloride Compounded Topical Gel... 667 Senna Fluidextract... 668 Senna Oral Solution... 668 Sildenafil Compounded Oral Suspension... 668 Sodium Bicarbonate Compounded Injection... 669 Sodium Bromide Compounded Injection, Veterinary... 670 Sodium Bromide Compounded Oral Solution, Veterinary... 670 Sodium Hypochlorite Compounded Topical Solution... 671 Sodium Phenylbutyrate Compounded Oral Suspension... 671 Sodium Phosphates Compounded Injection... 672 Sotalol Hydrochloride Compounded Oral Suspension... 673 Spironolactone Compounded Oral Suspension... 673 Spironolactone Compounded Oral Suspension, Veterinary... 674 Spironolactone and Hydrochlorothiazide Compounded Oral Suspension... 675 Sulfur Ointment... 675 Sumatriptan Compounded Oral Suspension... 676 Suspension Structured Vehicle... 676 Sugar-Free Suspension Structured Vehicle... 676 Syrup... 677 Tacrolimus Compounded Oral Suspension... 677 Tadalafil Compounded Oral Suspension... 678 Temozolomide Compounded Oral Suspension... 678 Terbinafine Compounded Oral Suspension... 679 Terbutaline Sulfate Compounded Oral Suspension... 680 Tetracycline Hydrochloride Compounded Oral Suspension... 680 Theophylline Compounded Oral Suspension... 681 Tiagabine Hydrochloride Compounded Oral Suspension... 682 Tolu Balsam Syrup... 683 Tolu Balsam Tincture... 683 Topiramate Compounded Oral Suspension... 683 Tramadol Hydrochloride Compounded Oral Suspension... 684 Tramadol Hydrochloride and Acetaminophen Compounded Oral Suspension... 685 Tramadol Hydrochloride Compounded Oral Suspension, Veterinary... 686 Urea Compounded Irrigation... 686 Ursodiol Compounded Oral Suspension... 687 Valacyclovir Compounded Oral Suspension... 688 Vanilla Tincture... 688 Verapamil Hydrochloride Compounded Oral Solution... 688 Verapamil Hydrochloride Compounded Oral Suspension... 689 Voriconazole Compounded Ophthalmic Solution, Veterinary... 690 Sterile Water for Injection... 690 Xanthan Gum Solution... 691 Zinc Oxide Ointment... 691 Zinc Oxide Paste... 692 Zinc Oxide and Salicylic Acid Paste... 692 Zinc Sulfide Topical Suspension... 692 Zonisamide Compounded Oral Suspension... 692