The USP Compounding Table of Contents is in reference to RAE Question #28 of the Proposed Regulation. pLL MAY—12017

Feb 201 7! USP Compounding Compendium Contents 3 Independent Regulatory Review Commission Contents tntroduction USP Compounding Compendium

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 83 (1160) Pharmaceutical Calculations in Pharmacy Practice 102

(1163) Quality Assurance in Pharmaceutical Compounding 125

(11 76) Prescription Balances and Volumetric Apparatus Used in Compounding 132

Section 3 (1) Injections and Implanted Drug—Product Quality Tests (Chapter to become officialMay 1, 2016) 140 (7) Labeling 146 (1 7) Prescription Container Labeling 153 (31) Volumetric Apparatus 156 (41) Balances 157 (51) Antimicrobial Effectiveness Testing 157 (55) Biological Indicators—Resistance Performance Tests 160 (61) Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests 163

(62) Microbiological Examination of Nonsterlle Products: Tests for Specified Microorganisms 169

(71) Sterility Tests 176

(85) Bacterial Endotoxins Test 184 (151) Pyrogen Test 190 (381) Elastomeric Closures for Injections 192 (601) inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quahty lests 197 (602) Propellants 223 (603) Topical Aerosols 224 (604) Leak Rate 225 (621) Chromatography 225 (659) Packaging and Storage Requirements (Chapter to become officialMay 1, 2019) 237 (660) Containers—Glass 243 (661) Plastic Packaging Systems and their Materials of Construction 249 (661.1) Plastic Materials of Constructions 250 (661 .2> Plastic Packaging Systems for Pharmaceutical Use 264 (671) Containers—Performance Testing 267 (698) Deliverable Volume 275 (699) Density of Solids 278 (721) Distilling Range 280 (731) Loss on Drying 281 4 Contents Feb 201 7 / USP Compounding Compendium

(741) Melting Range or Temperature 282 (785) Osmolality and Osmolarity 285 (788) Particulate Matter in Injections 287 (789) Particulate Matter in Ophthalmic Solutions 291 (791) pH 292 (811) Powder Fineness 296 (823) Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses 296 (831) Refractive Index 306 (841) Specific Gravity 307 (905) Uniformity of Dosage Units 308 (911) Viscosity—Capillary Methods 311 (1051) Cleaning Glass Apparatus 313 (1066) Physical Environments That Promote Safe Medication Use 314 (1072) Disinfectants and Antiseptics 326 (1079) Good Storage and Distribution Practices for Drug Products 332

(1 111) Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use 341

(1 116) Microbiological Control and Monitoring of Aseptic Processing Environments 342

(1 136) Packaging and Repackaging—Single-Unit Containers 355 (1151) Pharmaceutical Dosage Forms 366

(1 177) Good Packaging Practices 392

(1 178) Good Repackaging Practices 395 (1191) Stability Considerations in Dispensing Practice 397 (1 197) Good Distribution Practices for Bulk Pharmaceutical Excipients 402 (121 1) Sterilization and Sterility Assurance of Compendial Articles 424 (1228) Depyrogenation 429 (1228.1) Dry Heat Depyrogenation 434 (1228.3) Depyrogenation by Filtration 438 (1228.5) Endotoxin Indicators for Depyrogenation 441 (1229) Sterilization of Compendial Articles 445 (1229.1) Steam Sterilization by Direct Contact 451 (1229.2) Moist Heat Sterilization of Aqueous Liquids 454 (1229.3) Monitoring of Bioburden 459 (1229.4) Sterilizing Filtration of Liquids 462 (1229.5) Biological Indicators for Sterilization 469 (1229.6) Liquid-Phase Sterilization 472 (1229.7) Gaseous Sterilization 475 (1229.8) Dry Heat Sterilization 478 (1229.9) Physicochemical lntegrators and Indicators for Sterilization 481 (1229.10) Radiation Sterilization 481 (1229.1 1) Vapor Phase Sterilization 485 (1229.12) New Sterilization Methods 487 (1229.13) Sterilization-in-Place 487 (1231) Water for Pharmaceutical Purposes 489 (1251) Weighing on an Analytical Balance 525 (1265) Written Prescription Drug Information—Guidelines 531

Section 4 Acacia Syrup 535 Acetazolamide Compounded Oral Suspension 535 Diluted Acetic Acid 535 Feb 201 7 / USP Compounding Compendium Contents 5

Diluted Alcohol 536 Allopurinol Compounded Oral Suspension 536 Aiprazolam Compounded Oral Suspension 536 Aluminum Acetate Topical Solution 537 Aluminum Subacetate Topical Solution 538 Amiodarone Hydrochloride Compounded Oral Suspension 538 Amlodipine Compounded Oral Suspension 539 Anticoagulant Citrate Dextrose Solution 540 Anticoagulant Citrate Phosphate Dextrose Solution 541 Anticoagulant Citrate Phosphate Dextrose Adenine Solution 542 Anticoagulant Sodium Citrate Solution 544 Aromatic Elixir 544 Atenolol Compounded Oral Suspension 544 Atenolol Compounded Oral Suspension, Veterinary 545 Atenolol Compounded Oral Solution 546 Azathioprine Compounded Oral Suspension 546 Baclofen Compounded Oral Suspension 547 Beclomethasone Dipropionate Compounded Oral Solution 547 Belladonna Tincture 548 Benazepril Hydrochloride Compounded Oral Suspension, Veterinary 548 Bentonite Magma 549 Compound Benzaldehyde Elixir 549 Benzethonium Chloride Tincture 550 Compound Benzoin Tincture 550 Benzyl Benzoate Lotion 551 Bethanechol Chloride Compounded Oral Solution 551 Bethanechol Chloride Compounded Oral Suspension 552 Milk of Bismuth 552 Methylene Blue Injection, Veterinary 553 Buprenorphine Compounded Buccal Solution, Veterinary 554 Phenolated Calamine Topical Suspension 554 Calamine Topical Suspension 554 Calcium Hydroxide Topical Solution 555 Camphor Spirit 555 Captopril Compounded Oral Solution 555 Captopril Compounded Oral Suspension 556 Carbol-Fuchsin Topical Solution 556 Compound Cardamom Tincture 557 Aromatic Cascara Fluidextract 557 Cefazolin Ophthalmic Solution 557 Cherry juice 558 Cherry Syrup 559 Chioroquine Phosphate Compounded Oral Suspension 559 Chocolate Syrup 560 Cisapride Compounded Injection, Veterinary 560 Cisapride Compounded Oral Suspension, Veterinary 561 Compound Clioquinol Topical Powder 561 Clonazepam Compounded Oral Suspension 562 Clopidogrel Compounded Oral Suspension 562 Coal Tar Ointment 563 Coal Tar Topical Solution 563 Cocaine and Tetracaine Hydrochlorides and Epinephrine Topical Solution 563 6 Contents Feb 201 7 / USPCompounding Compendium

Codeine Phosphate Compounded Oral Solution 565 Collodion 565 Flexible Collodion 566 Cyclosporine Compounded Ophthalmic Solution, Veterinary 567 Dapsone Compounded Oral Suspension 567 Diltiazem Hydrochloride Compounded Oral Solution 568 Diltiazem Hydrochloride Compounded Oral Suspension 569 Dipyridamole Compounded Oral Suspension 569 Dolasetron Mesylate Compounded Oral Solution 570 Dolasetron Mesylate Compounded Oral Suspension 571 Doxycycline Compounded Oral Suspension, Veterinary 571 Enalapril Maleate Compounded Oral Suspension, Veterinary 572 Enalapril Maleate Compounded Oral Suspension 573 Enrofloxacin Compounded Oral Suspension, Veterinary 574 Ethambutol Hydrochloride Compounded Oral Suspension 574 Famciclovir Compounded Oral Suspension 575 Ferrous Sulfate Syrup 576 Flecainide Acetate Compounded Oral Suspension 576 Flucytosine Compounded Oral Suspension 577 Ganciclovir Compounded Oral Suspension 578 Granisetron Hydrochloride Compounded Oral Suspension 578 Green Soap 579 Green Soap Tincture 580 Anticoagulant Heparin Solution 580 Hydralazine Hydrochloride Compounded Oral Solution 581 Diluted Hydrochloric Acid 581 Hydrochloric Acid Compounded Injection 582 lchthammol Ointment 582 Indomethacin Compounded Topical Gel 583 Strong Iodine Solution 583 Iodine Topical Solution 583 Iodine Tincture 584 Strong Iodine Tincture 584 Ipecac Oral Solution 585 lsradipine Compounded Oral Suspension 586 Ketoconazole Compounded Oral Suspension 586 Labetalol Hydrochloride Compounded Oral Suspension 587 Lamotrigine Compounded Oral Suspension 588 Lansoprazole Compounded Oral Suspension 588 Lemon Tincture 589 Licorice Fluidextract 590 LisinoprilCompounded Oral Suspension 590 Magnesium Citrate Oral Solution 590 Marbofloxacin Compounded Oral Suspension, Veterinary 591 Metolazone Compounded Oral Suspension 592 Metoprolol Tartrate Compounded Oral Solution 593 Metoprolol Tartrate Compounded Oral Suspension 593 Metronidazole Benzoate Compounded Oral Suspension 594 Miconazole Compounded Ophthalmic Solution 594 Mineral Oil Emulsion 595 Morphine Sulfate Compounded Suppositories 595 Myrrh Topical Solution 596 Feb 201 7 / USP Compounding Compendium Contents 7

Naratriptan Compounded Oral Suspension 597 Nitromersol Topical Solution 597 Hydrophilic Ointment 598 White Ointment 598 Yellow Ointment 598 Omeprazole Oral Suspension 598 Ondansetron Compounded Oral Suspension 599 Opium Tincture 600 Vehicle for Oral Solution 600 Vehicle for Oral Solution, Sugar Free 600 Vehicle for Oral Suspension 601 Sweet Orange Peel Tincture 601 Compound Orange Spirit 601 Orange Syrup 602 Pantoprazole Oral Suspension 602 Paregoric 603 Pentoxifylline Compounded Oral Suspension 604 Peppermint Spirit 604 Pergolide Compounded Oral Suspension, Veterinary 605 Hydrophilic Petrolatum 605 Phenobarbital Compounded Oral Suspension 606 Phenoxybenzamine Hydrochloride Compounded Oral Suspension 606 Diluted Phosphoric Acid 607 Piroxicam Compounded Oral Suspension 607 Piroxicam Compounded Cream 608 Polyethylene Glycol Ointment 609 Potassium Bromide Compounded Oral Solution, Veterinary 609 Prednisolone Compounded Oral Suspension, Veterinary 609 Prednisolone Sodium Phosphate Compounded Oral Solution 610 Progesterone Compounded Vaginal Inserts 611 Propylthiouracil Compounded Oral Suspension 612 Pyrazinamide Compounded Oral Suspension 613 Pyrimethamine Compounded Oral Suspension 614 Quinidine Sulfate Compounded Oral Suspension 614 Compound Resorcinol Ointment 615 Rifabutin Compounded Oral Suspension 615 Rifampin Compounded Oral Suspension 616 Ringer’s Injection 61 7 Rose Water Ointment 618 SalicylicAcid Collodion 618 Selegiline Hydrochloride Compounded Topical Gel 619 Senna Fluidextract 620 Senna Oral Solution 620 Sildenafil Compounded Oral Suspension 620 Sodium Bromide Compounded Injection, Veterinary 621 Sodium Bromide Compounded Oral Solution, Veterinary 621 Sodium Hypochlorite Compounded Topical Solution 622 Sodium Phenylbutyrate Compounded Oral Suspension 622 Sotalol Hydrochloride Compounded Oral Suspension 623 Spironolactone Compounded Oral Suspension 623 Spironolactone Compounded Oral Suspension, Veterinary 624 Spironolactone and Hydrochlorothiazide Compounded Oral Suspension 625 8 Contents Feb 201 7! USP Compounding Compendium

Sulfur Ointment 625 Sumatriptan Compounded Oral Suspension 626 Suspension Structured Vehicle 626 Sugar-Free Suspension Structured Vehicle 626 Syrup 627 Tacrolimus Compounded Oral Suspension 627 Tadalafil Compounded Oral Suspension 628 Temozolomide Compounded Oral Suspension 628 Terbinafine Compounded Oral Suspension 629 Terbutaline Sulfate Compounded Oral Suspension 630 Tetracycline Hydrochloride Compounded Oral Suspension 630 Theophylline Compounded Oral Suspension 631 Tiagabine Hydrochloride Compounded Oral Suspension 632 Tolu Balsam Syrup 633 Tolu Balsam Tincture 633 Topiramate Compounded Oral Suspension 633 Tramadol Hydrochloride and Acetaminophen Compounded Oral Suspension 634 Tramadol Hydrochloride Compounded Oral Suspension, Veterinary 635 Tramadol Hydrochloride Compounded Oral Suspension 636 Ursodiol Compounded Oral Suspension 636 Valacyclovir Compounded Oral Suspension 637 Vanilla Tincture 638 Verapamil Hydrochloride Compounded Oral Solution 638 Verapamil Hydrochloride Compounded Oral Suspension 639 Voriconazole Compounded Ophthalmic Solution, Veterinary 639 Xanthan Gum Solution 640 Zinc Oxide Ointment 640 Zinc Oxide Paste 641 Zinc Oxide and SalicylicAcid Paste 641 Zinc Sulfide Topical Suspension 641 Zonisamide Compounded Oral Suspension 641