June 2020 / 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............................................................................................................... 27

Section 2
á795ñ Pharmaceutical Compounding—Nonsterile Preparations................................................................................. 29
á797ñ Pharmaceutical Compounding—Sterile Preparations....................................................................................... 36
á800ñ Hazardous Drugs—Handling in Healthcare Settings......................................................................................... 79
á825ñ Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging ....................................... 96
á1160ñ Pharmaceutical Calculations in Pharmacy Practice....................................................................................... 124
á1163ñ Quality Assurance in Pharmaceutical Compounding.................................................................................... 149
á1168ñ Compounding for Phase I Investigational Studies........................................................................................ 156
á1176ñ Prescription Balances and Volumetric Apparatus Used in Compounding...................................................... 164

Section 3
á7ñ Labeling............................................................................................................................................................ 171
á31ñ Volumetric Apparatus...................................................................................................................................... 178
á41ñ Balances.......................................................................................................................................................... 179
á51ñ Antimicrobial Effectiveness Testing.................................................................................................................. 180
á61ñ Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests........................................... 182
á62ñ Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms................................. 188
á71ñ Sterility Tests................................................................................................................................................... 197
á85ñ Bacterial Endotoxins Test................................................................................................................................. 204
á151ñ Pyrogen Test................................................................................................................................................. 209
á381ñ Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems ......................... 211
á659ñ Packaging and Storage Requirements............................................................................................................ 214
á660ñ Containers—Glass......................................................................................................................................... 220
á661ñ Plastic Packaging Systems and Their Materials of Construction...................................................................... 226
á661.1ñ Plastic Materials of Construction................................................................................................................. 233
á661.2ñ Plastic Packaging Systems for Pharmaceutical Use...................................................................................... 261
á671ñ Containers—Performance Testing.................................................................................................................. 265
á731ñ Loss On Drying.............................................................................................................................................. 273
á785ñ Osmolality and Osmolarity............................................................................................................................ 274
á821ñ Radioactivity.................................................................................................................................................. 284
á823ñ Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses........................ 290
á1066ñ Physical Environments That Promote Safe Medication Use........................................................................... 299
á1072ñ Disinfectants and Antiseptics....................................................................................................................... 311
á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products..................... 316
á1079.1ñ Storage and Transportation of Investigational Drug Products................................................................... 328
á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
Drug Products.......................................................................................................................................... 331
á1111ñ Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and
Substances for Pharmaceutical Use........................................................................................................... 334
á1113ñ Microbial Characterization, Identification, and Strain Typing....................................................................... 335
á1116ñ Microbiological Control and Monitoring of Aseptic Processing Environments.............................................. 339
á1151ñ Pharmaceutical Dosage Forms..................................................................................................................... 351
á1178ñ Good Repackaging Practices........................................................................................................................ 374
á1191ñ Stability Considerations in Dispensing Practice............................................................................................ 375
á1211ñ Sterility Assurance........................................................................................................................................ 380
á1229.5ñ Biological Indicators for Sterilization......................................................................................................... 388
á1231ñ Water for Pharmaceutical Purposes.............................................................................................................. 391
á1251ñ Weighing On An Analytical Balance............................................................................................................. 425
á1265ñ Written Prescription Drug Information—Guidelines..................................................................................... 430
á1821ñ Radioactivity—Theory and Practice.............................................................................................................. 432
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Section 4
Acacia Syrup........................................................................................................................................................... 446
Acetazolamide Compounded Oral Suspension........................................................................................................ 446
Diluted Acetic Acid................................................................................................................................................. 446
Acetylcysteine Compounded Solution..................................................................................................................... 447
Alcohol................................................................................................................................................................... 448
Diluted Alcohol....................................................................................................................................................... 450
Allopurinol Compounded Oral Suspension............................................................................................................. 450
Alprazolam Compounded Oral Suspension............................................................................................................. 451
Aluminum Acetate Topical Solution........................................................................................................................ 451
Aluminum Subacetate Topical Solution................................................................................................................... 452
Amiodarone Hydrochloride Compounded Oral Suspension.................................................................................... 453
Amlodipine Compounded Oral Suspension............................................................................................................. 453
Anticoagulant Citrate Dextrose Solution................................................................................................................. 454
Anticoagulant Citrate Phosphate Dextrose Solution................................................................................................ 455
Anticoagulant Citrate Phosphate Dextrose Adenine Solution................................................................................... 457
Anticoagulant Sodium Citrate Solution................................................................................................................... 458
Arginine Hydrochloride Compounded Oral Solution............................................................................................... 459
Aromatic Elixir........................................................................................................................................................ 460
Ascorbic Acid Compounded Oral Solution.............................................................................................................. 460
Atenolol Compounded Oral Solution...................................................................................................................... 461
Atenolol Compounded Oral Suspension................................................................................................................. 461
Atenolol Compounded Oral Suspension, Veterinary................................................................................................ 462
Azathioprine Compounded Oral Suspension........................................................................................................... 462
Baclofen Compounded Oral Suspension................................................................................................................. 463
Beclomethasone Dipropionate Compounded Oral Solution.................................................................................... 464
Belladonna Tincture................................................................................................................................................ 464
Benazepril Hydrochloride Compounded Oral Suspension, Veterinary...................................................................... 465
Bentonite Magma................................................................................................................................................... 465
Compound Benzaldehyde Elixir.............................................................................................................................. 466
Benzethonium Chloride Tincture............................................................................................................................ 466
Compound Benzoin Tincture.................................................................................................................................. 467
Benzyl Benzoate Lotion........................................................................................................................................... 467
Bethanechol Chloride Compounded Oral Solution.................................................................................................. 467
Bethanechol Chloride Compounded Oral Suspension............................................................................................. 468
Biotin Compounded Oral Suspension..................................................................................................................... 468
Milk of Bismuth...................................................................................................................................................... 469
Buprenorphine Compounded Buccal Solution, Veterinary....................................................................................... 470
Calamine Topical Suspension.................................................................................................................................. 470
Phenolated Calamine Topical Suspension............................................................................................................... 471
Calcium Hydroxide Topical Solution....................................................................................................................... 471
Camphor Spirit....................................................................................................................................................... 471
Captopril Compounded Oral Solution.................................................................................................................... 471
Captopril Compounded Oral Suspension................................................................................................................ 472
Carbol-Fuchsin Topical Solution.............................................................................................................................. 473
Carboxymethylcellulose Sodium Compounded Intraperitoneal Solution, Veterinary................................................ 473
Compound Cardamom Tincture............................................................................................................................. 474
Aromatic Cascara Fluidextract................................................................................................................................. 474
Cefazolin Ophthalmic Solution............................................................................................................................... 474
Cherry Juice............................................................................................................................................................ 475
Cherry Syrup.......................................................................................................................................................... 476
Chlorambucil Compounded Oral Suspension......................................................................................................... 476
Chloramphenicol Compounded Oral Suspenstion, Veterinary................................................................................. 477
Chloroquine Phosphate Compounded Oral Suspension.......................................................................................... 478
Chlorothiazide Compounded Oral Suspension........................................................................................................ 478
Chocolate Syrup..................................................................................................................................................... 479
Cisapride Compounded Injection, Veterinary.......................................................................................................... 479
Cisapride Compounded Oral Suspension, Veterinary.............................................................................................. 480
Clindamycin Hydrochloride Compounded Oral Solution......................................................................................... 481
Compound Clioquinol Topical Powder................................................................................................................... 481
Clomipramine Hydrochloride Compounded Oral Suspension, Veterinary................................................................ 482
Clonazepam Compounded Oral Suspension........................................................................................................... 483
Clonidine Hydrochloride Compounded Oral Suspension......................................................................................... 483
Clopidogrel Compounded Oral Suspension............................................................................................................ 484
Coal Tar Ointment.................................................................................................................................................. 485
Coal Tar Topical Solution........................................................................................................................................ 485
Cocaine and Tetracaine Hydrochlorides and Epinephrine Topical Solution.............................................................. 485
Codeine Phosphate Compounded Oral Solution..................................................................................................... 487
Collodion................................................................................................................................................................ 487
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Flexible Collodion................................................................................................................................................... 488

Cyclophosphamide Compounded Oral Suspension................................................................................................ 489
Cyclosporine Compounded Ophthalmic Solution, Veterinary.................................................................................. 489
Dapsone Compounded Oral Suspension................................................................................................................. 490
Dexamethasone Sodium Phosphate Compounded Injection................................................................................... 491
Diltiazem Hydrochloride Compounded Oral Solution............................................................................................. 492
Diltiazem Hydrochloride Compounded Oral Suspension......................................................................................... 492
Dipyridamole Compounded Oral Suspension......................................................................................................... 493
Dolasetron Mesylate Compounded Oral Solution................................................................................................... 494
Dolasetron Mesylate Compounded Oral Suspension............................................................................................... 494
Doxycycline Compounded Oral Suspension, Veterinary.......................................................................................... 495
Enalapril Maleate Compounded Oral Suspension.................................................................................................... 497
Enalapril Maleate Compounded Oral Suspension, Veterinary.................................................................................. 498
Enrofloxacin Compounded Oral Suspension, Veterinary.......................................................................................... 499
Estriol Compounded Vaginal Cream....................................................................................................................... 499
Ethambutol Hydrochloride Compounded Oral Suspension..................................................................................... 500
Famciclovir Compounded Oral Suspension............................................................................................................. 501
Fentanyl Citrate Compounded Injection................................................................................................................. 502
Fentanyl Citrate and Bupivacaine Hydrochloride Compounded Injection................................................................ 502
Fentanyl Citrate and Ropivacaine Hydrochloride Compounded Injection................................................................ 503
Ferrous Sulfate Syrup.............................................................................................................................................. 505
Flecainide Acetate Compounded Oral Suspension.................................................................................................. 505
Flucytosine Compounded Oral Suspension............................................................................................................. 506
Folic Acid Compounded Oral Solution.................................................................................................................... 507
Ganciclovir Compounded Oral Suspension............................................................................................................. 507
Granisetron Hydrochloride Compounded Oral Suspension..................................................................................... 508
Green Soap............................................................................................................................................................. 509
Green Soap Tincture............................................................................................................................................... 509
Guaifenesin Compounded Injection, Veterinary...................................................................................................... 510
Anticoagulant Heparin Solution.............................................................................................................................. 510
Hydralazine Hydrochloride Compounded Oral Solution.......................................................................................... 512
Hydrochloric Acid Compounded Injection.............................................................................................................. 512
Diluted Hydrochloric Acid....................................................................................................................................... 513
Hydrochlorothiazide Compounded Oral Suspension............................................................................................... 513
Ichthammol Ointment............................................................................................................................................ 514
Indomethacin Compounded Topical Gel................................................................................................................ 514
Iodine Topical Solution........................................................................................................................................... 515
Strong Iodine Solution............................................................................................................................................ 515
Iodine Tincture....................................................................................................................................................... 516
Strong Iodine Tincture............................................................................................................................................ 516
Ipecac Oral Solution............................................................................................................................................... 517
Isradipine Compounded Oral Suspension............................................................................................................... 518
Ivermectin Compounded Oral Solution, Veterinary................................................................................................. 518
Ketoconazole Compounded Oral Suspension.......................................................................................................... 519
Labetalol Hydrochloride Compounded Oral Suspension......................................................................................... 520
Lamotrigine Compounded Oral Suspension............................................................................................................ 520
Lansoprazole Compounded Oral Suspension.......................................................................................................... 521
Leflunomide Compounded Oral Suspension........................................................................................................... 522
Lemon Tincture...................................................................................................................................................... 523
Leucovorin Calcium Compounded Oral Suspension................................................................................................ 523
Licorice Fluidextract................................................................................................................................................ 524
Lidocaine, Racepinephrine, and Tetracaine Hydrochlorides Compounded Topical Gel............................................ 524
Lisinopril Compounded Oral Suspension................................................................................................................. 525
Magnesium Citrate Oral Solution............................................................................................................................ 526
Marbofloxacin Compounded Oral Suspension, Veterinary...................................................................................... 527
Methylene Blue Compounded Injection, Veterinary................................................................................................ 528
Metolazone Compounded Oral Suspension............................................................................................................ 528
Metoprolol Tartrate Compounded Oral Solution..................................................................................................... 529
Metoprolol Tartrate Compounded Oral Suspension................................................................................................ 530
Metronidazole Benzoate Compounded Oral Suspension......................................................................................... 530
Miconazole Compounded Ophthalmic Solution..................................................................................................... 531
Mineral Oil Emulsion............................................................................................................................................... 532
Mirtazapine Compounded Oral Suspension, Veterinary.......................................................................................... 532
Morphine Sulfate Compounded Injection............................................................................................................... 533
Morphine Sulfate Compounded Suppositories........................................................................................................ 534
Myrrh Topical Solution........................................................................................................................................... 535
Naproxen Compounded Oral Suspension............................................................................................................... 535
Naratriptan Compounded Oral Suspension............................................................................................................ 536
Nitromersol Topical Solution................................................................................................................................... 536
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Hydrophilic Ointment............................................................................................................................................. 537

White Ointment...................................................................................................................................................... 537
Yellow Ointment..................................................................................................................................................... 537
Omeprazole Oral Suspension.................................................................................................................................. 538
Ondansetron Compounded Oral Suspension.......................................................................................................... 538
Ondansetron Compounded Topical Gel.................................................................................................................. 539
Opium Tincture...................................................................................................................................................... 540
Vehicle for Oral Solution......................................................................................................................................... 540
Vehicle for Oral Solution, Sugar Free....................................................................................................................... 540
Vehicle for Oral Suspension..................................................................................................................................... 541
Compound Orange Spirit....................................................................................................................................... 541
Sweet Orange Peel Tincture.................................................................................................................................... 541
Orange Syrup......................................................................................................................................................... 542
Pantoprazole Oral Suspension................................................................................................................................. 542
Paregoric................................................................................................................................................................ 543
Pentoxifylline Compounded Oral Suspension.......................................................................................................... 544
Peppermint Spirit.................................................................................................................................................... 545
Pergolide Compounded Oral Suspension, Veterinary.............................................................................................. 545
Hydrophilic Petrolatum........................................................................................................................................... 546
Phenobarbital Compounded Oral Suspension......................................................................................................... 546
Phenoxybenzamine Hydrochloride Compounded Oral Suspension......................................................................... 547
Phenytoin Compounded Topical Gel...................................................................................................................... 547
Diluted Phosphoric Acid......................................................................................................................................... 548
Phytonadione Compounded Oral Suspension......................................................................................................... 549
Piroxicam Compounded Oral Suspension............................................................................................................... 550
Piroxicam Compounded Cream.............................................................................................................................. 550
Polyethylene Glycol Ointment................................................................................................................................ 551
Potassium Bromide Compounded Oral Solution, Veterinary.................................................................................... 551
Potassium Phosphates Compounded Injection........................................................................................................ 552
Prazosin Hydrochloride Compounded Oral Suspension........................................................................................... 553
Prednisolone Compounded Oral Suspension, Veterinary......................................................................................... 553
Prednisolone Sodium Phosphate Compounded Oral Solution................................................................................. 554
Progesterone Compounded Vaginal Inserts............................................................................................................. 555
Propylthiouracil Compounded Oral Suspension...................................................................................................... 556
Pyrazinamide Compounded Oral Suspension.......................................................................................................... 557
Pyrimethamine Compounded Oral Suspension....................................................................................................... 558
Quinidine Sulfate Compounded Oral Suspension.................................................................................................... 558
Compound Resorcinol Ointment............................................................................................................................ 559
Rifabutin Compounded Oral Suspension................................................................................................................. 559
Rifampin Compounded Oral Suspension................................................................................................................. 560
Ringer’s Injection.................................................................................................................................................... 561
Rose Water Ointment............................................................................................................................................. 562
Salicylic Acid Collodion........................................................................................................................................... 562
Selegiline Hydrochloride Compounded Topical Gel................................................................................................ 563
Senna Fluidextract.................................................................................................................................................. 564
Senna Oral Solution................................................................................................................................................ 564
Sildenafil Compounded Oral Suspension................................................................................................................ 564
Sodium Benzoate Compounded Oral Solution........................................................................................................ 565
Sodium Bicarbonate Compounded Injection........................................................................................................... 565
Sodium Bromide Compounded Injection, Veterinary.............................................................................................. 566
Sodium Bromide Compounded Oral Solution, Veterinary....................................................................................... 567
Sodium Hypochlorite Compounded Topical Solution.............................................................................................. 567
Sodium Phenylbutyrate Compounded Oral Suspension.......................................................................................... 568
Sodium Phosphates Compounded Injection........................................................................................................... 568
Sotalol Hydrochloride Compounded Oral Suspension............................................................................................. 570
Spironolactone Compounded Oral Suspension....................................................................................................... 570
Spironolactone Compounded Oral Suspension, Veterinary..................................................................................... 571
Spironolactone and Hydrochlorothiazide Compounded Oral Suspension................................................................ 572
Sulfur Ointment...................................................................................................................................................... 572
Sumatriptan Compounded Oral Suspension........................................................................................................... 573
Suspension Structured Vehicle................................................................................................................................ 573
Sugar-Free Suspension Structured Vehicle............................................................................................................... 573
Syrup...................................................................................................................................................................... 574
Tacrolimus Compounded Oral Suspension.............................................................................................................. 574
Tadalafil Compounded Oral Suspension................................................................................................................. 575
Temozolomide Compounded Oral Suspension....................................................................................................... 575
Terbinafine Compounded Oral Suspension............................................................................................................. 576
Terbutaline Sulfate Compounded Oral Suspension................................................................................................. 577
Tetracycline Hydrochloride Compounded Oral Suspension..................................................................................... 578
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Theophylline Compounded Oral Suspension.......................................................................................................... 579

Tiagabine Hydrochloride Compounded Oral Suspension........................................................................................ 579
Tolu Balsam Syrup.................................................................................................................................................. 580
Tolu Balsam Tincture.............................................................................................................................................. 580
Topiramate Compounded Oral Suspension............................................................................................................. 581
Torsemide Compounded Oral Suspension.............................................................................................................. 582
Tramadol Hydrochloride Compounded Oral Suspension......................................................................................... 582
Tramadol Hydrochloride Compounded Oral Suspension, Veterinary....................................................................... 583
Tramadol Hydrochloride and Acetaminophen Compounded Oral Suspension........................................................ 584
Urea Compounded Irrigation.................................................................................................................................. 585
Ursodiol Compounded Oral Suspension.................................................................................................................. 585
Valacyclovir Compounded Oral Suspension............................................................................................................ 586
Vancomycin Hydrochloride Compounded Oral Solution......................................................................................... 587
Vanilla Tincture....................................................................................................................................................... 587
Verapamil Hydrochloride Compounded Oral Solution............................................................................................. 588
Verapamil Hydrochloride Compounded Oral Suspension........................................................................................ 588
Voriconazole Compounded Ophthalmic Solution, Veterinary.................................................................................. 589
Purified Water......................................................................................................................................................... 590
Sterile Water for Injection....................................................................................................................................... 590
Sterile Water for Irrigation....................................................................................................................................... 590
Xanthan Gum Solution........................................................................................................................................... 591
Zinc Oxide Compounded Ointment....................................................................................................................... 591
Zinc Oxide Compounded Paste.............................................................................................................................. 592
Zinc Oxide and Salicylic Acid Paste......................................................................................................................... 592
Zinc Sulfate Compounded Injection........................................................................................................................ 592
Zinc Sulfide Topical Suspension.............................................................................................................................. 593
Zonisamide Compounded Oral Suspension............................................................................................................ 594