DRUG COMPOUNDING FOR VETERINARY PROFESSIONALS

Foreword xi
Preface xiii
List of Acronyms xiv
About the Companion Website xvi
Introduction xvii
1 Compounding Regulations 1
Organizations and Regulatory Agencies Involved with Compounding 3
Food and Drug Administration 3
United States Pharmacopeia 3
Drug Enforcement Administration 5
State Boards of Pharmacy 6
State Veterinary Boards 6
Compliance Policy Guides and Guidance for Industry Documents 6
What Is Compounding? 7
The Food, Drug, and Cosmetic Act 9
Animal Medicinal Drug Use Clarification Act 9
Preparing Compounds from an Approved Product or a Pure Drug Powder 10
Federal Versus State Law 11
Office Use Compounding 12
Drug Quality and Security Act 13
Finding Additional Information 13
2 Risk–Benefit Analysis of Compounded Medications 17
Benefits of Compounded Products 17
Dosage Form 17
Flavoring 20
Dosage Strength 20
Eliminating Ingredients 21
Availability Issues 22
Appropriate Use of Compounded Medications 22
FDA-Approved Drugs 23
Compounded Medication Risks 25
Compounded (USP) Versus Manufactured (cGMP) 26
Risks Associated with Compounded Medications – A Look at the Literature 28
Studies Showing Incorrect Potency 28
Studies Showing Lack of Stability 31
Studies Showing Lack of Efficacy 31
Risks Associated with Specific Types of Compounds 32
Active Ingredient Source Decisions 34
Patient-Specific Compounding Versus Office Use Compounding 35
Adverse Event Reporting 36
Identifying Potential Formulation Issues 37
Drug Recalls 38
Selecting a Compounding Pharmacy 39
Client Education 40
Reducing Risk in Practice 40
Conclusion 41
3 Beyond-Use Dating 45
Factors Considered When Assigning BUDs and Expiration Dates 45
USP Default BUDs 48
Stability Studies 49
Evaluating Stability Studies 50
Determining BUDs for In-House Formulations 51
BUD Considerations When Prescribing Compounded Medications 52
Conclusion 53
4 Identifying High-Quality Compounding Pharmacies 55
Case Study 1 55
Case Study 2 58
What to Evaluate 59
General Practices 59
Staff Skill Level 61
Familiarity with Veterinary Medicine 61
Pharmacy Culture 61
Ways to Evaluate Compounding Pharmacies 62
Looking Beyond the Pharmacy’s Website 63
What to Look for on a Tour 65
Questions to Ask the Pharmacist in Charge 65
Conclusion 67
5 Formulation Development 69
Dosage Forms 69
Oral Administration 69
Oral Solutions 69
Oral Suspensions 70
Oral Syrups 70
Oral Capsules 71
Oral Tablets 72
Oral Treats 73
Oral Emulsions 73
Oral Pastes 74
Oral Powders 74
Transdermal Administration 74
Topical Administration 75
Topical Solutions 75
Topical Ointments 76
Topical Shampoos 76
Topical Mousses 76
Topical Emulsions 76
Topical Creams 77
Topical Gels 77
Otic Administration 77
Otic Solutions 77
Otic Suspensions 77
Otic Ointments 78
Other Routes of Administration 78
Rectal Solutions 78
Intranasal Solutions 78
Injectable Preparations 78
Ophthalmic Preparations 79
Ingredients 79
Ingredient Selection 79
Solubility 81
Partition Coefficient 82
Density 83
Water Activity 83
pH 83
Chelators 84
Antioxidants 84
Preservatives 84
Flavors, Coating Agents, and Sweeteners 85
Coloring Agents 87
Salt Forms 87
Organic Salts 88
Inorganic Salts 88
Common Excipients by Dosage Form 89
Oral Liquid Medications 89
Oral Solid Medications 89
Emulsions 91
Transdermal Medications 91
Cream, Gel, and Ointment Medications 91
Hazardous Drugs 92
Beyond-Use Dates 92
Formulation Resources 93
Calculations 93
Measurements Used in Compounding 96
Displacement Factor 96
Capsules: Packing Statistics 98
Packing Statistic of Drug 98
Average Weight of Ingredients 98
Percentage of Drug per Capsule Using Bulk Powder 98
Percentage of Drug per Capsule Using Manufactured Tablets 99
Percentage/Amount of Filler per Capsule 101
Conversion to Grams 101
Compounding Formulations to Avoid 102
Formulation Development Process 103
Developing a Compounding Formula: Example 1 (USP Compounding Compendium) 104
Developing a Compounding Formula: Example 2 (Stability-Indicating Assay) 106
Compounding Formulation Assessment 108
6 Compounding in House 111
Documentation 111
Master Formulation Record 111
Compounding Record 111
Formulation Record Components 112
Quality Assurance and Quality Control 116
Labeling 118
Packaging and Storage 119
Compounding Techniques 120
Trituration 120
Sifting 121
Geometric Dilution 121
Wetting 121
Colored Tracers 122
Equipment 122
Mortars and Pestles 124
Glassware 125
Containers 125
Scales 127
Spatulas and Measuring Devices 129
Equipment Cleaning 129
Training 130
Formulation Instructions 132
Species-Specific Information 135
Flavoring 135
Toxicities 136
Potency Designations 138
Feasibility for a Veterinary Clinic 139
Index 141

Drug Compounding for Veterinary Professionals
Safely, effectively, and legally tailor drug treatments to the needs of your specific veterinary patients with this accessible guide
Drug Compounding for Veterinary Professionals provides an accessible, easy-to-use guide to all aspects of prescribing individualized mixtures of medications in veterinary practice. Its emphasis on practical knowledge and its discussion of both in-house and external options make it a comprehensive introduction to using compounded medications in animals. It guides practitioners through every step of the process, from formulating a compound to working with outside pharmacists.
The book presents guidance on how to get more information on current regulations, consider the risks and benefits, develop formulations, and more. Drug Compounding for Veterinary Professionals readers will also find:
• Figures and line drawings illustrating effective compounding techniques and concepts
• An emphasis on practical knowledge for clinical use
• Answers to frequently asked questions about drug compounding

Drug Compounding for Veterinary Professionals is essential for any veterinary practitioner, veterinary pharmacologist, or student looking to understand this crucial component of patient care.