Drug Compounding for Veterinary Professionals

The authors Lauren R. Eichstadt Forsythe, PharmD, DICVP, is a Clinical Assistant Professor and the Pharmacy Service Head at the University of Illinois Veterinary Teaching Hospital in Urbana, Illinois, USA. Alexandria E. Gochenauer, PharmD, DICVP, is a clinical staff pharmacist at the University of Illinois Veterinary Teaching Hospital in Urbana, Illinois, USA.

• Foreword xiPreface xiiiList of Acronyms xivAbout the Companion Website xviIntroduction xvii1 Compounding Regulations 1Organizations and Regulatory Agencies Involved with Compounding 3Food and Drug Administration 3United States Pharmacopeia 3Drug Enforcement Administration 5State Boards of Pharmacy 6State Veterinary Boards 6Compliance Policy Guides and Guidance for Industry Documents 6What Is Compounding? 7The Food, Drug, and Cosmetic Act 9Animal Medicinal Drug Use Clarification Act 9Preparing Compounds from an Approved Product or a Pure Drug Powder 10Federal Versus State Law 11Office Use Compounding 12Drug Quality and Security Act 13Finding Additional Information 132 Risk–Benefit Analysis of Compounded Medications 17Benefits of Compounded Products 17Dosage Form 17Flavoring 20Dosage Strength 20Eliminating Ingredients 21Availability Issues 22Appropriate Use of Compounded Medications 22FDA-Approved Drugs 23Compounded Medication Risks 25Compounded (USP) Versus Manufactured (cGMP) 26Risks Associated with Compounded Medications – A Look at the Literature 28Studies Showing Incorrect Potency 28Studies Showing Lack of Stability 31Studies Showing Lack of Efficacy 31Risks Associated with Specific Types of Compounds 32Active Ingredient Source Decisions 34Patient-Specific Compounding Versus Office Use Compounding 35Adverse Event Reporting 36Identifying Potential Formulation Issues 37Drug Recalls 38Selecting a Compounding Pharmacy 39Client Education 40Reducing Risk in Practice 40Conclusion 413 Beyond-Use Dating 45Factors Considered When Assigning BUDs and Expiration Dates 45USP Default BUDs 48Stability Studies 49Evaluating Stability Studies 50Determining BUDs for In-House Formulations 51BUD Considerations When Prescribing Compounded Medications 52Conclusion 534 Identifying High-Quality Compounding Pharmacies 55Case Study 1 55Case Study 2 58What to Evaluate 59General Practices 59Staff Skill Level 61Familiarity with Veterinary Medicine 61Pharmacy Culture 61Ways to Evaluate Compounding Pharmacies 62Looking Beyond the Pharmacy’s Website 63What to Look for on a Tour 65Questions to Ask the Pharmacist in Charge 65Conclusion 675 Formulation Development 69Dosage Forms 69Oral Administration 69Oral Solutions 69Oral Suspensions 70Oral Syrups 70Oral Capsules 71Oral Tablets 72Oral Treats 73Oral Emulsions 73Oral Pastes 74Oral Powders 74Transdermal Administration 74Topical Administration 75Topical Solutions 75Topical Ointments 76Topical Shampoos 76Topical Mousses 76Topical Emulsions 76Topical Creams 77Topical Gels 77Otic Administration 77Otic Solutions 77Otic Suspensions 77Otic Ointments 78Other Routes of Administration 78Rectal Solutions 78Intranasal Solutions 78Injectable Preparations 78Ophthalmic Preparations 79Ingredients 79Ingredient Selection 79Solubility 81Partition Coefficient 82Density 83Water Activity 83pH 83Chelators 84Antioxidants 84Preservatives 84Flavors, Coating Agents, and Sweeteners 85Coloring Agents 87Salt Forms 87Organic Salts 88Inorganic Salts 88Common Excipients by Dosage Form 89Oral Liquid Medications 89Oral Solid Medications 89Emulsions 91Transdermal Medications 91Cream, Gel, and Ointment Medications 91Hazardous Drugs 92Beyond-Use Dates 92Formulation Resources 93Calculations 93Measurements Used in Compounding 96Displacement Factor 96Capsules: Packing Statistics 98Packing Statistic of Drug 98Average Weight of Ingredients 98Percentage of Drug per Capsule Using Bulk Powder 98Percentage of Drug per Capsule Using Manufactured Tablets 99Percentage/Amount of Filler per Capsule 101Conversion to Grams 101Compounding Formulations to Avoid 102Formulation Development Process 103Developing a Compounding Formula: Example 1 (USP Compounding Compendium) 104Developing a Compounding Formula: Example 2 (Stability-Indicating Assay) 106Compounding Formulation Assessment 1086 Compounding in House 111Documentation 111Master Formulation Record 111Compounding Record 111Formulation Record Components 112Quality Assurance and Quality Control 116Labeling 118Packaging and Storage 119Compounding Techniques 120Trituration 120Sifting 121Geometric Dilution 121Wetting 121Colored Tracers 122Equipment 122Mortars and Pestles 124Glassware 125Containers 125Scales 127Spatulas and Measuring Devices 129Equipment Cleaning 129Training 130Formulation Instructions 132Species-Specific Information 135Flavoring 135Toxicities 136Potency Designations 138Feasibility for a Veterinary Clinic 139Index 141