1 Compounding Regulations
Organizations and Regulatory Agencies Involved with Compounding
Food and Drug Administration
United States Pharmacopeia
Drug Enforcement Administration
State Boards of Pharmacy
State Veterinary Boards
Compliance Policy Guides and Guidance for Industry Documents
What Is Compounding?
The Food, Drug, and Cosmetic Act
Animal Medicinal Drug Use Clarification Act
Preparing Compounds from an Approved Product or a Pure Drug Powder
Federal Versus State Law
Office Use Compounding
Drug Quality and Security Act
Finding Additional Information
2 Risk–Benefit Analysis of Compounded Medications
Benefits of Compounded Products
Dosage Form
Flavoring
Dosage Strength
Eliminating Ingredients
Availability Issues
Appropriate Use of Compounded Medications
FDA-Approved Drugs
Compounded Medication Risks
Compounded (USP) Versus Manufactured (cGMP)
Risks Associated with Compounded Medications – A Look at the Literature
Studies Showing Incorrect Potency
Studies Showing Lack of Stability
Studies Showing Lack of Efficacy
Risks Associated with Specific Types of Compounds
Active Ingredient Source Decisions
Patient-Specific Compounding Versus Office Use Compounding
Adverse Event Reporting
Identifying Potential Formulation Issues
Drug Recalls
Selecting a Compounding Pharmacy
Client Education
Reducing Risk in Practice
Conclusion
3 Beyond-Use Dating
Factors Considered When Assigning BUDs and Expiration Dates
USP Default BUDs
Stability Studies
Evaluating Stability Studies
Determining BUDs for In-House Formulations
BUD Considerations When Prescribing Compounded Medications
Conclusion
4 Identifying High-Quality Compounding Pharmacies
Case Study 1
Case Study 2
What to Evaluate
General Practices
Staff Skill Level
Familiarity with Veterinary Medicine
Pharmacy Culture
Ways to Evaluate Compounding Pharmacies
Looking Beyond the Pharmacy’s Website
What to Look for on a Tour
Questions to Ask the Pharmacist in Charge
Conclusion
5 Formulation Development
Dosage Forms
Oral Administration
Oral Solutions
Oral Suspensions
Oral Syrups
Oral Capsules
Oral Tablets
Oral Treats
Oral Emulsions
Oral Pastes
Oral Powders
Transdermal Administration
Topical Administration
Topical Solutions
Topical Ointments
Topical Shampoos
Topical Mousses
Topical Emulsions
Topical Creams
Topical Gels
Otic Administration
Otic Solutions
Otic Suspensions
Otic Ointments
Other Routes of Administration
Rectal Solutions
Intranasal Solutions
Injectable Preparations
Ophthalmic Preparations
Ingredients
Ingredient Selection
Solubility
Partition Coefficient
Density
Water Activity
pH
Chelators
Antioxidants
Preservatives
Flavors, Coating Agents, and Sweeteners
Coloring Agents
Salt Forms
Organic Salts
Inorganic Salts
Common Excipients by Dosage Form
Oral Liquid Medications
Oral Solid Medications
Emulsions
Transdermal Medications
Cream, Gel, and Ointment Medications
Hazardous Drugs
Beyond-Use Dates
Formulation Resources
Calculations
Measurements Used in Compounding
Displacement Factor
Capsules: Packing Statistics
Packing Statistic of Drug
Average Weight of Ingredients
Percentage of Drug per Capsule Using Bulk Powder
Percentage of Drug per Capsule Using Manufactured Tablets
Percentage/Amount of Filler per Capsule
Conversion to Grams
Compounding Formulations to Avoid
Formulation Development Process
Developing a Compounding Formula: Example 1 (USP Compounding Compendium)
Developing a Compounding Formula: Example 2 (Stability-Indicating Assay)
Compounding Formulation Assessment
6 Compounding in House
Documentation
Master Formulation Record
Compounding Record
Formulation Record Components
Quality Assurance and Quality Control
Labeling
Packaging and Storage
Compounding Techniques
Trituration
Sifting
Geometric Dilution
Wetting
Colored Tracers
Equipment
Mortars and Pestles
Glassware
Containers
Scales
Spatulas and Measuring Devices
Equipment Cleaning
Training
Formulation Instructions
Species-Specific Information
Flavoring
Toxicities
Potency Designations
Feasibility for a Veterinary Clinic
Index
