The Art and Science of Pharmaceutical Compounding
- Historical context: Compounding is pharmacy’s roots, All medications were compounded before mass manufacturing, Resurgence due to patient-specific needs
- Modern compounding: Combines traditional techniques with advanced technology, Requires specialized training, Regulated by state and federal standards, Fills gap left by commercial manufacturing
- When compounding is needed: Discontinued medications, Custom dosages, Allergy-friendly formulations, Combination medications, Alternative delivery methods, Pediatric or veterinary needs
- Difference from manufacturing: Individual patient prescriptions, Small batch or single-dose preparation, Customization for specific needs, Not for resale or distribution
1. Receiving and Verifying the Prescription
- Prescription review: Verify prescriber information and DEA number, Check patient information, Review medication, strength, quantity, Review directions and intended use, Identify any concerns or questions
- Consultation with prescriber if needed: Clarify unclear instructions, Discuss formulation options, Confirm intended use, Address any safety concerns
- Patient consultation: Discuss allergies and sensitivities, Review previous medication experiences, Explain compounding process, Set expectations for timeline, Discuss cost and insurance
- Documentation: Enter into pharmacy system, Create compounding record, Document all communications, Maintain compliance with regulations
2. Sourcing Pharmaceutical-Grade Ingredients
- Active pharmaceutical ingredients (APIs): Must be pharmaceutical-grade (USP/NF), Sourced from FDA-registered suppliers, Certificate of analysis required, Lot numbers tracked, Proper storage conditions
- Inactive ingredients (excipients): Bases and vehicles, Fillers and binders, Flavoring agents, Preservatives, Coloring agents (when appropriate)
- Supplier verification: FDA-registered facilities, Good manufacturing practices (GMP), Reliable supply chain, Quality documentation, Regular audits
- Ingredient receiving and testing: Visual inspection, Verify against order, Check certificates of analysis, Proper labeling, Appropriate storage, Expiration date tracking
- Inventory management: Proper storage conditions (temperature, humidity, light), Organized system, First-in, first-out rotation, Regular inventory audits, Expiration date monitoring
3. Calculations and Formulation
- Dose calculations: Convert prescriber’s order to workable formula, Calculate amount of each ingredient, Account for potency and purity, Double-check all calculations, Use of calculation software when appropriate
- Formulation development: Select appropriate base or vehicle, Determine best delivery method, Consider stability and compatibility, Account for patient preferences and needs, Reference formulation databases and literature
- Beyond-use dating: Based on ingredient stability, Consider preparation method, Account for storage conditions, Follow USP guidelines, Conservative when stability data limited
- Documentation: Master formulation record, Batch-specific calculations, Verification by second pharmacist, All calculations recorded, Maintained for regulatory compliance
4. Preparation and Compounding
- Preparation area setup: Clean and sanitize workspace, Gather all ingredients and equipment, Verify everything against formula, Don appropriate protective equipment, Follow standard operating procedures
- Non-sterile compounding process: Weighing and measuring (using calibrated equipment, Proper technique, Double-check measurements), Mixing and blending (Geometric dilution for potent drugs, Proper mixing technique, Appropriate equipment), Filling and finishing (Transfer to final container, Proper technique to avoid contamination, Accurate filling)
- Sterile compounding process (for injections): Performed in cleanroom, Aseptic technique, Laminar flow hood, Proper garbing, Environmental monitoring, More stringent procedures
- Quality checks during compounding: Verify each step, Check appearance and consistency, Ensure proper mixing, Confirm measurements, Document any deviations
- Common dosage forms: Capsules (powder-filled, Various sizes, Custom strengths), Creams and ointments (Topical application, Custom bases, Specific concentrations), Solutions and suspensions (Liquid medications, Custom flavoring, Specific concentrations), Troches and lozenges (Dissolve in mouth, Custom flavors, Specific strengths), Suppositories (Rectal or vaginal, Custom bases, Specific strengths)
5. Quality Control and Testing
- Visual inspection: Appearance, Color, Consistency, Homogeneity, Container integrity
- Weight/volume verification: Confirm correct amount, Check against target, Document results
- pH testing (when applicable): Ensures proper formulation, Affects stability and effectiveness
- Potency testing (when required): Verifies correct strength, High-risk or high-value compounds, Sent to analytical lab
- Sterility testing (for sterile compounds): Required for certain preparations, Ensures no microbial contamination
- Documentation: All quality control results recorded, Deviations investigated, Batch records maintained, Regulatory compliance
6. Labeling and Packaging
- Label requirements: Patient name and information, Medication name and strength, Directions for use, Quantity, Beyond-use date, Prescriber information, Pharmacy information, Auxiliary labels (warnings, storage)
- Packaging considerations: Appropriate container type, Light protection if needed, Child-resistant when required, Tamper-evident, Proper closure
- Patient information: Medication guide, Directions for use, Storage instructions, Potential side effects, Contact information
7. Patient Counseling and Delivery
- Pharmacist counseling: How to use medication, Storage requirements, Expected effects, Potential side effects, When to contact provider, Answer questions
- Delivery options: In-person pickup, Local delivery, Shipping (temperature-controlled if needed, Appropriate packaging, Tracking provided)
- Follow-up: Check on patient response, Address any concerns, Refill reminders, Ongoing support
Equipment and Technology
- Weighing and measuring: Analytical balances (accurate to 0.001g), Graduated cylinders, Volumetric flasks
- Mixing equipment: Mortars and pestles, Ointment slabs, Magnetic stirrers, Homogenizers, Ultrasonic mixers
- Specialized equipment: Capsule filling machines, Suppository molds, Ointment mills, pH meters, Hot plates
- Sterile compounding equipment: Laminar flow hoods, Biological safety cabinets, Autoclave, Sterile supplies
- Technology: Compounding software, Electronic records, Inventory management, Quality control systems
Quality Standards and Regulations
- USP standards: USP 795 (non-sterile compounding), USP 797 (sterile compounding), USP 800 (hazardous drugs)
- State board regulations: Licensing requirements, Inspection programs, Specific state requirements
- FDA oversight: Facility registration, Compliance with DQSA, Inspection authority
- Accreditation: PCAB (Pharmacy Compounding Accreditation Board), LegitScript certification, Voluntary quality standards
- Documentation requirements: Master formulation records, Compounding logs, Ingredient records, Quality control results, Adverse event reports
Advanced Scripts’ Compounding Process
- State-of-the-art facility, LegitScript certified, Experienced compounding pharmacists, Pharmaceutical-grade ingredients only, Rigorous quality control, Comprehensive documentation, Sterile compounding capabilities, Wide range of dosage forms
- Specialties: Hormone replacement therapy, Weight loss medications, Pain management, Peptides and injectables, Veterinary compounding, Pediatric formulations
- Quality commitment: Every medication individually prepared, Double-checked by pharmacists, Quality control testing, Proper storage and handling, Next-day delivery in Florida
- Patient support: Expert pharmacist consultations, Detailed instructions provided, Ongoing support, Refill reminders, Answer questions anytime
Frequently asked questions
About the Author: Prepared by Advanced Scripts Pharmacy pharmaceutical experts.
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