Compounding Procedures

Overview

Compounding is the process of preparing customized medications that are not commercially available, tailored to meet a patient’s individual needs. Within the Compounding Pharmacy Management System (PMS), compounding is tightly integrated with prescription data, inventory controls, and regulatory compliance to ensure accuracy, safety, and traceability.

1. Preparation & Formula Selection

System Features:

  • Formula database with pre-approved recipes, instructions, and beyond-use dates (BUDs)

  • Compatibility checks for dosage form (e.g., cream, capsule, suspension)

  • Links to required safety documents (SDS, USP guidelines)

User Actions:

  • Select the formula from the system or enter a new compound if approved by pharmacy leadership

  • Verify availability of active ingredients, excipients, and containers

  • Review any patient-specific modifications (flavoring, dosage adjustments, allergen avoidance)

2. Ingredient Verification

System Features:

  • Barcode scanning for lot numbers and expiration dates

  • Real-time inventory decrement when ingredients are assigned

  • Alerts if ingredient is expired, recalled, or insufficient

User Actions:

  • Match ingredient containers against PMS worksheet

  • Log initials and timestamp for chain-of-custody tracking

3. Compounding Execution

Technician Workflow:

  • Follow PMS-generated worksheet step by step

  • Record actual weights/volumes of each ingredient

  • Document equipment used (mortar, ointment mill, balance, capsule machine)

  • Capture environmental conditions when applicable (e.g., sterile cleanroom logs)

System Features:

  • Integration with scales for direct weight recording

  • Built-in calculations for scaling formulas (single vs. batch prep)

  • On-screen prompts for mixing order and techniques (levigation, trituration, geometric dilution, etc.)

4. Quality Control & Verification

Pharmacist Responsibilities:

  • Compare finished product to expected characteristics (appearance, consistency, volume)

  • Cross-check against PMS worksheet for ingredient accuracy and process compliance

  • Approve or reject compound before dispensing

System Features:

  • Digital QA checklist (ingredient verification, physical inspection, stability review)

  • Electronic sign-off with audit trail

  • Automatic lockout of dispensing until QA approval is complete

5. Documentation & Compliance

System Integration:

  • Automatically logs compounding event to prescription record

  • Tracks ingredient lots, expiration dates, and technician involvement for full traceability

  • Generates batch records for USP <795>, <797>, and <800> compliance

  • Supports recall management through backward ingredient traceability

6. Dispensing Readiness

System Actions:

  • Generates patient-specific labels (with auxiliary warnings, storage instructions)

  • Produces compounding log entry for regulatory reporting

  • Triggers inventory re-order thresholds if ingredients fall below par levels

Best Practices

  • Always perform double verification for active pharmaceutical ingredients (APIs)

  • Document exact measurements and avoid relying on approximations

  • Maintain separation of duties (technician compounds, pharmacist verifies)

  • Follow USP standards and state-specific compounding regulations at all times