22 Maintaining Quality and Safety of the Compounded Preparation

To ensure the quality and safety of compounded non-sterile preparations, pharmacies must adhere to a structured framework outlined in NAPRA’s Model Standards and Guidance Document. Many of these things have already been discussed in more detail.

1. Risk Assessment and Mitigation

• Conduct a risk assessment for every preparation to evaluate:
  • Product risks: Contamination (microbial, chemical, physical), stability, and formulation complexity.
  • Personnel risks: Exposure to hazardous ingredients (e.g., cytotoxic drugs, allergens).
• Assign a risk level (A, B, or C) using NAPRA’s decision algorithm, which dictates facility, equipment, and procedural requirements.
• Document mitigation strategies, such as engineering controls (e.g., ventilation), PPE, and workflow adjustments.

2. Personnel Competency and Training

• Initial and ongoing training: Ensure all compounding personnel complete training on SOPs, equipment use, and safety protocols.
• Competency assessments: Validate skills annually or when procedures change (e.g., capsule filling, hazardous drug handling).
• Designate a compounding supervisor (pharmacist or qualified technician) to oversee compliance and training.

3. Facility and Environmental Controls

• Level-specific requirements:
  • Level A: Designated clean area, separate from high-traffic zones.
  • Level B: Enclosed room with smooth, cleanable surfaces; potential ventilation upgrades.
  • Level C: Negative-pressure room with containment devices (e.g., ventilated hoods) for hazardous drugs.
• Cleaning and maintenance:
  • Daily cleaning logs for surfaces and equipment.
  • Regular calibration of balances, pH meters, and other tools.

4. Documentation and Formulation Integrity

• Master Formulation Records (MFRs):
  • Include evidence-based recipes, stability data, BUD rationale, and safety precautions
  • Update MFRs when formulations or procedures change
• Compounding records:
  • Document each batch, including ingredient verification, weights, and personnel involved
• Environmental and equipment monitoring
• Corrective actions taken for deviations or quality issues

5. Ingredient Verification and Handling

• Verify ingredients:
  • Check identity, purity, and expiry dates before use.
• Hazardous ingredients:
  • Use Safety Data Sheets (SDS), NIOSH lists, and WHMIS classifications to determine handling requirements (e.g., PPE, containment).

6. In-Process and Final Product Checks

• In-process verification:
  • Double-check calculations and measurements.
  • Use calibrated equipment for weighing and mixing.
• Final product inspection:
  • Physical checks for uniformity, color, and absence of contaminants.
  • Label accuracy (active ingredients, BUD, storage conditions).

7. Stability and Beyond-Use Dating (BUD)

• Assign BUDs using:
  • Published stability data (preferred).
  • Default NAPRA timelines (e.g., 30 days for water-containing topical preparations).
• Never exceed the shortest expiry date of any ingredient.

8. Environmental Monitoring and Cleaning

• Routine surface testing:
  • Swab compounding areas to detect microbial contamination.
• Waste disposal:
  • Segregate hazardous waste (e.g., cytotoxic residues) and use leak-proof containers.

9. Incident Management and Continuous Improvement

• Report deviations: Document errors, contamination events, or equipment failures.
• Corrective actions: Investigate root causes and update SOPs to prevent recurrence .
• QA audits:
  • Conduct regular audits using checklists to assess compliance with NAPRA standards

10. Transportation Considerations

If a compounded preparation is to be delivered or transported:

• Package securely to prevent leakage, breakage, or exposure to adverse conditions
• Use temperature-control measures when necessary (e.g., cold packs, insulated containers)
• Label outer packaging clearly with any necessary handling or storage instructions
• A tracking system should be in place to monitor delivery timelines and ensure timely receipt by the patient or caregiver.

11. Patient Understanding and Compliance

• The pharmacist must ensure the patient knows how to use and store the medication properly
• Counselling must occur for every new prescription to go over things like how to use, store and dispose the compounded preparation.

12.Batch Recall Procedures

• Lot numbers should be documented and have a system for product recalls
• Patients need to be contacted if a compounded batch is found to be compromised.

13. Standard Operating Procedures (SOPs)

• There must be SOPs or all critical steps in the compounding process

14. Label Template Standardization

• Using standardized labeling templates (with required warnings, BUD, storage instructions) help reduce errors and meet compliance requirements

Ensuring the safety and quality of non-sterile compounded preparations requires more than just adherence to technical protocols—it requires a culture of accountability, precision, and continuous improvement. This chapter has highlighted the essential systems that support safe compounding: risk assessment, training, environmental control, documentation, verification, and patient counselling.  Ultimately, quality and safety are not the responsibility of a single individual but the collective responsibility of the entire compounding team. By maintaining well-documented processes, proactively managing risks, and continuously evaluating outcomes through quality assurance measures, pharmacies can confidently deliver safe, effective, and personalized therapies to patients.