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27 Inventory Management

Efficient inventory management is a component of safe and compliant non-sterile compounding. It ensures that only high-quality ingredients are used, supports traceability, minimizes waste, and protects both human health and the environment. Proper handling of materials—beginning from receipt and storage through to disposal—must follow established protocols that align with NAPRA standards, provincial regulations, and environmental laws. By implementing robust inventory systems and clear documentation practices, pharmacies can ensure the integrity of compounded preparations while also fostering accountability and sustainability.

1. Receiving and Storing Ingredients

  • All materials must be checked upon receipt for:
    • Integrity of packaging
    • Expiry date and batch/lot numbers
    • Certificate of Analysis (CoA) for ingredients without an approved monograph
  • Store raw materials and components:
    • In designated, clean, and organized areas
    • Under conditions specified by the manufacturer (e.g., temperature, light protection)
    • With hazardous ingredients stored in accordance with safety protocols (separate, labeled, and secure)
  • Documentation:
    • All receipts and storage conditions must be logged and traceable.

2. Inventory Control

  • Maintain a real-time inventory system that tracks:
    • Quantity on hand
    • Expiry dates
    • Lot/batch numbers
    • First-expiry-first-out (FEFO) principles
  • Schedule regular inventory audits and stock rotation to reduce waste and avoid the use of expired materials.
  • Assign beyond-use dates (BUDs) for compounded products based on NAPRA’s risk assessment and stability guidelines.

 

3. Disposal of Materials

Quarantine and Recall Procedures – Pharmacies must have procedures in place to quarantine suspect materials and manage product recalls.

  • When to Quarantine Materials:

    • Product recall notifications

    • Damaged packaging or contaminated containers

    • Expired or mislabeled stock

    • Any product suspected of degradation or error

  • Recall Management:

    • Follow provincial and national guidance for recalls (e.g., Health Canada).

    • Notify patients, prescribers, and healthcare professionals if a dispensed product is affected.

    • Track down and remove all affected lots from inventory and patient supply.

    • Document all communication, investigation outcomes, and follow-up actions

Disposal Protocols:

 

Type of Waste Disposal Guidelines
Non-hazardous expired chemicals Return to supplier (if allowed), or dispose through municipal hazardous waste services
Hazardous chemicals or products Use licensed hazardous waste disposal companies in compliance with environmental laws
PPE and contaminated items Bag as hazardous waste (double-bag if necessary), label, and dispose via authorized routes
Sharps or glass Dispose in puncture-resistant, labeled containers following biomedical waste regulations

 

⚠️ Never dispose of chemicals down the drain unless permitted by local authority and clearly stated on SDS.

4. Environmental Considerations

NAPRA encourages pharmacies to minimize environmental harm while maintaining safety and compliance.

Best Practices:

  • Reduce waste by ordering only quantities needed for anticipated compounding.
  • Implement green purchasing practices (e.g., selecting suppliers with sustainable packaging).
  • Avoid overstocking and monitor expiry dates closely.
  • Recycle packaging materials when clean and permitted.
  • Ensure ventilation systems for hazardous compounding (e.g., C-PECs and C-SECs) are maintained to prevent environmental contamination.

♻️ Pharmacies should align with provincial and federal environmental regulations, such as CEPA (Canadian Environmental Protection Act).

 

5. Documentation & Standard Operating Procedures

Inventory management procedures must be supported by:

  • Standard Operating Procedures (SOPs) for ordering, receiving, storage, labeling, and disposal
  • Inventory records that are up to date and auditable
  • Training records for staff involved in inventory and waste handling

 

6. Spill Management Protocols

A clearly documented protocol ensures staff safety, protects the environment, and reduces risk of cross-contamination.

  • Every inventory area storing hazardous materials must have:

    • A readily accessible spill kit (appropriate for the type and volume of hazardous products stored)

    • A posted spill response procedure

    • Personnel trained in spill containment and clean-up procedure

  • Spill kits must be inspected and restocked regularly and should be replaced immediately after any use.

Sample Spill Management Protocol:

Step Action
1. Alert and Evacuate (if needed) Notify personnel in the area. Evacuate if spill involves volatile, inhalable substances.
2. Don PPE Wear appropriate PPE: double gloves (chemo-rated for HDs), gown, eye/face protection, and respirator (if risk of aerosol).
3. Contain the Spill Use absorbent pads or spill containment materials to limit spread. Do not use sweeping motions for powders—dampen first.
4. Clean Up Safely Follow spill kit instructions. Clean with a deactivating, decontaminating, then cleaning and disinfecting step (for HDs).
5. Dispose of Materials Dispose of all cleanup materials (e.g., pads, PPE) as hazardous waste. Seal and label.
6. Document Incident Record details in a spill incident report, including product, location, time, volume, personnel involved, and corrective actions.
7. Review and Update Procedures Review SOPs and retrain staff if the spill revealed a gap in safety or storage procedures.

 

Summary Checklist for Inventory Management:

 

Task Required? Notes
Track ingredient lot numbers & expiry dates For traceability and recalls
Separate hazardous/non-hazardous storage To prevent cross-contamination
Log disposal of expired/contaminated materials Maintain a waste disposal log
Follow SDS for all disposal steps Especially for hazardous materials
Audit inventory regularly Helps manage cost and reduce waste
Maintain spill kits in inventory areas Kits must be appropriate for materials stored and checked regularly
Train staff on hazardous spill response Use SOPs and PPE; document any incidents
Quarantine suspect or recalled products Label and segregate until investigation is complete
Document recall investigations and actions Maintain a recall log and notify stakeholders as needed

 

Effective inventory management goes far beyond tracking stock levels. It safeguards the quality of compounded preparations, ensures regulatory compliance, and minimizes risk to patients, staff, and the environment. By following structured procedures for receiving, storing, using, and disposing of ingredients, pharmacy teams can promote operational efficiency and uphold best practices. Environmental responsibility and documentation requirements are equally essential, helping to reduce waste and maintain a clean and safe workspace. With routine audits, SOP adherence, and continuous staff training, inventory management becomes a powerful quality assurance tool within any compounding pharmacy.

License

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Pharmacy Non-Sterile Compounding in Canada Copyright © by Janet Hoda BSP, BSc is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, except where otherwise noted.