SOP Guide for Pharma

SOP for Handling and Disposal of Expired Pharmaceuticals

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SOP for Handling and Disposal of Expired Pharmaceuticals

Standard Operating Procedure for Handling and Disposal of Expired Pharmaceuticals

1) Purpose

The purpose of this SOP is to provide systematic guidelines for the safe handling, segregation, and disposal of expired pharmaceuticals to prevent misuse, ensure regulatory compliance, and minimize environmental impact.

2) Scope

This SOP applies to all personnel in healthcare facilities, pharmacies, warehouses, laboratories, and manufacturing units involved in the handling, storage, and disposal of expired pharmaceutical products.

3) Responsibilities

  • Supervisors: Ensure expired pharmaceuticals are identified, handled, and disposed of properly as per this SOP.
  • Pharmacy/Store Staff: Segregate expired pharmaceuticals and maintain accurate records.
  • Waste Management Personnel: Collect, store, and arrange disposal through authorized vendors.
  • Safety Officers: Monitor compliance, conduct periodic inspections, and report any deviations.

4) Procedure

4.1 Identification and Segregation of Expired Pharmaceuticals

  1. Identification:
    1. Inspect pharmaceutical inventory periodically (monthly or quarterly) to identify expired products.
    2. Clearly label all expired products with:
      • “EXPIRED – DO NOT USE”
      • Date of expiration
      • Batch/lot number

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  2. Segregation:
    • Separate expired pharmaceuticals from active stock immediately to prevent accidental use.
    • Segregate products into the following categories:
      • Non-Hazardous Expired Pharmaceuticals: Over-the-counter medications, vitamins, etc.
      • Hazardous Expired Pharmaceuticals: Controlled substances, cytotoxic/cytostatic drugs, and heavy-metal-containing products.
  3. Storage of Segregated Expired Pharmaceuticals:
    • Store expired pharmaceuticals in a designated and secure area with restricted access.
    • Use color-coded containers:
      • Yellow bins: Hazardous and
cytotoxic drugs
  • Black bins: Non-hazardous expired pharmaceuticals
  • White bins: Expired sharps and contaminated items
  • Label containers clearly and ensure they are leak-proof, sealed, and tamper-proof.

    • 4.2 Documentation of Expired Pharmaceuticals

    1. Maintain a record of all expired pharmaceuticals, including:
      • Product name
      • Batch/lot number
      • Quantity
      • Expiry date
      • Category (hazardous or non-hazardous)
      • Storage location

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    2. Use the Expired Pharmaceuticals Log (Annexure 1) for accurate record-keeping and audit purposes.

    4.3 Handling and Transport of Expired Pharmaceuticals

    1. Handling Precautions:
      • Wear appropriate PPE (gloves, masks, goggles, and protective aprons) while handling expired pharmaceuticals.
      • Ensure containers are sealed properly to prevent leaks during handling and transport.

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    2. Internal Transport:
      • Transport containers to the designated storage area using trolleys or carts.
      • Disinfect trolleys and transport equipment after each use.
    3. External Transport:
      • Arrange collection and disposal through licensed pharmaceutical waste disposal vendors.
      • Ensure all transport manifests include details of the expired pharmaceuticals being transported.

    4.4 Disposal of Expired Pharmaceuticals

    Disposal of expired pharmaceuticals must be performed according to their classification and in compliance with local and international guidelines:

    1. Non-Hazardous Expired Pharmaceuticals:
      • Send for incineration in an approved facility or secure landfilling as per local regulations.
      • Ensure disposal records are maintained for audit purposes.

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    2. Hazardous Expired Pharmaceuticals:
      • Dispose of cytotoxic, cytostatic, and controlled drugs through high-temperature incineration.
      • Coordinate with licensed hazardous waste disposal vendors for safe destruction.
      • Document the disposal with waste manifests and vendor certificates.
    3. Controlled Substances:
      • Ensure destruction of controlled substances is witnessed and documented as per regulatory guidelines.
      • Obtain approval from relevant authorities where required.

    4.5 Record-Keeping and Reporting

    1. Maintain records for all expired pharmaceutical disposal activities, including:
      • Waste category
      • Quantity and disposal date
      • Method of disposal
      • Vendor details and waste manifests

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    2. Ensure records are retained for a minimum of five years for compliance and audits.

    4.6 Training and Awareness

    1. Train all staff involved in handling expired pharmaceuticals on:
      • Identification and segregation of expired products
      • Proper storage and handling procedures
      • Safety precautions and PPE requirements
    2. Conduct annual refresher training and document participation records.

    5) Abbreviations, if any

    • PPE: Personal Protective Equipment
    • SDS: Safety Data Sheet

    6) Documents, if any

    • Expired Pharmaceuticals Log
    • Disposal Manifest

    7) Reference, if any

    • WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals
    • EPA Resource Conservation and Recovery Act (RCRA)
    • Pharmacy Waste Management Rules (Local Regulatory Authority)

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Expired Pharmaceuticals Log
    Date Product Name Batch/Lot Number Expiry Date Category Quantity Disposed By
    DD/MM/YYYY Drug A 123456 MM/YYYY Hazardous 10 Boxes John Doe
    See also  SOP for Segregation of Incompatible Hazardous Chemicals
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