Proper storage of veterinary medicines is not just a regulatory requirement but a crucial aspect of animal healthcare that ensures the safety and effectiveness of treatments. In regions like Riyadh, where extreme temperatures and environmental factors can easily compromise the integrity of pharmaceutical products, adhering to best practices for storage is essential. 

The Saudi Food and Drug Authority (SFDA) has established stringent guidelines to govern the storage, handling, and distribution of veterinary medicines. These guidelines aim to prevent contamination, preserve the efficacy of medications, and ultimately safeguard the health of animals and humans alike. This article delves into the SFDA’s regulations and offers insights into how veterinary professionals and facilities can optimize their storage practices to meet these standards.

SFDA Regulations on the Proper Storage of Veterinary Medicines

The Saudi Food and Drug Authority (SFDA) has implemented rigorous guidelines under the Veterinary Products Act and Regulations to ensure the proper storage of veterinary medicines within the Kingdom of Saudi Arabia. These guidelines are designed to maintain veterinary products’ quality, efficacy, and safety throughout their lifecycle, from manufacturing to distribution.

1. Good Storage Practices (GSP)

Good Storage Practices (GSP) are a set of quality assurance measures that ensure veterinary products are stored under conditions that maintain their safety, efficacy, and quality. The SFDA mandates that these practices be strictly followed in all facilities handling veterinary medicines.

Products must be stored at temperatures specified by the manufacturer, typically between 2°C and 8°C for heat-sensitive medicines like vaccines and antibiotics. Warehouses must be equipped with appropriate refrigeration systems and temperature monitoring devices, including alarms for deviations.

Medicines sensitive to light must be stored in light-resistant containers or areas that prevent exposure to light. This is critical for products like certain injectable antibiotics, which can degrade under light exposure.

The storage area must be dry and well-ventilated to prevent moisture buildup, which can compromise the integrity of medicines. Warehouses should have dehumidifiers or ventilation systems to maintain optimal humidity levels and provide the proper storage of veterinary medicines.

2. Good Distribution Practices (GDP)

• Logistics and Handling: The SFDA outlines specific requirements for the transportation and distribution of veterinary medicines to ensure they remain within the specified temperature and humidity ranges. This includes the use of insulated containers, regular monitoring during transport, and immediate action in case of temperature excursions.
• Traceability and Documentation: Each batch of veterinary medicines must be traceable through detailed records from the point of manufacture to the end user. This includes maintaining logs of temperature conditions during storage and transport, as well as the personnel responsible for handling the products.

3. Warehouse Licensing and Requirements

• Licensing: Facilities involved in properly storing veterinary medicines must obtain a license from the SFDA. The licensing process includes an inspection to ensure the facility complies with GSP and GDP requirements.
• Facility Specifications: The SFDA specifies that storage facilities should be constructed from non-combustible materials, have floors elevated above ground level, and be equipped with reinforced roofing to protect against environmental hazards.
• Special Storage Areas: Hazardous materials, including veterinary pesticides, must be stored separately from other products. Additionally, narcotic substances require secure storage in airtight cupboards or separate rooms with controlled access.

4. Inventory and Expiry Management

• Inventory Control: Veterinary medicines must be inventoried regularly to ensure that expired or near-expiry products are used or disposed of according to SFDA regulations. This prevents the use of ineffective or potentially harmful products.
• Disposal of Expired Products: Expired or spoiled veterinary products must be disposed of through companies specializing in medical waste disposal, by scientific principles and SFDA guidelines.

5. Compliance and Inspections

• Regular Inspections: The SFDA conducts periodic inspections to ensure that all licensed warehouses and facilities adhere to GSP and GDP standards. Non-compliance can result in penalties, including the revocation of licenses.
• Monitoring and Reporting: Facilities must report any incidents affecting the safety or quality of stored products, such as temperature excursions or contamination, to the SFDA immediately.

SFDA Guidelines on The Proper Storage of Veterinary Medicines

The Veterinary Products Act and Regulations by the SFDA cover several key areas relevant to the proper storage of veterinary medicines, handling, and regulation of veterinary medicines. Beyond Good Storage Practices (GSP) and Good Distribution Practices (GDP), additional regulations ensure that veterinary products meet stringent quality and safety standards throughout their lifecycle.

1. Licensing and Registration of Veterinary Products and Facilities

• Manufacturer and Warehouse Licensing: Veterinary product manufacturers and warehouses must obtain a license from the SFDA, valid for five years. The licensing process includes thorough inspections to verify compliance with GSP and GDP standards. The warehouse must be properly equipped for the proper storage of veterinary medicines, including hazardous materials, and must have facilities like specialized refrigerators with temperature monitoring systems​.
• Registration Requirements: Veterinary products must be registered with the SFDA before they can be marketed or distributed. The registration process involves submitting detailed documentation, including proof of compliance with Current Good Manufacturing Practices (cGMP), product specifications, and safety assessments. Any changes in the product, such as a change in formulation or packaging, must be approved by the SFDA.

2. Handling of Hazardous and Narcotic Substances

• Special Provisions for Hazardous Materials: Veterinary pesticides and other hazardous materials must be stored separately from other veterinary products in a well-ventilated, secure area. This reduces the risk of contamination or accidental exposure, ensuring the safety of both the products and the personnel handling them.
• Narcotic Substances: Products containing narcotic substances must be stored in an airtight cupboard or a separate room with controlled access. The responsible personnel must be a licensed pharmacist or a qualified veterinary technician, ensuring that these substances are handled with the highest level of security and accountability.

3. Monitoring and Pharmacovigilance

• Side Effect Reporting: The SFDA requires that manufacturers and distributors of veterinary products have a system in place for monitoring and reporting adverse effects. This includes appointing a Qualified Person Responsible for Pharmacovigilance (QPPV) who is tasked with collecting and analyzing reports of side effects from veterinarians, farmers, and other users​.
• Periodic Safety Update Reports (PSUR): For the first two years after a product is registered, manufacturers must submit PSURs every six months, followed by annual reports for the next three years. These reports help the SFDA monitor the ongoing safety and efficacy of the veterinary products.

4. Inspection and Compliance

• Regular Inspections: The SFDA conducts regular inspections of manufacturing and storage facilities to ensure ongoing compliance with the required standards for the proper storage of veterinary medicines. Facilities that fail to meet these standards may face penalties, including the suspension or revocation of licenses. Inspectors have the authority to seize products or documents if they suspect a violation of the regulations.
• Quality Assurance: The SFDA mandates that all veterinary products undergo rigorous quality assurance processes, including stability testing, to confirm that they maintain their integrity under specified storage conditions. This helps to prevent the distribution of substandard or counterfeit products.

5. Disposal of Expired or Spoiled Veterinary Products

Expired, spoiled, or otherwise unfit veterinary products must be disposed of according to SFDA guidelines. Disposal must be carried out by a specialized company that handles medical waste, ensuring that these products do not pose a risk to public health or the environment.

Best Practices for the Proper Storage of Veterinary Medicines

Proper storage of veterinary medicines is essential to prevent contamination and maintain the effectiveness of treatments, ultimately protecting both animal and human health. Medicines should be stored in clean, dry, and frost-free environments, such as a farm office or utility room, to avoid exposure to harmful elements like temperature fluctuations, sunlight, dust, and moisture.

For instance, medicines like teat dips containing chlorhexidine can become irritating if they freeze and thaw, while vaccines with modified live organisms can lose their efficacy if not kept at appropriate temperatures. Heat-sensitive antibiotics should be stored between 2°C and 8°C in a refrigerator, while other medicines may require storage in cooler, non-refrigerated areas below 15°C.

Light-sensitive medications, such as injectable tetracyclines, need to be stored in light-resistant containers to prevent decomposition. Additionally, different types of veterinary medicines such as antibiotics, vaccines, and deformers should be stored on separate, clearly labeled shelves to avoid mix-ups. Secure storage is crucial to prevent unauthorized access, especially by children.

Effective inventory management involves purchasing only the necessary quantities of drugs, regularly checking expiration dates, and disposing of expired medicines properly to avoid risks. Safe disposal practices are equally important to prevent accidental exposure to hazardous chemicals, ensuring that unused or expired products are disposed of securely and according to local regulations.

By following these guidelines, veterinary professionals can ensure the proper storage of veterinary medicines, maintaining their efficacy and safety.

In Conclusion

Proper storage of veterinary medicines is crucial for maintaining their effectiveness and ensuring safety in animal care. By following SFDA regulations and best practices, veterinary professionals can help protect the integrity of these medicines and support overall animal health. Regularly reviewing and optimizing storage practices in line with SFDA standards is essential for achieving these goals.