The Salvadoran Technical Regulation RTS 11.02.04:24, officially published on December 18, 2024, provides comprehensive guidelines for the proper storage, distribution, dispensing, and transportation of pharmaceuticals for human use. These practices aim to maintain product quality, safety, and efficacy throughout their lifecycle.
Scope and Applicability
The regulation applies to all pharmaceutical establishments in El Salvador, whether public or private. This includes laboratories, pharmacies, distributors, and storage centers. The rules ensure compliance with established protocols to guarantee the quality and safety of regulated products.
Key Features
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Good Practices for Storage, Distribution, and Transportation (BPADyT):
- Establishments must implement quality management systems and maintain suitable environmental conditions (temperature and humidity) to preserve product integrity.
- Proper segregation of products, particularly for controlled substances and those requiring special storage conditions, is emphasized.
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Pharmaceutical Governance:
- A licensed pharmacist must oversee operations, ensuring compliance with legal and regulatory requirements. Their responsibilities include monitoring product recalls, managing customer complaints, and overseeing self-inspections.
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Documentation Requirements:
- Establishments must maintain detailed records, including product inventory, temperature logs, and complaint resolutions, for at least one year beyond a product's expiration.
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Facilities and Equipment:
- Storage areas must be clean, organized, and equipped with calibrated temperature and humidity monitoring devices.
- Refrigerated products require strict adherence to cold chain protocols, with backup energy systems to ensure uninterrupted storage conditions.
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Transport Guidelines:
- Vehicles must meet cleanliness and safety standards and maintain required conditions during transportation. Products should be protected from contamination and damage.
- Special attention is given to incidents during transport, such as temperature excursions or product losses.
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Addressing Counterfeits and Substandard Products:
- Any suspected counterfeit or substandard products must be segregated immediately, reported to the regulatory authority, and handled according to established procedures.
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Product Recalls and Returns:
- Establishments must have written procedures for handling product recalls, ensuring traceability and proper documentation throughout the process.
Transitional Period and Compliance
The regulation includes a four-year transitional period, during which establishments must gradually achieve full compliance. By the fourth year, they must meet 95–100% of the requirements based on inspections.
Significance of the Regulation
The publication of RTS 11.02.04:24 marks a pivotal step in El Salvador's commitment to aligning its pharmaceutical practices with international standards. This regulation represents a significant milestone in strengthening pharmaceutical governance and ensuring public health in El Salvador. For more details, you can find the Regulation (in Spanish) here.
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