NOM-059-SSA1: Who Qualifies and What You Get
Retail pharmacies in Mexico must follow these standardized guidelines for the proper storage of drugs to ensure product safety and compliance.
NOM-059-SSA1 provides standardized guidelines for good drug storage practices to ensure that medications are kept under the correct environmental conditions. This framework is designed to maintain the integrity and safety of pharmaceutical products through regulated storage protocols.
Who it's for
This scheme applies to all retail pharmacies operating within the country. It is a requirement for any retail pharmacy looking to maintain compliance with national health standards.
What you get
By following these guidelines, pharmacies implement "Buenas prácticas de almacenamiento" (good storage practices). These standardized guidelines provide a clear framework for how drugs should be stored, handled, and managed to ensure they remain effective and safe for public use.
What it costs you
Compliance requires a commitment of resources to maintain the physical environment of the pharmacy. Specifically, you will need to invest in and maintain specialized equipment designed for strict temperature and humidity control. Ensuring these levels remain stable is a continuous requirement for meeting the standard.
The catch to know
The most important detail to remember is how compliance is verified. During inspections, officials do not just look at your current setup; they will check your temperature logs for the last 12 months to ensure that your storage environment has been consistently stable over a long period.
How to apply
- Evaluate your current storage setup against the requirements for good drug storage practices.
- Invest in and install reliable equipment that provides strict control over temperature and humidity.
- Implement a system to record and track your environmental data daily.
- Maintain these temperature logs for at least 12 months so they are ready for official inspection.