NOM-019-ZOO: Who Qualifies and What You Get
Learn the safety requirements for clinics handling animal biologicals and pharmaceuticals to ensure your practice meets national standards.
This scheme establishes the official safety protocols that must be followed when handling animal health products, such as biologicals and pharmaceuticals.
Who it's for
This scheme applies specifically to clinics that manage, store, or administer animal biologicals and pharmaceuticals. If your veterinary practice handles these types of specialized animal health products, you fall under these regulatory requirements.
What you get
By adhering to this framework, you gain access to standardized safety protocols for animal health products. These guidelines provide a consistent way to manage biologicals, ensuring that the products used in clinical practice remain safe and effective for the animals under your care. It creates a uniform standard of care across the industry.
What it costs you
Compliance requires a commitment of both time and administrative effort. You are responsible for conducting regular self-audits to ensure your clinic remains in line with the official standards. Additionally, you must maintain thorough, consistent documentation of storage temperatures to prove that all pharmaceutical and biological materials have been kept in the correct environment.
The catch to know
The most significant challenge for many clinics is the strict focus on the "cadena de frío," or cold chain. When inspectors visit, they focus heavily on your ability to maintain the temperature-controlled supply chain. Any failure to prove that vaccines and other temperature-sensitive biologicals were kept at the correct temperature can be a major issue.
How to apply
- Review the official safety protocols issued for animal health products to understand the specific requirements for your clinic.
- Establish a rigorous system for monitoring and recording storage temperatures for all biologicals.
- Conduct regular internal self-audits to check your compliance with the national standards.
- Maintain organized documentation of all temperature logs and audit results to present to inspectors when required.