The Importance of Animal Food & Drug Testing
Developing and manufacturing food and drugs intended for animals in the U.S. carries its own set of guidelines and challenges.Depending on the product you’re developing you may also be dealing with different regulatory agencies, including the FDA and EPA.
Animal Drug Regulations
Animal drugs are regulated by the Center for Veterinary Medicine (CVM) in the FDA. The guidance on animal drug development are similar to those for human drug development, but have important differences, so that a drug developer with only human drug development experience may have a false sense of understanding. At Avomeen, we understand the differences in the regulations, which helps our clients navigate the regulatory process and avoid costly rework and project delays. Here are just some of the differences between animal health and human health regulations:
- Experimental animal drugs go directly from the lab into the target animal species. The formulation laboratory needs to develop product for the clinic without the extended timelines associated with human drugs due to animal toxicology.
- There is a single pivotal clinical trial that needs to be performed, though smaller trials are typically conducted prior. There is no Phase I, II, III process with submissions and approvals, as in drug development for humans.
- The Hatch-Waxman Act applies only to human drugs, so a clinical trial must be conducted for all follow-on animal drug products. The formulation for a generic animal drug does not need to match the innovator’s formulation, which is different from generic human drug development.
Looking for regulatory guidance for your animal drug pipeline?Talk to One of Our Experts.
Animal Feed Regulations
Animal feed manufacturing is also regulated by CVM. It is CVM’s responsibility to make sure animal feeds are:
- Pure and wholesome
- Produced under clean conditions
- Free of harmful substances
- Labeled appropriately and truthfully
There is a class of animal feed products that are combinations of FDA approved drugs and food, known as medicated feeds. These products are held to the same standards of safety and efficacy as animal drug products, with one additional concern. If livestock are treated with medicated feed, there needs to be an assurance that the residues of the drug substances are below the no-effect limit in the eggs, milk, and meat that enter the human food chain.
Many animal products which the public would normally consider drugs are actually not regulated by the FDA. Flea and tick products are considered insecticides and are regulated by the EPA under the Office of Pesticide Programs (OPP). Development of a new flea and tick product requires chemistry testing under EPA Series 830. OPP also may require kill studies to ensure that pesticide chemicals are still efficacious. These studies are often requested of “generic” pesticide products as resistance can develop in the insect population over time.
So, how do you, as a manufacturer of veterinary medicines, animal feed, or insecticides, ensure that your products are compliant with the necessary regulations? And what analytical tests need to be performed, prior to a market launch? It is important that animal health companies work with a CRO that has experience in and knowledge of animal drug, medicated feeds, and insecticide development in order to minimize time-to-market.
Curious about our experience with analytical testing of pet food?Read Our Blog
Rigorous Quality & Compliance for Animal Health Products
Avomeen’s expert scientists provide in-depth technical and regulatory support for a diverse range of companies and organizations that serve the animal health industry. Our combination of unrivaled scientific expertise and expansive capabilities help guide your veterinary products through the development life-cycle effectively and strategically.
As with human products, regulatory organizations are interested in more than just the end product:
- You’ll need to prove that the ingredients are safe for animal consumption and free of harmful substances.
- Production and manufacturing need to be performed with appropriate protocol and in a sanitary facility.
- The labeling of your goods must comply with specific state regulations, based on the markets that you intend to enter.
With services such as method development and validation, stability studies, testing and characterization, and packaging compatibility, Avomeen can help you achieve and document high-quality development and manufacturing of animal drugs, insecticides, and medicated food.
Avomeen’s Service Specialties
We offer a broad range of analytical testing services for the animal food & drug industry. Our animal health laboratory tests animal drug products. We do not perform testing on any animals.
- Method Development & Validation
- Quality Control
- Stability Programs
- 830 Series Pesticide Registration Testing
- Packaging Compatibility
- Impurities Characterization
- Regulatory Support
- Clinical Trial Materials Manufacturing
- Release Testing
- Formulation & Process Development
Do you have a project that we can help you with?Talk to a Scientist
Why Partner with Avomeen
Avomeen has decades of regulatory experience and numerous Ph.D. scientists ensure we meet your project needs with industry-leading technology and robust, comprehensive analytical methods.
Here’s a snapshot of some of the benefits of partnering with us.
From our project management team to our scientific experts, we offer regular, responsive communication and transparency into what we’re doing. We consider ourselves an extension of your team, creating a customized project, tailored to your product needs and timelines.
Technical and Regulatory Expertise
We apply scientific acumen and regulatory insights to a wide range of analytical challenges in the animal health industry. Our laboratories are cGMP compliant, FDA registered, and DEA licensed and our up-to-date regulatory knowledge, ensures compliance with regulatory agencies.
We have an “always available” mindset and can act as your outsourced R&D department. Our team has the ability to communicate complex data to those in every level of management to ensure that you are making informed business decisions.