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What is a New Animal Drug? A Comprehensive Legal Overview
Definition & Meaning
A new animal drug refers to any medication intended for use in animals, excluding humans. This includes drugs meant for animal feed. A drug is classified as a new animal drug if:
It is not widely recognized by experts as safe and effective for its intended use based on its labeling.
It has been recognized as safe and effective through investigations but has not been widely used outside of those investigations.
Additionally, a drug intended for minor use or for minor species may be considered a new animal drug if it does not meet specific regulatory criteria.
Table of content
Legal Use & context
The term "new animal drug" is primarily used in veterinary medicine and regulatory practices. It is relevant in areas such as:
Animal health regulations
Pharmaceutical development for veterinary use
Food safety concerning animal products
Users can manage related forms and procedures through resources like US Legal Forms, which provides templates drafted by legal professionals.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A new antibiotic developed for treating infections in dogs that has not yet been widely used or approved.
Example 2: A feed additive for cattle that has undergone safety trials but has not been marketed yet (hypothetical example).
Relevant laws & statutes
Key legislation includes:
21 USCS § 321 - Definition of new animal drugs.
Food, Drug, and Cosmetic Act - Governs the approval and regulation of animal drugs.
State-by-state differences
Examples of state differences (not exhaustive):
State
Regulatory Body
Specific Regulations
California
California Department of Food and Agriculture
Strict regulations on new animal drugs and their use in livestock.
Texas
Texas Animal Health Commission
Specific guidelines for new animal drugs in feed.
This is not a complete list. State laws vary, and users should consult local rules for specific guidance.
Comparison with related terms
Term
Definition
Differences
Animal Drug
A medication used in animals.
Not all animal drugs are new; some may be established and recognized.
Veterinary Drug
Any drug used specifically for veterinary purposes.
Veterinary drugs may include both new and established drugs.
Common misunderstandings
What to do if this term applies to you
If you are involved in the development or use of a new animal drug, consider the following steps:
Consult with a veterinary professional or legal expert to ensure compliance with regulations.
Explore US Legal Forms for templates related to animal drug approval and compliance.
If your situation is complex, seek professional legal assistance.
Find the legal form that fits your case
Browse our library of 85,000+ state-specific legal templates.