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Understanding Animal Drug Product [Food and Drugs]: A Legal Overview
Definition & Meaning
An animal drug product refers to the active ingredient in a new animal drug that is not primarily produced using advanced genetic manipulation techniques. This includes ingredients that may be salts or esters of the active ingredient, either on their own or combined with other active ingredients. The term is significant in the context of food and drug regulations, particularly concerning the safety and efficacy of veterinary medications.
Table of content
Legal Use & context
The term "animal drug product" is primarily used in the field of veterinary medicine and regulatory compliance. It is relevant in areas such as:
Pharmaceutical regulations
Animal health and welfare laws
Food safety regulations
Users may encounter this term when dealing with veterinary drug approvals, compliance with the Food and Drug Administration (FDA) regulations, or when utilizing legal templates for animal drug product applications through services like US Legal Forms.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company develops a new pain relief medication for dogs that contains a non-recombinant active ingredient. This product would be classified as an animal drug product.
Example 2: A veterinarian prescribes a combination of two active ingredients, neither of which is produced using genetic manipulation, for treating a horse's infection. This combination would also qualify as an animal drug product.
Relevant laws & statutes
The primary regulation governing animal drug products is found in Title 21 of the Code of Federal Regulations (CFR), particularly:
21 CFR Part 60 - Patent Term Restoration
21 CFR Part 514 - New Animal Drug Applications
Comparison with related terms
Term
Definition
Key Differences
Animal Drug Product
Active ingredient in a new animal drug not primarily made using genetic manipulation.
Focuses on non-recombinant ingredients.
Veterinary Drug
Any drug intended for use in animals.
Includes both recombinant and non-recombinant drugs.
Common misunderstandings
What to do if this term applies to you
If you are involved in the development or regulation of animal drug products, consider the following steps:
Review FDA guidelines for animal drug approvals.
Utilize legal templates from US Legal Forms for applications and compliance documents.
If you face complex regulatory issues, consult a legal professional with expertise in veterinary law.
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