Guidance & Regulations
Laws, Regulations, and Guidances; FDA's Center for Veterinary Medicine
The Food, Drug, and Cosmetic Act (FD&C Act) gives FDA and its centers, including the Center for Veterinary Medicine (CVM), their legal authority. The FD&C Act has been amended over the years by other acts that specifically address CVM’s authority, including:
- the Animal Drug Availability Act (ADAA)
- the Animal Medicinal Drug Use Clarification Act (AMDUCA)
- the Animal Drug User Fee Act (ADUFA)
- the Animal Generic Drug User Fee Act (AGDUFA)
- the Food Safety Modernization Act
- the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
- the Minor Use and Minor Species Animal Health Act (MUMS)
Laws Relevant to FDA/CVM
- Laws Enforced by FDA
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Administrative Procedure Act
- The Public Health Service Act
- Other Laws Affecting FDA
FDA issues regulations to implement laws for state and local governments, industry, other organizations, and the general public. Though they are not laws, regulations have the weight of law. FDA follows the procedures required by the Administrative Procedure Act when issuing regulations. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).
- Electronic Code of Federal Regulation (eCFR) Title 21
- eCFR part 200 (Labeling)
- eCFR part 225 – CGMPs for Medicated Feeds
- eCFR part 226 – CGMPs for Medicated Articles
- eCFR Title 21, Chapter 1, Subchapter E (Animal Drugs, Feeds, and Related Products)
- eCFR part 1240 (Control of Communicable Diseases)
- Searchable eCFR
Guidances describe FDA’s current thinking on a topic. These documents provide additional detail or perspective on matters described in laws and/or regulations, thereby giving stakeholders a better understanding of the Agency’s expectations. Guidance is not legally binding on the public or the Agency.
- Compliance Policy Guides (CPGs) are guidance documents that provide guidance to the field offices regarding compliance policy and other regulatory action.
- FDA follows the procedures required by its "Good Guidance Practices" regulation to issue FDA guidance.
- CVM Guidance
- CVM CPGs
- Newly Added CVM Guidance
- CVM Guidance by Number
- CVM Guidance by Subject
- CVM Guidances Under Development
- Withdrawn/Replaced Guidances
- FDA Guidance Search
Federal Register Notices
The Federal Register is the daily journal of the Federal government. The Federal Register contains federal agency regulations, proposed rules and notices of interest to the public, executive orders, proclamations, and other government documents.
- CVM's Latest Federal Register Notices
- See what is scheduled to be published in the Federal Register.
- Browse what has published in the Federal Register.
- Paperwork Reduction Act Notices