Guidance & Regulations

Laws

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

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Regulations

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).  

FDA Regulations

• Electronic Code of Federal Regulation (eCFR) Title 21
  • eCFR part 200 (Labeling)
    • Veterinary Drugs
    • New Drugs/New Animal Drugs
  • 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 

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Guidance Documents

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.  

Guidance Documents

• 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• Withdrawn/Replaced Guidances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

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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

Additional Resources Related to Laws, Regulations, and Guidances

Policies and Procedures

CVM’s Policies and Procedures (P&P) Manual provides a quick reference to the rules, regulations, and instructions pertinent to all program areas of CVM's responsibilities, including drafting regulations, reviewing new animal drug applications, monitoring marketed animal drugs, reviewing food additive petitions,, responding to citizen petitions, or performing other work.

Memoranda of Understanding

A Memorandum of Understanding (MOU) is a non-binding, formal agreement between the Food and Drug Administration (FDA) and federal, state, or local government agencies; academic institutions; and other entities (e.g., non-profit organizations). FDA enters into MOUs to define lines of authority or responsibility or to clarify cooperative procedures. MOU are intended to improve consumer protection through more effective use of collective resources and to eliminate duplication of activities.

Citizen Petitions

Any person can petition the FDA to make changes in health policy.

Regulations.gov

Search for regulations, guidance, citizen petitions, and certain other Agency actions on Regulations.gov.