Small Business Assistance: FDA Related Laws, Regulations, and Guidances

The mission of  FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook.  The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world.  The law is intended to assure the consumer that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.

• Prescription Drug User Fee Act (PDUFA): Frequently asked questions   (Posted 10/11/2002)

• Small Entity Compliance Guide: Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation  (Posted 11/7/2001)  This guidance states the legal requirements requiring that all prescription and over-the counter (OTC) aqueous-based drug products for oral inhalation be manufactured sterile. 

• Laws Enforced by the FDA.  Includes the Federal Food, Drug and Cosmetics Act, the 1997 Modernization Act, and over 30 other acts, amendments, provisions, and laws.

• Reduction of Civil Money Penalties for Small Entities.  FDA issued this final guidance for the reduction of civil money penalties (CMPs) for small entities (penalty reduction guidance (SBREFA) (Public Law 104-121) and the Presidential Memorandum of April 21, 1995 (60 FR 20621, April 26, 1995).  Federal Register Notice

• Code of Federal Regulations (CFR) Section 21.  The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR.  The CFR is divided into 50 titles which represent broad areas subject to Federal regulations.  The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act  and related statutes.  Section 21 of the CFR contains most of the regulations pertaining to food and drugs.   The regulations document all actions of all drug sponsors that are required under Federal law.

• CDER Guidance Documents.  Guidance documents represent the Agency's current thinking on a particular subject. Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts.  An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.  The FDA Guidances web page provides links to guidances from all five FDA Centers, including the Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996.

• Compliance Resources from the Office of Regulatory Affairs. (ORA) ORA is the lead office for all field activities of the FDA. This page provides links to documents, policies, and statements relating to regulatory compliance.  

• Drug Registration and Listing System.  A firm must register and list their commercially marketed drug product with FDA.  Information is provided on these requirements.

• Inspection References.  Information provided to FDA investigators and facilities inspectors to assist them in their daily activities.

• CDER's MaPPs (Manual of Policies and  Procedures).  Series of formalized guidelines for CDER staff on internal policy.