The Food and Drug Administration ( FDA or USFDA ) is a Government agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, tobacco products, dietary supplements, Medication drugs, vaccines, Biopharmaceutical, blood transfusion, medical devices, Electromagnetic radiation emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.
Organization
The FDA is an agency within the United States Department of Health and Human Services responsible for protecting and promoting the nation's public health. The FDA is headquartered in Rockville, MD with 223 field offices supported by 13 laboratories located throughout the United States, the U.S. Virgin Islands, and Puerto Rico. In recent years the agency began undertaking a large-scale effort to consolidate its DC-metro area operations from its main headquarters in Rockville and several fragmented office buildings in the vicinity to the former site of the Naval Ordnance Laboratory in the White Oak area of Silver Spring, MD. When FDA arrived, the site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak. The first building, a Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. The project is slated to be completed by 2013.
While most of the Centers are located around the Washington, D.C., area as part of the Headquarters divisions, ORA and OCI are primarily field offices, with their workforce spread across the country. ORA is considered the "eyes and ears" of the agency, conducting the vast majority of the field work the Agency. Consumer Safety Officers, more commonly called Investigators, are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 13 districts. Districts are based roughly on the geographic divisions of the Judicial System. Each district comprises a main district office, and a number of Resident Posts, which are FDA offices located away from the district office to serve a particular geographic area. ORA also includes the Agency's network of laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.
OCI was established in 2002 to help relieve ORA of the burden of pursuing and proving criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and are not focused on the technical aspects of whether a regulated product meets the standards under the law. Rather, OCI agents pursue and develop cases where criminal actions have occurred, such as fraudulent claims, or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI will pursue cases where Title 18 (18 USC XXXX) violations have occurred (e.g. conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of the FD&C Act (21 USC XXX). OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the FBI, US Assistant Attorney Generals, and even Interpol. OCI will receive cases from a variety of sources, including ORA, local agencies, and the FBI, and will work with ORA investigators to help develop the technical and science-based aspects of a case. OCI is a much smaller branch, comprising of about 200 agents nationwide.
The FDA frequently works in conjunction with other Federal agencies including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission. Often local and state government agencies also work in cooperation with the FDA to provide regulatory inspections and enforcement action.
Scope and funding
The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports.
The FDA's federal budget request for fiscal year (FY) 2008 (October 2007 through September 2008) totaled $2.1 billion, a $105.8 million increase from what it received for fiscal year 2007. In February 2008, the FDA announced that the Bush Administration's FY 2009 budget request for the agency was just under $2.4 billion: $1.77 billion in budget authority (federal funding) and $628 million in user fees. The requested budget authority was an increase of $50.7 million more than the FY 2008 funding - about a three percent increase. In June 2008, Congress gave the agency an emergency appropriation of $150 million for FY 2008 and another $150 million for FY 2009.
Legal authority
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act, (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. in many cases these responsibilities are shared with other federal agencies.
Important enabling legislation for the FDA includes:
- 1902 – Biologics Control Act
- 1906 – Pure Food and Drug Act
- 1938 – Federal Food, Drug, and Cosmetic Act
- 1944 – Public Health Service Act
- 1951 – 1951 Food, Drug, and Cosmetics Act Amendments PL 82–215
- 1962 – 1962 Food, Drug, and Cosmetics Act Amendments PL 87–781
- 1966 – Fair Packaging and Labeling Act PL 89–755
- 1976 – Medical Device Regulation Act PL 94–295
- 1987 – Prescription Drug Marketing Act
- 1988 – Anti–drug Abuse Act PL 100–690
- 1990 – Nutrition Labeling and Education Act PL 101–535
- 1992 – Prescription Drug User Fee Act PL 102–571
- 1994 – Dietary Supplement Health and Education Act
- 1997 – Food and Drug Administration Modernization Act 105-115
- 2002 – Bioterrorism Act 107-188
- 2002 – Medical Device User Fee and Modernization Act (MDUFMA) PL 107-250
- 2003 – Animal Drug User Fee Act PL 108-130
- 2007 – Food and Drug Administration Amendments Act of 2007
Regulatory programs
The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections.
Food and dietary supplements
Main article: Regulation of food and dietary supplements by the U.S. Food and Drug AdministrationThe Center for Food Safety and Applied Nutrition is the branch of the FDA which is responsible for ensuring the safety and accurate labeling of nearly all food products in the United States. One exception is meat products derived from traditional domesticated animals, such as cattle and chickens, which fall under the jurisdiction of the United States Department of Agriculture Food Safety and Inspection Service. Products which contain minimal amounts of meat are regulated by FDA, and the exact boundaries are listed in a memorandum of understanding between the two agencies. However, medicines and other products given to all domesticated animals are regulated by the FDA through a different branch, the Center for Veterinary Medicine. Other consumables which are not regulated by the FDA include beverages containing more than 7% alcohol (regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives in the Department of Justice), and non-bottled drinking water (regulated by the United States Environmental Protection Agency (EPA)).
CFSAN's activities include establishing and maintaining food standards, such as standards of identity (for example, what the requirements are for a product to be labeled, "yogurt") and standards of maximum acceptable contamination. CFSAN also sets the requirements for nutrition labeling of most foods. Both food standards and nutrition labeling requirements are part of the Code of Federal Regulations.
The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements. The FDA can take action against dietary supplements only after they are proven to be unsafe. Manuf
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