Regulation of therapeutic goods in the United States
Encyclopedia
Regulation of therapeutic goods
in the United States
is carried out by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter
at retail outlets and others by prescription only
.
The possession of some substances is prohibited by scheduling under the Controlled Substances Act
, under the joint jurisdiction of the FDA and the Drug Enforcement Administration
(DEA)
in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR
and Public Citizen
).
Regulation of therapeutic goods
The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency...
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
is carried out by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
at retail outlets and others by prescription only
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
.
The possession of some substances is prohibited by scheduling under the Controlled Substances Act
Controlled Substances Act
The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain...
, under the joint jurisdiction of the FDA and the Drug Enforcement Administration
Drug Enforcement Administration
The Drug Enforcement Administration is a federal law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States...
(DEA)
Pharmacovigilance
Three primary branches of pharmacovigilancePharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
in the U.S. include the FDA, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as RADAR
Research on Adverse Drug events And Reports
Research on Adverse Drug events And Reports is a pharmacovigilance team of 25 doctors who receive calls about possible adverse drug reactions and investigate. RADAR is based at Northwestern's Feinberg School of Medicine. RADAR is led by Dennis West...
and Public Citizen
Public Citizen
Public Citizen is a non-profit, consumer rights advocacy group based in Washington, D.C., United States, with a branch in Austin, Texas. Public Citizen was founded by Ralph Nader in 1971, headed for 26 years by Joan Claybrook, and is now headed by Robert Weissman.-Lobbying Efforts:Public Citizen...
).
See also
- Health care in the United StatesHealth care in the United StatesHealth care in the United States is provided by many separate legal entities. Health care facilities are largely owned and operated by the private sector...
- American Society of Consultant PharmacistsAmerican Society of Consultant PharmacistsThe American Society of Consultant Pharmacists is an international professional association that provides education, advocacy, and resources to advance the practice of senior care pharmacy, and that represents the interests of consultant pharmacists who work with elderly patients.The organization...
- Boston Collaborative Drug Surveillance ProgramBoston Collaborative Drug Surveillance ProgramThe Boston Collaborative Drug Surveillance Program , established in 1966, was a pioneer in the field of drug epidemiology, pharmacoepidemiology . Still active, the group has published over 400 articles and reviews in peer-reviewed journals...
- National Drug & Safety LeagueNational Drug & Safety LeagueThe National Drug & Safety League is a charitable organization based in DeSoto, Texas. It received the lowest possible rating from Charity Navigator, being awarded zero stars and a 0.0 rating. 64.3% of its funds went to fundraising activity in the last year of record, with an additional 13.2% going...