Term | Definition |
Food and Drug Administration | Is a Department of Health and Human Services which grants approval for drugs sold in the US, determines which drugs are prescriptions or OTC and regulates the labeling and advertising of Rx drugs |
Drug Enforcement Agency | Is part of the Department of Justice, Administers the Controlled Substances Act of 1970 and regulates the manufacture, distribution and dispensation of substances that have a potential for abuse such as opioids, stimulants and sedatives |
Omnibus Budget Reconciliation Act of 1990 | Requires that pharmacists must provide patient counseling and prospective drug utilization review for Medicaid patients |
Orphan Drug | Is a result of the Orphan Drug Act of 1983 which provides incentives for research for rare diseases which are defined as those disease affecting fewer than 200,000 individuals |
Food, Drug and Cosmetic Act of 1938 | Prohibits the commerce of drugs shown not to be effective or safe, prohibits refills unless indicated and requires certain drugs to be sold by prescription only = "Caution:Federal law prohibits dispensing without prescription". |
Durham Humphrey Amendment 1951 | Stops dispensing of (legend) prescription drugs without prescription. |
Kefauver-Harris Amendment 1962 | Passed because of the thalidome sickness |
Drug Abuse Control | 1965 first guidelines |
Pure food and drug act of 1906 | put end to sale of unsafe drugs regulate standards |
Sherley Amendment 1912 | Stops fake therapy claims |
prescription drug marketing act | Stops the importation of a drug into U.S. |
Anabolic Steroids Control Act 1990 | Hormonal, substances related to |