Amendments Flashcards
Pure Food and Drug Act (1906)
Prohibited the sale of misbranded or adulterated food and drugs. The basis of the law rested on the regulation of product labeling rather than pre-market approval.
Food, Drug, and Cosmetic Act (1938)
Established quality standards for food, drugs, medical devices, and cosmetics manufactured and sold in the United States. The law also provided for federal oversight and enforcement of these standards.
(After Sulfanilamide tragedy)
Durham-Humphrey Amendment (1951)
Defined two specific categories for medications, legend (prescription) and over-the-counter (OTC). Required any drug that was habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, “Caution: Federal law prohibits dispensing without prescription.”
Food Additives Amendment (1958)
Prohibited the use in food of additives which have not been adequately tested to establish their safety. If a substance were found to cause cancer in man or animal, then it could not be used as a food additive (Delaney Clause)
Color Additive Amendments (1960)
Required that only color additives (except coal-tar hair dyes) listed as “suitable and safe” for a given use could be used in foods, drugs, cosmetics, and medical devices.
Kefauver-Harris Amendment (1962)
An act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, EFFECTIVENESS, and reliability of drugs, authorize standardization of drug names, and clarify and strengthen existing inspection authority; and for other purposes. (After thalidomide tragedy)
Medical Device Amendments (1976)
Established three regulatory classes for medical devices (III being most regulated; sustaining life). The three classes are based on the degree of control necessary to assure that the various types of devices are safe and effective.
Orphan Drug Act (1983)
Facilitate development of orphan drugs—drugs for rare diseases such as Huntington’s disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy which affect small numbers (<200,000) of individuals residing in the United States.
Drug Price Competition Act (1984)
Hatch-Waxman Act; encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. “ANDA”
Prescription Drug Marketing Act (1987)
Enacted to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs. Required whole-sellers to be registered by the states.
Safe Medical Devices Act (1990)
Requires ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user facilities to report all incidents in which a medical device or user error may have caused or contributed to the death, serious injury or serious illness of a patient.
Generic Drug Enforcement Act (1992)
Requires that an individual convicted of a Federal felony for conduct relating to the development, approval, or regulation of any drug product be debarred from providing any services to a person that has an approved or pending drug product application.
Prescription Drug User Fee Act (1992)
Allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
Nutrition Labeling and Education Act (1990)
Provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (i.e., ‘high fiber’, ‘low fat’, etc.) and health claims be consistent with agency regulations.
Dietary Supplement Health and Education Act (1994)
Statute of United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices.
