Federal Acts Flashcards
Durham-Humphrey Amendment of 1951
Distinguishing between legend drugs and nonprescription drugs
Kefauver-Harris Amendment of 1962
as a result of a public safety concern about thalidomide, required that all new drugs marketed in the US had to be shown to be not only safe but also effective; came with the implementation of Good Manufacturing Practices
Medical Device Amendment of 1976
Better classification of medical devices according to their specific function, establishment of performance standards, and pre-market approval requirements
Orphan Drug Act of 1983
provided various fax and licensing incentives to manufacturers thereby making development of such drugs more appealing
The Drug Price Competition and Patent Term Restoration Act of 1984
congress streamlined the drug approval process for generic products requiring submission of only an abbreviated new drug application (ANDA)
The Prescription Drug Marketing Act of 1987
stringent controls on the distribution of prescription drug products and samples (prescription drug wholesalers be licensed by states under federal guidelines, banning the sale, trade or purchase of prescription drug samples, specifying precise storage, handling, and record keeping requirements for drug samples)
Safe Medical Devices Act of 1990
gave the FDA authority related to devices and requires a manufacturer to recall a device that could cause serious health consequences or death
Dietary Supplement Health and Education Act of 1994
enacted to exempt foods, food supplements and herbal products from the same standards as imposed on prescription and non-prescription drugs
FDA Modernization Act of 1997
Provisions for fast-track review of some New drug application submissions; increasing access to experimental drugs and devices
Prescription Drug User Fee Act
provides FDA the authority to collect “user fees” from pharmaceutical manufacturers to fund the cost of reviews of new drugs and shorten the tie it takes to review an NDA
Medical Device User Fee and Modernization Act
provides the FDA the authority to collect user fees from medical device manufacturers so that the FDA can make improvements to the review program
Best Pharmaceuticals For Children Act
designed to stimulate more studies in children in order to promote the development of treatments for children
Pediatric Research Equity Act
provides the FDA the authority to require studies in children concerning certain medical products and under specific circumstances
2013 Drug Quality and Security Act
as a result of the New England Compounding Center disaster; this legislation permits compounding pharmacies to register with the FDA as “outsourcing facilities” and to be subject to rules dealing with quality control
Poison Prevention Packaging Act (PPPA)
purpose is to protect children under 5yo from accidental poisoning; see list of drugs that are required to be packaged in child-resistant packaging. Other provisions: All new and refill prescriptions must be dispensed with a child-resistant closure, when preparing refills both body and closure of plastic containers must be replaced.
