Name: uyeon FDCA AMENDMENT REVIEW assignment. In the space provided below insert the correct amendment, act, law.
1. This law prohibited the adulteration and misbranding of foods and drugs in interstate commerce. The law fell short of short of providing that protection that Congres: intended, because of a US Supreme Court decision held that the misbranding provision in the law did not prevent false of misleading efficacy claims.
ANS: Pure Food and Drug Act
2. This law along with amendments forms the nucleus of todays' law. It provided that no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. This law also expanded the definitions of misbranding and adulteration, requiring that labels must contain adequate direction for use and warning about the habit-forming properties of certain drugs.
ANS: Food, Drug, and Cosmetic Act
This amendment established two classes of drugs-prescription and OTC- and provided that
they contain the legend "Caution: Federal law prohibits dispensing without a prescription". This amendment also authorizes oral prescriptions and refill of prescription drugs.
ANS: Durham-Humphrey Amendment
4. This amendment requires that components added to food products receive premarket approval for safety. Also contain in this law is the anticancer provision (Delaney Clause) which prohibits the approval of any food additive that might cause cancer.
ANS: Food Additives Amendment
5. The amendment requires manufacturers to establish the safety of color additives in foods, drugs, and cosmetics. Under this amendment the FDA can approve a color for one use but not for others (e.g. external use only)
ANS: Color Additives Amendment
This amendment is also called the Drug Efficiency Amendment, it strengthen the new drug approval process by requiring that drugs be proved not only safe but also effective. The efficacy requirement was made retroactive to all drugs marketed between 1938 and 1962. In addition, the amendment also transferred jurisdiction of prescription drug advertising form the FTC to the FDA, established GMP requirements and added more extensive controls for clinical investigations by requiring the informed consent of research subjects and reporting of adverse drug reactions.
ANS: Kefauver-Harris Amendment
7. This amendment requires classification of devices according to their function, premarket approval, establishes performance standards, conformance of GMP requirement and adherence to record and reporting requirements of medical devices.
ANS: Medical Device Amendment
Congress passes this Act to provide tax and exclusive licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of rare diseases or conditions (defined as those affecting fewer than 200,000 Americans.)
ANS: Orphan Drug Act
9. Also called the Waxman-Hatch Amendment, that act was enacted to streamline the generic drug approval process while giving patent extensions, in certain cases, to innovator drugs.
ANS: Drug Price Competition Act
Congress enacted this act in response to the growing alarm that a secondary or diversionary distribution system for prescription drugs was threatening the public health and safety. Further this law establishes sales restrictions and record keeping requirements for prescription dru