Federal Law Flashcards
1906: The Pure Food and Drug Act (PFDA)
This Act required all foods and drugs to meet a standard of strength and purity
1914: The Harrison Narcotic Act
This Act Regulated drugs that produced or sustain physical or psychological dependence. The importation, sale, manufacture and use of: OPIUM MARIJUANA SYNTHETIC AGENTS DERIVATIVES
1938: The Federal Food, Drug, and Cosmetic Act(FFDDCA)
Requires that :
•Manufacturers of drugs and cosmetics must prove that their products are safe
•Medical devices must be proved effective
(this gave the FDA limited authority to remove product from the marketplace if they are found to be ineffective or unsafe)
1951: The Durham-Humphrey Amendments to the FFDCA
Further clarified the distinction between prescription and over-the-counter (OTC) drugs based on whether or not drugs were habit-forming, narcotic, hypnotic, or potentially harmful.
Requires a physicians consent in order to dispense refills, giving rise to the legend, “Caution:Federal law prohibits dispensing without a prescription.” Warning must be affixed to prescription containers for al Legend drugs.
1962: The kewfauver-Harris Amendments to the FFDCA
This required drug manufacturers to prove the safety and efficacy of their products before approval was given by the FDA for marketing.
Hazardous Substances Labeling Act
1970: Poison Prevention Packaging Act
This act requires Child Proof packaging
1970:Controlled Substances Act (CSA)
Classified drugs based on their potential for abuse, Schedule I, II, III, IV, & V.
Federal Law requires that all controlled substances dispensed bear the following: “Federal law prohibits the transfer of this drug to any person other than patient for whom prescribed.”
Federal Laws that affect pharmacy
Federal law requires that all prescriptions expire one year from the date written. “PRN” indicate refills as needed within the one year requirements of federal law
