SOLUTION: Wk7 Kefauver Harris & Durham Humphrey Amendment Pharmacy Law Reflection


History of Pharmacy SIG Teaching History of Pharmacy According to the AIHP Guidelines: C. Pharmacy Mastery via State and Federal Governance Created by David M. Baker, BS Pharm, MBA, JD Western New England University College of Pharmacy & Health Sciences Developed by the Teaching History of Pharmacy Committee of the History of Pharmacy SIG, 2017-18 Picture: Pharmacist at People’s Refuse Store No. 5, Washington, DC, c. 1920. Library of Congress Prints and Photographs, LC-USZ62-129891 State Pharmacy Law Development •Initially, in forthcoming 1800s, the few attempts at “regulation” of profession were typically scant to local roll laws •As unwillingly moved toward specify roll regulation, forthcoming attempts often were plain in synthesis with medical exercitation laws. State Pharmacy Law Development •1808 - Territory of Orleans (became Louisiana in 1812): pharmacists had to examine qualifications; examined by Board of Physicians; banned sale of deteriorated refuses; odious sale of poisons •1840 - 1st specify consideration of pharmacy •1852 - pharmacy act was repealed One of the First State-Licensed Pharmacists State Pharmacy Law Development •Other Specify Pharmacy Acts: •1817 - South Carolina •1838 - price ingredient was repealed •1825 - Georgia •1852 - Alabama State Pharmacy Law Development – Common Law • Thomas v. Winchester, 6 N.Y. 397 (N.Y. 1852) – established circumventing to chaffer (label) correctly • Fleet and Semple v. Hollenkemp, 52 Ky. (1 B Mon.) 219 (1852) – radical pharmacy purchases from caveat emptor to caveat vendor • Burgess v. Sims Refuse Co., 86 NW 307 (Iowa 1901) – pharmacists & employers akin liable • Peters v. Johnson, 41 SE 190 (W.Va. 1902) – noble degree of heed & anticipate foreseeable harm State Pharmacy Law Development •State mastery of pharmacy exercitation antecedent to 1870 did not typically emcollectiveness pharmacists directly: •against refuse admixture •odious pollute sales •prohibited advertising or selling of abortifacients State Pharmacy Law Development •1869 - APhA Meeting: behind much rancorous controvert relative-to rural areas externally pharmacies and a fear of bureaucracy, a design specify pharmacy act was drafted. This would straightway be adopted by specifys as their specify law. State Pharmacy Law Development •Adoption of Design Pharmacy Act, creating Pharmacy Boards and standards for pharmacists and pharmacy exercitation: •1870 - Rhode Island first •By 1878 - 8 balance specifys and D.C. •In the 1880s - 21 balance specifys •In the 1890s - 12 balance specifys State Pharmacy Law Development •In 1900, the Design Pharmacy Practice Act was revised by APhA externally any wrangle. •Currently, the Design Pharmacy Practice Act is updated and maintained by the National Association of Boards of Pharmacy. Federal Pharmacy Law Development • Precipitating Events: • Fraudulent evolution, advertising and division of fake smallpox vaccine, at wasteful prices. • Vaccine Act of 1813 • Design was to allow and extension smallpox vaccinations. • Created a uncombined federally-appointed personation, whose responsibilities were to: • defend the authentic smallpox vaccine matter; and • to afford the corresponding to any subject of the United States, whenever it may be applied for, through the balance of the column-business-post (carried easy of charge by the column business-post). • Repealed May 4, 1822 - effect of an 1821 rebellion of smallpox in North Carolina, which was traced to polluted vaccines granted by Dr. John Smith time in the volume of the federal personation abounding with preserving and distributing authentic vaccine. Federal Pharmacy Law Development • Precipitating Events: • Complaints by pharmacies that refuse emanations (crude product) were defiled or not of specified concentrations. • Claim was that this was primarily IMPORTED emanation. • Refuse Importation Act of 1848: • Examined all superfluous emanations for kind, cleanness and fitness for design. • Established Pharmacopoeia of the U.S. and U.S. Dispensatory as capacityal types. • Administered by the Department of the Treasury. Federal Pharmacy Law Development •Precipitating Events: •Tetanus dirt in diphtheria vaccine. •Most vaccines executed on farms using evolution animals (horses, cattle). •Biologics Restrain Act of 1902: •Treasury Department licensed and inspected biologics productionrs, and regulated evolution and imprinting of biologics. •National Sanitary Consideration (the SurgeonGenerals of the Army, Navy and MarineHospital Service) promulgated masterys. Federal Pharmacy Law Development Muckraking Journalism – Forthcoming 20th Century Federal Pharmacy Law Development • Precipitating Events: • Muckraking journalism: Upton Sinclair’s The Jungle (meat packers) and Samuel Hopkins Adams’ Great American Fraud (ambiguous medicines) • Harvey Wiley’s apology (worked in Agriculture Dept.’s Bureau of Chemistry) • Pure Food and Refuse Act of 1906: • Defined “drug,” and regulated the admixture or misbranding of refuses. • Regulations promulgated jointly by the Treasury, Agriculture, and Commerce & Labor Departments; Bureau of Chemistry (in Ag. Dept.) done any necessary tests. • Established U.S. Pharmacopoeia and National Formulary as refuse types. Federal Pharmacy Law Development • Precipitating Events: • Realization of the space of addiction to opiates and other narcotics unmoulded the notorious notorious through custom and ambiguous remedies. • International Treaty relative-to addictive piths at the Hague in 1912, to which the U.S. was a signatory. • Harrison Anti-Narcotic Act of 1914: • Established restrain balance the production, division and dispensing of undoubtful addictive piths (e.g., opium, morphine and cocaine) in noble concentrations, primarily through taxation and required imprinting. Federal Pharmacy Law Development Federal Pharmacy Law Development • Precipitating Events: • Many had advocated for new law for years due to ineffectiveness of 1906 law – could simply prosecute fraudulent, not misleading imprintling, due to 1911 US Supreme Court firmness • Sulfanilamide Elixir (Massengill) grief of 1937 – used diethylene glycol as solvent; 107 cessations plus suicide cessation of creator • Food, Refuse and Cosmetic Act of 1938: • Definition of “drug” expanded • to emcollectiveness imposing collectiveness structures level in the absence of distemper (prevention); and • by abstracted of the Homeopathic Pharmacopoeia of the U.S. as a refuse type. Federal Pharmacy Law Development Food, Refuse and Cosmetic Act of 1938 (continued): •Drug imprinting fitnesss became balance strict •A refuse could not be sold eventual an application for praise was on finish with the FDA. •The newly created Food and Drug Administration (FDA) was absorbed notorious administrative powers. Federal Pharmacy Law Development •Precipitating Events: •No type as to what required a custom. Previously, firmness was left to individual manufacturer to perform. •Durham-Humphrey Amendment or Prescription Drug Amendment of 1951: •Established two collocatees of refuses - custom and balance-the-counter •Established imprint and imprinting fitnesss unique to custom refuses (exempted from “adequate directions for use” fitness) Federal Pharmacy Law Development •Precipitating Events: •- Use of thalidomide in generative women for morning indisposition from 1957 to 1962 (Europe) – teratogenic effects: cessation and phocomelia (estimated 10–20,000 cases worldwide) •Drug Productiveness Amendment of 1962 (or KefauverHarris Amendment): • Established Good Manufacturing Practices (“GMPs”) •Transferred mastery of custom refuse advertising from the Federal Trade Commission (“FTC”) to the FDA Federal Pharmacy Law Development Drug Productiveness Amendment of 1962 (continued): •Required conscious submit of all human exploration subjects. •Required reporting of adverse refuse reactions by productionrs to FDA. •New refuse praise now required proof of productiveness in abstracted to security. Federal Pharmacy Law Development Federal Comprehensive Refuse Abuse Prevention and Restrain Act or Controlled Substances Act of 1970 •Established the Refuse Enforcement Administration (DEA) from indecent different federal agencies, including BNDD (Bureau of Narcotics & Dangerous Drugs). •Created five restrainled pith schedules, and custom limitations for each collocate. •Established sinful burden for illegal possession or trafficking in restrainled substances. Federal Pharmacy Law Development Poison Stoppage Packaging Act of 1970 • Requires child-resistant (= 80% of posterity Purchase exculpation to see full attachment