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Food and Drug Act of 1906
Created by FDR, it provided agency with the powers to enforce seizure of any food or drug misbranded. It was not incorporated into the health department or human services.
- did not limit the claims a manufacturer can make with respect to their product as long as the product was correctly identified
- did not require premarket inspections and approval
- United States Pharmacopeia and the National Formulary were given official status -
Harrison Narcotic Act of 1914
passed to control the importantion, sale and distribution of opium and its derivatives as well as other narcotic analgesics -
Food, Drug, and Cosmetics Act of 1938
public outcy spurred the act through congress after 100 ppl died after using the toxic elixir that had not been tested and proven safe for human consumption
- FDA was given authority to verify that drugsa re safe for human consumption -
JCAHO
began with the idea of "end result system of hospital standardization in 1910
- Joint Commission on Accreditation of Healthcare Organizations created in 1951
- verify minimum standards upheld in healthcare institutions
- institutions that upheld standards were accredited -
Durham-Humphrey Amendment
- FDA given power to designate certain drugs safe only with a medical professional because of their habit forming or potentially harmful effects
- required that any drug designated in that category could not be dispensed without a legal document called a prescription
- "prescription only" medications were designated as well as drugs safe for over the counter use
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Kefauver-Harris Amendment
- signed into law by JFK
- a response to the Thalidomide exposure across the world that cased birth defects in tens of thousands of children
- probably one of the largest modern medical tragedies
- drug was marketed as a sedative that cured morning sickness in 50's and 60's -amendment says that drug manufacturers must provide proof of drug effectiveness and safety before application for FDA approval -required drug advertising to disclose accurate info about drug side effects
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Social Security Amendments
congress passed the social security amendments and deemed institutions with JCAHO accreditation to be authorized institutions for Medicare/Medicaid reimbursements -
Controlled Substances Act
- any drug that has the potential for abuse was categorized into 5 schedules
- this act necessitated the need for higher regulation of these meds
- creation of the Drug Enforcement Agency
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DEA
creation of the Drug Enforcement Agency -
Chicago Tylenol Murders
September of '82 in Chicago, IL, 7 ppl were poisoned by unknowingly ingesting extra-strength tylenol capsules laced with potassium cyanide. 4 of which were sharing same bottle
- Johnson & Johnson halted production of the drug and issued urgent nationwide warnings to hosptitals and disributers
- spurred a change in FDA code of Federal Regulations under title 21-tamper-resistant packaging were then required on all OTC medicines
