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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 -
passed to control the importantion, sale and distribution of opium and its derivatives as well as other narcotic analgesics
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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 -
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 -
- 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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- 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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congress passed the social security amendments and deemed institutions with JCAHO accreditation to be authorized institutions for Medicare/Medicaid reimbursements
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- 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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creation of the Drug Enforcement Agency
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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
