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chap 2 Law & Ethics

AB
1906 Federal Food & Drug Actenacted to stop the sale of inaccurately labeled drugs
1914 Harrison Narcotic actmust have a prescription to obtain opium
1938 Food,Drug, & Cosmetic actall controlled substances were required to be labeled "Warning: May be habit forming". also provided the legal status for the FDA. Drug companies required to include package inserts
1951 Durham-Humphrey AmendmentAdded more instructions for drug companies and required the labeling"Caution:Federal law prohibits dispensing without a prescription" Made distinction between legend drugs & OTC
1962 Kefauver-Harris Amendmentsensure the safety & effectiveness of all new drugs on the market
1970 Comprehensive Drug Abuse Prevention and Control actenforce the laws concerning controlled substance & their distrubition
1970 the POison Prevention Packaging actrequires manufacturers & pharmacies to place all medication with childproof caps
1983 Orphan Drug actallowed drug companies to bypass the lengthy time requirements of testing a new drug and the new costs that accompanied testing to provide a medication to persons who had a rare disease


Health Science Technology Instructor
Klein Oak High School
Spring, TX

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