Pharmacy Law
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| 1906 Federal Food and Drug Act | prohibit the sale of mislabeled drug, food and drinks
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| 1914 Harrison Narcotic Act | limit the transport of opium.
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| 1938 FD&CA | defines mislbld or adulteration of drugs to be illegal.
require package insert
req. companies to label drug maybe habit forming.
new drugs must be pass the fda guidelines before marketing
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| 1951 DHA | over the counter drug vs. legend drug
req. drug comp. to label "F C P D w/o a pres."
legend drug must be supervise under physician
OTC w/o a pres. must include:
Product Name
Manufc. Name and address
Active Ingr.
Quant. all other ingr. actv or n
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| 1962 KHA | any drugs made from 1938............
Req. GMP
Req. Manafucture must prove.....
FTC handles the drug adver...
Req. Manufacture:
Report any adverse reaction
inspected every 2 years
register annually
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| 1970 CSA | DEA. consist of Five schedules C
Class 1 have highest potential
Class 5 is the least potential
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| 1970 Poison Prevention Packaging Act | Req. childproof.
exception is nitroglycerin or drugs that comes to small quantities
under 5
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| 1983 ODA | enables FDA to promote...
of rare disease
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| 1984 Hatch waxman amnd. (DPC & PTR) | process of granting approval of generic drugs
allow drug manufature to create new drug by giving patent extention
allow generic drug companies to ability to rely
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| 1988 F&DA | Dept of Health & Human Service
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| 1988 PDMA | banned the sale, trade or purchase of drug samples.
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| 1990 OMNIBUS | Requires pharmacist to attempt or offer counseling to patients.
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| 1996 HIPAA | privacy and security of patient Health Information
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| 2006 CMEA | limit the purchased of PSE to 3.6g per day to 9g per 30 days.
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