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Pharmacy Law

1906 Federal Food and Drug Act prohibit the sale of mislabeled drug, food and drinks
1914 Harrison Narcotic Act limit the transport of opium.
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
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
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
1970 CSA DEA. consist of Five schedules C Class 1 have highest potential Class 5 is the least potential
1970 Poison Prevention Packaging Act Req. childproof. exception is nitroglycerin or drugs that comes to small quantities under 5
1983 ODA enables FDA to promote... of rare disease
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
1988 F&DA Dept of Health & Human Service
1988 PDMA banned the sale, trade or purchase of drug samples.
1990 OMNIBUS Requires pharmacist to attempt or offer counseling to patients.
1996 HIPAA privacy and security of patient Health Information
2006 CMEA limit the purchased of PSE to 3.6g per day to 9g per 30 days.
Created by: calisurf