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PTCB
Pharmacy Law
| Question | Answer |
|---|---|
| 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
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