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Pharm Laws/Amend.

Pharm Laws and Amendments

QuestionAnswer
All food, drugs and cosmetics must be safe and effective 1938, Food, Drug, and Cosmetic Act
Reduce accidental poisonings in children; child resistant containers (with the exception of Nitroglycerin and other sublingual life saving meds-must have consent from patient or doctor for easy open containers) Poison Prevention Packaging Act
Regulates the distribution of drugs and other substances of abuse; empowers DEA; established the 5 schedules of controlled substances based on abuse potential and accepted medical use 1970, Controlled Substances Act (CSA)
Requires that only drugs approved as safe and effective are reimbursed; pharmacy must provide counseling to patients; pre and post drug utilization review (DUR) must be done 1990, OBRA
All labels or items with patient names and medical history must be shredded; $25000 fine per violation, max $250000 fine and 10 yrs. in prison 2003, HIPAA
No sale of products containing Ephedrine, Pseudoephedrine, Phenylpropaline without ID; 3.6 gms/day or 9 gms/30 days 2005, Combat Methamphetamine Epidemic Act
Separates drugs into 2 categories: legend and non-legend 1951, Durham and Humphrey Amendment
Regulates drug ads; requires package inserts (NOT TO BE GIVEN TO THE PATIENT); proper manufacturing processes 1962, Kefauvir-Harris Amendment
Rxs to treat addiction (Methadone, Suboxone, Subutex); prescriber has UIN (unique identification number) in addition to DEA # (for history of opioid addiction); UIN is same as DEA #, but first letter is "X" Drug Addiction Treatment Act (DATA), 2000
Created by: ABPharmTech2
Popular Pharmacology sets

 

 



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