Pharmacy Law, Amendments and Acts

alchemist04's version from 2018-10-05 02:33


Which Act replaced Food and Drug Act of 1961Federal Food, Drug and Cosmetic Act (FDCA)
Waxman-Hatch Amendment is also know asDrug Price Competition and Patent Term Restoration Act
Drug Efficacy Amendment is also known asKefauver Harris Amendment
Why is Orphan Drug Act established in 1983?To facilitate development of drugs for rare disease, also known as Orphan drugs


What is the purpose of Orange book?1) contains therapeutic equivalence for generic drug 2) List Patents that protect each drug and the one that cannot be infringe
What type of Pregnancy Category is NFDA has not yet classified the drug into a specific pregnancy category
What is DAW 7Brand must be dispensed as mandated by the state law
What type of Pregnancy Category is CRisk of fetal fetus can not be ruled out. Animal test showed fetal fetus; maybe used if benefit outweighs risk


What are the benefits associated with Orphan Drug Act?1) reduced taxes 2) patent protection and market right 3) Clinical Research Subsicides
What are the purposes of Controlled Substances Act?1) to regulate manufacturing, possessing, using and distributing certain substances 2) to classify certain substances into 5 Schedules
What are the purposes of Kefauver Harris Amendment?1) makes drug manufactures provide proof of efficacy 2) makes drug advertisement to disclose accurate information about drug side effects 3) prevent cheap drugs being advertised as expensive "breakthrough" medications
What are the purposes of Waxman-Hatch Amendment?1) provides protection for drug innovators 2) Encourage generic drugs to be produced 3) Established easy pathway for generic drugs thru ANDA 4) provides research exceptions/safe harbor for manufacturers trying to make generic drugs 5) making sure that generic drug has bioequivalence as the brand


Question Answer
DAW 3Pharmacist selected the Brand name, though substitute is allowed
DAW 4The Generic drug is not in stock, substitution is allowed
DAW 5Brand is dispensed at generic price, substitution is allowed
DAW 6Override, this is used when an override is required
DAW 8Only Brand is available in the market, no generic drug is available


Durman-HumphreyPrescription drug Amendment; OTC and Legend Rx
Delaney ClauseAnticancer provision; Food additive Amendment and Color additive amendment
Prescription Drug Marketing Actsecondary or diversionary distribution of prescription drugs
DSHEADietary Supplement Health and Education Act
Food and Drug Administration Act of 2007 (FDAA)REMS; Risk Evaluation and MitigationStrategies
USPCUnited State Pharmacopeia Convention, Publishes monograms for drugs


Members of USPCPhysicians, Pharmacists, Scientists, FDA
FTCFederal Trade Commission, enforce unfair business practices and antitrust violation
Identify two medications marketed before 1938, which received amendments to ensure uniform potency. Insulin, Penicillin
Identify two medications resulting in tragedy that were catalysts for major legislationSulfanilamide, Diethylene Glycol