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3/6 p/t ch3 part 1

ptch/3 part 1

QuestionAnswer
what is drug appoval process clinical studies phase 4 post-marketing trials used to establish long term effects
developing drugs risky and costly how many will make it to approval 5000-10000 conponds 250 preclinical/5 will enter human/1 will be approved answer is 1
developing new drug time and cost 10 years one billion efforts
how long are patents extented for companies to recoup cost 17yrs from date signed and 20 from applied which ever is longest
public law 109-177 places ephedrine/psedoephedrine(pse)and phenylpropanolamine in a new controlled substances act category of scheduled listed chemical products law will only apply otc of these listed above
what do prarmacies do with drug catorgized in p/law 109-177 behine counter must show id and signed pharmacies must keep a log book
how much is the consumer allowed to buy according to public law 109-177 daily sales 3.6gr monthly 9gr does not apply to prescriptions
when did public law 109-177 go into effect april 8th 2009 and must maintain a log book
which law do you follow-federal vs state regulations strictest law will be followed
what is occupational and safety act passed 1970 ensure every working man and woman safe and healthful working conditions
what does the hazardous communications standard state employees have the need and right to know the hazards and identities of the chemicals they are exposed to when working
MSDS (Material safety data sheet)what must it provide by manufacturer must be provided by the manufacturer for each hazardous chemical in the workplace employer must maintain copies and ensure that they are accessible to employees example chemo drugs
state board of pharmacy 1st responsibility has alot of power registration and licensure of pharmacies
state board of pharmacy (2)responsibility dealing w/complaints of professional miscontuct and disciplinary proceedings
state board of pharmacy (3)responsibility regulations related to filling and refilling prescription and general pharmacy practices
state board of pharmacy (4)responsibility inspecitions poisons schedules
what is JCAHO (joint comm on accredidation of healthcare organizations) establishes optimal standards for health care providers evaluates by on-siteinspec and survey as part of accreditation
what are some of the places JCAHO will inspect home infusion hospital pharmacy you pay jcaho to inspect you without the accredidation most insurance co will not pay
what JCAHO accredidation mean for pharmacy orginizations higher level and quility of achievement in providing patient care
Is Jcaho mandatory no it is completely voluntary process
Created by: jddmmin7
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