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pht 100-4

chapter 2 part 4

the fda has limited oversight in diet supplement market because they don't regulate them
the dietary supplement health & education act of 1994 defined & gave guidelines on diet supplements
the fda may only look at false advertisements & monitor safety thus removing dangerous supplements after having proven that it is dangerous
the health insurance portability & accountability act of 1996, has a wide range of provisions
the health insurance portability & accountability act of 1996 is the HIPAA
pharmacists must tell patients how their info is kept safe & provide proof of that, plus they should have employees renew their training yearly
the food/drug administration modernization act (1996-2003), was passed to update rx labeling which authorized the NDA fees that the FDA uses to increase new drug reviews
the medicare rx drug improvement & modernization act of 2003 was better known as medicare part d
the medicare part d gives medicare eligible patients rx drug coverage
medicare part d of 2003 is a voluntary programwhere patients pay an extra premium & usually has deductibles
the combat methamphetamine epidemic act of 2005, put restrictions on the availibility of pseudo[ephedrine] & phenylpropanolamine
nat'l oversight agencies are the FDA, the drug enforcement, the occupational safety & health administration, the nat'l association of boards of pharm], & the state boards of pharm]
the fda is a fed. gov't agency responsible for monitoring safe & efficient food/drugs prepared for market
the fda is under the health & human services dept.
the fda's center for drug evaluation & research (cder) impacts pharm]s with new drug development/review, generic review, otc review, & post drug approval activities
the fda's primary resposibility is to enforce laws & they have no legal authority over pharm] practice in each state
the fda's activities are to get applications for investigation & approval as filed by manufacturers, to give packaging & advertising guidelines, to oversee dangerous product recalls, & to produce an annual orange book reference
the fda regulates otc labels to be understandable in layman's terms
the DEA is the branch of u.s. justice department that's responsible for regulating sale/use of potentially addictive drugs
most of the dea's efforts are spent on illegal drug trafficking & they supervise legal controlled drugs
the dea inspects medical facilities/pharm]s that may be suspected of suspicious acts
the dea also maintains an audit trail of narcotics from manufacturer>warehouse>pharm]>patient
a dea registration is needed for organizations that want controlled substances for manufacturing, distributing, dispensing, researching, instructing activities, detox programming, im/exporting, & compounding
the csa defines who can buy controlled substances
rx's for C scheduled must be handwritten for reasons relating to physicians practice
phoned/faxed controlled rx's are for emergencies only
the occupational safety & health administration ensures the safety & health of u.s. workers
the osha role in health care environments to protect workers against inadvertent needle stabs, oversee policies protecting against unnecessary drug exposure & ensure safe syringe disposals
the nat'l association boards of pharm] represents pharm] practice in each state & develops pharmacists licensure exams
the administrative process of relicensure of pharmacists in another state is known as reciprocation
the nabp has no regulatory authority, coodinates reciprocation of pharmacists practicing in other states, guides state boards of pharm] & developes model state pharm] practices act for nat'l continuity
the state board of pharm] has leaders from the pharm] community & consumer members
the state board of pharm] reviews applications & administers examinations developed by the nabp
the state board of pharm] maintains a database of active pharmacists & inspects all new pharm]s
Created by: frescah



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