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Important pharmacy laws & regulations
Terms in this set (28)
pure food and drug act 1906
required government pre-approval of drugs. required labels do not contain false information ; "misbranding" & "adulteration".
harrison tax act 1914
regulated drugs that produced or sustained physical or psychological dependence (opiates).
food, drug & cosmetic act 1938
required new drugs to be shown as safe before marketing.
durham-humphrey amendment 1951
identifies which drugs require a prescription ; "rx only".
kefauver-harris amendment 1962
requires drug manufacturers to provide proof of both safety and effectiveness before marketing.
an amendment to the food & drug act of 1906.
fair packaging & labeling act 1966
requires all products in interstate commerce to be honestly & informatively labeled.
poison prevention packaging act 1970
requires child-proof safety packaging on all controlled & most prescription medications. states that non child-proof containers may be used only at the request of the patient or prescriber.
controlled substances act (CSA) 1970
classifies drugs that have potential for abuse into 5 levels of controlled substances. restricts distribution of controlled substances.
medical device amendment 1976
requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting devices.
orphan drug act 1983
provides incentives to promote research, approval, and marketing of drugs needed for treatments of rare diseases.
drug price competition & patent term restoration act 1984 (hatch-waxman act)
established the modern system of generic drugs.
allowed manufacturers of would-be generic drugs to file an abbreviated new drug application to seek FDA approval.
prescription drug marketing act 1987
restricted distribution of prescription drugs to legitimate commercial channels & required drug wholesalers to be licensed by the states.
omnibus budget reconciliation act 1990 (OBRA)
requires pharmacists to offer counseling to medicaid patients regarding medications. requires the maintenance of a patient profile in any pharmacy setting.
anabolic steroid control act 1990
places any drug or hormonal substance related to testosterone under regulatory provisions of the CSA.
heath insurance portability & accountability act 1996 (HIPPA)
defined the scope of health information that may and may not be shared among health care providers without patients' consent.
provided strict regulations to protect patients' right to privacy.
american society of consultant pharmacists (ASCP)
sets standards for pharmacists who provide medication distribution & consultant services to nursing homes.
food and drug administration (FDA)
the leading enforcement agency for drug product regulations at the federal level.
drug enforcement administration (DEA)
agency that enforces controlled substances laws & regulations.
united states pharmacopoeia (USP)
voluntary, non-governmental, not-for-profit organization that sets standard for the manufacturing & distribution of drugs & related products.
the joint commission
non-government, not-for-profit organization that establishes national standard & compliance for nearly 20,000 health care programs in U.S.
what temp is allowed for refrigerated items?
what temp is allowed for room temp items?
what temp is allowed for cold temp items?
< 8 celcius.
what temp is allowed for warm temp items?
medicare part a
hospital coverage, inpatient hospital care, inpatient stays in most skilled nurse facilities, hospice & home health services.
medicare part b
medical coverage, dr & clinical lab services.
medicare part c
offered by private insurance, provide both hospital & medical coverages (HMO & PPO)
medicare part d
prescription drug lan.
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