40 terms


alberty food produts v. u.s.
-the united states court of appeals rules that the
purose for which a drug is to be used must be included
with a label (1950)
durham-humphery amendment
-this law defines what drugs require a prescription by
a licensed practitioner and requires them to include this
"legend" on the label: "caution: federal law prohibits dispensing without a prescription" or the more recent
"RX only" (1951)
kefauver- harris amendment
-requires drug manufactuers to provide proof of both
safety and effectiveness before marketing the drug
Fair packaging and labeling act(1966)
-this requires all consumer products in interstate commerce to be honestly and informatively labled
(1970) controlled substance act CSA
-classifies five levels of drugs that have potential for abuse
and therefore restricts their distribution.
1976 medical device amendment
-requires pre-market approval for safety and effectiveness of life-supporting medical devices
1970 poison prevention act
-requires child-proof packaging on all controlled and most prescriptio durgs dispensed by pharmacies. Non-child-proof
containers may only be used if the prescriber or patient
requests one.
1983 orphan drug act
-provides inentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases
1984 d drug price competition and patent term restoration act(hatch-waxman)
-this act allowed for both the extension of drug patent terms
and quicker introduction of lower-cost generic drugs.
1987 prescription drug marketing act
-restricts distribution of prescription drugs to legitimate commercial channels and requires drug wholesalers to be
licensed by the states
1990 omnibus budges reconciliation act(OBRA)
-this act requires pharmacists to offer cunseling to medicad patients regarding medications
1990 anabolic steroid control act
-this act was passed to "address the abuse of steroids by athletes, and, especially, youngsters and teenagers.
-20-100 patients
time: several months
purpose: mainly safety

new drug approval
phase 1
new drug approval
phase 1
-up to several hundred patients
time: several months to two years
purpose: short-term safety but mainly effectivenss
new drug approval
phase 2
new drug approval
phase 2
-several hundred to several thousand patients
time: 1-4 years
purpose: safety, dosage, and effectiveness
new drug approval
phase 3
*safety, efficacy, and uses, and the additional post-marketing surveillance
new drug approval
phase 4
What should be contained on labels of over-the counter-medications
-product/drug name
-name and address of manufacturer or distributor
-list of all active ingredients
-adequate warnings
-adequate directions for use
combat methamphetamin epidemic act (CMEA)
-federal law that sets daily and montly limits on OTC sale of psudoephedrine and ephedrine
*3.6 grams/day
*7.5 grams/month
What does the combat methamphetamin epidemic act (CMEA) requires at at the time of purchase??
-photo ID
*requires retailers to keep personal information about the purchases for at least two years after each purchase
-product name
- quantity sold
- name & address of purchaser
- date & time of the sale
- proof of identification
- signiture of purchase
NDC(national drug code)
*an identification number assigned by the manufacturer to a drug product
NDC: first set
first set -ncludes the manufacturer
NDC: second set
-medication strength
-dosage form
NDC:third set
-package size
what are the requirements on prescription labels
-name and address of dispenser
-prescription number
-patient name
-directions for use
-name, qty, strength, manufacturer and dosage form
-exp. date
-refills avaliable
*initials of dispensing pharmacits
-date filled
-each drug has a high potential for abuse and no accepted medical use in the U.S.
-may not be prescribed
heroin, various opim derivatives, & hallucinogenic
schedule I
-each drug has a high potential for abuse and may lead to physical or psychological dependence, but has accepted medical use in the U.S.
amphetamines, opium, cocaine, methadone, and opiates
schedule II
-each drug's potential for abuse is less and has currently accepted medical use in the U.S.
-may lead to moderate or low physical dependence or high psychological dependence
anabolic steroids
schedule III
-each drug has a low potential for abuse and has current accpeted medical use in the U.S.
-may lead to limited physical dependence or
psychological dependence
schedule IV
-each drug has a low potential for abuse and has current accepted medical use
-may lead to limited physical or psychological
limited amounts of narcotics such as codeine
schedule V
schedule II drugs
-must be kept on file for 7 years
-must be kept separate from non-controlled drug records
DEA form 222
-U.S. official order form for schedule I & II
DEA form 106
-report of theft or loss of controlled substances
where there is a strong likelihood that the product will cause serious adverse effects or death
Class I
where a product may cause temporary but reversible adverse effects, or in which there is little
likeihood of serious adverse effects
Class II
where a product is not likely to cause adverse effects
Class III
american society of health-system pharmacists:
-an association for pharmacits practicing in hospitals, HMOs, long-term care facilities, home care agencies, and other health care systems
United states pharmacopiea:USP
-a voluntary not-for-profit organization that sets standards for the manufacture and distribution of drugs and related products in the U.S.
Joint commission on accrediation of health care organizations:JCAHO
- independent non-profit organization that establishes standards and monitors compliance for nearly twenty thousand health care progrms in the U.S.
american society for consultant pharmacists:ASCP
-sets standards for pracatice of pharmcists who provide medication distribution and consultant services to nursing homes
Laminar Flow Hood
-establishes and maintains an ultraclean work area
-air channels through a HEPA filter that removes particles larger than 0.3 um(microns)
*if shut off must allow 30 minutes for it to warm-up when shut back on