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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
(1962)

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
containing
-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

NDC
first set -ncludes the manufacturer

NDC: second set

-medication
-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
-prescriber
-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
Examples:
heroin, various opim derivatives, & hallucinogenic
substances

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.
Examples:
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
Examples:
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
Examples:
phenobarbital

schedule IV

-each drug has a low potential for abuse and has current accepted medical use
-may lead to limited physical or psychological
dependence
Examples:
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:
ASHP

-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

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