Laws
this act requires all foods and drugs to meet a standard of strength and purity.
The pure food and drug act
the mission is to improve the quality of care provided to the general public. responsible for the accreditation of the institutional settings.
Joint commission on accreditation of health care organizations
study participants: 300 to 3000 volunteers who have the disease or condition. purpose is efficacy and monitoring of adverse reactions.
Length of study: 1-4years
25-30% of drugs move to the next phase.
Phase III(3)
Low abuse potentiol, may be solf OTC but must be 18 to purchase
ex. phenergan with codeine
schedule V(5)
a product that might cause a temporary health problem or pose a slight threat of a serious nature,
class II(2)
this act regulated drugs that produced or sustained physical or psychological dependence. the importation, sale, manufacturer and use of: opium, marijuana, synthetic agents, derivatives
Harrison narcotic act
responsible for the safety in the work place
Us department of labor occupational safety and health organization.(OSHA)
several thousand volunteers who have the disease/condition. Often called postmarketing surveillance trials are conducted after a drug or device had been approved for sale.
purpose:safety and efficacy
phase IV(4)
less potentiol abuse, same dispensing rules as schedule III
ex. ambien and lunestsa
schedule IV (4)
a dangerous or defective product that could cause serious helaht problems or death
class I(1)
required a physician's consent in order to dispense refills, giving rise to the legend, "Caution: federal law prohibits dispensing without a prescription." warning must be affixed to prescription containers for all Legend drugs.
Durham humphery
Approves new drugs to be sold in the us, regulates package insterts.
How many phases are there
4
Ex. Marihuana, heroin
Schedule I C-1
files must be maintained for all paper prescriptions, shed II must be kept separately and if schedule III, IV, V are stored together they must contain a red "C" not less than 1 on all c controlled substances
Paper Rx
this required drug manufacturers to prove the safety and efficiency to their products before approval was given by the FDA for marketing
Kefauver-harris
regulate licensing of pharmacist and techs, sets state laws and outline the operating guidelines in the pharmacy
Board of pharmacy(BOP)
20-100 healthy volunteers or poeple with disease/condition.purpose if saftey and dosage.
length of study:several months
70% of drugs move to the next phase
Phase(I) 1
high abuse, no refil-need orinal signed rx. if there is a partical fill have 73 housrs to refil.
ex. demerol, fentanyl
Schedulr II(2)
must be retained electronically x2 years, must be available at registered location and capable of printing or transfering
Electronic Rx
classified drugs based on their potential for abuse. (I, II, III, IV & V). Federal law requires that all controlled substances dispensed bear the following: "Federal law prohibits the transfer of this drug to any person other than patient for whom prescribed."
controlled substance act
Tracks controlled substances manufactured and sold, sets DEA schedule definitions, and investigates all violations involved in controlled substances.
Drug enforcement agency (DEA)
study up to several hundred people with the disease/condition.Purpose if efficacy and side effects.
length of stidy: several months to 2 years
approximatlye 33% of drugs move to the next phase
Phase II(2)
less potentiol for abuse, can be redilled 5x in 6 mo
ex. tylenol with codeine, testorstrone
schedule III( c-3
products that are unlickley to cause any adverse health reaction, but violates FDA labeling or maufactring laws
Class III(3)