pharm legal and ethical considerations Flashcards
what does the HPFB do
- administers and enforces:
Food and drug act
-controlled substance act - consumer protection against fraud, health hazards, cosmetics, medical devices
what does the TPD (therapeutic products directorate) do
regulates food and drug act and the controlled drug and substance act.
what level are the HPFB and TPD
federal
schedule A of FDA
list of diseases for which treatment may not be promoted
schedule B of FDA
compliance with official prescribing standards
schedule C of FDA
radiopharmaceuticals list (ex- diagnostic tests and CAT scan)
schedule D of FDA
allergenic substances, immunizing agents (vaccines), insulin, ant pit extracts, drugs obtained from rDNA tech, blood derivatives
schedule E of FDA
manufacturing, labeling, packaging, importing interprovincial and internationally
schedule F of FDA
prescription drug list. all drugs that require a perscription
schedule G of FDA
controlled drugs. opiates, narcotics, benzos
schedule H of FDA
restricted drugs. ex- LSD
when was the controlled drug and substance act passed
1997 replacing the narcotic control act of 1952
what does the controlled drug and substances act do
prohibits the possession and transporting of narcotics and restricted drugs
schedule 1 of controlled drugs and substances act
opium heroin, morphine, cocaine, methamphetamine
schedule 2 of controlled drugs and substances act
cannabis related drugs, marihuana and its derivatives
schedule 3 of the controlled drugs and substances act
amphetamines and lysergic acid diethylamide (LSD)
schedule 4 of the controlled drugs and substances act
barbiturates and anabolic steroids (prescription required)
schedule 5 and 6 of the controlled drugs and substances act
precursors required to produce controlled substances
schedule 7 and 8 of the controlled drugs and substances act
amount of cannabis and cannabis resin required for charge and sentencing
when was cannabis legalized
oct 17, 2018
what does the cannabis act and cannabis regulations do
addresses cannabis for medical purposes
how is cannabis consumed
resins, oils, extractions, edible, dried form for smoking
first phase of investigational drug studies
small number of healthy subjects (less than 100)
second phase of investigational drug studies
larg # of volunteers with disease (100-300)
