Drug Safety Flashcards
(78 cards)
What happened in the 1906 pure food and drug act
first attempt to protect consumers in manufacture of drugs/food
minimal standards
label if dangerous
2 references
What were the 2 references for the 1906 pure food and drug act
USP- United States Pharmacopeia
NF- National Formulary
what happened in the 1938 Federal food, drug, and cosmetic act
passed after sulfa drug incident
safety for new drugs, factory inspections, new standards for food
what happened in the 1951 FD &C Durham-Humphrey Amendment
Defined drugs that could only be purchased if the patients had a prescription from a licensed practitioner
what happened in the 1958 FD &C Food additives amendment
approval of new food additives
“No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal”
What were the amendments to the FD & C food additives
GRAS (generally recognized as safe)
if FDA or USDA had previously approved them
what happened in the 1960 FD &C Color additives amendment
all colors must be approved
what happened in the 1962 FD &C Kefauver-Harris amendment
standard labeling for adverse reactions/ contraindications
what happened in the 1970 FD &C comprehensive drug abuse prevent and control act
controlled substances act
regulate dispensing of drugs
assigned 5 schedules
what happened in the 1994 Dietary supplements health and education act
FDA responsible for taking actin against any unsafe supplement after it reaches market
Schedule 1
high abuse potential
no medical use
Schedule 2
high abuse potential
accepted medical use
Schedule 3
moderate abuse potential
accepted medical use
Schedule 4
low abuse potential
accepted medical use
Schedule 5
limited abuse potential
accepted medical use
examples of schedule 1 drugs
heroin LSD marijuana ecstasy methaquaione peyote
examples of schedule 2 drugs
Vicodin cocaine dilaudid Demerol ocycontin Dexedrine Adderall ritalin
examples of schedule 3 drugs
tylonol with codeine
ketamine
anabolic steroids
testosterone
examples of schedule 4 drugs
Xanax soma Darvocet valium Ativan ambien tramadol
examples of schedule 5 drugs
robitussin AC (codeine) lomotil motofen lyrica parepectalin
Reinvestigation of 1996 Food quality protection act
pesticide tolerance levels
FDA
Food and drug administration
Food labeling food ingredients and packaging pharmaceuticals supplements medical devices vaccines animal food tabacco cosmetics
DEA
Drug Enforcement Administration
Controlled substances only
USDA
US Department of Agriculture
Food distribution
school lunch programs
