laws , standards , regulations

FDA (food and drug administration)

ensures safety and efficiency of drugs

DEA ( drug enforcement administration)

regulates controlled substances

CDC (centers for disease control & prevention)

oversees public health initiatives

OSHA ( occupational safety & health administration )

worker safety

EPA ( environmental protection agency )

hazardous waste disposal

DEA form 222

order scheduled drugs at pharmacy

DEA form 106

report theft / loss

DEA form 41

document destruction of scheduled drugs

DEA form 224

registration for dispensing controlled substances

USP <795>

non sterile compounding

USP <797>

sterile compounding

USP <800>

hazardous drug

schedule 1

high abuse potential , no medical use

schedule 2

high abuse potential , accepted use ( no refills )

schedule 3

moderate abuse potential , up to 5 refills / 6 months

schedule 4

low abuse potential , up to 5 refills / 6 months

schedule 5

lowest abuse potential

pure food and drug act of 1906

prohibited misbranded / adulterated drugs

food , drug & cosmetic act of 1938

required proof of drug safety

durham - humphrey amendment of 1951

defined prescription vs otc drugs

kefauver - harris amendment of 1962

required drug efficacy before marketing

controlled substance act of 1970

established drug schedules

how long to keep prescription drug records ?

2 years at minimum

when must DEA inventories be completed

every 2 years

class 1 recall

dangerous or defective products that can cause serious health problems

class 2 recall

products might cause temporary or medically reversible health problems