Federal Laws and Acts

Chapter 2

Pure food and drug act of 1906

prohibit the interstate transportation or sale of adulterated and misbranded food or drugs

food, drug, and cosmetic act of 1938

created FDA, requires all new drug applications be filed with the FDA, defined adulteration and misbranding of drugs

Safety Data Sheets

for hazardous chemicals to users to communicate information on these hazards. There are 11 sections

Four hazardous wastes

F-list, K-list

P-list, U-list :In the pharmacy

HIPPA privaacy rule

covers patient health information

HIPPA security rule

administrative, tactical, and physical safeguards are required to protect patients health information

HIPPA electronic health care transactions and code sets standards

require every provider that does business electronically to use the name health care transactions, code sets, and identifiers.

6 hazardous criterias

carcinogenicity, teratigencity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, new drugs that mimic existing hazardous drugs.

Pharmacy personnel training

occurs every 12 months (once a year)

PPE

Personnel protective equipment (gloves, gowns, head, hair, and show covers) (eye and face protection)

solid waste

a term used to define all solid, liquid, and gaseous waste

hazardous material

any substance or mixture of substances capable of producing adverse effect son the health and safety r the environment of human being.

infectious waste

includes blood, blood products and bodily fluids, infectious sharps waste, and laboratory waste.

Ignitability

has a flash point less than 60C, example include silver nitrate

corrosivity

has a pH less than 2 or greater than 12.5 example is sodium hydroxide

reactivity

liable to explode, react violently, or release toxic gases, example is nitroglycerin

toxicity

contains a regulated substance at a concentration above the limit, example is zinc

P-list

warfarin >0.3%, epinephrine, nitroglycerin

U-list

warfarin <0.3%, mercury, cyclophosphamide

DEA number

drug enforcement administration number, has 9 characters

add the first, fifth, and seventh number then add the second fourth, and sixth number x two and add together, if last number on both match then they are correct.