Laws and Legislation

Question 1

FDA

Answer 1

Researches and approves drugs

Question 2

job of physician

Answer 2

Prescribe (can dispense samples)

Question 3

job of pharmacist

Answer 3

dispense

Question 4

job of allied health professional

Answer 4

liaison between physician and pharmacist, and will get a lot of questions from the patient about their prescription

Question 5

USP-NF

Answer 5

sets standards for purity, potency, quality, efficacy

Question 6

DEA

Answer 6

combat drug trafficking and illegal drug use

Question 7

Pure Food and Drug Act

Answer 7

made USP-NF but had many loopholes

Question 8

Shirley amendment

Answer 8

prohibited fraudulent claims by the manufacturer

Question 9

Harrison narcotic act

Answer 9

established the term narcotic and regulated opium and codeine

Question 10

Food, Drug, and Cosmetic Act

Answer 10

safety testing on all drugs (test for toxicity and report side effects), formed FDA

Question 11

Durham-Humphrey amendment

Answer 11

• distinguished between otc and rx and labeling as such

- required warning labels

Question 12

Kefauver-harris amendment

Answer 12

required proof of effectiveness

Question 13

Controlled substances act

Answer 13

repealed all previous legislation:

• regulated drugs with potential for abuse
• established 5 schedules
• made rehab for drug abuse and dependence
• created BNDD (Bureau of narcotics and dangerous drugs)
• created DEA

Question 14

Bureau of narcotics and dangerous drugs

Answer 14

register people who manufacture, prescribe, dispense, or administer any controlled substances

Question 15

Poison prevention packaging act

Answer 15

ensure child-resistant packaging for otc and rx

Question 16

Drug Listing Act

Answer 16

established national drug code for FDA to identify manufacturer, formulation, size of packaging using a unique code

Question 17

Drug regulation and reform act

Answer 17

briefer investigation of new drugs, faster consumer access

Question 18

orphan drug act

Answer 18

established funding for research for the use of drugs in the treatment of rare, chronic illnesses

Question 19

Drug price competition and patent term restoration act

Answer 19

eased requirements for marketing generic drugs by allowing companies to prove bioequivalence without duplicate trials

Question 20

Omnibus budget reconciliation act

Answer 20

OTC drugs are an important part of the medical record and should be documented

Question 21

anabolic steroids control act

Answer 21

put anabolic steroids as a controlled substance

Question 22

prescription drug amendments of 1992

Answer 22

rapid FDA approval of medications for life-threatening diseases and debilitating conditions

Question 23

Food and Drug administration modernization act

Answer 23

rapid FDA approval of medications for life-threatening diseases and debilitating conditions