Chapter #2 Intro to Pharmacy Tech

Question 1

How is pharmacy practice controlled?

Answer 1

• Laws/Regulations
  (passed by federal, state, and local government)
• Standards
  (Established by professional organizations)

Question 2

Federal & State Regulatory Agencies

Answer 2

1) Food and Drug Administration (FDA)

• Regulates the manufacture and sale of drugs

2) Drug Enforcement Administration (DEA)

• Enforcement authority over controlled substances

3) State Boards of Pharmacy
4) State Health and Welfare Agencies

Question 3

United States Pharmacopeia (USP)

Answer 3

• Sets standards for drug formulations, dosage forms

Question 4

Professional Organizations

Answer 4

• APhA , JCAHO, ASHP

Question 5

Pure Food and Drug Act of 1906

Answer 5

• Prohibited the interstate transportation or sale adulterated and misbranded food and drugs.

Question 6

Food, Drug, and Cosmetic Act of 1938

Answer 6

• 1937: 107 death occurred from sale of a sulfa drug product that contained diethylene glycol (antifreeze)
• Created the FDA
  -Required manufactures to file (NDA) with each new drug prior to marketing. (Had to be prove that the product was safe for humans)
• Had to be approved by the FDA

Question 7

Durham - Humphrey Amendment of 1951

Answer 7

• Establish the distinction between prescription (Controlled substance) and over-the-counter (OTC) drugs.
• Authorized Verbal Prescriptions
• Authorized refilling of prescriptions (limited of controlled substance abuse)

Question 8

Kefauver-Harris Amendment of 1962

Answer 8

• Passed due to the response to the birth of thousands of infants with severe congenital abnormalities whose mothers had taken a new tranquilizer called “Thalidomide”
• Required the drugs be safe AND effective for humans
• Drug manufacturers must file an investigational new drug application (INDA) with the FDA before conducting human trials
• NDA submitted after safety and effectiveness are proven in clinical trials (7- 10 yrs)

Question 9

19th Century (1800’s)

Answer 9

-Drugs in U.S unregulated
-Medicines marketed w/o proof of safety or effectiveness
EX: “Miracle Cures” sold from town to town
- High alcohol content that made the customer “feel better”

Question 10

Poison Prevention Packaging Act of 1970

Answer 10

• Pass to prevent accidental childhood poisonings from Rx and non-Rx products
• Requires most OTC and Rx drugs be packaged in a child-resistant container that cannot be opened by 80% of children