Pharmacy laws

Question 1

1906 Federal and Food Drug Act

Answer 1

Enacted to stop sale of inaccurately labeled drugs(manufacturers had to give truthful information)

Question 2

1914 Harrison Narcotic Act

Answer 2

Enacted to curb recreational use of opium(no longer available without prescription)

Question 3

1938 Food drug and Cosmetic Act

Answer 3

1. Law of 1906 not worded strictly

2. Required instructions for the patient and package inserts (labels: Warning-May be habit forming)

Question 4

1951 Durham Humphrey Amendment

Answer 4

1. Require label “Caution: Federal law prohibits dispensing without a prescription”
2. doctor’s supervision
3. made distinction between legend drugs and OTC

Question 5

1962 Kefauver

Answer 5

1. Ensure safety and effectiveness of all new drugs

2. Good manufacturing practice (GMP)

Question 6

1970 Comprehensive Drug Abuse Prevention and Control Act

Answer 6

1. DEA reinforce laws with controlled substances
2. created a step chair(schedules I-V)
3. issue physician a DEA number

Question 7

1970 Poison Prevention Packaging Act

Answer 7

1. medication require a childproof cap

2. there is exceptions

Question 8

1972 Drug Listing Act

Answer 8

1. 10 digit number with 3 segments
2. first segment: labeler code
3. second segment: product code
4. Third segment package code

Question 9

1983 Orphan Drug Act

Answer 9

eased restrictions for development of new drug for rare cases

Question 10

1987 Prescription Drug Marketing Act

Answer 10

1. regulation for people covered by medicaid or medicare
2. Originally addressed problems regarding the quality of health care for older adults
3. Drug Utilization Review (DUR)
4. review possible drug interaction, appropriate dosages, duration of therapy, and contraindication
5. offer counseling for all patients

Question 11

1990 Anabolic Steroid Control Act

Answer 11

1. penalty for physicians that advise for steroids when not needed, steroid is a schedule III

Question 12

1996 Health Insurance Portability and accountability act(HIPPA)

Answer 12

Health Insurance Portability and Accountability Act(HIPAA): a family member is not considered a HIPAA covered entity