Federal Pharmacy Law

Question 1

Jenni

Answer 1

Awesomely

Question 2

What was the Food and Drugs Act? (1906)

Answer 2

It prohibited adulterated and misbranded foods and drinks. No longer active.

Question 3

What is the Harrison Narcotic Act (1914)?

Answer 3

It required a license to import/export opium

Limited to medical use only

Question 4

What is the Drug and Cosmetic Act (FDEA, 1938)

Answer 4

1937 sulfanilamide tragedy- drug ads, FTC-PDA
Required safety testing
Expanded definition of adulteration and misbranding
Required adequate directions for use

Question 5

What is the Durham-Humphrey Amendment (1951)?

Answer 5

Exemptions for some, adequate directions for uses
Started legend drugs
Distinguish adequate directions/information for use
(To person)/(to prescriber)

Question 6

What is the Kefaurer-Harris Amendments (1962)?

Answer 6

Required efficacy testing
Good manufacturing practices
NDA process
DESI- drug efficacy study implementation 
Pre-FDCA were God-fathered

Question 7

What is the Controlled Substances Act (1970)?

Answer 7

Created DEA

Drug schedules

Question 8

What is the poison prevention packaging Act (1970)?

Answer 8

Child resistant containers

Question 9

Medical Device Act (1976)

Answer 9

Established standards for medical devices

Question 10

Orphan Drug Act (1983)

Answer 10

Incentives for manufactures to develop tx for rare diseases

Question 11

Drug Price Competition Act (1984)

Answer 11

Accelerated drug approval process for generics

Created the “Abbreviated New Drug Application” (ANDA)

Question 12

Prescription Drug Marketing Act (1987)

Answer 12

Establishes drug pedigrees

Question 13

Prescription Drug User Fee Act (1992)

Answer 13

Fees on manufacturers and their products

Used by FDA for improving regulatory processes

Question 14

Nutrition Labeling Education Act (1990)

Answer 14

Regulations on nutritional supplements so they couldn’t make disease prevention claims

Question 15

Dietary Supplement and Health Education Act (1994)

Answer 15

Removed dietary supplements from food category
Can’t claim they diagnose, cure, treat, or prevent disease
Can make 4 claims:
1. benefit of nutritional deficiency disease
2. Describe structure or function in human body
3. Characterize the documented mechanism
4. Promote general well-being
Required labeling to state that it has not been evaluated by FDA

Question 16

Food and Drug Administration Modernization Act (1997)

Answer 16

Overhauled the FDA

Intended to improve efficiency

Question 17

Best Pharmaceuticals for Children Act (2002)

Answer 17

Stimulate research into pediatric data

Voluntary incentive

Question 18

Pediatric Research Equity Act (2003)

Answer 18

Allows FDA to mandate research on certain drugs before licensing

Question 19

FDA Amendments Act (2007)

Answer 19

FDA could get more fees to improve drug safety and surveillance programs

Question 20

Patient Protection and Affordable Care Act (2010)

Answer 20

Mandate to carry health insurance

Question 21

Drug Quality and Safety Act (2013)

Answer 21

Amended regulations on compounding facilities

Coordination with State Boards of Pharmacy regarding disciplinary actions

Question 22

Omnibus Budget Reconciliation Act (1990) OBRA-90

Answer 22

Intent to promote cost savings and better fiscal management in government sponsored health care (Medicaid, Medicare)
Included:
1. Rebate programs- requires manufacturer to provide state Medicaid with best price
2. Demonstration projects- encouraged scientific studies on patient outcomes
3. Drug Utilization Review programs

Question 23

Health Insurance Portability and Accountability Act (HIPAA)

Answer 23

1996
Created electronic standards to simplify transfer of electronic information
To protect privacy and confidentiality of patients, added the Privacy Rule or PHI

Question 24

Medicare/Medicaid Fraud and Abuse Act

Answer 24

Prohibits knowingly making a false statement of material fact in any application for benefit or payment
Anti-kickback provision- prohibits soliciting, receiving, offering, or paying rewards for referrals or providing services/goods paid for by Medicaid/Medicare

Question 25

Swettham Innej

Answer 25

Jenni Matthews in reverse