Laws

Question 1

1906

Pure Foods (Wiley Act)

Answer 1

Prohibited the marketing of adulterated and misbranded food and drugs

Question 2

1st legislation that protected consumers from drug misused

Based on Upton Sinclair’s “The Jungle”

Answer 2

1906

Pure Foods (Wiley Act)

Question 3

Drugs met strength, quality, purity in USP and National Formulary

Answer 3

1906

Pure Foods (Wiley Act)

Question 4

Meat inspection and comprehensive food/drug law.

Accurate product labeling.

Answer 4

1906

Pure Foods (Wiley Act)

Question 5

1938

Created FDA

Answer 5

Food Drug and Cosmetics Act

Question 6

1938

Defines misbranding and adulteration, drug devices, cosmetics, and labeling

Answer 6

Food Drug and Cosmetics Act

Question 7

1938

Ensured SAFETY of new drugs prior to market

Allowed FDA to inspect manufacturing facilities and seek injunctions (court orders) from courts

Answer 7

Food Drug and Cosmetics Act

Question 8

1938

Pharmacy is exempt from FDA registration when it is in conformance with local law and regularly engaged in dispensing Rx Drugs

Answer 8

Food Drug and Cosmetics Act

Question 9

1951

Answer 9

Durham-Humphrey Amendment

Question 10

1951

Formally distinguished Rx vs. OTC

Answer 10

Durham-Humphrey Amendment

Question 11

1951

Legend drugs are created (Rx)

Labeling requirements are made

Answer 11

Durham-Humphrey Amendment

Question 12

RX Definition Made

Answer 12

Durham-Humphrey Amendment

1. Drugs that are habit forming
2. Unsafe for use except under expert supervision
3. RX only under a manufacturer’s NDA

Requires “Federal law prohibits dispensing without a prescription”

Question 13

1962

Drug manufacturers NEED to show effectiveness + safety

Answer 13

Kefauver-Harris Amendment

Question 14

1962

Drug manufacturers must report adverse drug effects to FDA

Answer 14

Kefauver-Harris Amendment

Question 15

1962

Drug manufacturers to ensure advertisements disclose all risks as well as benefits

Answer 15

Kefauver-Harris Amendement

Question 16

1962

Creation of NDA and Current GMPs

Inspection required every 2 YEARS

Answer 16

Kefauver-Harris Amendement

Question 17

Who regulates advertising for RX drugs?

Answer 17

FDA

Question 18

Who regulates advertising for OTCs?

Answer 18

FTC

Question 19

1970

Enforced by consumer product safety commission

Child resistant packaging

Answer 19

Poison Prevention Packaging Act

Question 20

Child-Resistant Packaging

Answer 20

< 5 years – Difficult to open within a reasonable time, but easy for adults

Question 21

1972

Required each drug to have a unique NDC

Answer 21

Drug Listing Act

Question 22

NDC (First 4-5 Digits)

Answer 22

Labeler Code – Manufacturer

Question 23

NDC (Middle 3-4 Digits)

Answer 23

Product Code – Strength, Dosage, Formulation

Question 24

NDC (Last 1-2 Digits)

Answer 24

Package Size

Question 25

1982 Caused by the Chicago Tylenol Murders

Answer 25

Anti-Tampering Regulations

Question 26

1982 Requires that cosmetic liquid, oral hygiene products, vaginal products, contact lens solutions, and most OTCS -- be packaged in this packaging

Answer 26

Anti-Tampering Regulations

Question 27

1983 Diseases that affect < 200k people OR offer no reasonable expectations of profits were incentivized

Answer 27

Orphan Drug Act Reduced Taxes + 7 years market exclusivity

Question 28

1984 Streamlines generic drug approvals and grants protection to drug innovators Creation of ANDA and 505(b)(2) application

Answer 28

Hatch-Waxman Act 5 years of exclusivity

Question 29

1987 Requires states to license wholesale distributors of RX drugs

Answer 29

Prescription Drug Marketing Act (PDMA)

Question 30

1987 Bans reimportation of Rx drugs (except by manufacturer or emergency use)

Answer 30

Prescription Drug Marketing Act (PDMA)

Question 31

1987 Mandates storage, handling, and recordkeeping requirements for drug samples

Answer 31

Prescription Drug Marketing Act (PDMA)

Question 32

1987 Bans trafficking of drug coupons Prohibits resale of drugs purchased by hospitals or healthcare facilities

Answer 32

Prescription Drug Marketing Act (PDMA)

Question 33

1990 FDA-approved health claims on food labels Required a uniform format for labels that include serving size, contents, calories, nutrients, recommended daily allowance, and number of servings per container

Answer 33

Nutrition Labeling and Education Act (NLEA)

Question 34

1992 Speeds up approval of new products Allows the FDA to accept user fees... from drug and biologic companies in return for committing to review new drug and biologic products within certain time frames

Answer 34

Prescription Drug User Fee Act (PDUFA)

Question 35

1994 FDA must prove the supplements as unsafe vs manufacturers having to demonstrate safety on these products

Answer 35

Dietary Supplement Health and Education Act (DSHEA)

Question 36

1994 Established labeling requirements, allowed nutritional support statements, and provided FDA to issue CGMP regulations for products like vitamins and certain energy drinks

Answer 36

Dietary Supplement Health and Education Act (DSHEA)

Question 37

1997 Changed Rx label to "RX Only"

Answer 37

FDA Modernization Act

Question 38

1997 Provided federal requirements governing compounding

Answer 38

FDA Modernization Act

Question 39

1997 FDA uses expert panel in drug approval process Established fast-track approval for certain new drugs and approval for innovative devices

Answer 39

FDA Modernization Act