Drug Regulation -A Time Line

Question 1

Food and Drug Act of 1906

Answer 1

Prohibits interstate commerce in adulterated or misbranded food, drinks, and drugs. Government pre approval is required.

Question 2

1914 Harrison Tax Act

Answer 2

Establishes that manufacturers, pharmacist, importers, and physicians prescribing narcotics should be licensed and required to pay a tax.

Question 3

1927 Food, Drug and Insecticide Administration

Answer 3

Law enforcement agency is formed. Renamed in 1930 as the Food and Drug Administration.

Question 4

1938 Food, Drug and Cosmetic (FDC) Act

Answer 4

Requires new drugs be shown to be safe before marketing

Question 5

1950 Alberty food products v U.S.

Answer 5

The U.S. Court of Appeals rules that the purpose for which a drug is to be used must be included on the label

Question 6

1951 Durham-Humphrey Amendment

Answer 6

Defines which drugs require a prescription by a licensed practitioner and requires them to include this legend on the label “Caution: Federal Law prohibits dispensing without a prescription” or “Rx only”

Question 7

1962 Kefauver-Harris Amendment

Answer 7

Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug

Question 8

1965 Social Security Act

Answer 8

Establishes the Medicare Program

Question 9

1966 Fair Packaging and Labeling Act

Answer 9

Requires all consumer products in interstate commerce to be honestly and informatively labeled

Question 10

1970 Poison Prevention Packaging Act

Answer 10

Requires childproof Packaging on all controlled and most prescription drugs dispensed by pharmacies

Question 11

1970 Controlled Substance Act

Answer 11

Classifies 5 levels of controlled substances that have potential for abuse and therefore restricts their distribution; establishes that Drug Enforcement Administration DEA

Question 12

1976 Medical Device Amendment

Answer 12

Requires premarket approval for safety and effectiveness of life sustaining and life supporting medical devices

Question 13

1983 Orphan Drug Act

Answer 13

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment or rare diseases

Question 14

1984 Drug price competition and patent term restoration act (Hatch-Waxman)

Answer 14

Allows for both the extension of drug patent terms and quicker introduction to lower cost generic drugs

Question 15

1987 Prescription Drug Marketing Act

Answer 15

Restricts distribution of prescription drugs to legitimate commercial channels; requires drug wholesalers to be licensed by the states

Question 16

1990 Omnibus Budget Reconciliation Act (OBRA)

Answer 16

Among other things, this act requires pharmacist to offer counseling to Medicaid patients regarding medication

Question 17

1990 Anabolic Steroid Control Act

Answer 17

Passed to “ address the abuse of steroids by athletes, and especially youngster”

Question 18

1996 Health Insurance Probability and Accountability Act

Answer 18

This Act defined the scope of health information that may and may not be shared among health care providers without patient consent and provided for broad and stringent regulations to protect patients right to privacy

Question 19

2003 Medicare Modernization Act

Answer 19

Establishes the optional Medicare Part D to provide coverage for prescription drugs and Medication Therapy Management (MTM)

Question 20

2005 Combat Methamphetamine Epidemic Act

Answer 20

Establishes strict controls of OTC sales of pseudoephedrine, ephedrine, and phenylpropanolamine

Question 21

2010 Patient Protection and Affordable Care Act

Answer 21

Health-care reform legislation of the 111th United States Congress intended to expand health insurance access for uninsured Americans

Question 22

2012 FDA Safety Innovation Act

Answer 22

Establishes user fees to enhance access to medications and medical devices and made provisions for addressing drug products shortages in the United States