Rx Law Assignment 1

Front 1

Requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. Act also requires FDA to use these funds to hire more reviewers to assess applications

Back 1

Prescription Drug User Fee Act (1992)

Front 2

Mandated individual health insurance , eliminated the Medicare Part D "donut hole" coverage gap, eliminated insurance premium discrimination for pre-existing medical conditions, established health insurance exchanges, and numerous other provisions

Back 2

Patient Protection and Affordable Care Act (2010)

Front 3

Improves safety and efficacy of patented and off-patent medicines for children. Market exclusivity of a drug is extended by six months when a manufacturer carries out studies of effects of drugs when taken by children

Back 3

Best Pharmaceuticals for Children Act (2002)

Front 4

Designed to improve the country's ability to prevent and respond to public health emergencies

Back 4

Public Health Security and Bioterrorism Preparedness and Response Act (2002)

Front 5

Regulated the OTC sale of any product containing ephedrine, pseudoephedrine, or pheylpropanolamine by placing them into a new category known as "scheduled listed chemical products" and limited the quantity that could be purchased in a 30-day period

Back 5

Combat Methamphetamine Epidemic Act of 2005

Front 6

Defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner, establishing two classes of drugs: prescription and over-the-counter.

Back 6

Durham-Humphrey Amendment (1951)

Front 7

Extended control to cosmetics and therapeutic devices, required new drugs to be shown safe before marketing, and numerous other provisions

Back 7

Food, Drug and Cosmetic Act of 1938

Front 8

Requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas

Back 8

Drug Importation Act (1848)

Front 9

Requires drug wholesalers to be licensed by states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons

Back 9

Prescription Drug Marketing Act (1988)

Front 10

Issued by FDA to prevent poisonings as results of deaths from cyanide placed in Tylenol capsules, which occurred in Chicago Illinois 1982, making it a crime to tamper with packaged consumer products

Back 10

Federal Anti-Tampering Act (1983)

Front 11

Prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs.

Back 11

Food and Drugs Act (1906)

Front 12

Established the Medicare Part D prescription drug benefit

Back 12

Medicare Prescription Drug Improvement and Modernization Act (2003)

Front 13

Authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S.

Back 13

Project BioShield Act of 2004

Front 14

Enabled FDA to promote research and marketing of drugs needed for treating rare diseases.

Back 14

Orphan Drug Act (1983)

Front 15

New sleeping pill is found to have caused birth defects in thousands of babies born in western Europe. News reports on role of Dr. Frances Kelsey, FDA medical officer, in keeping drug off the U.S. market, arousing public support for stronger drug regulation

Back 15

Thalidomide (1962)

Front 16

Passed to ensure drug efficacy and greater drug safety. For first time, drug manufacturers were required to prove their products were effective for their labeled indications to FDA before marketing them.

Back 16

Kefauver-Harris Amendment of 1962

Front 17

Poisonous solvent diethylene glycol kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

Back 17

Elixir of Sulfanilamide (1937)

Front 18

Established the first compendium of standard drugs for the United States.

Back 18

U.S. Pharmacopeia (1820)

Front 19

Passed to ensure safety and effectiveness of medical devices, including diagnostic products, requiring manufacturers to register with FDA and follow quality control procedures

Back 19

Medical Device Amendments of 1976

Front 20

Reauthorizes Prescription Drug User Fee Act of 1992 and contains numerous provisions including measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.

Back 20

Food and Drug Administration Modernization Act (1997)