Drug Regulations

Question 1

Food and Drug Act of 1906

Answer 1

Prohibits interstate commerce in adulterated or misbranded drugs, government pre approval of drugs is required.

Question 2

1914 Harrison Tax Act

Answer 2

In response to growing addiction of opiates and cocaine containing medicines. Establishes pharmacist, importers and physicians prescribing narcotics should be licensed and require to pay a tax.

Question 3

1927 Food, Drug and Insecticide Administration

Answer 3

The law enforcement agent is formed; would be renamed in 1930 as the food and drug administration.

Question 4

1938 Food Drug Cosmetic Act

Answer 4

In response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction. Requires new drugs to be safe for marketing.

Question 5

1950 Alberty Food Products v. U.S

Answer 5

US 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 label “RX Only”.

Question 7

1962 Kefauver-Harris Amendment

Answer 7

Requires drug manufacturer 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 honestly and informatively labeled.

Question 10

1970 Poison Prevention Packaging Act

Answer 10

Requires child proof packaging on all controlled/most prescription drugs dispensed by pharmacies. Non childproof containers may only be used if requested by patient.

Question 11

1970 Controlled Substances Act (CSA)

Answer 11

Classifies 5 levels of controlled substances that have potential for abuse and therefore restricts their distribution. Established by the DEA as a division of the Justice Department.

Question 12

1983 Orphan Drug Act

Answer 12

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

Question 13

1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)

Answer 13

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

Question 14

1987 Prescription Drug Marketing Act

Answer 14

Restricts distribution of prescription drugs to legitimate commercial channels. Requires drug wholsalers to be licensed by the states.

Question 15

1996 Health Insurance Portability and Accountability Act

Answer 15

Defined the scope of healthcare info that may/may not be shared among healthcare providers without patient consent. Protects patient’s right to privacy. These regulations govern the transfer of patient health info.

Question 16

2003 Medicare Modernization Act

Answer 16

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

Question 17

1976 Medical Device Amendment

Answer 17

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

Question 18

1990 Omnibus Budget Reconciliation Act (OBRA)

Answer 18

Requires pharmacists to offer counseling to Medicaid patients regarding medications.

Question 19

1990 Anabolic Steroid Control Act

Answer 19

Passed to “address the abuse of steroids by athletes, and especially youngsters and teenagers”.

Question 20

2005 Combat Methamphetamine Epidemic Act

Answer 20

Establishes strict controls on 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 and Innovation Act

Answer 22

Establishes user fees to enhance access to medications and medical devices. Made provisions for addressing drug product shortages in the US.