Laws & Dates

Question 1

Harrison Tax Act

1914

Answer 1

Established that manufacturers, pharmacists, importers and physicians prescribing narcotics are licensed and taxed.

Question 1

Combat Methamphetamine Epidemic Act

2005

Answer 1

Reclassifies and restricts access to products containing pseudoephedrine.

Question 2

CSA

Controlled Substance Act

1970

Answer 2

The DEA was established as a division of the justice department and classifies 5 levels of drugs that have potential for abuse

Question 3

Drug Price Competition & Patent-Term Restoration Act

1984

(Hatch-Waxman)

Answer 3

Encouraged quicker introduction of both generic and new drugs and extension of patent terms

Question 5

Laws & Dates

Durham-Humphrey Amendment 1951

Answer 5

Explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC); requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, “Caution: Federal law prohibits dispensing without a prescription.”

Question 5

Dual Marketing Status

Answer 5

17 years old and younger need a prescription but 18 & over it’s OTC

Question 7

Exempt Narcotics

Answer 7

Medications that contain habit forming ingredients, but can be sold by a pharmacist without a prescription to persons 18 or older with 48 hour dosage limits with records maintained in a bound book

Question 8

FDC

Food, Drug & Cosmetic Act

1938

Answer 8

Created FDA and required manufacturers to file new drugs before marketing.

Question 9

Food, Drug administration Act

2004

Answer 9

Rx Only instead of legend phrase

Question 10

HIPPA

Health Insurance Portability & Accountability Act

1996

Answer 10

Established safeguards to protect patient confidentiality, to keep insurance when moving to new job.

Question 11

Kefauver-Harris Amendment

1962

Answer 11

Requires that drugs not only be safe for humans, but also effective

Question 12

Omnibus Budget Restoration Act

1990

Answer 12

Requires offer of counsel to Medicare patients regarding their medications

Question 13

Orphan Drug Act

1983

Answer 13

Encourages development of new drugs to treat rare diseases by providing tax incentives and fast review.

Question 14

Poison Prevention Packaging Act

1970

Answer 14

Mandated child-resistant containers (some exceptions)

Question 15

Pure Food & Drug Act

1906

Answer 15

Prohibited Interstate transportation and sale of adulterated or misbranded food and drugs

Question 16

The Thalidomide Lesson

Answer 16

In 1962 a new sleeping pill was found to cause severe birth defects when used by pregnant women. From then on drugs needed to be safe and effective before marketed.