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100

What act requires OTC and legend drugs to be packaged in child-resistant containers?

Poison Prevention Packaging Act

100
Agency that regulates controlled substances.
Drug Enforcement Administration (DEA)
100

What Act created the FDA to oversee the safety of drugs?

Food, Drug, and Cosmetic Act of 1938

100
What controlled drug schedule does anabolic steroids belong to?
Schedule III
100

A reasonable probability exist that the use of the product will cause or lead to serious adverse health events or death.

Class I recall

200

A statute is a ________ that is passed by federal, state, or local legislatures.

law

200
Agency that regulates and maintains pharmacy practices in their state.
State Board of Pharmacy (SBOP)
200
Law that requires all prescriptions bear the legend, "Caution: Federal law prohibits dispensing without a prescription".
Durham-Humphrey Amendment of 1951 AKA the Prescription Drug Amendment
200
A law that requires all drug establishments register their products with the FDA.
Drug Listings Act of 1972
200

The use of the product will probably not cause an adverse health event.

Class III recall

300

The party that brings the action in a civil lawsuit is called:

Plaintiff

300
Law that was enacted to provide for federal inspection of meat and forbade the sale of adulterated food products and poisonous medications.
The Pure Food and Drug Act of 1906
300
The Food and Drug Administration Modernization Act of 1997 abbreviated the federal legend to say:
"Rx Only"
300
An act that requires pharmacists to offer counseling and perform DURs.
Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
300
The schedule of controlled substances of which there are no medical use and not accepted in the US.
Schedule I
400

The _____________  __________  _________ Act allowed re-importation of drugs into the U.S. by the manufacturer only.

Prescription Drug Marketing Act

400
Federal agency that is charged with protecting public health and safety through the investigation, identification, prevention, and control of disease.
Centers for Disease Control and Prevention (CDC)
400

This law was a legislative response to the Thalidomide Disaster and required drugs to be both safe and effective. 

Kefauver-Harris Amendment of 1962

400

The Federal Trade Commission (FTC) has the authority over____________________________________.

direct-to-consumer drug advertising

400
Schedule III- IV can be refilled ____ times within ____ months.
5 times within 6 months
500

An _________ drug is intended for the use in a few patients with a rare disease.

Orphan drug

500
Agency that is responsible for ensuring the safety, efficacy, and security of drugs and medical devices.
Food and Drug Administration (FDA)
500
A drug category that is currently accepted for medical use in the US and has a high potential abuse rate.
Schedule II drugs
500

What entity carries out a rigorous inspection during its accreditation process of hospitals?

Joint Commission

500

The main use for the FDA Orange book in the pharmacy is to

provide therapeutic equivalence for drug products