The Early Days
A Bunch of Hippies
Totally 80's
Modern Times
I went to Harvard.
100
This law enacted in 1906 was inspired by the publication of Upton Sinclair's The Jungle.
What is Pure Food and Drug Act of 1906.
100
Double Jeopardy: The Federal Drug Administration (FDA) is a federal agency under this executive office.
What is Department of Health and Human Services.
100
This act was passed to provide exclusive licensing incentives for manufacturers to develop and market drugs/biological for treatment of rare disease or conditions (affecting fewer than 200,000 Americans).
What is the Orphan Drug Act
100
This law required pharmacists to OFFER counseling to all patients receiving prescriptions; a patient waiver must be signed if the patient refuses.
What is the Omnibus Budget Reconciliation Act (OBRA) 1990
100
Soma (carisopradol) is a schedule ____ drug.
What is schedule IV.
200
Importation of this substance from China and other Asian countries lead to the Harrison Narcotic Act of 1914.
What is opium.
200
This drug lead to the passage of the Kefaeuver-Harris Amendment 1962 which requires drugs to show efficacy AND safety prior to approval.
What is thalidomide.
200
This amendment helped streamline the process of approval for generic medications, creating an abbreviated NDA process and started the first listings of bioequivalent drugs (Orange Book).
What is Hatch-Waxman Amendment 1984
200
US law designed to provide privacy standards to protect patients' medical records and other personal health information provided to health plans, doctors, hospitals and other health care providers.
What is HIPAA (Health Insurance Portability and Accountability Act)
200
FDAs publication of Approved Drug Products with Therapeutic Equivalence Equations
What is the Orange Book.
300
Double Jeopardy: How many numbers are contained in a National Drug Code (NDC)?
What is eleven.
300
This act of 1970 requires child-resistant packaging for all human, oral prescription drugs, most OTCs, and some household hazardous substances
What is Poison Prevention Packaging Act 1970
300
Double Jeopardy: This is the number of times a prescription for a C2 can be transferred in the state of Kansas?
What is zero.
300
This was an amendment to the Federal Food, Drug, and Cosmetic Act to establish standards for dietary supplements
What is Dietary Supplement Health and Education Act 1994
300
This type of recall signifies there is reasonable probability that using the drug will cause serious adverse health consequences or death
What is a Class I Recall.
400
This law enacted in 1938 expanded the purity standards outlined in the Pure Food and Drug Act to include cosmetics and devices.
What is Food Drug and Cosmetic Act of 1938.
400
The FDA Bureau of Drug Abuse Control and Treasury Department Bureau of Narcotics are both transferred to the Department of Justice and combined to form this agency, consolidating efforts to police traffic in abused drugs.
What is the Bureau of Narcotics and Dangerous Drugs (BNDD)
400
Double Jeopardy: This is the number of students or interns a pharmacist licensed in the state of Kansas can precept at any given time.
What is two.
400
This added part D to Medicare, providing an optional prescription drug benefit program.
What is Medicare Prescription Drug, Improvement and Modernization Act 2003
400
This law prohibits physicians from self-referring Medicare and Medicaid patients - that is, referring a patient to a medical facility from which the physician stands to gain financially
What is Stark's Law.
500
This legislation passed in 1951 differentiated created two drug classes: prescription and over the counter (OTC).
What is Durham Humphrey Amendment 1951
500
Title 2 of this act passed in 1970 requires that pharmacies be registered with the DEA to distribute controlled substances.
What is the Comprehensive Drug Abuse Prevention and Control Act.
500
Double Jeopardy: This is the number of months a C2 prescription is valid from the date it is written.
What is six months.
500
This law regulates over the counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine, limiting daily and 30-day sales, required log books and ID verification, as well as placing product behind the counter.
What is Combat Methamphetamine Epidemic Act 2006
500
FDAs regulation on the promotion of off-label prescribing of medications
What is Off-Label Prescribing of Prescription Drugs 1999