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WorksheetsPharmacy Tech Quiz: Laws and Regulations
Total questions: 20
Worksheet time: 10mins
Which act established the Food and Drug Administration (FDA) and required manufacturers to prove their drugs were safe before marketing them?
Food, Drug, and Cosmetic Act of 1938
Pure Food and Drug Act of 1906
Kefauver-Harris Amendment of 1962
Controlled Substances Act of 1970
The Pure Food and Drug Act of 1906 was the first law to regulate medications. What was its main purpose?
To require proof of drug effectiveness
To prohibit the sale of adulterated or misbranded food and drugs
To establish the DEA
To regulate drug advertising
What is the primary function of the Drug Enforcement Administration (DEA)?
Regulating over-the-counter (OTC) drugs
Overseeing the distribution and use of controlled substances
Approving new drug applications
Investigating pharmacy benefit managers (PBMs)
The Kefauver-Harris Amendment of 1962 was a direct response to the thalidomide tragedy. What did this amendment require?
That all drugs be proven safe
That all drugs be proven effective and safe
The creation of the DEA
A national registry for all pharmacists
Which act established two classes of drugs: prescription (legend) and over-the-counter (OTC)?
Prescription Drug Marketing Act of 1987
Durham-Humphrey Amendment of 1951
Poison Prevention Packaging Act of 1970
Comprehensive Drug Abuse Prevention and Control Act of 1970
The Controlled Substances Act (CSA) of 1970 created a schedule system for drugs with abuse potential. How many schedules are there?
3
4
5
6
Which schedule is defined as drugs with a high potential for abuse and no currently accepted medical use in the United States?
Schedule II
Schedule IV
Schedule I
Schedule V
The Poison Prevention Packaging Act (PPPA) of 1970 requires that most OTC and prescription drugs be packaged in what kind of containers?
Tamper-resistant
Light-resistant
Child-resistant
Easy-open
What year was the Health Insurance Portability and Accountability Act (HIPAA) enacted, and what is its primary focus?
1996; protecting patient privacy and health information
1970; preventing drug abuse
1987; regulating drug samples
2003; standardizing prescription formats
The Omnibus Budget Reconciliation Act (OBRA) of 1990 is significant because it requires pharmacists to perform what action for all Medicaid patients?
Offer new prescriptions at a lower cost
Provide a drug utilization review (DUR) and offer patient counseling
Collect a co-payment
Verify the patient's insurance information
The Anabolic Steroid Control Act of 1990 placed anabolic steroids into which drug schedule?
Schedule I
Schedule II
Schedule III
Schedule IV
The Combat Methamphetamine Epidemic Act of 2005 regulates the sale of products containing what ingredient?
Aspirin
Pseudoephedrine
Ibuprofen
Acetaminophen
Which act requires a unique 10-digit number, known as the National Drug Code (NDC), to be assigned to every drug?
Food, Drug, and Cosmetic Act of 1938
Drug Listing Act of 1972
Prescription Drug Marketing Act of 1987
Dietary Supplement Health and Education Act of 1994
What was the purpose of the Prescription Drug Marketing Act (PDMA) of 1987?
To prevent the reimportation of drugs and regulate drug samples
To mandate electronic prescriptions
To set standards for drug advertising
To create the first FDA drug safety program
The Drug Quality and Security Act (DQSA) of 2013 was a response to a fungal meningitis outbreak. What did it establish?
A nationwide prescription drug monitoring program
A system for tracking prescription drugs through the supply chain (drug supply chain security act or DSCSA)
The first national compounding standards
A requirement for all pharmacies to have a sterile compounding room
Which of the following laws allowed the FDA to regulate and approve biosimilar drugs?
Drug Price Competition and Patent Term Restoration Act of 1984
Biologics Price Competition and Innovation Act of 2009
Food and Drug Administration Safety and Innovation Act of 2012
The Family Smoking Prevention and Tobacco Control Act of 2009
The Dietary Supplement Health and Education Act (DSHEA) of 1994 placed the burden of proof for the safety and effectiveness of dietary supplements on what entity?
The FDA
The manufacturer
The consumer
The pharmacy
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was created to address what issue?
The illegal sale of prescription drugs over the internet
The counterfeiting of controlled substances
The promotion of illegal drug use on social media
The theft of controlled substances from pharmacies
Which act created a faster pathway for the FDA to approve generic drugs?
Pure Food and Drug Act of 1906
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
Prescription Drug Marketing Act of 1987
Medical Device Amendments of 1976
The first law to address consumer protection and drug safety was the Pure Food and Drug Act. What was the year of its creation?
1906
1938
1951
1962
