CORRECT ANSWERS LATEST VERSIONALREADY

Federal Pharmacy Law ACTUAL EXAM 160 QUESTIONS AND

CORRECT ANSWERS LATEST VERSION//ALREADY

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What did the Pure Food and Drug Act of 1906 establish? - ANSWER-1. Prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded

• Did not require manufacturers to list ingredients or directions for use
• Did not regulate cosmetic products or medical devices

What did the Food, Drug, and Cosmetic Act (FDCA) of 1938 establish? - ANSWER-1. Required that any new drug could not be marketed unless it had first been proven to be safe when used according to directions on the label

• Included cosmetic and medical devices
• Drugs marketed prior to 1938 were grandfathered and did not have to be labeled or proven safe

What did the Durham-Humphrey Amendment of 1951 establish? - ANSWER-1. Amendment of the

FDCA that established two classes of drugs:

• Legend Drugs - Those that required medical supervision to be used safely did not have to list

adequate directions for use, but were required to include the legend "Caution: Federal law prohibits dispensing without a prescription."

• Products that did not require medical supervision for their use were classified as OTC or

nonprescription drugs

• Allowed oral prescriptions and prescription refills

What did the Kefauver-Harris Amendment of 1962 establish? - ANSWER-1. Amendment to the FDCA that required all new drugs marketed in the US have to be shown to be not only safe, but also effective

• Placed authority for regulating prescription drug advertising into the hands of the FDA
• Required informed consent for individuals who were research subjects in clinical investigations,

reporting of adverse drug reactions, and creation of Good Manufacturing Practice (GMP) requirements

What did the Medical Device Amendment of 1976 establish? - ANSWER-1. Amendment to the FDCA provided better classification of medical devices according the their specific function, 1 / 3

establishment of performance standards for these devices, pre-market approval requirements, conformance with GMP standards, and requirements for adherence to record and reporting requirements

What did the Orphan Drug Act of 1983 establish? - ANSWER-1. Provided various tax and licensing incentives to manufacturers of orphan drugs

• A rare disease is usually considered one that affects < 200,000 people in the US

What did the Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman) establish? - ANSWER-1. Amendment to the FDCA that streamlined the process for generic products by requiring submission of only an abbreviated new drug application (ANDA)

• Requires that proof of bioequivalence with the brand name counterpart be established
• Drug manufacturers were provided with incentives to develop new drug products by being

awarded up to five additional years of patent protection to compensate them for the lengthy time it takes to go through the FDA approval process

What did the Prescription Drug Marketing Act of 1987 establish? - ANSWER-1. Required that prescription drug wholesalers be licensed by states under federal guidelines

• Banned the re-importation of prescription drugs produced in the US
• Banned the sale, trade, or purchase of Rx drug samples
• Specified precise storage, handling, and record keeping requirements for drug samples
• Prohibited the resale of Rx drugs purchased by hospitals or health facilities

What did the FDA Modernization Act of 1997 establish? - ANSWER-1. Provisions for fast-track review of some New Drug Application submissions to expedite the approval of drugs used to treat serious or life threatening conditions

• Clarified the conditions under which pharmacies may perform extemporaneous compounding
• The prescription drug legend, "Caution: Federal law prohibits dispensing without a prescription" is

replaced with "Rx only"

• Eliminated the "Warning - May be habit forming" label
• Manufacturers may publicaly diseminate information about the unapproved uses provided a

statement is included specificying that the use has not been approved by the FDA

• Encouraged drug manufacturers to perform pediatric studies by providing them with an additional
• months of market exclusivity
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What did the Patient Protection and Affordable Care Act (Health Care Reform Act) of 2010 establish?

• ANSWER-1. Required that all individuals have health insurance
• Stop agreements between brand name and generic manufacturers to limit or delay competition

from generic drugs

• Phased elimination of the catastrophic threshold

What does it mean for a drug to be listed in USP/NF or HPUS? - ANSWER-It must meet the requirements specified in either book, otherwise the designation "Not USP/NF," which means the drug is considered to be either misbranded or adulterated

What is the AAC? - ANSWER-Actual Acquisition Cost (AAC) - The actual price a pharmacist pays when purchasing units of the drug

What is the AARP? - ANSWER-American Association of Retired Persons (AARP)

What is an ADE or ADR? - ANSWER-Adverse Drug Experience (ADE) or Adverse Drug Reaction (ADR)

What is the AMP? - ANSWER-Average Manufacturer Price (AMP) - Average price paid by wholesalers to a manufacturer for drugs that are to be sold at retail value

What is an ANDA? - ANSWER-Abbreviated New Drug Application (ANDA)

What is the ATF? - ANSWER-Alcohol, Tobacco, and Firearms agency (ATF)

What is the AWP? - ANSWER-Average Wholesale Price (AWP) - A published wholesale price for a drug product that can be used as the basis for pricing prescription drugs

What is a CAM? - ANSWER-Complementary and Alternative Medicine (CAM)

What is the CDER? - ANSWER-Center for Drug Evaluation and Research (CDER)

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