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Law Exam 2, Part 1
Highlights from slides 1 - 42 (through Medicaid) of the Pre-Exam Review presentation.
82
Health Care
Professional
04/10/2010
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Term
The goal of the Pure Food and Drug Act of 1906 is:
 Definition
Accurate labeling of food and drugs
Term
The Pure Food and Drug Act of 1906 aims for accurate labeling of food and drugs based on these two things:
 Definition
Adulteration and misbranding
Term
This law recognized the USP-NF as the official standard for drugs:
 Definition
The Pure Food and Drug Act of 1906
Term
This law replaced the Pure Food and Drug Act of 1906:
 Definition
Food, Drug, and Cosmetic Act
Term
The Food, Drug, and Cosmetic Act mandated these three things for drug:
 Definition
New drugs must be proven safe for use under labeled conditions, Labeling to contain adequate directions for use, approval by FDA required
Term
Quality assurance of cosmetics and devices is included under this law:
 Definition
Food, Drug, and Cosmetic Act
Term
True or False: Drugs developed and marketed before 1938 are not subject to the Food, Drug, and Cosmetic Act:
 Definition
True
Term
The Food, Drug, and Cosmetic Act of 1938 defines "Food" as:
 Definition
Articles used for food or drink for man or other animals; chewing gum; articles used for components of any such article
Term
The Food, Drug, and Cosmetic Act of 1938 defines "Drugs" as:
 Definition
Articles listed in the USP or NF; articles other than food intended for the diagnostis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body; intended to be used as a component of any of the above.
Term
The Food, Drug, and Cosmetic Act of 1938 defines "Device" as:
 Definition
An instrument, apparatus, implement, machine, contrivance, implant, invitro reagent, or other similar or related article intended for the diagnosis, cure, mitigation, treatment, or prevention of disease or other medical conditions, AND DOES NOT ACHIEVE ITS EFFECT BY CHEMICAL ACTION OR BY BEING METABOLIZED.
Term
The Food, Drug, and Cosmetic Act of 1938 defines "Adulteration" as:
 Definition
Failure to conform to USP-NF standards for purity, quality, strength, and appropriate assays or not stored under USP standards
Term
Failure to store a drug under USP standards is an example of:
 Definition
Adulteration
Term
Incomplete or misleading labeling is an example of:
 Definition
Misbranding
Term
Labeling of all legend and OTC drugs is approved by the:
 Definition
FDA
Term
This amendment to the FDCA of 1938 created a new class of drugs -- OTC drugs:
 Definition
Durham-Humphrey Act
Term
The Durham-Humphrey Act states that drugs not requiring medical supervision for their safe use are referred to as:
 Definition
OTC drugs
Term
The Durham-Humphrey Act states that drugs not requiring medical supervision for their safe use are referred to as:
 Definition
OTC drugs
Term
The Durham-Humphrey Act states that drugs not requiring medical supervision for their safe use are referred to as:
 Definition
OTC drugs
Term
The Durham-Humphrey Act states that drugs not requiring medical supervision for their safe use are referred to as:
 Definition
OTC drugs
Term
The Durham-Humphrey Act states that drugs not requiring medical supervision for their safe use are referred to as:
 Definition
OTC drugs
Term
This law mandates that drugs requiriing medical supervision for their safe use must have a "legend" stating, "Caution: Federal law prohibits dispensing without a prescription":
 Definition
Durham-Humphrey Act
Term
The Durham-Humphrey Act created which two categories of drugs:
 Definition
OTC Drugs and Legend (Rx) drugs
Term
This law adds efficacy to safety as a prerequisite for FDA new drug approval:
 Definition
Kefvauer-Harris Amendment to the FDCA of 1938
Term
This law shifted from pre-market "notification" to FDA pre-market "approval" by the FDA:
 Definition
Kefvauer-Harris Amendment
Term
This law established Good Manufacturing Practices, and adds clinical study oversight safeguards and important patient protections:
 Definition
Kefvauer-Harris Amendment
Term
The Kefvauer-Harris Amendment mandates that drugs may not be marketed unless:
 Definition
1) Proven safe and effective for intended use; 2) adequate labeling (approved by FDA); 3) meetgs Good Manufacturing Practices; 4) produced by a registered manufacturer
Term
This class of medical devices must be approved by the FDA:
 Definition
Class III Devices (high risk)
Term
This class of medical devices includes infusion pumps, x-ray machines, and powered wheelchairs:
 Definition
Class II Devices (medium risk)
Term
Low risk medical devices are categorized as which class of device?
 Definition
Class I
Term
Class III devices must be proven safe and effective in clinical trials, and pass ______________.
 Definition
FDA premarket approval process (510K)
Term
An orphan drug is one used to treat a disease affecting < _____________ in the U. S.
 Definition
200,000
Term
Companies are given tax reductions and extended marketing exclusitivity for _____ years post-FDA approval for orphan drugs.
 Definition
Seven
Term
This law mandates that demonstration of bio-equivalency is sufficient data to approve a generic drug:
 Definition
Waxman-Hatch Amendment
Term
The Waxman-Hatch Amendment granted patent term extensions to brand name drugs for up to how many years?
 Definition
Five
Term
This law requires the FDA to publish the "Orange Book" of brand/generic bioequivalency:
 Definition
Waxman-Hatch Amendment
Term
This law created the Abbreviated New Drug Application:
 Definition
Waxman-Hatch Amendment
Term
This law mandates record-keeping and re-sale limits on "samples":
 Definition
Prescription Drug Marketing Act
Term
This law prohibits the re-sale of drugs bought by non-profit institutions except for its own patients, employees, and related entities (i.e., "Own Use" doctrine):
 Definition
Prescription Drug Marketing Act
Term
This law requires state licensure of wholesalers and other secondary distributors, repackagers, etc.:
 Definition
Prescription Drug Marketing Act
Term
True or False: The Prescription Drug Marketing Act prohibits retail pharmacies from receiving drug samples.
 Definition
True
Term
True or False: The Prescription Drug Marketing Act does NOT allow the use of "starter packs" to be distributed free of charge to pharmacies.
 Definition
False -- The PDMA does allow the use of starter packs to be distributed free of charge to pharmacies
Term
True or False: Vouchers and coupons are allowed to be redeemed at a pharmacy due to the Waxman-Hatch Act.
 Definition
False -- They are allowed under the Prescription Drug Marketing Act
Term
Which of the following is not mandated by the Prescription Drug Marketing Act?

a)Hospitals may receive samples only if requested by a physician

b)Sales reps are held responsible for all samples and take an annual inventory

c) Allows drugs to be re-imported into the U. S. by wholesalers

d) Mandates proper storage and distribution records
 Definition
C -- Only the manufacturer may re-import drugs into the U. S.
Term
This law standardizes "descriptor" use, such as: "Low" calorie, sugar "free", "light", and "high" fiber:
 Definition
Nutrition and Labeling Eduaction Act
Term
This law regulates nutrient/disease relationships, such as: Calcium/osteoporosis, fiber/cancer, and sodium/hypertension:
 Definition
Nutrition and Labeling Education Act
Term
This law requires dietary supplements to include a "Statements not evaluated by FDA" disclaimer:
 Definition
Dietary Supplement and Health Education Act
Term
The Dietary Supplement and Health Education Act prohibits dietary supplements from making these claims:
 Definition
"_____ is intended to treat, prevent, or cure".
Term
Which of the following is illegal under the Dietary Supplement and Health Education Act?
a) "Bob's smiling now that he's got a little 'spring' back in his step thanks to Enzyte."

b) "Take Viactive to help prevent osteoporosis!"

c) "Hi, Billy Mayes here with a great new thing to help you lose weight along with diet and exercise!"

d) "Take No-Doz to help you stay focused!"
 Definition
B -- This clearly states that Viactive is intended to prevent a disease
Term
Which phase of clinical trials involves limited trials in patients with a disease?
 Definition
Phase II
Term
This phase of clinical trials typically enrolls healthy volunteers:
 Definition
Phase I
Term
In vitro and in vivo animal testing is performed during this phase of the new drug development process:
 Definition
Pre-clinical testing
Term
This form is the first application that a manufacturer must submit to the FDA:
 Definition
Investigational New Drug
Term
How long does the FDA have to approve an Investigational New Drug Application?
 Definition
30 days
Term
The purpose of phase I clinical trials is to:
 Definition
Evaluate toxicology/safety and pharmacokinetics
Term
The purpose of phase III clinical trials is to:
 Definition
Compare effectiveness versus standard therapy
Term
The typical sample size of a phase III trial is:
a) < 100
b) 100 - 1000
c) 1000+
d) 10,000-100,000+
 Definition
C -- Very large groups of thousands of patients
Term
When may a New Drug Application be submitted?
 Definition
After phases I, II, and III clinical trials
Term
When may an Abbreviated New Drug Application be used?
 Definition
For approval of generic drugs
Term
A manufacturer must submit this application to make changes in a drug's synthesis, production procedures, packaging, labeling, etc.:
 Definition
Supplemental New Drug Application
Term
The first five digits of an NDC identify whom?
 Definition
The manufacturer
Term
The last five digits of an NDC identify what?
 Definition
The drug and package size
Term
True or False: All prescription drugs must use child-resistant containers, per the Poison Prevention Packaging Act.
 Definition
False -- There are some exceptions for certain listed products.
Term
The standards for child resistant containers state that at least ___% of adults having been shown how, can open the container within 5 minutes.
 Definition
90
Term
The standards for child resistant containers state that not mroe than ____% of children < 5 y/o, having been shown how, can open within 5 minutes.
 Definition
20%
Term
True or False: Child resistant containers may be reused up to three times.
 Definition
False -- CRCs may NOT be reused.
Term
True or False: Prescribers may request that a child resistant container not be used, as well as make a "Blanket" request.
 Definition
False -- Prescribers may NOT make blanket requests
Term
True or False: Patients may make blanket requests to not use child resistant containers.
 Definition
True
Term
An Orange Book therapeutic equivalence evaluation of "A" means the products are considered ________________.
 Definition
A = products are considered therapeutically equivalent to "reference" product
Term
"B"-rated products are considered:
 Definition
Not therapeutic equivalents
Term
"AB" rated products are products that have:
 Definition
Actual or potential equivalency problems
Term
The recall of a product that is likely to cause injury or death is which class of recall?
 Definition
Class I
Term
Class II product recalls are for drugs that:
 Definition
May cause temporary or reversible health problems from use of the drug
Term
Which class of drug recall is assigned to products that are not likely to cause health problems?
 Definition
Class III
Term
Minor health risks or minor FDA violations may result in this type of recall:
 Definition
Market withdrawal
Term
The expiration date for compounded non-aqueous liquids and solids is:
 Definition
Not more than 25% of the time remaining on the commercial product or a maximum of 6 months (whichever is less)
Term
The expiration date for compounded aqueous solutions obtained from manufactured products is:
 Definition
14 days when stored at a cold temperature
Term
For all other compounded products besides non-aqueous liquids and solids and aqueous solutions the expiration date is:
 Definition
No more than 30 days.
Term
A physician obtains his DEA number before 1985. What is the first letter of his DEA number?
 Definition
A
Term
A physician receives his DEA number in 1985. What is the first letter of his DEA number?
 Definition
B
Term
A nurse practitionre is assigned a DEA number. What is the first letter of the DEA number?
 Definition
M
Term
Medicare Part A covers what?
 Definition
Hospital services
Term
In order to qualify for Medicaid, a person must be deemed either ____________ or ____________.
 Definition
Medically indigent (Blind, disabled, aged) or Financially indigent (No or low income and asset base)
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