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Federal Drug Law Quiz 1

Terms in this set (39)

basically if the packing or drug is bad
Define Adulteration:
when labeling is false or misleading
Define Misbranding:
adulteration deals with a drug's strength, purity and quality, misbranding focuses on the representations made by the manufacturer on the label or labeling
Compare misbranding v. adulteration
widespread food and drug adulteration problems / law prohibited the adulteration and misbranding of foods and drugs in interstate commerce
What was the problem that caused the 'Pure Food and Drug Act of 1906'? What did the act do?
problem was that "miracle drugs" were being marketed and they were unsafe / act prohibited the marketing of new drugs until proven SAFE and approved by the FDA - Also must contain adequate directions for use / also applies to cosmetics and devices
What was the problem that caused the 'Food, Drug, and Cosmetic Act of 1938'? What did the act do?
problem was that (FDCA) required labels to contain "adequate directions for use", however, many drugs on the market were not safe unless given under medical supervision / Amendment established and 'RX' and 'OTC' Class / Labels on commercial bottles mist have legend "Caution, federal law prohibits dispensing without a prescription" or "RX only"
What was the problem that caused 'Durham-Humphrey Amendment of 1951? What did the amendment do?
problem (thalidomide tragedy), was that a sleep aid was being used as morning sickness for women (causing babys to have seal limbs) / amendment stated that drugs must also be proven 'effective' in addition to safe (also caused FDA to take over advertising of prescription drugs)
What was the problem that caused 'Kefauver-Harris Amendment of 1962'? What did the amendment do?
Problem was that the FDA had no authority to review medical devices for safety and efficacy before marketing under the FDCA / 1. required premarket approval (not for all devices) 2. Good manufacturing practices 3. adherence to record and reporting requirements 4. classification of device according to function
What was the problem that caused 'Medical Device Amendments of 1976'? What did the amendment do?
problem was that it was expensive for drug manufacturers to develop and market drugs that effect relatively few people / provided tax and licensing incentives for manufacturers who developed drugs or biologicals for rare diseases or conditions
What was the problem that caused 'Orphan Drug Act of 1983'? what did it do?
caused companies to be able to make generic drugs with bioequivalence testing (lazy companies were half-ass making generics)
What was the DPC and PTRA Act of 1984?
forced FDA to regulate dietary supplements more as foods than as drugs / created the class of 'Dietary supplements'
What was the purpose of DSHEA of 1994?
1. articles recognized in USP of HPUS
2. articles intended for use in diagnosis, cure, mitigation, treatment or prevention of disease
3. articles other than food intended to affect the structure or function of the body
What is a drug?
FDA
If it is deemed to be a drug, who has authority?
special dietary need that exists for disease, pregnancy, infancy, underweight, overweight, sodium restriction...etc
What are special dietary foods?
Amino acid restrictions
What are medical foods?
article intended to be rubbed, poured, sprinkled, or sprayed on, to apply to the human body of any part to clean, beautify, etc...
What is a cosmetic?
viatmin, mineral, herb, or other botanical, amino acid, or substance used to supplement the diet by increasing total dietary intake
What is a dietary supplement?
1. recognized in USP formularly
2. for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
3. to affect the structure or any function of the body of man or other animals
4. does not achieve purposes through chemical action within or on the body of man or animal, is not metabolized
What is a device?
NO
can dietary supplements contain an FDA approved drug?
1. Benefiting a classical nutrient deficiency disease
2. Describing the role of the DS in affecting the structure/function of the body
3. Characterizing the mechanism by which a DS act to maintain the structure or function
4. Statements of general well-being
What are the 4 types of nutritional support claims?
"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
What label disclaimer must be on dietary supplements?
misbranding and/or adulteration. / 1.recepient and subsequent delivery of an adulterated or misbranded drug
2. doing of any act which causes a drug to be counterfeit
3. alteration or mutilation of the labeling
What are most prohibited acts by the FDCA and what are applicable to pharmacies?
Class 1: Least regulation, must register facility and products, maintain records, reports etc.. (needles, scissors, exam gloves, stethoscopes, toothbrushes...)
Class 2: Specific performance standards required to be met ( insulin syringes, infusion pumps, thermometers, diagnostic reagents, electric heating pad)
Class 3: Must have premarket approval because of unreasonable risk of illness or injury (soft contact lenses, pacemakers, replacement heart valves)
What are the classes of medical devices and give examples
class 1: reasonable probability for serious adverse health consequences or death
class 2: may cause temporary or medically reversible adverse health
Class 3: not likely to cause adverse health consequences
What are the 3 classes of recall?
approved by the FDA
No person may introduce a new drug into interstate commerce unless ____________
Phase 1: toxicity, metabolism, bioavailability, elimination (test on healthy patients)
Phase 2: test on patient with actual disease
Phase 3: tested on lots of patients (after phase 3 the NDA is submitted to FDA for approval)
Phase 4: post-approval clinical studies (may not be required)
What is the new drug process?
180 days
After the NDA has been submitted, how long does the FDA have?
When it is possible for the drug to treat a life-threatening disease (conditional on manufacturer agreeing to phase 4)
Expedited review can happen when?
terminate at any time and its not subject to judicial review
The FDA can do what to testing?
1. name and address of manufacturer
2. Established name of drug (generic/brand)
3. Ingredient information
4. strength
5. quantity
6. symbol (RX only)
7. Route, LOT, Storage
8. Container to dispense
9. Expiration date
What must a prescription drug label have?
Adequate directions for use
OTC and RX both must have what?
1. generally recognized as safe and effective for the claimed therapeutic indication
2. Not generally recognized as safe and effective or unacceptable indications
3. insufficient data to permit classification
What are the categories of OTC products?
FDCA requires all advertisements to be objective and not misleading (anything given to professionals is labeling)
Advertising: Manufacturer to professionals
No specific laws - FDA allows manufacturers to provide a summary or risk, provided the consumer is offered full labeling information from another source - present info in user friendly ways
Advertising: Manufacturer to Consumers
guidance documents
____________ permit companies to distribute off-label use information subject to restrictions
FTC
Who regulates advertising of nonprescription drugs?
FDA regulates advertising
Who regulates advertising of prescription drugs?
1. Medication Guide or Package insert (required to be dispensed with the drug)
2. Communication Plan (education sent to providers)
3. Elements To Assure Safe Use (required medical interventions or other actions healthcare professionals need to execute prior to PRESCRIBING or DISPENSING the drug to the patient...aka lab tests, training,etc....)
4. Implementation System (drugs manufacturer takes reasonable steps to monitor and evaluate those in the healthcare system who are responsible for implementing ETASU measures
What are the 4 elements of REMS?
pharmacies
____________ must keep documentation of compliance with ALL REMS programs
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