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Law Chapter 2
Terms in this set (73)
What are the functions of the FDA?
2. issue guidance documents
3. incorporate advice from standing advisory committees of outside experts
A DRUG is an article recognized in the USP or homeopathic pharmacopeia.
DRUGS do NOT inclue articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease.
Drugs can be articles other than food intended to affect structure or function of the body.
Why is the definition of a drug intentionally broad?
to include almost anything with an intended therapeutic purpose or purpose of altering the structure/function of the body
How do you know if its a food or drug?
its a food if its used for its ordinary purpose in an ordinary manner
What are the "legal categories" of food?
1. special dietary foods
2. Medical foods
What are publicly conceived categories of food?
nutraceuticals and functional foods
What can a manufacturer do to a food that might make it considered a drug?
having a health claim for the food
What is the Nutrition Labeling and Education Act of 1990?
allows foods to have health claims if approved by the FDA or by the "significant scientific agreement" test
How does a manufacturer get approval from the FDA to have a health claim on their food?
must submit considerable evidence to support the claim
What does DSHEA stand for?
Dietary Supplement Health and Education Act of 1994
What did DSHEA do?
created the category "dietary supplements"
What is a dietary supplement?
vitamin, mineral, herb, or other botanical; amino acid; substance used to supplement the diet by increasing total dietary intake
What are the 4 nutritional claims DSHEA permits?
1. benefiting a classical nutrient deficiency disease
2. describing role of DS in affecting the structure/function of the body
3. characterizing the mechanism by which a DS acts to maintain structure/function
4. statements of general well-being
A DS label must contain ______.
Health claims can be made without FDA approval.
True, but the claims must not be misleading or false and accompanied by a disclaimer. FDA allows qualified and unqualified health claims
Dietary supplements can be manufactured to concentrate the natural drug ingredient.
Can an article be a DS if it was approved as a drug prior to being marketed as a DS?
What is an adulterated product?
presenting significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.
Devices exclude articles that achieve their purpose through chemical action and metabolism
What is a cosmetic?
generally topical articles intended for cleansing, beautifying, or altering appearance
When can a cosmetic become a drug?
if the seller makes a health or structure/function claim
What is labeling?
written or printed graphic matter "accompanying" the article
What is the USP?
sets uniform standards
What is HPUS?
publish standards for homeopathy products
Most prohibited acts involve _____ and _____.
misbranding or adulteration
What can the FDA do to enforce authority?
2. criminal action
3. seizure of products
4. warning letters
Can a drug be considered adulterated based on the facility it was produced in?
When is a drug considered adulterated?
if its strength, quality or purity differs from the compendia standards, unless plainly stated on the label.
Or if strength, quality, or purity differs from the label
adulteration or misbranding?
Failure to manufacture product in a tamper-resistant container when required by law
misbranding is if the labeling is false or misleading
labeling must include a list of active ingredients, quantity, and inactive ingredients in alphabetical order
Label does not need directions for use or warnings against children or others whom use might be dangerous
If a drug cannot be labeled with "adequate directions for use," what must it contain?
"adequate information for use
it is misbranding if a drug imitates another drug
When are BBWs required?
when a drug may lead to serious injury or death
1st segment of an NDC identifies?
manufacturer or distributor
2nd segment of NDC identifies?
strength, dosage for, and formulation
3rd segment of NDC identifies?
package size and type of drug
What is a "new drug"?
drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the labeling
how can an approved drug become a new drug?
1. addition of new substance
2. new combination of approved drugs
3. change in proportion of the ingredients
4. new intended use
5. dosage, method, or duration of administration or application is changed
Why must a new drug application be submitted?
Notice of Claimed Investigational Exemption for a new drug must be received in order to ship drug to conduct phase 1-3 studies
How long does the FDA have to act on a completed NDA?
New drug approval is based on:?
safety & efficacy, manufacturing process, and risk-benefit ratio
What is a supplemental new drug application (SNDA)?
required when a manufacturer makes any change in an approved drug or in its production
What is a "change being effected" SNDA?
allows sponsor to make changes before FDA approval, which are important for labeling
What is risk evaluation and mitigation strategy (REMS)?
FDA require REMS as a condition for a new drug approval. REMS is to ensure benefits out weight the risks
What is postmarket labeling?
FDA can require manufacturers to add safety information or warnings postmarket
What is the Drug Efficacy Study Implementation (DESI)?
initiated to evaluate the efficacy of drugs approved between 1938 and 1962
The FDA created ANDA to do what?
require bioequivalence and manufacturing methods on generic drugs rather than proof of safety and efficacy
Is the manufacturing of generic drugs considered a "new drug?"
yes. US supreme court ruled and must seek FDA approval
Drug Price Competition and Patent Term Restoration Act (PTRA) of 1984 did what?
created the ANDA, which expedites generic approvals
Patent Considerations of ANDA?
1.parent drug's patent will not be infringed by the generic company
2. ANDA applicant must notify patent holder
How long is the delay for a generic manufacturer when the patent holder sues for patent infringement?
How does the OTC drug process differ from prescription drugs?
OTCs are approved on the basis of therapeutic category and conformance to a monograph rather than on a drug by drug basis
There are thousands of unapproved drugs on the market. How?
2. FDA hasn't removed all drugs lacking efficacy since DESI
3. Lax FDA polices on generic approvals prior to 1984
4. unscrupulous manufacturers
If a manufacturer obtains NDA approval for an unapproved marketed drug, all marketed drugs in the class must obtain NDA approval within one year.
When can a patient be treated with investigational drugs outside of phase 1, 2, 3 trials?
if patient has serious or life-threatening diseases for which no comparable or satisfactory alternative therapy is available and the risk from the drug is no greater than the risk of the disease
Abigail Alliance decision ruled what?
patient's do not have a constitutional right to investigational new drugs
What is "Fast Track" or expedited approval process?
expedited review possible for drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs for the condition
What are biologics?
products derived from living organisms
voluntary reporting system to allow report of AEs, product use errors, and product quality issues
Pharmacy patients are provided with an FDA MedWatch number
Medical Device Amendments of 1976
1. FDA can reclassify devices based on safety and efficacy
2. manufacturers and users must report death or serious injury from device
3. FDA can make firms notify healthcare professionals, repair or replace device, or refund.
4. FDA can recall device
Do cosmetics require premarket approval?
Can FDA remove cosmetics from market?
yes if misbranded, adulterated, or a health hazard
How are cosmetic ingredients labeled?
in order of predominance and appropriated warnings
Who regulates Rx drug advertising?
Who regulates OTC drug advertising?
Advertisements must contain?
true statement and brief summary
Brochures, booklets, mailings, bulletins, calendars, and other information distributed to healthcare professionals by a manufacturer is considered labeling
Lanham Trademark Act
prohibits use of false description or representation. allows for private cause of action and recovery of monetary damages
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