chapter 2 Flashcards
The Pure Food and Drug Act prohibited the
adulteration and misbranding of Foods and Drugs. IT DID NOT REGULATE the adulteration and misbranding of devices and cosmetics.
The Pure Food and Drug Act only prevented false statements on a drugs ____
Identity ( strength, quality, and purity). IT DIDN’T prevent false or misleading efficacy claims. IT didn’t include list of ingredients, directions for use or provide warnings.
The Food Drug and Cosmetic Act provides for the comprehensive regulation of all drugs introduced into interstate commerce. The intent of this law is to protect consumers from adulterated or misbranded _____, _____, _____ or ______. It also said NO NEW DRUG can be marketed and sold unless ______
foods, drugs, cosmetics, and devices
it has been proved to be both safe and effective for its intended use, described on the label and approved by the FDA.
The Food Drug and Cosmetics act also expanded on the definitions of ____ and ____ requiring that labels must also contain _______ and ______ about the habit forming properties of certain drugs.
misbranding and adulteration
adequate directions for use
warnings
The FDA is a component of the _____ and has actual authority for administering the _____
Department of Health and Human Services (DHHS)
Food Drug and Cosmetic Act (FDCA)
The Office of Medical Products and Tobacco: coordinates and leads the scientific and regulatory evaluations and interpretations for ______.
Drugs, Biologics, Medical Devices, and Tobacco Products
The FDA interprets the FDCA through both _____ and ______
rulemaking (regulations) AND
by the means of guidance documents
The term “drug” means _______ (under section A)
articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them
The term “drug” means ________ (under section B)
articles intended for use in the diagnosis, cure, mitigation, treatment, or other prevention of disease in man or other animals
The term “drug” means _____- (under section C)
articles (other than food) intended to affect the structure or any function of the body of man or other animals
The Office of Medical Products and Tobacco - coordinates and leads scientific and regulatory evaluations and interpretation for _____
Drugs
Biologics
Devices
Tobacco
The Food Drug Cosmetic Act, once passed in 1938 required that no new drug can be marketed unless it is proven to be _____. It didn’t initially require a drug be _____ until the _______ came into legislation.
safe
effective
Kefauver-Harris Amendment
The Food Drug Cosmetic Act created 2 special categories of foods _____ and _____.
Special Dietary foods
Medical foods
TRUE or FALSE
Special dietary foods and Medical foods are not considered drugs
True
TRUE or FALSE
Special dietary foods and medical foods can make therapeutic health claims
True
The Dietary Supplement and Education Act (DSHEA) - created a new special category of foods called ____
dietary supplements
The Dietary Supplement Health and Education Act mandates that the FDA regulates dietary supplements more as a _________ rather than ______
special type of food
rather than a drug
A dietary supplement is defined as a _____, _____, _______ or other ______, ______, or substance used to supplement the diet by increasing total dietary intake.
vitamin mineral herb botanical amino acid
TRUE or FALSE
Dietary supplements require premarket approval
False
they do not require
TRUE or FALSE
The DSHEA altered the FDA’s authority to regulate dietary supplements
True
prior to the DSHEA amendment the FDA had regulated dietary supplements as drugs
The DSHEA permits(allows) four types of nutritional support claims to be made:
1-benefitting a classical nutrient deficiency disease
2-describing role of the dietary supplement in affecting the structure/function of the body (as long as NOT making a health or therapeutic claim)
3-characterizing the mechanism by which a DS acts to maintain the structure or function
4-statements of general well-being
-claims must be substantiated as truthful and not misleading
-the label must contain a disclaimer
True or False
The Dietary Supplement Health and Education Act excludes an article as a dietary supplement if it was approved as a drug prior to being marketed as a dietary supplement.
True
Infant formulas, artificial sweeteners and caloric supplements are examples of ______
special dietary foods
Define Medical Foods
are foods formulated for oral or external use under the supervision of a physician and that are intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements are established by medical evaluation.
TRUE or FALSE
Medical foods must be specially formulated or naturally occurring, and must provide nutritional requirements that would be impossible for the patient to meet through a normal diet.
False
medical foods can NOT be naturally occurring
The Dietary Supplement Health and Education allows Dietary Supplement manufacturers to make health claims if either __________ or ___________
the FDA approves the claim by regulation
OR
by the significant agreement test
After the Pearson Case dietary supplement and food manufacturers could make either ___________ or _________ health claims
unqualified OR qualified
In order for dietary supplements to make any of the 4 nutritional support claims, it must have substantiation that they are truthful and not misleading, and the label must contain the disclaimer ______
“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”
How long does the manufacturer have to notify the FDA if it makes one of the permitted statements?
within 30 days
TRUE or FALSE
Unqualified health claims require a disclaimer as pursuant to Pearson
FALSE
unqualified health claims DO NOT require a disclaimer
Dietary Supplement and Food manufacturers are allowed to make unqualified health claims if ________
Authorized by the agency by means of a regulation because the manufacturer met the significant scientific test.
TRUE or FALSE
Qualified health claims must contain a disclaimer as pursuant to Pearson
TRUE
The Pharmanex case established that a dietary supplement CANNOT be _______________ to concentrate the ______________
specially manufactured
natural drug ingredient
The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires _____________ to report serious adverse events from there products within ______
manufacturers, packers or distributers whose name appears on the label to to report serious adverse events from there products within 15
business days of receiving the report.
TRUE or FALSE
The FDA can remove a dietary supplement from the market at any point
FALSE
The FDA can only remove a dietary supplement from the market on the basis of public safety only if the agency can prove the product is adulterated.
The Durham-Humphrey amendment established what two classes of drugs?
OTC and prescription
The Durham-Humphrey amendment: also legally established
- The verbal transmission of prescriptions
- The legal right for pharmacists to honor refill authorizations
- criteria for distinguishing prescription drugs from OTC drugs
TRUE or FALSE
Prior to the Durham-Humphrey Amendment, it was the manufacturers that determined if there product should be OTC or prescription
TRUE
TRUE of FALSE
The Durham-Humphrey Amendment, specifies the minimum information that a dispensed Rx label must contain
TRUE
The Kefauver-Harris amendment required that drugs be proved not only to be ____ but ______
safe and effective
The Orphan Drug Act provided: tax and exclusive incentives for manufacturers to develop and market drugs or biologics for the treatment of __________
rare disease or conditions
The Prescription Drug User Fee Act (PDUFA) requires manufacturers seeking approval of a new drug application (NDA) to pay fees for applications and supplements when the FDA must review _______
clinical studies
The Food and Drug Administration Modernization act (FDAMA) created a _____________- approval process for drugs intended for serious life threatening conditions.
fast traack
Almost any food may be considered a drug if a ___________ or ________ is made for it. Therefore the FDCA has created the following two special foods categories ______ and ______-
therapeutic claim
health claim
Special dietary foods
Medical foods
Under the Dietary Supplement Health and Education Act (DSHEA) a dietary supplement is defined as a product that is intended for ingestion and is intended to supplement the diet and contains any one or more of the following_______
vitamin, mineral, herb or other botanical, amino acid
DSHEA (Dietary Supplement Health and Education Act exempts Dietary Supplements from the part C of the drug definition and this permits
structure/function claims
The FDA can remove a dietary supplement from the market on the basis of public safety only if the agency can prove the the product is ____
adultered
The Medical Device Amendment (MDA) differentiates devices from drugs by stating that a device does not achieve any of its principle intended purposes through __________ and is not dependent on being ________ for the achievement of any of its principles intended purposes.
chemical actions
metabolized
A cosmetic may become a drug if its ___________ fits under the drug defintion
intended use
The (FDCA) Food Drug and Cosmetic Act differentiates the definition of “label” from that of “labeling”
The term “label” means _________________
The term “labeling” means_______________
label: means a display of written, printed or graphic matter upon the immediate container of any article
Labeling: means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers or accompanying such article
Qualified health claims may be made when a claim does not meet the significant scientific agreement test and the claim ____________
would be misleading without qualifications. Qualified claims will be allowed only when there is more evidence for the claim than against it. Qualified health claims MUST have a disclaimer.
The United States Pharmacopeia of the United States establishes ________ standards and the Homeopathic Pharmacopeia of the United States establishes ___________ product standards.
Uniform drug
Homeopathic
The FDCA establishes 2 major offenses ________ and _______
adulteration and misbranding
Violations of the FDCA are of strict liability nature, which means that commission of any of the listed offenses violates the FDCA, regardless of the persons ________ and _______
intentions AND knowledge
class 1 recalls are issued when there is a reasonable probability that the product will cause ________________
serious adverse health consequences or death
The term “device” does include _____________ used to aid in the diagnosis of disease or verification of___________
in vitro diagnostic products
pregnancy
Some products are both cosmetics and drugs. Examples include______________
shampoo is a cosmetic because its intended purpose is to clean hair, but antidandruff shampoo is a cosmetic and drug because it has an intended purpose to treat the dandruff.
deodorants that are antiperspirants and toothpastes that contain fluoride are other examples of cosmetics that are also drugs
A drug is considered misbranded or adulterated if it is not recognized in the _____________- or __________, yet claims to be so.
The United States Pharmacopeia
OR
Homeopathic Pharmacopeia Convention of the United States
Cosmetics can not make _________ or __________–
Health or Structure/Function claims
if one of these is made the cosmetic will be deemed a drug and be regulated as a drug as well
