Federal Drug Statutes and Regulations Flashcards
Definition of the term “drug”
-article or any supplements to those that is recognized in:
-> United States Pharmacopoeia
-> Homoeopatic Pharmacopoeia of the US
-> or National Formulary
those 3 make up the official compendium
-intended use in diagnosis, cure, treatment, mitigation, or prevention of disease in man or animals
-articles (other than food) intended to affect the structure and function of the body (dietary supplements cant really do that)
Definition of Food
articles used for food or drink for man or other animals
(2) chewing gum
(3) articles used for components of any such article
Definiton of State
-any State or Territory of the United States
-the District of Columbia
-the Commonwealth of Puerto Rico
Definition of “Person”
-individual
-partnership
-corporation
-association
Definition counterfeit drug
A counterfeit drug is a drug that uses the name or logo of a real company without permission, pretending to be their product.
What are the 4 groups of Dietary Supplements?
-Vitamins
-minerals
-amino acid
-herbs or other botanical
Definition of a device
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar agent
Definition of a cosmetic
- intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body
-for cleansing, beautifying, promoting attractiveness, or altering the appearance
-Soaps are not included!
What is a major difference between Dietary Supplements and drugs?
drugs can affect the structure and function of the body
-> FDA looks after them to see if they make drug claims
Which statement can be found on the label of supplements?
-not been evaluated by the FDA
-this supplement is not intended to diagnose, cure, treat or prevent a disease
When is a statement of a dietary product unqualified?
Health claim
when there is a significant scientific agreement with the FDA
-the FDA provides model languages and approves the claims
How many unqualified statements are approved by the FDA?
12
example:
Calcium and osteoprosis -> “may reduce the risk of osteoporosis” = structure and function claim
folic acid and neural tube defects
fiber and CHD risk
Dietary Lipids (Fat) and Cancer
Dietary Non-cariogenic Carbohydrate Sweeteners and Dental Caries
When is a statement of a dietary product qualified?
Health claim
When there is no significant scientific agreement
-must contain qualifying language
- “scientific evidence suggests but does not prove…”
- “supportive but not conclusive research shows…”
Marketing and regulating unsafe supplements?
Can unsafe dietary proudcts be marketed and sold?
Yes
once they are on the market and they are shown to be harmful, they can be removed by the FDA
What do misbranding and adulteration mainly refer to?
Adulteration: something is wrong with the drug
Misbranding: something is wrong with the labeling
When is a product considered alduterated?
when Filthy, putrid, decomposed, or prepared, packed or held under unsanitary conditions
Manufacturing: methods or facilities not working under cGMP
-> such that a drug -may not- meet safety, strength, and quality standards
-> so lack of quality doesn’t have to be proven, just the suspicion is enough to be considered adulterated
Which products are affected by the Federal Anti-Tampering Act?
consumer products (often OTC products)
-not Rx
-barriers must be hard to duplicate or replace
-can be on the container or secondary container (box)
-handling must not routinely destroy the features
Does the Federal Anti-Tempering Act trying to prevent Adulteration or Misbranding?
Adulteration -> something is wrong with the drug
tampering may affect the drug
When is a product considered Misbranded?
-when it is a drug and the labeling is false or misleading
targeted at the manufacturer:
if it is not labeled with the name and place of business of the manufacturer, packer, distributor
What must be on the label to not be considered Misbranded?
-generic name - has to be at least 1/2 the size of the brand name
example: Lipitor (32 font), atorvastatin (16 font)
-names of inactive ingredient
-type and percent of alcohol
-must have directions of use and warnings
What does the term label mean?
written paper put on the container the manufacturer
What does the term labeling mean?
the label and other written graphic matter on any article or container
What if the drug product doesn’t contain the package insert (medical info)?
it is considered Misbranding
What has to be on the prescription !label! to not be considered misbranded FEDERALLY?
-name and the address of the dispenser (pharmacy)
-serial number (Rx number)
-date of prescription OR of its filling (date of issue?)
-name of the prescriber
-name of the patient
-directions of use
-cautionary statements (if any)
What is the Consumer Medication Information (CMI)? FEDERAL
-should be given with every NEW prescription
Which type of labeling is specific for oral contraceptives?
Patient Package Insert (PPI)
-also estrogen-containing drugs and pro-gestational drugs intended to be used as an OC
-give it with every package:
fe: if you give a 3 month supply -> give the PPI with each package (so 3 PPIs)
How often should PPIs be given in an institutaional setting?
Initially and every 30 months
-> if not, it is considered MISBRANDING
Difference in dispensing between CMI and PPIs
CMI: give with every NEW prescription
PPI: give with every package
