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 to 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
What are factors that determine if a package needs a Medication Guide
used when drug pose a serious concern
-> Labeling could help prevent serious side effects
-> drug has serious risks the patient should be aware of
-> patient adherence is crucial for effectiveness
fe: opioids, NSAIDs, many more
How often must MedGuides be given?
With every dispensing
(also every refills)
What are Risk Evaluation and Mitigation Strategies (REMs)
when FDA thinks MedGuides, PPIs, CMIs, and BBW are not enough to protect the patient
-> FDA requires the manufacturer to develop these
Example of REMS
-additional training
-required pill count (Clozaril)
-negative pregnancy test
-patient counseling and give a MedGuide
What is required for Legend drugs (Rx)?
-require supervision of safe and effective use by a “practitioner” -> who is a practioneir (allowed to prescribe? -> defined by the State
-there are specific places where legend drugs are allowed to be possessed,
fe: Pharmacists in a Pharamacy
Why are some products sold OTC and Rx at the same time?
depending on the indication the drug needs supervision or not
fe: Oxybutynin: Rx for urinary incontinence or OTC for overactive bladder; meclizine (Antivert) for motion sickness - OTC and Rx for vertigo
Behind the Counter
Nonprescription Under Condition of Safe Use
-Consumers should talk to the Pharmacist before use
fe: Sufafed
When is a drug considered a New Drug?
-New dose
-contains new substance
-new combination of drugs
-dosage, method, duration of administration has changed
-not been deemed GRAS or GRAE by the FDA
What are Orphan drugs
Drug that treat rare diseases or conditions
rare = 200 000 cases or fewer in the US
OR if > 200 000 but the manufacturer has no chance to make a profit on these drugs
What is the DESI loophole?
Drug Efficacy Study Implification
-drugs after 1938 but before 1962
-these drugs are believed to be safe and are already on the market but not proven to effective
Examples of Pre 1938 durgs
-releases before 1938 (safety act)
-assumed to be safe bc used for so long
-Thyroid
-Morphine, Codeine
-Nitroglycerin
What are Biologics?
-derived from living organisms
-antitoxins, blood products
Which organization licenses Biologics?
Public Health Service Act
What is the FDA’s reporting system called?
MedWatch
What are the classes of Recall?
Class I: serious adverse health consequences or death
Class II: may cause reversible consequences
Class III: not likely to cause harm
How is information about drug use in pregnant consumers delivered?
OLD: used to be categorized: A, B, C, D, X
NEW: in the package insert -> more focused on information -> use judgment to decide if to use
What is the NDC number?
National Drug Code
is found in most prescription drug containers, also found on most OTC product
-> requested but not required
3 parts: Manufacturer# - Drug info# - Size
example: Pfizer - Viagra 50 mg tab - 30 count
Which act was involved in operating labeled drugs (Rx)?
Durham-Humphrey Amendment
What is the purpose of the Orange Book?
To find equivalents between generics and their brand products
NO information on therapeutic substitutions
What does the A code mean in the Orange book?
No known or suspected bioequivalence problems
the 2nd letter indicates the dosage form
What does the AB code mean in the Orange book?
AB: there have been bioequivalence problems -> but they have been resolved
B: Not resolved and not considered bioequivalent
use judgment to decide if you can substitute a B rated drug
When to be very cautious when substituting drugs?
Drugs with a narrow therapeutic index
Levothyroxine, Warfarin, phenytoin, lithium
What are Biosimilars?
highly similar,
doesnt mean interchangeable
Interchangeable = Biosimilar+
Where to check Interchangeable of Biosimilars?
Purple Book
Which of the two should NOT have legend drug samples (Rx) based on the Prescription Drug Market Act, Retail pharmacies or hospitals?
Pharmacies should NOT have label drugs samples
Hospitals can have them and use them
What are the exceptions that allow hospitals to resell drugs?
-they are selling to another qualified hospital
-to a non-profit affiliate
-Hospitals or healthcare facilities under common control
-For emergencies
-Selling or dispensing according to a prescription
(they are allowed to buy from pharmacies)
What are the issues that were tackled by the Prescription Drug Market Act?
-Re-importation
-Diversion of Rx samples
-trying to limit the amount of drugs sold by hospitals to other places (hospitals get special pricing for drugs)
What are the institutions that are most likely
4 to conduct inspections?
Board of Pharmacy
DEA
less likely: FDA (does not need a warrant), Health Department
What is the Poison Prevention Packaging Act PPPA (1970) referred to?
Protect kids under the age of 5 from accidental poisoning (hazardous household substances)
enforced by the Consumer Product Safety Commission (CPSC)
-if complying with the standards it should prevent a child from getting a dangerous amount in a reasonable time
To which drugs does the PPPA apply?
-Oral legend drugs (NOT to injectables, topicals, ear drops)
-Controlled substances
-some OTC
The PPPA standards are child RESISTANT and child PROOF T/F
False
they are child RESISTANT
they are NOT child PROOF
Which term is used to describe a container that should be child-resistant?
special packaging indicating safe containers
When is it allowed to dispense easy open prescription vials?
with an exemption -> comes from the CPSC
with a waiver -> from the patient, patient representative, or prescriber
What are the reasons for an exemption from using special packaging for oral legend drugs issued by the CPSC?
-No safety concerns for kids (it would not significantly harm the child)
-must be readily available (fe Nitroglycerin with acute chest pain)
Examples:
dosepacks: prednisone, methylprednisolone
OC’s
SL nitroglycerine
conjugated estrogens
How must a prescriber write a waiver?
only for one Rx drug on a prescription -> valid for all refills
he can’t use one prescription to waive all Rx drugs of a patient - must be for one Rx each
How can a patient request a waiver?
they can ask for all Rxs to be in an easy open waiver
or ONE by ONE
they can rotate whenever they want
Do patient waivers need to be signed by the patient?
No it is not required
it can be revoked
When can child-resistant vials be reused?
if the safety mechanism is in the lid:
replace the lid it is PLASTIC after finishing using
can be reused when it is metal
if the safety mechanism is in the lid and in the vial
both need to be replaced if both are PLASTIC
THINK of replacing them if they are made of plastic and subject to being worn out
What is the Posion Help phone number?
1-800-222-1222
How are alcohol inventories reported?
Which unit?
in proof gallons
1 gallon of 50% alcohol
How many proof gallons are represented by 9 gallons of 70% alcohol?
Calculation:
1 gallon … 50% alc
1.4 gallon … 70% alc
-> convert to proof gallon -> x9
12.6 gallons
not on EXAM
When is it NOT allowed to advertise for prescription drugs?
when they are unapproved (for an indication?)
-> regulated by the FDA
Who regulates OTC advertising?
Federal Trade Commission (FTA) (primarily)
-> the FDA is involved
