Tennessee State Law FD Cosmetic Act Flashcards
What has to be on the bottle of drug classes of Narcotics and hypnotics?
TN State Law
WARNING: May be Habit Forming
-> if not they are Misbranded
What are the exemptions of selling drugs without a prescription?
Wholesaler to Pharmacies
Pharmacists selling to physicians, dentists, vets, optometrists
Who is authorized to prescribe in TN?
-Physicians
-Physician Assistant
-Dentist
-Vets
-Optometrists
-Authorized nurse (also nurse practitioner)
Who is not allowed to use drugs that cause abortion based on TN law?
Nurse practitioner
Physician Assistant (PA)
Misbranded drugs are deemed to be adulterated based on TN law T/F
True
we dont see that on the federal law
Which drugs are prohibited from being prescribed for weight gain or weight loss?
Amphetamines classified as Schedule II stimulant
Ritalin
Lisdexamfetamin (Vyvanse)
Dextroamphetamine
When shall the indication be included on the label of Rx drugs?
When requested or provided by
Prescriber
Patient
Caregiver of the patient
Death of a prescriber
C-II not dispensable
New prescription, never filled -> fill within 90 days after death
NON-Scheduled though (New-Ninety)
C-III, C-IV, and C-V refills -> void after 90 days of death - Federal overrules
Non-scheduled refills -> void after 180 days
Prescription has to be valid (so not expired!)
Which law enables the pharmacist to decline dispensing?
Prevention of Drug Abuse
intended to protect the professional judgment
When are pharmacists able to decline dispensing?
Lack of therapeutic value
Lack of medical purpose
Is the promotion of Off-Label use allowed in TN?
Yes
must be truthful (should be evidence-based)
fe: Sales reps providing information about the Off label use of a drug
Which Act deals with the dispensing of Generic or Brand drugs?
TN Affordable Drug Act of 2005
Pharmacists should change to generic to save money
Prescribers should allow for substitution to generic, what are exceptions to that?
Brand is necessaery
Generic is not available
Anti-epileptic drugs
The prescriber must note on the prescription if the brand is necessary
Generic dispensing
Pharmacists should dispense the least expensive generic equivalent covered by a plan
Pharmacists should try to contact prescribers if new generic are available
If the brand is cheaper, dispense it
Comply with patients requests (if the patient wants brand, dispense brand -> if the patient wants generic but the prescriber says brand is necessary, do what?)
What must be on the the immediate container that pharmacies receive from the manufacturere?
Name of manufacturer
Address of manufacturer
What must be on the label if the drug is substituted with the generic?
Generic name
if the generic is in the vial you must put the generic name on the label -> otherwise Misbranding
Generic Substitutes with rated drugs
Substituiton of Generics with A-rated drugs is allowed
but not with B-rated drugs (Not resolved and not considered bioequivalent)
(on the federal level it is up to professional judgment)
substitution with an unrated drug is up to professional judgment
Who needs to be notified when antiepileptic drugs are interchanged?
before the interchange! if the epilepsy/seizure is currently controlled! (check if they are on the same dose for a while)
Prescriber
Patient
Relatives
close friend
one of them
Interhange:
change in manufacturer
Generic to brand
Brand to generic
Generic to a different generic
if their epilepsy/seizure is currently not controlled, this rule is not applicable
-not applicable in an institutional setting
When is the law for interchanging antiepileptics not applicable
-if their epilepsy/seizure is currently not controlled
-in an institutional setting, bc they will be monitored there
Within how many business days must a pharmacist notify the prescriber of the substitution of a Biologic?
Within 5 business days
also include the Name of the manufacturer and the name of the product
Which type of prescriptions have to be tamper-proof?
Written and printed prescriptions from TN prescriber -> must be written on tamper-proof paper
-doesn’t apply to fax, electronic prescriptions, or prescriptions from another state that doesn’t require tamper-proof prescriptions!
-also doesn’t apply to veterinarians, inpatients, facilities
-> but can give emergency supplies
What must tamper-proof prescriptions prevent?
-copying of prescriptions
-erasure/altering info on forms
-making counterfeit (fake) forms
can include serial numbers, but don’t have to