Tennessee State Law FD Cosmetic Act

Question 1

What has to be on the bottle of drug classes of Narcotics and hypnotics?

TN State Law

Answer 1

WARNING: May be Habit Forming

-> if not they are Misbranded

Question 2

What are the exemptions of selling drugs without a prescription?

Answer 2

Wholesaler to Pharmacies
Pharmacists selling to physicians, dentists, vets, optometrists

Question 3

Who is authorized to prescribe in TN?

Answer 3

-Physicians
-Physician Assistant
-Dentist
-Vets
-Optometrists
-Authorized nurse (also nurse practitioner)

Question 4

Who is not allowed to use drugs that cause abortion based on TN law?

Answer 4

Nurse practitioner

Physician Assistant (PA)

Question 5

Misbranded drugs are deemed to be adulterated based on TN law T/F

Answer 5

True

we dont see that on the federal law

Question 6

Which drugs are prohibited from being prescribed for weight gain or weight loss?

Answer 6

Amphetamines classified as Schedule II stimulant

Ritalin
Lisdexamfetamin (Vyvanse)
Dextroamphetamine

Question 7

When shall the indication be included on the label of Rx drugs?

Answer 7

When requested or provided by

Prescriber
Patient
Caregiver of the patient

Question 8

Death of a prescriber

Answer 8

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!)

Question 9

Which law enables the pharmacist to decline dispensing?

Answer 9

Prevention of Drug Abuse

intended to protect the professional judgment

Question 10

When are pharmacists able to decline dispensing?

Answer 10

Lack of therapeutic value
Lack of medical purpose

Question 11

Is the promotion of Off-Label use allowed in TN?

Answer 11

Yes
must be truthful (should be evidence-based)
fe: Sales reps providing information about the Off label use of a drug

Question 12

Which Act deals with the dispensing of Generic or Brand drugs?

Answer 12

TN Affordable Drug Act of 2005

Pharmacists should change to generic to save money

Question 13

Prescribers should allow for substitution to generic, what are exceptions to that?

Answer 13

Brand is necessaery
Generic is not available
Anti-epileptic drugs

The prescriber must note on the prescription if the brand is necessary

Question 14

Generic dispensing

Answer 14

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?)

Question 15

What must be on the the immediate container that pharmacies receive from the manufacturere?

Answer 15

Name of manufacturer
Address of manufacturer

Question 16

What must be on the label if the drug is substituted with the generic?

Answer 16

Generic name

if the generic is in the vial you must put the generic name on the label -> otherwise Misbranding

Question 17

Generic Substitutes with rated drugs

Answer 17

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

Question 18

Who needs to be notified when antiepileptic drugs are interchanged?

Answer 18

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

Question 19

When is the law for interchanging antiepileptics not applicable

Answer 19

-if their epilepsy/seizure is currently not controlled

-in an institutional setting, bc they will be monitored there

Question 20

Within how many business days must a pharmacist notify the prescriber of the substitution of a Biologic?

Answer 20

Within 5 business days

also include the Name of the manufacturer and the name of the product

Question 21

Which type of prescriptions have to be tamper-proof?

Answer 21

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

Question 22

What must tamper-proof prescriptions prevent?

Answer 22

-copying of prescriptions
-erasure/altering info on forms
-making counterfeit (fake) forms

can include serial numbers, but don’t have to