Example Questions Flashcards
You get a prescription from a NP from Arkansas where they can legally prescribe. They signed the prescription with their name, credentials, and identification number. Can you fill this prescription in Indiana?
YES, we can fill out of state APRN prescriptions
T or F - United State Code (USC) is an area that lists Federal Rules
FALSE
lists Federal laws or statues
Which of the following lays out Federal Statutes:
- IAC
-USP
-CFR
-USC
USC - United States Code
Which of the following lays out Indiana Rules:
- IAC
-USP
-CFR
-USC
IAC - Indiana Administrative Code
What type of action applies to a patient believing they were harmed when a pharmacist dispensed a prescription from their physician?
Civil
NOT: administative or criminal
A pharmacist provides the citation 21 CFR 1306.07 (f)(2)(i). What does the (2) indicate?
The 2nd subsection under subsection (f)
Which of the following are included in BOTH the defition of drug and device: (select all)
- found in the USP
- does not achieve its primary intended purpose through chemical action
- found in the NF
- intended for the use of a disease in man or animal
- found in HPUS
Found in USP, NF
Intended use
A new drug that requires lab tests to monitor for ADR at normal doses would likely be approved as:
- OTC
- C-II
- C-III
- C-V
- hazardous drug
- Rx
Rx with REMS
***hazardous drugs are toxic at LOW doses
Pharmacy Compounding have the following requirements:
- follow cGMP
- must be for an individual
- need clinical trials to prove efficacy
- based on a valid prescription
Must be for an individual
Must be based on valid prescription
Must be compounded by licensed pharmacist or physician (or under direct supervision)
A manufacturer recently recalled a specific lot of prescription birth control that had the pills in reverse order. What type of recall most likely was called?
Class II
Rank Classes of Devices from MOST serious to LEAST serious
Class III (most)
Class II
Class I (least)
Contact lenses are in what device class?
Class III (require a prescription)
Syringes are in what device class?
Class II
require special controls
Select all of the following situations that would NOT be considered adulterations:
a. a pharmacy repackages a drug and forgets to put an expiration date
b. a company follows cGMP when manufacturing a product
c. a drug product doesn’t conform to standards but is labeled “not USP”
d. a drug product has a lower strength than what the label says
e. a drug product in a conatiner that is radioactive
B
C
Select all situations that would be considered misbranding:
a. an oral controlled substance is not dispensed with CRC
b. a brand name drug lists the generic name on the label
c. a drug product can develop a precipate and there is a warning on the PI
d. a prescription drug is dispensed without a prescription
e. a drug product is manufactured with an unsafe coloring agent
A
D
What class of device requires pre-market approval?
Class I
T or F: a surgeon is allowed to write a prescription for a non-surgical issue
TRUE
Which of the following ar CORRECT in regard to MAX refills and expiration: (select all)
A. Tylenol #3, 0 refills, expires 6 months
B. Codeine, 5 refills, expires 1 year
C. Gabapentin 5 refills, expired 6 months
D. Lisinopril, unlimited refills, expires 1 year
E. Sertraline, 11 refills, expires 1 year
D
Which prescription medication cannot be called in by an agency nurse for a provider?
- Pentazocine
- Sonata
- Syndros
- Ketamine
- Potiga
Syndros (C-II)
Which of the following must ALWAYS be on a prescription label according to Federal Law:
- Name and address of pharmacy
- Drug name
- Drug dose
- Directions
- Name of patient
- Cautionary statemnets
Name and address of pharmacy
Which of the following may be on a prescription label if its on the prescription according to Federal Law:
- Name and address of pharmacy
- Drug name
- Drug dose
- Directions
- Name of patient
- Cautionary statemnets
- patient name
- directions
- cautionary statements
*** name and address of pharmacy must ALWAYS be on a prescription
Which of the following are NOT required to be on a prescription label according to Federal Law:
- name of dispenser
- address of dispenser
- name of prescriber
- address of prescriber
- date of prescription or its filling
- prescription number
Address of prescriber
What are the max refills for a Xyrem prescription?
5 refills
Xyrem (GHB) is a C-III
What are the max refills for a Carfentanil prescription?
ZERO
C-II drug
What is the expiration date for a Demerol prescription written on 5/4/23?
5/4/24
Demerol (Meperidine) is a C-II
What is the expiration date for a Amobarbital suppository prescription written on 6/30/23?
12/20/23
C-III amobarbital suppository
Amobarbital tablets are C-II
For a product with the NDC number of 01777-3523-01, 3523 indicates what?
- manufacturer
- package size
- drug product
- dosage form
Drug product
What is NOT required labeling:
- Anti-tampering technology used on an OTC product
- MedGuide given with a Prevacid prescription
- Patient Package Insert given with a Mirena
- “Not reviewed by FDA” on a dietary supplement
PPI for Mirena (not an estrogen product)
What is NOT seen as required law to follow federally?
- USC
- USP 797
- HIPAA
- OBRA ‘90
USP 797
Which is TRUE regard the PPPA?
a. CRC are required for all drug products
b. CPRC provides full exemptions of drugs
c. prescribers can issue a blanket waiver for patients
d. there are no standards for what is special packaging
e. all children shound struggle to open CRC within the first 5 minutes
B
Which of the following can make a blanket waiver for all of their precriptions to NOT be in special packaging?
Patients and patient reps
Which drug products always require special packaging when dispensing without a waiver (choose all)
a. Errin tablet
b. Mebendazole tablet
c. Amoxicillin suspension
d. Methylprednisolone tablet
e. Pancrelipase powder
C
Which drug products require special packaging when dispensing without a waiver (choose all)
a. Voltaren gel
b. Naproxen sodium tablets
c. Isosorbide dinitrate SL tablets
d. Latanoprost eye drops
e. Ondansetron ODT
B
E
What is the BUD for a compounded drug with the following prescription: Amoxocillin suspension diluted with sterile water to a concentration of 5 mg/ 10 mL
14 days
What is the BUD for a compounded sterile cream using hydrophobic components?
180 days
Which of the following is NOT a crime by the Anti-Tampering Act?
- opening a bottle of OTC pain reliever to see what it looks like
- placing a tablet you made in a bottle of OTC cough suppressant
- Removing the shrink wrap from a Rx product
- calling the police to report an OTC was tampered when it had not been
- Planning to switch the liquid in an OTC eye drop
Removing the shrink wrap from a Rx product
Which of the following is WRONG about dietary supplements?
- all dietary supplements must contain a disclaimer
- products may claim to benefit a classical nutrient deficiency
- required to undergo premarket approval
- dietary supplements cannot make misleading statements
required to undergo premarket approval
Select all that are prohibited by the PDMA:
a. a doctor selling drug samples
b. a patient purchasing manufacturer coupons for a drug
c. a manufacturer importing their own drug into the US from Canada
d. a hospital selling drugs to a retail pharmacy
A
B
D
Which of the following is true about inspections:
- DEA can copy sales
- pharmacist can deny of FDA agent with an adminstrative inspection warrant
- A state board inspector can be denied entry without a warrant
-Pharmacist can revoke permission to inspect from a DEA who provided a NOI
- Inspectors cannot view any patient information due to HIPAA
Pharmacists can revoke permission from a DEAagent with a Notice of Inspection