Dispensing Requirements

Question 1

CLIA protocol (Test and Treat COVID, UTI, Flu, etc) age limit?

Answer 1

Must be 18 years or older

Question 2

How many times can CIII-V be transferred?

Answer 2

Once but chains can transfer up to maximum refills

Question 3

CS transfers can be communicated between interns orally. True or false?

Answer 3

False

Question 4

CII-V how long to report to PMP?

Answer 4

24 hours or next business day (whichever comes later)

Question 5

Can tech enter PMP?

Answer 5

Yes! But every pharmacist must register.

Question 6

Can you disclose PMP info to patient?

Answer 6

No

Question 7

Automated counting/dispensing systems expiration dispensing

Answer 7

Dispense lot expiring soonest.

Question 8

What must automated counting/dispensing systems maintain in records?

Answer 8

-Bin filling record
-lot number
-fill date
-exp date
-pharmd verificaiton

Question 9

Label requirements for dispensed drugs

Answer 9

-name/address of pharmacy
-date of filling
-name of pt
-name of prescriber
-sig
-rx number
-drug name/quantity/strength

Question 10

Can compounding drugs be kept ‘for office use’?

Answer 10

No

Question 11

How long do you have to return opened pharmacy kits to pharmacy?

Answer 11

72 hrs

Question 12

Define adulteration

Answer 12

Purity, quality or strength issues

Question 13

Define misbranding

Answer 13

Misleading labeling or label lacking required information

Question 14

Can hospitals have samples?

Answer 14

Yes but prescribers must dispense to patients and physician must place order in writing for themselves

Question 15

What % can pharmacy distribute without having to register as distributor?

Answer 15

5% of gross annual drug sales

Question 16

OTC Label Requirements (in order)

Answer 16

active ingredients, including amount of active ingredients in each dosage unit
purpose of product
indication
specific warnings
side effects
directions for use
lot number
pregnancy/BF warnings
Questions, call x
inactive ingredients

Question 17

Wording for dietary supplements

Answer 17

Can: health claims, structure/function claims, nutrient
Cannot: treat, prevent, alleviate

Question 18

Repackaged OTC products are subject to FD&C act. True or false?

Answer 18

True

Question 19

Max pseudoephedrine without Rx

Answer 19

3.6 g per day or 9 g per 30 days

Question 20

Storage of pseudoephedrine

Answer 20

Behind counter or locked in cabinet inaccessible to public

Question 21

What must you bring to buy Sudafed?

Answer 21

Government issued photo ID and sign that they understand limits and penalties

Question 22

What happens if you don’t keep Sudafed records for 2 years?

Answer 22

Class 1 misdemeanor

Question 23

CS Scripts Must be electronic unless

Answer 23

-prescriber is dispensing directly to patient
-prescription is for someone in a hospital, assisted living, nursing home or residential health facility
-receiving services from hospice or outpatient dialysis facility
-electronic difficulties (must write this in medical record)
-dispensed on federal property (must write in medical record)
-vet rx
-research protocol
-

Question 24

Vet Rx CS Stipulations

Answer 24

-cannot prescribe for human use
-can be written or oral rx
-Rx: date, signature, name address of owner, species of animal, name/address/dea number of prescriber

Question 25

In the setting of drugs repackaged with automated counting device, what is the protocol in setting of drug recall?

Answer 25

If a lot added in the past 3 months is implicated, all drugs should be removed and not used for patient care. Exceptions include-bin can recognize what needs to be removed, bin is empty

Question 26

How many days supply can be given via unit dose dispensing system in hospitals/LTCFs?

Answer 26

7 days if licensed; 72 hours f unlicensed

Question 27

How long must hospital EMS kit records be kept?

Answer 27

1 year; except for CS which is 2 years

Question 28

Can you repackage already dispensed medications from a different pharmacy?

Answer 28

Yes if patient at LTCF to put into unit dose. Must keep records

Question 29

How many doses allowed per blister for ephedrine products?

Answer 29

2

Question 30

Recordkeeping requirements for ephedrine products

Answer 30

-name of purchaser -address of purchaser -date/time of sale -amount of product sold *remember* need to present a government issued ID and sign log book

Question 31

Rules for having an emergency kit with CS in non DEA registered LTCF:

Answer 31

-where they get drugs from is DEA registered -security safeguards -LTCF and supplier keep records of CS in kit -notice that could have state revocation, denial or suspension if these rules are not followed

Question 32

How long does a pharmacy have to inform patient of HIPAA breach?

Answer 32

60 days

Question 33

What is difference between restricted and non restricted manufacturer?

Answer 33

-non restricted can do rx drugs -restricted only non rx and can make gas for medical use

Question 34

PMP reporting requirements

Answer 34

-pt name and address and dob -CS quantity -date of dispense -prescriber and pharm ID number -method of payment

Question 35

FDA can require a medication guide in which of the following scenarios

Answer 35

-will prevent ADRs -drug has serious risks which patient should be aware of -adherence is crucial

Question 36

A hard-copy prescription must be written in ink, or individually typed/printed (true or false)

Answer 36

true

Question 37

pharmacist may not provide refills on C-II through C-V controlled substances without the prescriber’s authorization (true or false)

Answer 37

true

Question 38

What are exceptions to 1 medication rx per prescription?

Answer 38

-hospitalized pt -LTCF -hospice -home infusion -govt organizations such as jails, DOH, etc.

Question 39

What are exceptions to physicians offices needing to obtain a dispensing license from BOP?

Answer 39

-dispense manufacturer samples -medical emergency -when pharmaceutical services are not available

Question 40

Emergency kits in LTCF-can a CS be dispensed without prescription?

Answer 40

No BUT you can give verbal!!!

Question 41

CSOS can be used for CII only. True or false?

Answer 41

False-can be used for CII-V

Question 42

If you deny to fill a written rx, what must you write on back?

Answer 42

“Declined” Name/address/telephone number of the pharmacy Date Signature

Question 43

Return to stock drug exp date

Answer 43

1 year from dispense or manufacturer date, whatever is earlier

Question 44

Drugs in compliance packaging must have what on each label

Answer 44

-date/time drugs should be taken -name of drug within -MAIN packaging label shall contain all required elements for outpatient prescription label and a physical description of drug

Question 45

Examples of misbranding

Answer 45

label not having name/place of business of manufacturer, quantity of contents in terms of weight/measure/numerical count, drug name

Question 46

Delivery of prescription drugs by mail must include what in shipment

Answer 46

-written notice alerting the consumer that under certain circumstances chemical degradation can occur -toll free number to respond to consumer questions for chemical degradation

Question 47

Where must prescriptions awaiting delivery be kept?

Answer 47

secured area outside of prescription department, not accessible to the public

Question 48

If dispensing meds while pharmacist is on duty what records must be kept?

Answer 48

patient name rx number date signature of person receiving keep records for 1 year