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Pharmacy Law 2022 > Chapter 27 LABOP rules > Flashcards

Chapter 27 LABOP rules Flashcards

1
Q

Who needs CDS licensure?

A

Every person who manufactures, distributes, prescribes, or dispenses controlled substances or anyone that engages with those.

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2
Q

Who is exempt from registration of CDS licensure?

A

Workmen for the company, contract carriers, warehouseman.
People located on the site of a licensed entity (hospital)

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3
Q

How many CDS licenses must a practitioner have?

A

Must have another license before their CDS, May have one CDS for their prescribing, but must have INDIVIDUAL licenses for each of their sites.

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4
Q

What are the rules for a CDS license for pharmacies?

A

Must be licensed by the BOP
CDS license is only valid at the address on the license -> get a different license for a different location

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5
Q

If manufacturers and distributors are out of state, what do they need for CDS?

A

Must be credentialed by the appropriate LA licensing body
If out of state, you need a CDS if transporting inside the State

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6
Q

What must researchers have for a CDS licensure?

A

Must have institutional review board approval for a trial and reviewed by board to determine if eligible

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7
Q

What must drug reps have for a CDS license?

A

Must show proof of employment if carrying and delivering CDS

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8
Q

How do you get a CDS license?

A

Application to BOP
One CDS license per applicant per location.
Can not fax in
If not licensed by other board, must submit to a background check.

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9
Q

How long is a CDS license good for?

A

1 year from date of issue

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10
Q

If a CDS license is expired for __ days, the license dies.

A

30 days

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11
Q

If CDS license is a late renewal (w/i 30 days) then?

A

pay late fees + registration

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12
Q

If a CDS license is expired for < 1 year:

A

An administrative assistant may renew

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13
Q

If a CDS license is expired for 1-5 years:

A

The board member in charge of CDS may renew

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14
Q

If the CDS is expired for > 5 years

A

A full board hearing is required

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15
Q

All changes of location for a CDS license must be provided within __ days.

A

10 days

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16
Q

What will a board inspector be looking for at a location?

A

Type of activity conducted
What CDSs are handled
Quantity of CDS
Location of licensee
Type of building and characteristics
Adequacy of security
Type of storage
Who enters premises
Local police
Documentation

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17
Q

How do you store controls in a pharmacy?

A

I: Always locked, substantial cabinet
II-V: Stored in a securely locked, substantial cabinet OR may disperse such substances throughout the stock of NC substances

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18
Q

Significant loss or theft must be reported within __ day.

A

1

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19
Q

What if a central fill pharmacy loses a controlled substance?

A

The contractor is responsible to report to DEA and BOP

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20
Q

When should records for CDSs be kept by practitioners?

A

Practitioners are required to keep records for all CDSs which are dispensed.
They are required if prescribed for DETOX or MAINTENANCE of addiction.
If they charge for administered or dispensed meds, they must document.
Midlevels must keep documentation of what they MAY prescribe.

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21
Q

When are records NOT required to be kept for CDSs?

A

If practitioners prescribe or administer

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22
Q

How long should CDS records be kept?

A

at least 2 years

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23
Q

Executed order forms should be kept where?

A

in the pharmacy

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24
Q

How long should CDS prescription records be kept?

A

at least 2 years AFTER the date of the last refill

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25
Q

Prescriptions for controls must be stored in the following ways?

A

CIII-CV would have to have a red C stamped on them unless the pharmacy has an electronic database OR have a CII, CIII-CV, and a NC file

26
Q

Inventories must be in __.

A

hard copy.
Electronic: print it
Oral: transcribe it

27
Q

When is the initial inventory date?

A

occurs when the business first handles CDSs

28
Q

When are other times you should do a CDS inventory besides annually?

A

Change in PIC (when old one leaves AND when new on starts)
Substantial loss of CDS
Closure of pharmacy

29
Q

Who do you notify for a significant loss in CDS?

A

New orleans field division office of the DEA
BOP
WITHIN one business day and submit 106 form

30
Q

If you sell _% or more of your annual amount of any CDS. You are a _____ and must register as one

A

5%; Distributor

31
Q

How long should duplicate copies of a DEA 222 form must be retained?

A

at least 2 years

32
Q

Who is exempt from filing a 222?

A

Central fill pharmacies to a retail pharmacy

33
Q

Ordering of CIII-CV requires what?

A

Name, Address, and DEA license of supplier
Name of CDS
Dosage form and strength
Amount
When received

34
Q

Who can prescribe controlled substances?

A

Physicians
Dentists
Vets
PAs and Advanced RN per protocol
Optometrist
Medical psychologists (not narcotics)

35
Q

What controlled substances can be used for outpatient detox programs?

A

only FDA approved CIII-CV (Suboxone)
Methadone written for detox can NOT be filled by a retail pharmacy if used for detoxification or maintenance

36
Q

What needs to be on a CDS rx?

A

Must be dated (for date written)
Full name and address
Drug name, strength, and dosage form
Quantity of drug
Directions
Name, address, telephone number and DEA number of prescriber (if suboxone, DEA starts with X)

37
Q

Which prescribers don’t have a DEA number?

A

Hospital interns/residents use a hospital DEA plus unique ID for prescriber
Military personnel use their service ID number

38
Q

What format must be used for CDS Rxs?

A

1) Must be on a slip no smaller than 4 x 5 inches
2) Must be in ink
3) Must clearly indicate who prescribed the medication
4) May have a max of four rxs on one script
5) Pre-printed DAW
6) Refill info
7) Printed signature line w manual signature

39
Q

Who can dispense CDS prescriptions?

A

A pharmacist at a pharmacy
Physician, dentist, or vet (not written for office use)

40
Q

Who can administer narcotic drugs?

A

Practitioners BUT they cant PRESCRIBE meds for detox or maintenance

41
Q

Can you fax a CII?

A

Yes, as long as it’s written RX is turned in.

42
Q

What are the exceptions for a faxed CII?

A

Patient in LTCF
If med will be compounded and administered directly to the patient by the prescriber
Patient in hospice, but the pharmacist must write on the fax “hospice patient”

43
Q

Can you phone in a CII?

A

Yes if it’s an emergency
Quantity is limited to the emergency period.
It must be IMMEDIATELY reduced to writing.
Physician ID is verified.
Within 7 days, the physician must provide a written RX for the emergency

44
Q

What is the maximum day supply for a CII?

A

MAX: 3 rxs for a total of 90 days (two must have do not fill before dates)

45
Q

What is the maximum day supply for a CII for LTCF?

A

60 days

46
Q

How can CIII-CV be provided to a pharmacy?

A

Written, Phone (to pharmacist), Fax (as long as its of the completed written rx, from practitioner’s office), electronic

47
Q

Can CIII-CIV be refilled?

A

Yes for up to 5 refills (total of 6 fills) no longer than 6 months after the original date

48
Q

Can a CV be refilled?

A

Yes, it has the same rules as a non controlled rx. Refill for up to a year.

49
Q

Can a pharmacist alter a CII?

A

Pharmacist may record: Drug strength and quantity prescribed and directions for use
Pharmacist may add (without prescriber): Drug dosage form and prescriber’s DEA

50
Q

What CAN’T a pharmacist add/record for a CII?

A

Patient’s name
Date of issue
Drug name (generic ok)
Prescriber signature

51
Q

What info must be on a dispensed CII label?

A

1) Name, address, and telephone of pharmacy
2) Rx number
3) Date of dispensing
4) Prescribing practitioner’s name
5) Patient’s name
6) Drug name and strength
7) Directions
8) Pharmacist’s name or initials
9) Federal warning

52
Q

What must a pharmacy document on a CII if a central fill pharmacy fills it?

A

Write central fill on the rx
Record name, address, and DEA of pharmacy. Date of transmittal
Maintain original for at least 2 years
Document receiving filled rx

53
Q

What must a central fill pharmacy document on a CII if they fill it?

A

Keep copy of Rx
Keep record of date received, pharmacist dispensed, and date dispensed
Keep dat delivered and how sent

54
Q

What are the rules of dispensing controls to institutionalized patients?

A

May not dispense more than a 34 day supply or 100 dosage units
End user may NOT possess medication
Safe guards implemented
System to identify supplier, product, patient, directions for use

55
Q

Do CIII-CV have to be cancelled?

A

They don’t need a line drawn through them but they must have dispensing pharmacist’s name and initials

56
Q

Can a CIII-CV be transferred?

A

Yes, one time

57
Q

What must be documented by the transferring pharmacist for a CIII-CV transfer?

A

Invalidation of script
On the back of the script: Name address, DEA number of other pharmacy. Name of pharmacist.
Date of transfer, name of pharmacist giving transfer

58
Q

What must be documented by the receiving pharmacist for a CIII-CV transfer?

A

The Rx was a transfer
Name, address, DEA number of other pharmacy.
Date or original rx
Original number of fills and fills remaining
Date of original fill
Name of pharmacist transferring

59
Q

What CDS can be dispensed without a prescription?

A

8 ozs of any CDS with opium
4 ozs of another CDS
48 dosage units of any CDS with opium
24 dosage units of any other CDS

60
Q

When is partial fill of a CII okay?

A

Must pick up all meds within 72 hours of initial fill if the pharmacy is out OR within 30 days of the prescription being written or lose remainder

61
Q

How long is a partial fill good for in LTCF for CIIs?

A

Must fill entire amount within 60 days
Notion must be on script
Can not dispense more than what was written for

62
Q

May i loan some CDSs to another pharmacy?

A

Yes, Fill out a DEA 222 and don’t do more than five percent of ur inventory

Pharmacy Law 2022 (8 decks)

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