EXAM 2 Federal Controlled Substance Law Pt4

Question 1

1306 is about

Answer 1

C-III, C-IV, and C-V

Question 2

Called and Faxed prescriptions

Answer 2

can be faxed or called
-same Rx requirements as for C-II (patients name, address, etc)

-written and faxed Rx must be signed by the prescriber

Question 3

What is the maximal amount of refills for C-III, and C-IV drugs?

Answer 3

5 refills
partial refills add up to one refill

Question 4

What is the period of time in which the Rx and refills can be filled for C-III, C-IV, and C-V)?

Answer 4

6 months

C-V is not addressed -> but it implies 6 months

Question 5

Documentation rule

Answer 5

make sure that the computer system that is showing the hard copy of the original prescription is accurate -> so that the refill which is based on the original prescription, is accurate

-required for C-III and C-IV

Question 6

What needs to be on the label for C-III, C-IV, and C-V drugs?

Answer 6

same as with C-II -> except the Date of the initial fill
-Date of initial fill
-Pharmacy Name
-Pharmacy Address
-Rx (serial) number
-Patient name
-Prescriber Name
-Direction of Use
-Cautionary statement

Question 7

When is the labeling of C-III, C-IV, and C-V not required?

Answer 7

institutional patients (similar to C-II)

here:
- < 34-day supply or 100 dosage units of C-III, C-IV, and C-V (for C-II is less than 7 day supply)
-drug not in possession of the ultimate user
-appropriate safeguards, and record-keeping in place
-adequate pharmacy system to retrieve drug/patient information

Question 8

How often can a prescription be transferred from one pharmacy to another?

Answer 8

One time - unless the pharmacies share a real-time online database (Walgreens and CVS do)

Question 9

Who can communicate transfers of prescriptions?

Answer 9

it has to be between the pharmacists (may be done by the intern under supervision of the pharmacist)

-technicians cant do it

Question 10

What has to be written of the hard copy of the prescription that has been transferred to another pharmacy?

Answer 10

write VOID on the hard copy, or add the info on the e-script

-record receiver info on the back of the hard copyä
Pharmacy Name
Address
DEA number
Pharmacist name
Date of Transfer

Question 11

What informer does the receiver of the transferred prescription need to record?

Answer 11

infos of where it was filled (receiver) and where it came from (sender)

-Original date of issuance
-Original refill #

-Date of original dispensing
-Refills remaining and dates/locations of previous refills
-Pharmacy Name, Address, DEA #
-Rx number
-RPh name
-Original fill pharmacy info

Question 12

Additional DEA interpretation

Answer 12

-transferring original unfilled prescriptions (written, fax oral) is not allowed by the CSA nor the DEA

-after filling them the refills may be transferred
???

Question 13

Who must authorize the sale of Non-prescription C-V drugs?

Answer 13

Only the pharmacist

Question 14

What is required in order to sell an OTC non-prescription drug?

Answer 14

all OTC scheduled drugs are now C-V
-not all C-Vs are OTC

-Pharmacist is the only one on the authorize
-must “know” the purchaser - or see an ID
-purchaser must be 18 years old

-Record:
Name of purchaser
Address of purchaser
Date of dispensing
Drug dispensed
Quantity dispensed
Name or initials of the Pharmacist

Question 15

What is the maximum amount of a codeine-containing drug that is allowed for a non-prescription sale?

Answer 15

only 120 ml (4oz) of any codeine-containing drug to an individual purchaser within 48 h

for example Cheratussin AC (Robitussin with codeine)

Question 16

What is the maximum amount of an opioid-containing drug that is allowed for a non-prescription sale?

Answer 16

240 ml (oz) to an individual purchaser within 48h
(there is non available on the market)

Question 17

Rules of Central Fills for C-III, C-IV, and C-V

Answer 17

same as with C-II

copy-paste:
Scenario: the pharmacy sends a prescription to a central fill to fill it -> and they send it back to the pharmacy to dispense it

-must write “Central Fill” on the Rx and record lots of additional info (DEA number)
-retail pharmacy needs to keep original for 2 years

Question 18

Which information can be changed on the scheduled prescription?

Answer 18

C-III, C-IV, C-V:
can add the patient’s address without consultation and agreement with the patient’s prescriber

for dosage form
dosage strength
drug quantity
direction of use
issue date
-> Need a new prescription from the prescriber

for C-II: professional judgment (treat like C-III, C-IV, C-V) -> if need to change the name for example will need a new written Rx unless it is an emergency (which is an exemption, covered it Pt3)

Question 19

Which of the scheduled drugs require a “No transfer” label?

Answer 19

C-II, C-III, and C-IV

in the CFR:
“Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”

-> DEA interprets: can be dispensed to the patient or member of the patient’s household

Question 20

What is the maximum number of refills allowed on a lorazepam prescription?

Answer 20

C-III and C-IV allow 5 refills

how many for C-II? -> No refills for C-II
how many refills for C-V and non-controlled? - unlimited bc the max is not stated

Question 21

Prescriptions valid

Answer 21

how long is C-II prescription valid? - 1 year
how long are C-III and C-IV valid? 6 months
how long are C-V valid? - 1 year

Question 22

Max number of daily supply for C-II

Answer 22

federally max number of daily supply of C-II: 90 days, but they don’t say anything about number of prescriptions (can be high, typically you see 3) they have administration date (fill on this date)
-> how long are these prescriptions valid? 1 year