Controlled Substance Laws

Question 1

Pharmacies can dispense “Schedule I” controlled substances pursuant to a valid, hand-signed prescription? (True or False)

Answer 1

False

• “Schedule I” controlled substances are not legal for medical use

Question 2

In what setting might you find “Schedule I” controlled substances?

Answer 2

Research laboratory

Question 3

“Schedule II” Controlled Substance prescription records can be stored in the same file as other prescription medications? (True or False)

Answer 3

False

• “Schedule II” prescription records must be stored separately from all other prescription records

Question 4

After an initial inventory of controlled substances has been taken, such as when a new pharmacy first opens for business, how frequently must an inventory of controlled substances be conducted?

Answer 4

At least once every two years

Question 5

According to the federal Controlled Substances Act (CSA), how should you store “Schedule III - V” prescription files?

Answer 5

• separately from all other prescription records

- stored with non-controlled prescription records, and be marked with the letter “C” in red ink

Question 6

When “Schedule II” controlled substances are sent to a reserve distributor because they are expired, damaged, or otherwise unusable, what form should be used?

Answer 6

DEA Form 222

Question 7

Who would be responsible for filling out the DEA Form 222?

Answer 7

Reverse distributor

entity receiving the substance is always the one that fills out the form

Question 8

When “Schedule III - V” Controlled Substances are returned, is a DEA form 222 necessary? Yes or No

Answer 8

No

• “Schedule III” to “Schedule V” controlled substances may be transferred via invoice
• DEA form 222 is used for “Schedule I” and “Schedule II” controlled substances

Question 9

How long must the pharmacy keep controlled substance return records, prescription records, and inventory records?

Answer 9

2 years

Question 10

The following information [patient’s full name and address / prescriber’s full name, work address, and DEA number / drug name and strength / dosage form / quantity prescribed / directions for use / number of refills authorized (if any)] must be included on what type of prescription?

Answer 10

Controlled substance prescription

Question 11

Federal Law prohibits e-prescribing of C-II drugs? (True or False)

Answer 11

False

• federal law permits e-prescribing of C-II through C-V drugs, but prescribers and pharmacies must be DEA certified to use the software

Question 12

According to federal law, C-II prescriptions must be filled within how many days after being signed by the prescriber?

Answer 12

None

• even though federal law places no time limit of C-II prescription(s) being filled (prescriptions is considered legally valid for an unlimited time period after it is issued), other individual state laws may impose a time limit

Question 13

According the federal law, the maximum quantity that can be dispensed is a 30-day supply for controlled substances? (True or False)

Answer 13

False

• even though there are no specific federal limits, some states and insurance companies may limit the prescription quantities to a 30-day supply
• pharmacies must follow the more stringent law law, as federal and state laws differ

Question 14

Are verbal orders (prescriptions that are called in by the prescriber where there is no prescriber-signed prescription hard copy) for C-II prescriptions permitted (Yes or No)

Answer 14

Yes

• only for emergencies (as determined by the pharmacist), and pharmacists must reduce the verbal order to writing and limit a fair medication quantity amount to treat the patient only for the duration of the emergency period

Question 15

After calling in an emergency C-II prescription, what must the prescriber do next?

Answer 15

Provide the pharmacy with a written and signed hard copy, which the pharmacy files along with the verbal order

Question 16

When emergency C-II prescriptions are called in, a presciber has how many days to furnish the pharmacy with a written and prescription hardcopy?

Answer 16

7 days

• according to federal law

Question 17

C-II prescriptions may be refilled up to 5 times in 6 months? (True or False)

Answer 17

False

• “Schedule II” prescription refills are legally prohibited

Question 18

Are C-II prescriptions valid when received by facsimile (fax machine)? (Yes or No)

Answer 18

Yes

• pharmacies can use a faxed C-II prescription copy to fill a prescriptions, but prior to dispensing, the patient (or customer) must present the original signed prescription

Question 19

What are the three types of prescription orders for which a pharmacy can dispense a faxed C-II prescription without requiring presentation of the original signed prescription?

Answer 19

1) home infusion order
(patient receiving the order outside the hospital or clinical setting)
2) long-term care facility order
(variety of services to meet a patient’s health or personal care needs during a short or long period of time)
3) hospice program order
(service providing care for sick or terminally ill patient)

Question 20

A patient presents (6) prescriptions for Adderall 5 mg. Each prescription is written for 30 tablets with the instructions to take 1 tablet by mouth every morning and 1 tablet by mouth every afternoon at 3 pm. Is it legal for the patient to process this many prescriptions for a C-II drug? (Yes or No)

Answer 20

Yes

• federal law does permit (prudent way) prescribers to issue multiple C-II prescriptions at one time as long as the total days’ supply does not exceed 90 days, would need to have the earliest fill date written on them (“do not fill until 4/15”, “do not fill until 4/30”, etc.)

Question 21

By what means can a prescriber issue C-III, C-IV, and C-V prescriptions?

Answer 21

• orally/verbally
• by writing form
• by fax
• electronically (e-prescribing) where state law permits

Question 22

Does the law allow for C-III, C-IV, and C-V prescription refills? (Yes or No)

Answer 22

Yes

• prescribers can refill C-III and C-IV prescriptions within six months of the date written from the original prescriptions
• refill limitations do not apply to C-V prescriptions

Question 23

For non-controlled substance prescriptions, a prescriber’s agent (nurse or secretary) may call in a verbal prescription, can they call in “Schedule III - V” prescriptions? (Yes or No)

Answer 23

No

• prescribers must personally make the call verbally to submit a “Schedule III” through “Schedule V” prescription verbally

Question 24

Are prescribers required to personally send faxes when C-III through C-V prescriptions are transmitted to pharmacies by fax? (Yes or No)

Answer 24

No

• prescriber’s agent may send faxes for “Schedule III”, “Schedule IV”, and “Schedule V” prescriptions

Question 25

Can a prescriber post-date a prescription for a controlled substance (e.g. record the date written as 8/14/16 when he/she actually wrote the prescription on 8/12/16)? (Yes or No)

Answer 25

No

• prescribers might try to do this when they don’t want the patient to have the prescription filled 8/14/16, but they should record the written date as 8/12/16 and write on the prescription “do not fill until 8/14/16”

Question 26

Can a controlled substance be delivered or shipped to an individual in another country if they have a valid prescription? (Yes or No)

Answer 26

No

• federal “Controlled Substance Act” prohibits exportation of controlled substances

Question 27

Prescribers that want to prescribe “Schedule III - V” controlled substances for treatment of narcotic addiction (i.e. products containing buprenorphine) must display what unique identifier on the face of the prescription?

Answer 27

“X”

• DEA registration number beginning with the letter “X” must be displayed, grants certain prescribers with special waivers to prescribe, administer, and/or dispense C-III through C-V substances to treat narcotic addicted patient(s) within and outside the Narcotic Treatment Facility (NTF)

Question 28

What must the pharmacy do in the event of theft or loss of a controlled substance?

Answer 28

Notifying the DEA and completing a “DEA 106 Form” to document any details of the theft or loss