Controlled Substances (Federal Requirements)

Question 1

Schedule I

Answer 1

illegal, no accepted medical use, high potential for abuse

Question 2

3 examples of FDA-approved cannabis-related drugs

Answer 2

canabidiol (CBD) (Epidiolex), dronabinol (Marinol, Syndros), nabilone (Cesamet)

Question 3

Schedule II

Answer 3

accepted medical use, high potential for abuse, no refills

Question 4

Schedule III

Answer 4

accepted medical use, moderate potential for abuse, maximum of 5 refills within 6 months

Question 5

Schedule IV

Answer 5

accepted medical use, moderate-to-low potential for abuse, maximum of 5 refills with 6 months

Question 6

Schedule V

Answer 6

accepted medical use, low potential for abuse, most but not all require a prescription

Question 7

Who must register with the DEA?

Answer 7

manufacturers, dispensers, distributors

Question 8

How long do DEA registrations last?

Answer 8

1-3 years (usually 3 for a pharmacy)

Question 9

format of a DEA number

Answer 9

two letters followed by seven numbers

Question 10

The first letter of a DEA number can only be …

Answer 10

A, B, F, G, M, X

Question 11

The second letter of a DEA number must be …

Answer 11

the first letter of the practitioner’s last name or of the facility’s name

Question 12

two methods to verify a DEA number

Answer 12

checksum calculation or online look-up

Question 13

If the DEA number begins with A, B, F, G, the registrant must be …

Answer 13

a high-level practitioner (doctor, osteopath, dentist)

Question 14

DEA Form 222

Answer 14

used to order CI and CII drugs, or to return CII drugs (maximum of 10 per form)

Question 15

If the DEA number begins with M, the registrant must be …

Answer 15

a mid-level practitioner (physician assistant, nurse practitioner, midwife, optometrist)

Question 16

DEA Form 106

Answer 16

used to report a theft or loss of controlled substances

Question 17

DEA Form 41

Answer 17

used to dispose of controlled substances in the presence of a witness

Question 18

Pharmacies must keep CS records for …

Answer 18

2 years (5+ in some states), with CII records kept separately

Question 19

storage of CII substances

Answer 19

in a locked cabinet

Question 20

Pharmacies must inventory their CS every …

Answer 20

2 years, with an exact count/measure required in most cases

Question 21

DEA Form 224

Answer 21

used by pharmacies to register/renew with the DEA

Question 22

DEA Form 225

Answer 22

used by distributors, exporters, importers, manufacturers, and researchers to register/renew with the DEA

Question 23

DEA Form 363

Answer 23

used by narcotic treatment programs to register/renew with the DEA

Question 24

excluded (exempt) substance

Answer 24

a non-narcotic substance containing a controlled substance but excluded from all schedules (states may add them back to a schedule though)

Question 25

A CS prescription must include ...

Answer 25

date, patient name and address, prescriber's name and DEA#, prescriber signature (no stamp or agent)

Question 26

format of a CS prescription

Answer 26

written only; no e-prescribing; fax, email, phone only in emergencies

Question 27

regulations regarding pharmacy technicians and CS

Answer 27

Pharmacy technicians may never dispense a CS. They may, in some states, count CS drugs, inventory them, and conduct record keeping. Many states also require that a pharmacist keep the key to, and supervise a technician when he or she accesses, a CS containment area.

Question 28

prescribing CS for oneself and immediate family members

Answer 28

federal law is non-specific; AMA does not recommended it outside of emergencies

Question 29

A CS manufacturer stock bottle must include ...

Answer 29

the symbol CX or C-X, where X is the schedule written in Roman numerals; if the bottle is too small to fit the symbol, it may be placed only on the box and package insert

Question 30

initial inventory

Answer 30

a complete CS inventory prior to a new pharmacy opening

Question 31

perpetual inventory

Answer 31

shows the current number of units in stock; required for hospitals and recommended for pharmacies

Question 32

receipts for CS

Answer 32

use Form 222 for CI-II drugs and the invoice for CIII-V drugs

Question 33

dispersal record

Answer 33

record of a drug's removal from inventory for any reason, e.g., dispensing, theft

Question 34

A CS prescription label must include ...

Answer 34

pharmacist's name, pharmacy name and address, NDC#, date filled, prescriber's name, patient's name, directions, caution statements (auxiliary labels), schedule symbol

Question 35

partial filling of a CII prescription (rules)

Answer 35

only allowed if the pharmacist can't fill the total quantity, the rest must be filled within 72 hours or the prescriber notified as a new Rx is required, the patient can never request a partial fill

Question 36

partial filling of a CII prescription (record keeping)

Answer 36

note the date of partial fill, quantity dispensed, quantity remaining, pharmacist's ID

Question 37

partial filling of CIII-V prescriptions

Answer 37

treat like a refill, fill the total amount within 6 months

Question 38

three filing systems for prescriptions

Answer 38

3-File: CII, CIII-V, non-CS 2-File: CII, CIII-V 2-File (alternate): all CS, all non-CS