Controlled Substances (Federal Requirements) Flashcards
Schedule I
illegal, no accepted medical use, high potential for abuse
3 examples of FDA-approved cannabis-related drugs
canabidiol (CBD) (Epidiolex), dronabinol (Marinol, Syndros), nabilone (Cesamet)
Schedule II
accepted medical use, high potential for abuse, no refills
Schedule III
accepted medical use, moderate potential for abuse, maximum of 5 refills within 6 months
Schedule IV
accepted medical use, moderate-to-low potential for abuse, maximum of 5 refills with 6 months
Schedule V
accepted medical use, low potential for abuse, most but not all require a prescription
Who must register with the DEA?
manufacturers, dispensers, distributors
How long do DEA registrations last?
1-3 years (usually 3 for a pharmacy)
format of a DEA number
two letters followed by seven numbers
The first letter of a DEA number can only be …
A, B, F, G, M, X
The second letter of a DEA number must be …
the first letter of the practitioner’s last name or of the facility’s name
two methods to verify a DEA number
checksum calculation or online look-up
If the DEA number begins with A, B, F, G, the registrant must be …
a high-level practitioner (doctor, osteopath, dentist)
DEA Form 222
used to order CI and CII drugs, or to return CII drugs (maximum of 10 per form)
If the DEA number begins with M, the registrant must be …
a mid-level practitioner (physician assistant, nurse practitioner, midwife, optometrist)
DEA Form 106
used to report a theft or loss of controlled substances
DEA Form 41
used to dispose of controlled substances in the presence of a witness
Pharmacies must keep CS records for …
2 years (5+ in some states), with CII records kept separately
storage of CII substances
in a locked cabinet
Pharmacies must inventory their CS every …
2 years, with an exact count/measure required in most cases
DEA Form 224
used by pharmacies to register/renew with the DEA
DEA Form 225
used by distributors, exporters, importers, manufacturers, and researchers to register/renew with the DEA
DEA Form 363
used by narcotic treatment programs to register/renew with the DEA
excluded (exempt) substance
a non-narcotic substance containing a controlled substance but excluded from all schedules (states may add them back to a schedule though)
A CS prescription must include …
date, patient name and address, prescriber’s name and DEA#, prescriber signature (no stamp or agent)
format of a CS prescription
written only; no e-prescribing; fax, email, phone only in emergencies
regulations regarding pharmacy technicians and CS
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.
prescribing CS for oneself and immediate family members
federal law is non-specific; AMA does not recommended it outside of emergencies
A CS manufacturer stock bottle must include …
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
initial inventory
a complete CS inventory prior to a new pharmacy opening
perpetual inventory
shows the current number of units in stock; required for hospitals and recommended for pharmacies
receipts for CS
use Form 222 for CI-II drugs and the invoice for CIII-V drugs
dispersal record
record of a drug’s removal from inventory for any reason, e.g., dispensing, theft
A CS prescription label must include …
pharmacist’s name, pharmacy name and address, NDC#, date filled, prescriber’s name, patient’s name, directions, caution statements (auxiliary labels), schedule symbol
partial filling of a CII prescription (rules)
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
partial filling of a CII prescription (record keeping)
note the date of partial fill, quantity dispensed, quantity remaining, pharmacist’s ID
partial filling of CIII-V prescriptions
treat like a refill, fill the total amount within 6 months
three filing systems for prescriptions
3-File: CII, CIII-V, non-CS
2-File: CII, CIII-V
2-File (alternate): all CS, all non-CS
