Law Exam 2 study questions Flashcards
What quantity is limited to sell at one time for OTC controlled products?
limited to 240 mL or 48 dosage units containing opium
limited to 120 mL or 24 dosage units controlled substance without opium
-both in a 48 hour period
What is the quantity limit to sell for BTC products (pseduoephedrine, ephedrine, phenylpropanolomine)
3.6 grams/day max
9 grams in 30 days
What does a DEA form 224 allow for?
dispensing or instructing registration
What does a DEA form 225 allow for?
manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer, or exporter registration
What types of DEA registration do not allow for coincident activities?
reverse distributing
exporting
What coincident activites are allowed for an instructing/dispensing registration?
-can perform central fill activities as a retail pharmacy
-can compound a NARCOTIC controlled substance in schedule II-V in a proportion to not exceed 20% of the solution
-distribute controlled substance to another pharmacy as long as it does not exceed 5% or more of total dosage units dispensed that year
What things are considered for a DEA registration to be granted?
type of activities the place engages in
type and form of controlled substances handled
quantity of controlled substances handled
location of the place
storage system of the controlled substances
What does readily retrievable controlled CII-V prescriptions mean?
Have a red “C” stamped in the lower right corner of the prescription’s face
-have to be able to identify prescription by prescription number, prescriber name, patient name, drug dispensed and date filled
What records cannot be stored in central recordkeeping?
-CII-CV prescriptions
-bienniel inventories
-power of attorney
-DEA 222 forms that are executed
What is a DEA form 222a?
used to order DEA form 222’s
What do you do if DEA forms are lost or stolen?
report to the DEA immediately
What are the differences with the DEA electronic 222s?
cannot be endorsed from one supplier to another
What controlled substances can be estimated in inventory counts?
can be estimated unless it is over 1000 count bottles; then it must be exact
How may a C-II prescription be written?
written, faxed = wet signature
electronic prescription with e-signature
What C-II faxed prescriptions are acceptable?
-C-II to be compounded for immediate injection to the patient
-C-II for a resident of a long term care facility
-C-II narcotic for a patient in hospice care
What information is required for a controlled prescription label?
date of filling
dispensing pharmacy name and address
prescription number
name of the patient
name of the prescriber
directions for use
cautionary statements, if any **
transfer label
What can you not change on a P2 prescription?
-name of the prescriber
-name of the patient
-name of the medication (except for generic drug substitution)
What do you need to document for refill documentation?
-writing on the back of the presription
-name and dosage form of controlled substance
-date filled or refilled
-quantity dispensed
-initials of dispensing pharmacist for each refill
-total number of refills for that prescription
What is needed for the alternative record of CS refill documentation?
-original prescription number
-date of issue
-name and address of patient
-name, address and DEA of prescriber
-name, strength, dosage form, quantity prescribed of drug
-refills authorized
-refill history
How long do you have to fill the remainder of a C-II partial fill if requested by a patient?
30 days
How long do you have to fill the remainder of a C-II partial fill if the pharmacy was out of stock?
72 hours
How long do you have to fill the remainder of a C-II partial fill for a LTCF/Terminal Illness patient?
60 days
What additional requirements are there for central fill pharmacies to fill controlled substances?
-write the words “Central Fill” on the face of the prescription
-record the name, address, and DEA number of the central fill pharmacy
-record the retail pharmacists name and the date of the transmittal to the central fill pharmacy
What documentation must central fill pharmacies keep when filling controlled substances?
-a copy of the faxed prescription or electronic record with the name, address, and DEA number of the retail pharmacy
-date prescription was received, pharmacist filling the prescription, and the date the prescription was filled
-how the prescription was delivered to the pharmacy and when it was
-also needs to record the date the prescription was filled and refilled
can controlled substance prescriptions be transferred if never filled?
electronic prescriptions; one time transfers
non-electronic CIII-CVs must be filled once before it can be transferred
no written C-II can be transferred
