QUESTIONS AND ANSWERS SURE A+
✔✔What items can be changed on a CII prescription? - ✔✔strength of drug, quantity of
drug, directions for use, and the date the RX was issued. All changes require
prescribing practitioner approval. Note the date and time of change, and the reason for
the change.
✔✔Which items can NOT be changed on a CII prescription? - ✔✔name of the patient,
name of the drug, signature of the prescribing practitioner.
✔✔Can a prescription blank contain more than one CII medication? - ✔✔YES. If it's
being filled immediately, the prescription can contain multiple CIIs, other controlled
medications, or non-controlled medications. They just have to be filed appropriately.
(make copies, reference the original rx/C2 on the copies)
✔✔Can a pharmacist return a written C2 prescription? - ✔✔yes, only if the medication
has not already been dispensed. If the medication has been dispensed, the pharmacist
shall not return the rx to the patient.
✔✔Can multiple drugs be on a single prescription blank if the medication is issued for
future use? - ✔✔NO. any C2 with "do not fill before" or some version thereof must be
alone on that prescription blank.
,✔✔When must a C2 prescription for future use be tendered? - ✔✔within 14 days of the
future date indicated (on or before the 14th day).
✔✔True or false: the date indicated on a C2 for future use must not be later than 4
months after the date on which the prescription is written. - ✔✔FALSE - no later than
THREE months.
✔✔True or false: for C2s with future fill date; "no combination of prescriptions for the
same medication may exceed a 90-day supply based on the date indicated." -
✔✔TRUE.
✔✔Are pharmacists allowed to dispense a partial fill on C2 medications? - ✔✔YES. If
the pharmacist is unable to supply the full quantity, you can fill a partial quantity - note
the quantity dispensed on the RX. The remaining quantity must be filled within 72 hours.
If the remainder cannot be filled within 72 hours, the pharmacist must notify the
prescriber. No further quantity may be supplied beyond the 72-hour period without a
new prescription.
✔✔How long is a C2 prescription valid for after a partial fill? - ✔✔if it's a regular patient,
the remainder must be filled within 72 hours. For patients in LTCF or hospice/terminally-
ill, the prescription is valid for 60 days after its written date unless the rx is terminated
earlier by d/c of the medication.
✔✔Can C-3 to 5 be partially filled by the pharmacist? What counts as a full refill? -
✔✔YES, schedule 3 to 5 can be partially filled. A patient will not receive a full refill until
the entire quantity of the first prescription has been dispensed. Example: patient has RX
for Xanax 2 mg, # 60. Patient can pick up #20. It will not count as a "full" fill until the
patient picks up a total of 60.
✔✔Up to how long can C3-5 rxs be partially filled or refilled? - ✔✔no more than 6
months after the date it was originally written.
✔✔If a pharmacist is hired as a new pharmacy manager, when must they conduct a
controlled inventory by? - ✔✔within 48 hours, with the preceding pharmacist. Both must
sign the inventory.
✔✔How often must an inventory of controlled substances be conducted? - ✔✔Biennially
(every 2 years). "on any date which is within 2 years of the date on which the previous
biennial inventory was conducted."
✔✔Which records must be maintained in regards to the sale of controlled substances to
a practitioner? - ✔✔DEA 22 form for all controlled substances (2-5), plus, a certificate
placed on the written order, signed by the pharmacist filling the order and the person
,receiving the order and specifying the date the order was filled and any deletion or
change in the order.
✔✔If a DEA 222 form is lost or stolen, who and when must the pharmacist notify? -
✔✔notify the DEA immediately upon discovery of loss or theft.
✔✔What are the requirements to sell/dispense a controlled medication that by law does
not require a prescription? - ✔✔(1) dispensing only by the pharmacist/intern. (2) no
more than 60ml or 2oz in any 48-hr period. (3) purchaser is at least 21 yo. (4) validate
the ID/age of the purchaser if unknown to the pharmacist. (5) maintain a log book . (6)
the medication is not required by law to have a prescription.
✔✔What items must be contained in the log book for selling non-prescription controlled
medications? - ✔✔(1) name and address of the purchaser, (2) name and quantity of
drug sold, (3) date of each purchase, (4) initials/name of pharmacist who dispensed the
medication
✔✔What are the requirements in dispensing Paregoric? - ✔✔Paregoric is camphorated
tincture of opium, used for GI issues. Can dispense is (1) it has been mixed with at least
3 oz of non-narcotic medication/mixture, (2) contains no more than 1 oz total paregoric.
✔✔True or false: a practitioner may prescribe or administer controlled substances (C2s)
for himself, his spouse, or his children if it's in the usual course of his professional
practice. - ✔✔FALSE - only in cases of emergency.
✔✔How long does a pharmacist have to notify the DEA and Board of Pharmacy of any
loss or theft of controlled substances? - ✔✔within 10 days after the date of discovery of
the theft or loss.
✔✔What items are required in the log book for the sale of precursors to
methamphetamines? - ✔✔(1) name of the product sold, (2) quantity of the product sold,
(3) name and address of the purchaser, (4) date and time of the sale
✔✔How long must records for the sale of precursors to methamphetamine be
maintained? - ✔✔at least 2 years.
✔✔What is the max of pseudoephedrine product that can be purchased in a single day?
30 days? - ✔✔3.6 grams per day. 9 grams per 30 days.
✔✔What are the elements of negligence? - ✔✔duty owed, breach of duty, causation
and damage. All four elements required to prove legal liability.
, ✔✔What is the difference between a prescription drug and an OTC drug? -
✔✔Prescription drugs are intended for human use, but are generally not safe unless
taken under the supervision of a practitioner. OTC medications are generally seen as
safe, must be manufactured using current GMPs, and have adequate directions for use
for the lay-person.
✔✔What is the difference between an NDA and an ANDA? - ✔✔NDA is a new drug
application. Typically reserved for new chemical entities, or new indications/dosage
forms/routes of administration, etc of already known chemical entities. These require
safety and efficacy data for the FDA to give pre-marketing approval. And ANDA =
abbreviated new drug application. These are used for generics of brand name
medications who's patent just ran out. Safety/efficacy studies not generally required, but
bioequivalency studies are needed.
✔✔What is an SNDA? - ✔✔Supplemental new drug application. An application process
for previously FDA approved drug products that want to request a change to the
production of the drug, manufacturing process, or to the labeling of the drug.
✔✔What is an OTC monograph? - ✔✔a regulation specifying the conditions (dosage,
indications) under which specific active ingredients and combinations may be
formulated in OTC drug products without prior FDA approval.
✔✔What is an NDC? - ✔✔national drug code - it identifies all drug products, is required
on all OTC and prescription drug labels. A drug with an NDC does not mean is has an
approved NDA. First section = manufacturer. 2nd section = drug product. 3rd section =
packaging.
✔✔What is the difference between adulteration and misbranding? - ✔✔Adulteration is
concerned with the physical conditions of drugs or devices and the environment of their
manufacture. Misbranding is concerned with the representations made by the
manufacturer concerning the drug or device.
✔✔Misbranding or adulteration: does not bear generic name in type not less than ½
size of the trade or brand name? - ✔✔misbranding
✔✔Misbranding or adulteration: does not bear adequate directions for use. -
✔✔misbranding
✔✔Misbranding or adulteration: label fails to state name and place of business of
manufacturer and accurate statement of quantity. - ✔✔misbranding
✔✔Misbranding or adulteration: does not bear caution: warning, may be habit forming, if
the substance is habit forming. - ✔✔misbranding