complete solutions16
A physician asks if the pharmacy can prepare a specific compounded sterile preparation (CSP)
needed for surgical procedures. The physician has a list of ingredients needed for the CSP. The
procedures can be scheduled on short notice and the physician may not be able to provide
patient-specific prescriptions in advance. The pharmacy is a traditional 503A pharmacy.
According to Title I of the Drug Quality and Security Act (the Compounding Quality Act), which
of the following statements is true?
A) The physician can order any quantity of compounded sterile preparations by filling out an
order form
B) The physician must provide patient-specific prescriptions to the pharmacy
C) The physician must provide an approximate number of patients he would see in a week
D) The pharmacy must register with the FDA as a 503A pharmacy before compounding sterile
preparations for office use.
E) As long as the pharmacy follows curren - ANSWERS-B
The manufacturer of a novel oral anticoagulant has provided a prescriber with free samples. The
prescriber would like to give it out to her patients at the anticoagulation clinic. Which of the
following statements is true regarding drug samples?
A) Drug samples can be stored at the outpatient pharmacy that is adjacent to the clinic.
,B) The prescriber must make a written request in order to receive the samples; verbal requests
are not acceptable.
C) The clinic can charge patients for the samples, at no more than 25% of the retail cost.
D) Drug samples can only be furnished if the patient's insurance does not cover the drug
E) The patient must enroll in an approved patient assistance program before receiving drug
samples - ANSWERS-B
A patient presents the following prescription to a retail pharmacy:
Mary Smith, MD
1234 Anywhere Street
Hometown, State, 94110
415-345-6834
DEA number: BS1212125
Patient name: Courtney Grey DOB 8/11/1972
Rx: Methadose 40 mg #2
Sig: 2 tablets PO daily
No refills
Signature: Mary Smith Date: 3/1/2017
What should the pharmacist do?
, A) Dispense as written
B) Contact the prescriber and clarify the quantity
C) Contact the prescriber and clarify the dose frequency
D) Contact the prescriber and clarify the route of administration
E) The 40 mg dose is only available at a methadone clinic, refer the patient to a methadone
clinic - ANSWERS-E
Which of the following is not required on a label for a unit dose?
A) Beyond use date
B) Lot number
C) Drug name
D) NDC number
E) Quantity of the active ingredient - ANSWERS-D
White Memorial Hospital has the following layout for their sterile compounding area. There is a
separate room for preparing sterile, non-hazardous drugs and a separate area for preparing
sterile, hazardous drugs (mostly chemotherapy drugs). These two rooms share an ante room.
What is the minimum ISO requirement for this ante room?