FedPharmCompounding Flashcards
For a compounder to pass the media-fill test, how long must the sample remain free from turbidity?
A. 24 hours
B. 72 hours
C. 7 days
D. 14 days
E. 30 days
D. 14 days
Which of the following is required to prepare a sterile, hazardous drug?
A. Containment primary engineering control
B. Tertiary aseptic engineering hood
C. Secondary engineering control
D. Laminar airflow workbench
E. Powder containment hood
A. Containment primary engineering control
A pharmacist is preparing a topical compound containing glycolic acid 5%, hydroquinone 1%, and tretinoin 0.025% in a cream base (Aw = 0.968) and it will contain a preservative. What is the maximum beyond-use date that can be applied to the label?
A. 7 days
B. 10 days
C. 14 days
D. 35 days
E. 6 months
D. 35 days
Which of the following requires a pharmacy to register as a 503B facility with the FDA?
A. Preparation of small batches in advance based on dispensing history
B. Compounding sterile preparations in bulk to distribute to other pharmacies
C. Repackaging medications for distribution to a long-term care facility
D. Compounding hazardous topical preparations for patient-specific use
E. Preparing compounds that contain controlled substances
B. Compounding sterile preparations in bulk to distribute to other pharmacies
The pharmacist intern is reconstituting a 1 gram vial of ceftazidime with 10 mL of sterile water for injection. The reconstituted solution will be added to a bag of normal saline for IV administration. The primary engineering control used to compound this IV admixture should have: (Select ALL that apply.)
A. Positive air pressure
B. Unclassified air
C. At least ISO 5 air quality
D. At least ISO 7 air quality
E. Unidirectional airflow
A. Positive air pressure
C. At least ISO 5 air quality
E. Unidirectional airflow
Which of the following drugs would be eligible for an Assessment of Risk (AoR)?
A. Methotrexate tablets that are split in half
B. Hydroxyurea powder used to prepare an oral solution
C. Carboplatin intravenous solution that is added to a bag of normal saline
D. Tamoxifen tablets which are repackaged into unit-dose packets
E. Carmustine powder which is reconstituted with dehydrated alcohol
D. Tamoxifen tablets which are repackaged into unit-dose packets
Which of the following must follow Current Good Manufacturing Practices (CGMPs)? (Select ALL that apply.)
A. Drug manufacturers
B. Outsourcing facilities
C. Traditional compounding pharmacies
D. Retail pharmacies
E. Hospital pharmacies
A. Drug manufacturers
B. Outsourcing facilities
Which of the following United States Pharmacopeia (USP) standards is best consulted to determine the personal protective equipment requirements while compounding an oral suspension of colchicine?
A. USP 797
B. USP 795
C. USP 800
D. USP 798
E. USP 503
C. USP 800
Colchicine is a hazardous drug. USP 800 sets standards for safe handling of hazardous drugs, including personal protective equipment (PPE) requirements. USP 795 can be consulted for the preparation standards to compound this suspension (e.g., beyond-use dates), but it does not provide details on PPE.
Where do the pharmacy personnel don garb for sterile compounding?
A. Primary engineering control
B. Buffer room
C. Wash and storage area
D. Biological safety cabinet
E. Anteroom
E. Anteroom
Which of the following must be compounded in a negative-pressure hood?
A. Naltrexone capsules
B. Cyclophosphamide oral suspension
C. Lidocaine lip balm
D. Ondansetron suppositories
E. Sildenafil sublingual troches
B. Cyclophosphamide oral suspension
Cyclophosphamide is a hazardous drug. All hazardous drugs (sterile and non-sterile) must be compounded in a containment primary engineering control (C-PEC) at negative air pressure.
A pharmacy compounds cream formulations for a pain management clinic in the same medical building. Which of the following is an acceptable compounded product?
A. Ketamine 40%, baclofen 1%, gabapentin 2%
B. Ketamine 35%, baclofen 2%, gabapentin 5%
C. Ketamine 30%, baclofen 2%, gabapentin 5%
D. Ketamine 15%, baclofen 2%, gabapentin 10%
E. Ketamine 25%, baclofen 3%, gabapentin 15%
D. Ketamine 15%, baclofen 2%, gabapentin 10%
“A pharmacy cannot compound a preparation that contains > 20% controlled substances.”
Question: A technician is preparing the label for a calamine-zinc oxide ointment he has prepared.
Following is a list of ingredients with individual expiration dates:
Calamine, exp 4/2024
Zinc oxide, exp. 7/2024
Aquaphor, exp. 8/2024
Mineral oil, exp. 1/2025
The water activity (Aw) = 0.43. If today’s date is January 31, 2024, what is an appropriate BUD for this compounded product?
Answer Choices:
A. July 31, 2024
B. March 2, 2024
C. February 28, 2024
D. February 14, 2024
E. April 30, 2024
E. April 30, 2024
The BUD for nonsterile, nonaqueous formulations that are not oral liquids is up to 6 months from the date of preparation. Calamine expires 4/2024, which is sooner than 6 months; therefore, the BUD is April 30, 2024.
Which of the following drugs would be found on the NIOSH list? (Select ALL that apply.)
A. Bleomycin
B. Nystatin
C. Tacrolimus
D. Medroxyprogesterone
E. Isotretinoin
A. Bleomycin
C. Tacrolimus
D. Medroxyprogesterone
E. Isotretinoin
Which of the following would be found on the Safety Data Sheet for valganciclovir? (Select ALL that apply.)
A. Personal protective equipment recommendations
B. First aid procedures
C. Drug compatibility information
D. Spill clean-up procedures
E. Significant drug interactions
A. Personal protective equipment recommendations
B. First aid procedures
D. Spill clean-up procedures
