Chapter 17 (Compounding III: Documentation & Preparation)
Which test confirms the integrity of a filter that will be used for terminal sterilization?
Bubble-point test
The Continental (dry gum) and the English (wet gum) are methods of preparing which type of dosage form?
Emulsions
The multi-dose vial of Herceptin will be used to prepare doses for multiple patients. What is the risk level of the Herceptin admixtures?
Medium-risk
Using a multi-dose vial to prepare multiple doses is considered medium-risk. To prepare multiple doses, the compounder will need to enter the same vial multiple times, increasing the risk of contamination.
Which of the following is a correct statement about withdrawing Herceptin from a vial when a closed-system transfer device (CSTD) is not available?
Air should not be injected into the Herceptin vial before drug removal
Compounding Method
What technique should be used in step 3 of the instructions?
Geometric dilution
Which of the following drugs do NOT have a CSP risk level assigned by USP? (Select ALL that apply.)
Fluconazole in dextrose 400 mg/200 mL premixed bag
Meropenem in NS 500 mg/50 mL ready-to-use drug delivery system
Rank the following steps used to compound molded tablets in the correct order. (Left-click to drag and order the answer options; the first step must be placed in the top box. ALL options must be used.)
Place the following steps for making an ointment in the correct order. (Left-click to drag and order the answer options; the first step must be placed in the top box. ALL options must be used.)
The pharmacy receives a prescription for 100 grams of 5% hydrocortisone ointment. The pharmacy has a 10% hydrocortisone ointment and a 2.5% hydrocortisone ointment available. Using only these products, how many grams of the 10% ointment should be used to compound this prescription? (Answer must be numeric; no units or commas; round the final answer to the nearest ONE DECIMAL PLACE.)
33.3
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 powder, exp.
4/2022
Zinc oxide powder, exp. 7/2022
Aquaphor (non-aqueous ointment base), exp.
8/2022
Mineral oil, exp. 1/2023
If today's date is January 31, 2022, what is an appropriate BUD for this compounded product?
April 30, 2022
The BUD for non-sterile, non-aqueous formulations is up to 6 months from the date of preparation. Calamine expires 4/2022, which is sooner than 6 months; therefore, the BUD is April 30, 2022.
Which statement is correct regarding the use of intravenous (IV) medications in the hospital setting?
The pH of IV solutions should be close to neutral (pH of 7)
The pharmacy technician would like to prepare an emulsion using the Continental gum method (also known as the dry gum method). Place the steps that the technician will need to take in the correct order. (Left-click to drag and order the answer options; the first step must be placed in the top box. ALL options must be used.)
1. Levigate the gum with oil
2. Add water all at once
3.
Triturate until cracking sound is heard and the mixture looks creamy
white
4. Add other ingredients and water to sufficient to make
the final volume
5. Homogenize the emulsion
Due to a nationwide shortage of sodium bicarbonate injection, a pharmacist is looking at the possibility of using non-sterile sodium bicarbonate powder to compound sterile intravenous sodium bicarbonate. What beyond-use date should be on the label if the final preparation will be stored at room temperature?
24 hours
High-risk sterile compounding uses non-sterile ingredients or equipment. The beyond-use date for a high-risk CSP stored at room temperature is 24 hours.
Which of the following can be used for sterility testing of high-risk compounded sterile products (CSPs)? (Select ALL that apply.)
Tryptic soy broth
Fluid thioglycollate medium
Bacterial endotoxin test
The technician has finished compounding a doxycycline IV admixture. Which of the following must be included on the label? (Select ALL that apply.)
Name and concentration of ingredients
Route of administration
Storage information
Appropriate auxiliary labels
The pharmacist is preparing intravenous conventional amphotericin B for a patient with AIDS with invasive aspergillosis. What diluent should be used to reconstitute the drug?
Sterile water for injection
All of the following must be documented in the compounding record EXCEPT:
When the compounding area was last cleaned
A pharmacy technician is compounding cefazolin 2 g in 50 mL of D5W for intravenous infusion. How should the pharmacist verify that the correct volume of ingredients was used in the preparation?
Direct visualization of the syringe before compounding
The density factor is needed to prepare which formulation type?
Suppository
A compounding pharmacist receives a prescription for thirty 60 mcg levothyroxine (T4) capsules. How many 150 mcg tablets will he need to compound this prescription? (Answer must be numeric; no units or commas; round the final answer to the nearest WHOLE number.)
12
30 x 60 mcg caps = 1800 mcg needed
1800 mcg / 150 mcg per cap = 12 capsules needed
The pharmacy receives a prescription for 50 grams of 5% salicylic acid ointment. The pharmacy has a 30% salicylic acid ointment and petrolatum available. Using only these products, how many grams of petrolatum should be used to compound the prescription? (Answer must be numeric; no units or commas; round the final answer to the nearest ONE DECIMAL PLACE.)
41.7
(50 g)(5%) = (x)(30%)x = 8.3 g
50 g - 8.3 g = 41.7 g
Which document provides directions on how to make a calamine-zinc oxide ointment?
Master formula
Stability: A beyond-use date of 56 days can be used for this preparation only when it is stored in a refrigerator. The reported stability study used the injection as the source of the drug
Today's date is January 31st.
What is an appropriate BUD for this compounded preparation if it is stored in the refrigerator?
March 28th
Put the required steps to complete preparation item #2 and #3 in the correct order? (Left-click to drag and order the answer options; the first step must be placed in the top box. ALL options must be used.)
1. Inject 50 ml of air into the vial of 0.9% sodium chloride
2.
Withdraw 50 ml of liquid from the vial of 0.9% sodium chloride
3. Inject 50 ml of 0.9% sodium chloride into the vial of
cyclophosphamide
4. Withdraw 50 ml of reconstituted
cyclophosphamide solution from the vial
5. Add 50 ml of
reconstituted cyclophosphamide solution to the graduated cylinder
A pharmacist has received an order to compound 200 mg progesterone suppositories. She will use a white, amorphous low density progesterone powder that aerosolizes easily.
The master formulation record includes the following
ingredients:
Theobroma oil
Progesterone powder
Sodium
lauryl sulfate
In the formula above, what is the purpose of the sodium lauryl sulfate?
Surfactant, charge neutralizer
What is the most commonly used dosage form for manufactured oral medications?
Compressed tablets
A pharmacy technician reconstitutes a single-dose vial of cefazolin and transfers it to a 50 mL bag of D5W. The dose is prepared in an ISO 5 horizontal airflow workbench, which is located in an ISO 7 cleanroom with an ISO 8 anteroom. What beyond-use date should be on the label if the cefazolin will be stored in the refrigerator?
14 days
The BUD date for a low-risk CSP stored in the refrigerator is 14 days.
A multi-dose vial of ondansetron is being used to prepare doses for multiple patients at the same time. The doses are prepared in an ISO 5 laminar airflow workbench, which is located in an ISO 7 cleanroom with an ISO 8 anteroom. According to USP 797, what BUD should be assigned to these IV admixtures if stored at room temperature?
30 hours
Batch preparation requires multiple entries into the same vial, which increases the risk of contamination. Batching is considered medium-risk compounding, and the BUD for medium-risk CSPs stored at room temperature is 30 hours.
A pharmacist needs to prepare a 4% hydrocortisone ointment to treat a
rash on a patient’s forearms and to protect the skin from drying.
The master formulation includes these
ingredients:
Hydrocortisone powder
Mineral oil
Petrolatum
Dimethicone
The compound is being prepared on January 1st. The earliest expiration date of any ingredients is December 30th of that same year. What is the beyond-use date (BUD) of the hydrocortisone ointment (assuming all are within the same year)?
July 1st
The BUD of non-sterile, nonaqueous formulations is up to 6 months from the preparation date. If any of the ingredients expire before 6 months, the earlier expiration date should be used.
Place the following steps for making the hydrocortisone ointment in the correct order. (Left-click to drag and order the answer options; the first step must be placed in the top box. ALL options must be used.)
1. Weigh the hydrocortisone powder
2. Plave the powder on an ointment slab.
3. Add a small amount of mineral oil to the powder
4. Levigate the powder using an ointment slab and spatula
5. Add petrolatum using geometric dilution
The pharmacist has prepared 60 g of the 4% hydrocortisone ointment and is concerned that the strength is too strong for the patient’s thin, cracked skin. How much petrolatum should be added to reduce the strength to 2.4%?
40 g
(60 g)(4%) = (x)(2.4%)x = 100 g
100 g - 60 g = 40 g
The pharmacist does not have enough petrolatum to use for the above preparation. The pharmacist will prepare 60 grams of the 2.4% by combining the 4% hydrocortisone ointment with a 1.5% hydrocortisone ointment the pharmacy has in stock. How many grams of each ointment will be required?
21.6 g 4%, 38.4 g 1.5%
The pharmacist receives the following compound prescription on March 5th.
Spironolactone/Hydrochlorothiazide Suspension
Spironolactone/Hydrochlorothiazide 25 mg/25 mg tablets -
quantity 24 tablets
Ora-Plus - quantity 120 mL
The ingredients on the label of the Ora-Plus suspending
vehicle are listed as: purified water, microcrystalline cellulose,
carboxymethylcellulose sodium, xanthan gum, carrageenan, calcium
sulfate, trisodium phosphate, citric acid, sodium phosphate,
dimethicone, methylparaben and potassium sorbate.
The pharmacist notes that the Ora-Plus expires on 4/30 of this year and the spironolactone/hydrochlorothiazide tablets expire on 6/30 of this year. Assuming the product is packaged and stored correctly, which beyond use date is correct for this product?
March 19th
**case above**
Which auxiliary label must be placed on the final product?
shake well before using
Which of the following compounded preparations would have the shortest beyond use date?
A water-containing oral solution that is stored in the refrigerator
A pharmacist is compounding an emulsion by first combining acacia (gum) with water to form a mucilage and then slowly adding the oil to form the emulsion. What is this process called?
English method
A technician is compounding a minoxidil 5% and finasteride 0.1%
topical liquid with the following
ingredients:
Minoxidil
Finasteride
Propylene
glycol
Ethanol 95%
Purified water
What technique
should he use when mixing ingredients to ensure that all the
ingredients are uniformly distributed in the final preparation?
Geometric dilution
A pharmacy technician is preparing amiodarone 150 mg in 100 mL D5W for intravenous infusion. After swabbing the rubber stopper of the amiodarone vial with alcohol, what is the correct order of the steps he should take to correctly remove the drug from the vial? (Left-click to drag and order the answer options; the first step must be placed in the top box. ALL options must be used.)
1. Pull back the syringe plunger to draw up the volume of air that is
equal to the desired volume of amiodarone
2. Position the needle
at 45-degree angle on the vial, with the bevel up
3. While
pushing the needle through the stopper, reposition the needle to a 90
degree angle
4. Inject the air into the vial
5. Invert the
vial and needle; withdraw the desired volume of amiodarone
According to USP 797, what beyond-use date should be placed on the vancomycin if it is stored at room temperature?
48 hrs
The vancomycin preparation is considered low-risk. The BUD for low-risk CSPs stored at room temperature is 48 hours.
A pharmacist is compounding a hard lozenge for sore throat relief. Which of the following would be an appropriate base for the lozenge?
Sucrose
A pharmacist is preparing a topical compound containing glycolic acid 5%, hydroquinone 1% and tretinoin 0.025% in a cream base. What is the maximum beyond-use date that can be applied to the label?
30 days
The cream base indicates that it is an aqueous formulation. The beyond-use date for water-containing topical formulations is 30 days.
JG is complaining of worsening nausea since the Exelon patch strength was increased last month. The medical director has ordered lansoprazole suspension 15 mg once daily, which the pharmacist will prepare using a compounding kit:
300 mL lansoprazole 3 mg/mL suspension
Ingredients: lansoprazole 0.9 g, artificial strawberry flavor, FD&C Red #40, Magnasweet 100 (ammonium glycyrrhizate), poloxamer 188, propylene glycol, purified water, simethicone emulsion, sodium bicarbonate, sodium citrate, sucralose, benzoic acid and xanthan gum.
What is the percentage strength (%w/v) of the prepared lansoprazole suspension?
0.3%
3 mg/mL = x/100 mL300 mg = 0.3 g = 0.3%
**case above**
The pharmacist will label the suspension using ratio strength. Which of the following provides the correct approximate ratio strength for the label?
1:333 lansoprazole solution
0.3 g/100 mL = 1/xx = 333
Which CSP risk level does NOT match the correlating non-hazardous area requirements?
low-risk; ISO 5 PEC, an ISO 8 buffer room and an ISO 8 ante area.
Rank the following steps for preparing capsules using the punch method in the correct order. (Left-click to drag and order the answer options; the first step must be placed in the top box. ALL options must be used.)
1. Triturate the dry ingredients
2. Mix all of the ingredients
together using geometric dilution
3. Smooth the powder to a
height that is one-third of the length of the capsule
4. Take the
base of the capsule and "punch down" into the pile of
powder
5. When the base is filled, fit the cap over the base