A Non-Sterile Compounding Overview: Summarizing USP <795>
1. Which of the following identifies the major differences between compounding and manufacturing?
a. Compounding is patient-specific whereas manufacturing is performed on a large scale.
b. Compounding is creating generic medications whereas manufacturing applies to brand name
medications
c. Compounding and manufacturing are very similar and differ only in that a pharmacist
compounds and a PhD manufactures.
d. Compounding refers to preparing medications for veterinary patients and manufacturing is
preparing medications for human patients.
2. Which of the following laws is correctly matched with its effect on pharmacy?
a. Pure Food and Drug Act – Established to address safety of food and drugs
b. Food, Drug, and Cosmetic (FD&C) Act – Established the requirement for manufacturers to
apply for FDA authorization before marketing new drugs
c. Animal Medicinal Drug Use Clarification Act (AMDUCA) – Made it legal for veterinarians to
use medications off-label
d. All of the above
3. Which of the following is the current USP mission statement?
a. To improve non-sterile compounding by ensuring the quality, safety, and benefit of
compound products.
b. To improve drug quality by ensuring the quality, safety, and benefit of manufactured
products.
c. To improve public health by increasing availability of medications through large-scale
compounding.
d. To improve global health through public standards and related programs that help ensure the
quality, safety, and benefit of medicines and foods.
4. What organization is responsible for enforcing USP standards?
a. USP is an enforcement body and therefore responsible for enforcement of its standards.
b. USP is a subset of the FDA and therefore FDA is responsible for its enforcement
c. It is up to the state boards of pharmacy to enforce USP standards
d. USP only provides suggestions and therefore is not enforceable
5. Which of the following records kept by a compounding pharmacy is correctly matched with its
purpose?
a. CoAs: contain safety information for all products used in compounding
b. SOPs: detailed instructions for training, equipment maintenance, inventory, and
compounding processes
c. Formulation records: The documentation of what was really done when compounding
d. Compounding records: ‘Recipes’ for compounding
6. Which of the following is contained within USP-NF?
a. Official substance monographs
b. Official product monographs
c. Official preparation monographs
d. All of the above
7. Which of the following USP chapters are considered "enforceable"?
a. Chapters numbered less than 1000
b. Chapters numbered greater than 1000
c. All chapters
d. USP is not enforceable
8. Which of the following factors led to the decrease in compounding from 1930-1980?
a. Advertising of trade name products b. Time constraints
c. Third-party payers
d. All of the above
9. MJ is an elderly woman who is currently taking metoprolol BID, Lisinopril QD, furosemide BID, and
spironolactone BID for her heart failure. She is having difficulty keeping all of these medications straight
and is asking you (a compounding pharmacist) if there is any way she can just get one medication to
take instead of keeping track of all of these. Your first thought is a combination capsule containing all of
the necessary medications. Which of the following areas of concern should be considered prior to
agreeing to compound the medication?
a. Capsule size that would work best for the patient
b. Potential interactions between the medications if they are all within the same capsule
c. Size of the capsule necessary to hold the medications
d. All of the above
10. Who is responsible for developing the master formulation for this patient's combination capsule?
a. The patient
b. A pharmacist
c. A pharmacy technician
d. The pharmacy manager
11. What would be the longest appropriate BUD for these capsules?
a. 14 days
b. 30 days
c. 180 days
d. 1 year
12. A patient brings a prescription for 98mg doxycycline capsules to your compounding pharmacy.
What would be the correct course of action?
a. Compound this medication and give it a 180-day BUD as doxycycline is not commercially
available in 100 mg capsules
b. Contact the prescriber and explain that capsules are only good for 2 weeks so the patient
should only receive a 2-week quantitiy
c. Contact the prescriber and explain that doxycycline 100 mg capsules are commercially
available and ask if there is a specific reason as to why the patient is not able to receive the
commercially available product
d. Compound a 98 mg/mL suspension based on the patient's request. There is no need to
contact the prescriber
13. When preparing a compounded aqueous suspension, what BUD should be assigned based on USP
criteria
a. 14 days at room temperature
b. 14 days refrigerated
c. 30 days refrigerated
d. 180 days at room temperature
14. which ingredient grade is the first choice when using bulk chemicals to compound?
a. ACS reagent
b. Chemically pure (CP)
c. USP/NF
d. Technical
15. Which physical tests should be performed for quality control on a suspension?
a. Individual weights, pH
b. Individual weights, pH, physical observation
c. pH, physical observation
d. Total preparation weight
16. Which of the following are possible concerns with using manufactured products as the base for a
compound?
a. They are allowed a tolerance range, compromising the strength of the compound
b. Additional excipients can pose problems with patient allergies or certain formulations
c. Effects of excipients on stability of the compound
d. All of the above
17. Which type of medication would NOT be appropriate for compounding into capsules?
a. Salt forms of drugs
b. Light and fluffy powders
c. Medications needed in small quantities
d. All of the above
18. A competitive jumping horse is in need of doxycycline 5g BID. Doxycycline is commercially available
as 100 mg capsules. The vet called into your compounding pharmacy asking about administration
options. Which of the following should be considered before answering the vet's question?
a. Most ideal dosage form
b. Legal implications
c. Appropriate flavoring
d. All of the above
19. Which of the following describes the appropriate analysis of this request?
a. The commercially available capsules are the most appropriate dosage form for this horse
b. This horse is likely a food animal and therefore, this product should not be compounded
c. Apple may be an appropriate flavor but the owner can be consulted for the best flavor for
this horse
d. All of the above
20. Which law provides guidelines that can be used to determine if compounding is appropriate for this
horse?
a. AMDUCA
b. DQSA
c. FD&C Act
d. USP