USP compounding non-sterile products - Survey powered by eSurveysPro.com

USP <795> compounding non-sterile products

1. How many beds are in the facility?

1-100

101-200

201-400

More than 400

2. Is the facility JCAHO accredited?

a. Yes

b. No

3. How many technicians and pharmacists are on staff at the facility?

4. Is the pharmacy staff aware of the USP<795> chapter on non-sterile compounding?

a. Yes

b. No

5. Is the pharmacy compliant with the USP<795>?

a. Completely compliant

b. Partially compliant

c. Not compliant at all

d. Don't know

6. Is there a dedicated staff devoted to non-sterile compounding?

a. Yes

b. No

7. Has the staff received formal training for non-aqueous sterile compounding?

a. Yes

b. No

8. Is there a designated area for non-sterile compounding?

a. Yes

b. No

9. Is there a water purification system available to prepare non-sterile compounds and to rinse the equipment used to prepare these compounds?

a. Yes

b. No

10. If no water purification system is available, what is used to prepare non-sterile compounds or to rinse the equipment used to prepare these compounds? Check all that apply:

a. Use distilled water

b. Use tap water

c. Use sterile water for injection

d. Equipment is not rinsed with purified water

c. Use sterile water for injection

d. Equipment is not rinsed with purified water

11. What equipment does the pharmacy have to prepare non-sterile compounds? Check all that apply:

a. Professional, certified digital or Torison balances

b. Graduated cylinders

c. Stirrers

d. Homogenizer

e. Mortar & pestles

f. pH meter

g. Thermometer

h. Mixer

i. Blender

j. Electronic mortar & pestle

k. Ointment mill

l. Capsule machine

m. Compounding software

n. Suppository molds

12. Does the pharmacist research the information for stability and effectiveness to create a formulation record?

a. Yes

b. No

13. Are the formulations prepared by the facility based on reliable, published information or stability studies?

a. Yes

b. No

14. How is the beyond-use date (BUD) assigned to a formulation? Check all that apply:

a. Dating published in texts or journals

b. 6 months for non

c. 1 year for tropical’s

d. 14 days refrigerated for water-containing formulations

e. 30 days or less for any formulation

f. 7 days or less for oral liquids and suspensions

15. What are the sources for active ingredients used to prepare non-sterile compounds? Check all that apply:

a. USP/NF grade bulk chemicals

b. Manufactured drug products

c. Bulk chemicals with certificates of analysi

16. Is each ingredient weight or measurement and the calculations double-checked during the compounding process?

a. Yes

b. No

17. Are all the weights and measurements within 10% of the calculated weights and measurements?

a. Yes

b. No

c. Don't know

18. Is there a quality assurance program for assessing all non-sterile compounds and procedures?

a. Yes

b. No

19. What is the content of a label on a non-sterile compounded preparation? Check all that apply:

a. Name of preparation

b. Assigned internal identification number of formula

c. Beyond-use date

d. Compounder's initials

e. Storage requirements

f. Strength or concentration

g. Total weight or volume

h. Bar-code

i. List of active ingredients (if compound contains multiple actives)

j. Patient-specific labeling

20. A formulation record is a file of individually compounded preparations or 'recipes'. Is a formulation record kept in the pharmacy?

a. Yes

b. No

21. What information is listed in the formulation record? Check all that apply:

a. Name, strength, and dosage form of compounded preparation

b. All ingredients and their quantities

c. Equipment needed

d. Mixing instructions

e. Beyond-use date

f. Container(s) used in dispensing

g. Storage requirements

h. Quality control procedures

i. References

22. The compounding record is the documentation of the preparation of a compound. How long are the compounding records retained or kept on file by the pharmacy? Check all that apply:

a. Compounding records not done for non-sterile compounded preparations.

b. Compounding records done only for batch-prepared non-sterile compounded preparations

c. Compounding records are permanently retained

d. Compounding records are retained for 1 year

e. Compounding records are retained for same time as a prescription record

f. Not aware that compounding records need to be maintained.

23. What information is listed in the compounding record? Check all that apply:

a. Name and strength of the compound

b. Assigned internal lot number or prescription/physician order number

c. Sources, lot numbers, and expiration dates for all ingredients

d. Total number of dosage units prepared

e. Name of compounder

f. Name of pharmacist that checks the compounder's work

g. Date of preparation

h. Beyond-use date

i. Results of quality control procedures

j. Container(s) used

k. Copy of label

24. Are MSDS information readily accessible to all employees involved in working with drug substances and chemicals?

a. Yes

b. No

25. Are all non-sterile compounds visually inspected to ensure that they appear as expected?

a. Yes

b. No

26. Are the compounding procedures for each formulation verified to ensure that the calculations, weighing and measuring, order of mixing, and compounding techniques are appropriate and accurately performed?

a. Yes

b. No

c. Don't know

27. Are non-sterile compounds prepared in batches and kept on-hand in the pharmacy?

a. Yes

b. No

28. Is the potency testing done (in-house or out-sourced) on non-sterile compounded preparations? Check all that apply:

a. Never done

b. Done only if there is a reported problem or discrepancy

c. Done to verify new compounded formulations

d. Done only with batch-prepared compounds

29. Is there a procedure or system to recall compounded preparations if there is a recall on any ingredient used to prepare compounds?

a. Yes

b. No

30.

What compounding references are available in the pharmacy? Check all that apply:

a. USP/NF or the USP Pharmacist's Pharmacopeia

b. Trissel's Stability of Compound Formulations

c. Remington

d. Allen's Compounded Formulations

e. Suppositories

f. The Children's Hospital of Philadelphia Extemporaneous Formulations

g. Pediatric Drug Formulations

h. International Journal of Pharmaceutical Compounding

i. Compounding Today.com

j. The Art, Science, and Technology of Pharmaceutical Compounding

k. Secundum Artem

l. Lexi-Comp

m. Micro-Medex

n. Martindale

o. Handbook of Pharmaceutical Excipients

p. American Journal of Health-System Pharmacist

q. Online medical library


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