UMD-CERSI Expert Questionnaire

Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

CERSI UMD Questionnaire Final

UMD-CERSI Expert Questionnaire

OMB: 0910-0871

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Survey Questions


  1. What is your current level of training? (i.e. physician, naturopath, nurse practitioner)

  2. What specialty(ies) do you hold? (i.e. endocrinology, hepatology)

  3. What is your current practice setting? (i.e. clinic, health-system, hospital)

  4. Do you currently use ________ substance in your practice?

  5. What type of product containing this substance do you use in your practice (e.g., FDA-approved drug, compounded drug, dietary supplement)?

  6. Check all of the conditions or diseases for which you use this substance in your practice.

  7. List any additional conditions or diseases for which you use this substance.

  8. How do you, or the patient, administer this substance?

  9. What dosage form do you use of this substance?

  10. What strength do you use of this substance?

  11. List the patient population in which you prescribe or administer this substance.

  12. In the past 5 years, how many prescriptions have you written for this substance?

  13. Has this number changed over time? If so, how?

  14. Do you order “office stock” supplies of compounded drug products containing this substance to keep on hand for use with patients as needed?

  15. If you order “office stock” supplies of these compounded drugs, why? (e.g., convenience, emergency use)

  16. If an FDA-approved product containing this substance exists,

    1. Are you using the product containing this substance instead of the FDA-approved product? If so, why?

    2. Are you using that FDA-approved product in conjunction with another product containing this substance? If so, why?

  17. If an FDA-approved product containing this substance does not exist, are there any FDA-approved products that are used to treat the disease or condition?

    1. If yes, are you using the product containing this substance instead of the FDA-approved product used to treat the disease or condition? If so, why (e.g., failure of traditional therapy, side effects of traditional therapy)?

    2. If yes, are you using such FDA-approved products in conjunction with another product containing this substance? If so, why?

  18. For which, if any, diseases or conditions do you consider this substance standard therapy?

  19. Does your specialty describe use of this substance in medical practice guidelines or other resources?



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