UMD-CERSI Expert Focus Groups and Interviews

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

UMD Interview Questions Final

UMD-CERSI Expert Focus Groups and Interviews

OMB: 0910-0871

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Interview/Focus Group 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 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. What are the conditions or disease for which you use this substance for in your practice?

  7. Please discuss the route of administration, dosage form, and strength that you use of this substance.

  8. What patient population do you prescribe or administer this substance?

  9. How often do you prescribe or use this substance in your practice?

  10. Has there been any change in the frequency in which you use this substance? If so, why?

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

  12. In your opinion, why do you need “office stock” supplies of these compounded drugs instead of writing a patient-specific prescription for the drug to be compounded when a patient presents a need for the drug?

  13. Why would you use a compounded drug containing this substance over an FDA-approved product? (i.e. failure of traditional therapy, side effects of traditional therapy)

  14. 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?

  15. 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?

  16. For which, if any, conditions do you consider this substance standard therapy?

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

  18. Is there any data to support the use of this substance for each indication?

  19. What side effects are there for this substance?


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