BHRT and the FDA
CE accredited for Pharmacists and Technicians. To get credits for this talk go https://compoundingce.com/courses/pha...
BHRT and the FDA
Presenter: Rachael Pontikes & Emily Hussey from Reed Smith
Learning Objectives
Describe how compounded BHRT is currently regulated by federal and state agencies
Explain the latest steps by FDA to regulate compounded BHRT
Review the recent study completed by the National Academy of Science, Engineering and Math (NASEM) regarding the clinical utility of compounded BHRT and what comes next for regulating such medication
Assessment Questions
1. Multiple-Choice Question What did NASEM conclude as to the clinical utility of compounded BHRT?
A. It was inconclusive
B. It found strong evidence for clinical utility
C. It found no evidence for clinical utility
D. None of the above
2. Multiple-Choice Question Why is compounded BHRT ill-suited for the new drug approval process?
A. It is patient specific
B. It is ill-suited for large-scale manufacturing
C. Compounded products do not go through the NDA process
D. All of the above
3. Multiple-Choice Question What are some concerns or criticisms associated with NASEM’s study?
A. It was biased in favor of pharmaceutical companies
B. It took too long
C. It was heavily influenced by FDA
D. Both A and C
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