Comment from Merz North America part 2 of 2

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Summary: Merz North America is submitting a formal request for the inclusion of several bulk drug substances (Fentanyl Citrate, Oxytocin, Vancomycin Hydrochloride, Hydromorphone Hydrochloride, Morphine Sulfate Pentahydrate, Midazolam Hydrochloride, and Norepinephrine Bitartrate) for use in compounding. They argue that using bulk APIs is clinically necessary to ensure potency, sterility, and safety, while also meeting specific prescriber requirements for varying concentrations and volumes.
Please see attached files for a comment from Merz North America and associated Tabs 20-38. This is Part 2 of a 2-part submission due to the limit on the number of attachments permitted by regulations.gov. Please refer to Part 1 of this submission, consisting of the comment from Merz and Tabs 1-19, under tracking number 1k3-9d2g-skib.

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