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In addition to raw material constraints, the synthesis process itself presents technical and environmental limitations
Niki, E., Traber, M.G., 2012
and the Pharmacy Compounding Advisory Committee subsequently voted against adding it to the Category 1/503A bulk drug substances list at its late-2024 meetings, leaving it without a confirmed legal compounding pathway at that time
The API must be accompanied by a valid Certificate of Analysis which verifies the APIs quality and compliance with regulatory standards and conducts routine and rigorous third-party quality testing to check for potency, sterility, quality and contamination to ensure patient safety in compliance with state and United States Pharmacopeia standards
West, M
Some adverse effects reported were irritation of nasal passages, headaches, and a bloody nose
