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Both are sterile water preparations, but they serve different purposes: Sterile water without preservative is single-use by design once the seal is broken, the sterility is compromised because there's no preservative to resist contamination
For malabsorption (e.g., pernicious anemia), injections are often preferred, though some clinicians still use very high-dose oral regimens (NIH ODS)
If the FDA agrees to it, they have to initiate what is called a formal notice-and-comment rulemaking process, which Holt says generally takes well over a year
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