(a) All info submitted beneath this part must be transmitted to FDA electronically in accordance with § 207.61(a) unless FDA has granted a ask for for waiver of this necessity prior to the day on which submission of this sort of data is thanks. Submission of a request for waiver won't justification well timed compliance Together with the registrat
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A registrant who also relabels or repacks a drug that it salvages need to record the drug it relabels or repacks in accordance with § 207.fifty three rather then in accordance using this part. A registrant who performs only salvaging with respect to a drug must provide the following listing info for that drug.Substances for which a petition has lo
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