A registrant who also relabels or repacks a drug that it salvages need to record the drug it relabels or repacks in accordance with § 207.53 rather then in accordance with this area. A registrant who performs only salvaging with regard to a drug should deliver the next listing facts for that drug.Olestra, or Olean, can be a cholesterol-absolutely
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(a) All information submitted beneath this aspect have to be transmitted to FDA electronically in accordance with § 207.sixty one(a) Unless of course FDA has granted a ask for for waiver of this necessity before the date on which submission of these kinds of info is thanks. Submission of a request for waiver will not justification timely complianc
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