The licensed manufacturer shall submit to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research (see mailing addresses in §600.2), information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. The interval between distribution reports shall be 6 months. Upon written notice, FDA may require that the licensed manufacturer submit distribution reports under this section at times other than every 6 months.
CFR 21-600.81-2014 history
2014CFR 21-600.81-2014 Food and drugs. Part600:Biological products:general. SubpartD:Reporting of adverse experiences. Section600.81:Distribution reports.