FDA Releases Guidance Electronic Submission of Lot Distribution Reports

FDA has provided licensed manufacturers of products distributed under an approved biologics license application (BLA) with recommendations on how to submit lot distribution reports (LDRs) for biological products in an electronic format. The draft guidance follows FDA’s June 10, 2014 rule that amended the requirements for biological LDRs required under Title 21 of the Code of Federal Regulations 600.81 (21 CFR 600.81). Under FDA’s rule, applicants are required to submit LDRs to FDA in an electronic format that the agency can process, review, and archive (79 Federal Register 33072). The requirement goes into affect on June 10, 2015.

According to the draft guidance, applicants must submit LDRs containing certain specified information about the quantity of the product distributed under their BLAs (including to distributors) every six months to the Center for Biologics Evaluation and Research or to the Center for Drug Evaluation and Research, as appropriate. “FDA may require an applicant to submit more detailed product distribution information.  Furthermore, upon written notice, the agency may request distribution reports at times other than every six months.”