New guidance issued by the US Food and Drug Administration (FDA) is intended to clarify how biopharmaceutical companies should submit so-called "lot distribution reports" (LDRs)—reports detailing the quantity of a product which has been legally distributed.
As required by 21 CFR 600.81, LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted at least every six months, though FDA can, at its discretion, request the reports be submitted at different intervals.
In recent years, FDA has moved away from a paper-based LDR system in favor of its electronic-based Lot Distribution Database (LDD), which the regulator has said will "improve accuracy, efficiency and timeliness."
In June 2014, FDA issued a final rule regarding the submission of all postmarket safety reports for drugs and biological products in electronic format, including LDRs. The rule, similar to other eSubmissions systems at the agency, calls for the use of FDA’s electronic submission gateway (ESG) and Structured Product Labeling (SPL).
FDA initially outlined these changes in a draft guidance, Electronic Submission of Lot Distribution Reports, which it finalized on 20 March 2015.
FDA's final guidance is nearly identical to its draft guidance with the exception of some "editorial changes," FDA explained in a Federal Register announcement accompanying the guidance.
The guidance calls for LDRs to be formatted "in the same electronic messaging standard used for drug registration and listing information and for the content of labeling for BLAs," known as the Health Level Seven (HL7) standard.
Lot distribution files should also be included under Module 3 of the electronic common technical document (Section 3.2.R, Regional Information). The guidance contains extensive information about how to generate SPL files, instructions on how to create and validate SPL files, and how to transmit SPL files. The guidance also notes that FDA can waive LDR submission requirements, such as when an applicant is unable to submit a file (e.g. a natural disaster).
The guidance also applies to biological products regulated by the Center for Drug Evaluation and Research (CDER) under approved BLAs, such as some monoclonal antibodies.
Electronic Submission of Lot Distribution Reports (FR)