FDA Issues Guidance on Submitting Establishment Registrations Electronically

June 4, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

This week the US Food and Drug Administration released the final version of Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing.

Last week the US Food and Drug Administration released the final version of Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing. The guidance was developed to assist manufacturers with electronic submissions of drug establishment registration and drug listing information. As of June 1, 2009, FDA no longer accepts submissions in paper format unless a waiver is granted.

Drug establishment registration is mandated in the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act, and 21 CFR Part 207. According to these requirements, establishment owners or operators (with some exceptions) must register their establishment and submit listing information for all drugs in commercial distribution “upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs.” The requirements apply to the repackaging and relabeling of drugs and to establishments that import drugs to the United States.

The Food, Drug, and Cosmetic Act now requires registrations to be submitted electronically, unless the establishment is granted a waiver, using structured product labeling (SPL) files with coded data fields. The final guidance describes who must list the information; what information should be listed; how to create an SPL file using code sets and codes; the submission process; implementation; and how companies may obtain technical assistance and waiver requests.

Meanwhile, the agency is considering comments to its proposed rule that would amend 21 CFR part 207 to require electronic submission of drug establishment registration and drug listing information. This proposed rule includes certain changes to the National Drug Code (NDC) system and requirements regarding where the NDC should be placed on the drug label. When the proposed rule is final, FDA will revise, reissue, or revoke this guidance document to ensure it is consistent with the final rule.

The guidance can be downloaded from FDA's website.