Structured Product Labeling

Electronic Registrations and Drug Listings

In June 2009, the U.S. Food and Drug Administration (FDA) issued a guidance, “Providing Regulatory Submissions in Electronic Format — Drug Establishment Registration and Drug Listing” on its expanded requirements for submissions in the Structured Product Labeling (SPL) format. The FDA Amendments Act of 2007 (Public Law 110-85) requires that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. Beginning June 1, 2009, all companies that manufacture, prepare, propagate, compound, or process prescription (Rx) products (including human pharmaceuticals, biologics, or vaccines), over-the-counter (OTC), and veterinary medicine products are required to provide FDA with establishment registration and drug listing information in SPL format. These requirements impact the manufacturers of drug products that are required to register establishments and drug list to comply with Title 21 Code of Federal Regulations, Part 207 — Registration of Producers Of Drugs And Listing of Drugs in Commercial Distribution.

History of SPL Submission Format

The submission of information in the SPL format has evolved and expanded over the past several years.  Companies with Rx products have been required to submit physician (U.S. Package Insert) and patient labeling in the SPL format since October 2005. Biologics companies have been required to submit labeling in this format since 2008. In June 2009, changes to the SPL standard accommodate the inclusion of drug establishment registration, and drug listing information and use with OTC and veterinary medicine products were implemented. Section 510 of the Federal Food, Drug, and Cosmetic Act, Section 351 of the Public Health Service Act, and/or CFR 21 Part 207 contain changes resulting from the FDA Amendments Act of 2007 (Public Law 110-85) requirement that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted.

Guidelines to Submit via SPL Electronic Format

Before the introduction of the SPL electronic format, companies were required to submit several paper forms to register manufacturing and packaging establishments (i.e., registration listing), and to "list" (i.e., drug listing), e.g., provide ingredient composition, dosage form, and packaging information.

FDA no longer accepts the Drug Registration and Listing paper forms (forms 2656, 2657, and 2658).  Instead, companies should submit NDC Labeler Code Requests, Registration Establishment Requests, and Drug Listing data in a fully electronic format via SPL submissions. Companies that produce and distribute Rx products (including biological and vaccine products), OTC, and veterinary medicine products should submit an SPL file to register establishments that manufacture, package, analyze, import, or serve as a U.S. agent for the company’s products or product components (registration listing). Companies should submit another electronic SPL file (drug listing) for each product listing its composition and packaging information, and providing its usage information (prescribing information [full content of labeling] for products requiring a prescription and patient-use information for both prescription and OTC products).

Additional Reading

• Process Map for Labeling Change: New Rule Published to Product on Shelf
• FDA Resources for Data Standards