U.S. FDA Drug Regulations

Owners or operators of all U.S. and non-U.S. drug establishments that engage in the manufacture, preparation, propagation, compounding, or processing of drugs are required to register and submit a list of every drug in commercial distribution by way of U.S. FDA's new Electronic Drug Registration and Listing System (eDRLS). For assistance with drug establishment registration and listing regulations, simply click the Drug Certificate of Registration shown on the left.

As of June 2009, all establishment registrations, drug listings, annual renewals, and updates must be submitted to U.S. FDA electronically. Establishments that were previously registered with the U.S. FDA may be able to transition their old paper filings to U.S. FDA's new Electronic Drug Registration and Listing System (eDRLS). For assistance transitioning to the U.S. FDA's new electronic drug registration and listing system, simply click the Drug Certificate of Registration shown on the left.

The U.S. FDA now requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. Registrar Corp can help modify your drug labeling to comply with U.S. FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from the U.S. FDA. To learn how U.S. FDA drug labeling regulations apply to your products, simply click the Notice of FDA Action shown on the left.

A drug color additive is any dye, pigment, or other substance that can impart color to a drug product. Drug color additives are regulated by the U.S. FDA. To determine how U.S. FDA's drug color additive regulations apply to your drug products, simply click the Notice of FDA Action shown on the left.

A Drug Master File is a submission to the U.S. FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. Registrar Corp's team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions. For assistance submitting a Drug Master File, simply click the Drug Master File Certificate shown on the left.

Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their U.S. FDA registrations. A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your U.S. FDA registration. For more information, click the Drug Certificate of Registration shown on the left.