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 in the United States.
FDA 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 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 FDA.
A Drug Master File is a submission to 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.
Adverse Event Contact for OTC Drugs
U.S. FDA requires labels of OTC drugs marketed without an approved application to bear a United States address or phone number to receive consumer reports of serious adverse events. Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA.
Outsourcing Facility Regulations
Compounding Pharmacies that register with FDA as Outsourcing Facilities may qualify for exemption from certain FDA approval and labeling requirements. Registrar Corp’s Regulatory Specialists can register pharmacies as Outsourcing Facilities as well as help them comply with FDA’s regulations for doing so, including submission of annual drug product reports.
Self-Identification for Generic Drug Facilities
Operators of facilities that produce generic drugs and generic drug APIs must submit “self-identification” information to FDA between May 1 and June 1 of each year.
Third-party Logistics (3PL) and Wholesale Drug Distributors (WDD) must report to FDA between January 1 and March 31 of each year.
Companies shipping products to the United States may find their shipments subject to Detention Without Physical Examination (“DWPE”) by FDA. Products subject to DWPE are held at the port of entry while FDA performs additional scrutiny, testing, and analysis. Delays from DWPE may be lengthy for businesses anxious to deliver products on schedule.
Color Additive Regulations
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 FDA.
Export Certificates to Foreign Governments
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.