U.S. FDA Drug Establishment Registration and Listings
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.
Drug Labeling and Ingredient Reviews
FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. ALN can help modify your drug labeling to comply with FDA regulations. ALN 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.
U.S. FDA Drug Master Files (DMF)
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. ALN’s team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions.
U.S. FDA Self-Identification Requirements 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.
U.S. FDA Outsourcing Facility Regulations
Compounding Pharmacies that register with FDA as Outsourcing Facilities may qualify for exemption from certain FDA approval and labeling requirements. ALN’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.
U.S. FDA 3PL/WDD Reporting
Third-party Logistics (3PL) and Wholesale Drug Distributors (WDD) must report to FDA between January 1 and March 31 of each year.
Data Universal Numbering System (D-U-N-S®)
The Data Universal Numbering System (D-U-N-S®) is a business identification system operated by the private company Dun & Bradstreet®. D-U-N-S® numbers are required for drug establishments to register and list products with FDA.
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.
Certificate of U.S. FDA Registration
Companies registered with FDA often are asked by their customers and suppliers to verify their FDA registrations. A Certificate of Registration issued by ALN serves as a third-party verification of your FDA registration.