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U.S. FDA Drug Regulations

The U.S. FDA regulates drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of humans or animals. Registrar Corp provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S. Companies in the Drug Industry.

New Drug Establishment Registration & Listings
New Drug Establishment Registrations & 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 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.
Drug Labeling and Ingredient Reviews
Label Reviews and Graphic Design
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.
U.S. FDA Drug Master File (DMF)   DMF Examples
Drug Master Files (DMF)
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.
Data Universal Numbering System (DUNS Number)
Data Universal Numbering System (DUNS Number)
FDA requires Data Universal Numbering System (DUNS) numbers for drug establishments as well as the registrant owner of the establishment if it is in a different location. To obtain a DUNS number for your establishment free of charge, simply click the certificate on the left.
New FDA Self-Identification Requirements
Label Reviews and Graphic Design
Operators of facilities that produce generic drugs and generic drug APIs are required to submit "self-identification" information to the U.S. FDA by December 3, 2012. The law imposes a new user fee on certain companies identified in generic drug submissions, including Abbreviated New Drug Applications (ANDA), amendments to ANDAs, and Prior Approval Supplements (PAS). Not all establishments will be required to pay the fee. Operators of generic drug facilities and certain sites and organizations that are identified in a generic drug submission must submit self-identification information to FDA, from which FDA will determine which firms must pay the new user fees and in what amount. The fee schedule is expected to be published by FDA by January 31, 2013.
Drug Color Additives and Drug Color Batch Certification
Drug Color Additive Notice of FDA Action
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.
Certificate of Registration issued by Registrar Corp
Certificate of Registration issued by Registrar Corp
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.
Detention Without Physical Examination ("DWPE") Assistance
Detention Without Physical Examination Assistance
Companies shipping products to the United States may find their shipments subject to "Detention Without Physical Examination" by U.S. FDA. Products subject to detention without physical examination are held at the port of entry while U.S. FDA performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule. For assistance with a detention, simply click on the Notice of Action shown on the left.

U.S. FDA Regulations:

U.S. FDA Regulation: 21 C.F.R. Part 207

Food and Drug Amendments Act of 2007 (Public Law 110-85) (FDAAA)

U.S. FDA Drug Labeling: 21 C.F.R. Part 201 Subparts A and C

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420

U.S. FDA Color Additives: 21 C.F.R. Parts 73, 74, and 80


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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