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January 30, 2025


The U.S. Food and Drug Administration (FDA) has stopped updating the National Drug Code (NDC) data base, and DailyMed.


These measures are in place because the new president has ordered the U.S. Health and Human Services (HHS) , which includes the Food and Drug Administration, to cease communicating with anyone outside the department.  No one knows when, or if, this restriction will be lifted.


The effect of such an order is that drug marketing of new human and animal OTC and Rx drugs, supplements, vitamins, vaccines, and other therapeutic and life-saving drugs has stopped.  The economic impact to small companies is immeasurable.  The human cost will be devastating.


Contact your congressman or senator and urge them to take immediate action to address this crisis.


Reg-E-Stration LLC

  • YOUR FDA REGISTRAR OF CHOICE

  • STAFFED BY Ex-U.S. FDA PROFESSIONALS

  • WE PROVIDE PERSONAL AND TIMELY COMMUNICATION WITH OUR CLIENTS


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    You can Rely on Reg-E-Stration LLC for cost effective compliance with FDA's Electronic Establishment Registration & Drug Listing requirements.


    Reg-E-Stration LLC was founded in 2009 to meet the FDA's electronic establishment registration and drug listing challenge.  We provide a complete service for human and animal pharmaceutical products, medical device site registration and device listing, as well as cosmetics and homeopathic product listing.


    Reg-E-Stration LLC simplifies the process, because we have the expertise and experience to make this a quick and painless procedure.   We were one of the 1st companies started in 2009 dedicated to assisting industry with FDA's eDRLS registration and drug listing requirements.


    Reg-E-Stration makes things easy.   All you have to do is provide us with some basic information about your company or products and we do the rest!


    What sets us apart?   We really KNOW how the FDA works.  Our principal has over 20 years employment with the U.S. FDA as an Engineer, Compliance Officer,  Investigator, and ran the Small Business Assistance Office in the Dallas FDA Regional Office.  He has also held management positions in both the medical device and pharma industries for 20 years. 


    Our team of Associates capabilities encompass virtually every aspect of developing and implementing cost effective FDA compliance solutions.  Reg-E-Stration LLC has the people, the background, knowledge, and experience to solve any FDA registration or drug listing issue you may have.

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    Our Services


    • MoCRA COSMETIC SITE REGISTRATION & LISTING IS AVAILABLE

    • Initial Establishment Registration [Drugs, Medical Devices, Cosmetics, Food, FFRM, GDUFA]

    • Annual Establishment Registration Renewal [Drugs, Medical Devices, Cosmetics, Food, FFRM, GDUFA]

    • Non-Rx Drug Product Listing [OTC, Unapproved, Bulk, API, Homeopathic, Dietary Supplements, Animal]

    • Rx Drug Product Listing [Human, Animal, Medical Gas, Unapproved]

    • FURLS - GDUFA - FFRM Facility Registration

    • Medical Device Establishment Registration and Device Listing

    • Annual Certification of Drug Product Listing

    • Administrative & Professional Services

     
    NEWS YOU CAN USE

    2023 Over-The-Counter Monograph Drug User Fee Program (OMUFA)

    • On March 24, 2023, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2023 in a Federal Register Notice (FRN) titled “External link opens in new tab or windowOver-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023.” This FRN publishes fees for OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2023.  Use the Code of Federal Regulations link to review the fees:

    External link opens in new tab or windowCFR LinkCFR Link


    INFORMATION

    The U.S. Food and Drug Administration (FDA) Registration & Drug Certification Renewal period is October 1 to December 31 each year.  If you do not register or renew your establishment registration by the deadline, you will be in violation of FDA regulations.  Contact External link opens in new tab or windowInfo@Reg-E-Stration.comExternal link opens in new tab or window now to Register your site.

    • The FDA will remove ALL drug listings from the NDC database that are not certified during the proscribed renewal period.

    • Are your drug listings at risk of removal by FDA?

    • Contact us at External link opens in new tab or windowInfo@Reg-E-Stration.comExternal link opens in new tab or window  and we will identify your products that have been removed by FDA and tell you how to reverse this action. 


    News, Information and Resources for the U.S. FDA Regulated industries.


    COMING SOON!


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    Telephone:  +1 281-236-3872 USA

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    e-Mail:  External link opens in new tab or windowinfo@Reg-E-Stration.com


    Copyright 2017 Reg-E-Stration LLC


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