Drug Establishment Registration and Listing Services

FDA Drug Establishment Registration

The US FDA requires domestic and foreign establishments that manufacture, repack, or re-label drug products in or import to the United States to register each establishment. Additionally, drug manufacturers, re-packers or re-labelers must electronically list all of their commercially marketed drug products.

US Agent Services for Drug Establishments

All foreign establishments manufacturing, repacking, or relabeling drug products for the US Marketplace must appoint a US Agent to serve as the contact point with the FDA. According to 21 CFR Sec. 207.69, the responsibilities for the US Agent are as follows:

Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;
Responding to questions concerning those drugs that are imported or offered for import to the United States;
Assisting FDA in scheduling inspections; and
If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA’s providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.

Official Contact Services for Drug Establishments

The AJW Technology Consultants team is poised and ready to support both US-based and international drug manufacturers prepare and submit their drug establishment registrations and complete the mandatory annual renewals (between October 1 and December 31 each year).

The drug establishment registration process requires that each organization identify the name, address, phone number and email address for the official contact.

Our office headquarters in Tampa Bay, Florida is well-positioned and experienced in service as the US Agent and official contact for foreign pharmaceutical establishments.

Drug Listings

The US FDA requires that all OTC, Rx, Homeopathic, and API (Active Pharmaceutical Ingredient) be listed for each drug product manufactured and labeled for the US marketplace. The listings are submitted electronically via the FDA submission portal, Electronic Drug Registration and Listing System (eDRLS). The eDRLS utilizes Structured Product Label (SPL) format for each drug to be listed. Drug listings may be submitted by the manufacturer or labeler (or private label distributor). Each labeler must request a unique labeler code or National Drug Code (NDC) which is issued by the FDA and is used to link the labeler to the drug products it is marketing as well as specific formulations and packaging configurations. An active NDC must be established prior to the submission of each drug listing.

Any changes to established drug listings must be reported to the FDA immediately, upon implementation. If there are no changes to the drug listing(s) during the course of the year, a mandatory no change certification is required annually between October 1 and December 31, otherwise the FDA will consider the drug listing to be inactive and will be removed from the Agency databases.

FDA 510(j)(3) Drug Amount Reporting
FDA requires all registered drug establishments to submit an annual Drug Amount Report under section 510(j)(3) of the FD&C Act. The report is submitted through the FDA NextGen portal and includes the amount manufactured during the calendar year for each NDC listed under the establishment. This requirement applies to US and foreign establishments, including those that did not manufacture or distribute any product during the reporting year.

AJW Technology Consultants assists establishments with meeting this requirement by reviewing the NDCs associated with the registered facility, verifying the business operations linked to each product, and completing the manual entry process in the FDA NextGen portal. This includes addressing any validation errors and submitting the final report, along with providing confirmation documentation for your records.

Please feel free to contact our office if you have any questions or would like to request a project quotation at info@ajwtech.com.

Pricing

Initial Establishment Registration : $500.00

Annual Renewal : $250.00/facility

US Agent Services : $950.00/year

Official Contact Services : $500.00/ year

NDC Labeler Code Request : $500.00

OTC or Rx Drug Listing : $950.00

Annual Listing Certification : $250.00 per NDC

FDA 510(j)(3) Drug Amount Reporting : $75.00 per NDC

Please contact us at info@ajwtech.com for any questions about the process or to request a proposal.