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As you are probably aware, per 21 CFR 207.57 FDA drug establishment registrants must review and, if necessary, update listing information each June and December. This includes all drug listings, including bulk products.

EAS provides support with facility registrations and product listings and we would be glad to assist you with these and all other regulatory requirements pertaining to your Rx and OTCmedical device and combination products. Contact us for more information on our services.

Regardless of who facilitates these annual updates, each company should confirm:

  1. any newly marketed product is listed with the FDA,
  2. any discontinued products have entered the end marketing date into the listing,
  3. update any needed changes to an existing listing, including the PDP image uploaded to the file.

Of course, it is advised to update your listings at the time that a change occurs, however, at the least a company is expected to update the listing the June or December following said change.

This year, in light of the new OMUFA facility user fee implementation, it is also a good idea to confirm your registration business processes accurately reflect your establishment’s current situation. Of note, if you are solely an API manufacturer, this should be the only business process, other than possibly Analysis, which you have identified. Reviewing now will remove some of the end of the year pressure many companies experience with the holiday season and staff PTO.

Please let us know if you have any questions in this regard. We look forward to working with you and serving as your regulatory partner.

Posted in Client Update, Drugs.