The U.S. Food and Drug Administration (FDA) recently sent an email to FDA-registered drug establishments reminding them of an approaching deadline for prescription drug labeling. Prescription drug manufacturers, packagers, and re-packagers must affix a “product identifier” to their product packaging by November 27, 2018.

Due to the large number of questions we received from industry after FDA sent this email, Registrar Corp published a blog today with information about the new product identifiers and what this means for the upcoming registration renewal period: http://bit.ly/fda-serialization

This information is prudent for industry to know, as FDA stated in the email that manufacturers and repackagers that do not have the new product identifiers on their packaging should NOT certify that their listings are up-to-date during the upcoming registration renewal period. They should update their listings with a new sampling of the labeling incorporating the product identifier. Listings that are neither updated or certified in 2018 may be removed from FDA’s database in 2019, deeming the unlisted products misbranded.

If you would like to talk with one of our Regulatory Specialists about the new requirement, please don’t hesitate to ask.

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Sincerely,

Devon McClellan
Director of Marketing
Registrar Corp
144 Research Drive
Hampton, Virginia, USA 23666
Tel: +1-757-224-0177
Fax: +1-757-224-0179
Email: dmcclellan@registrarcorp.com
Web Site: http://www.registrarcorp.com

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