NEW FDA REQUIREMENT!!DRUG PRODUCT LISTING ANNUAL RENEWAL!!

As a part of the eDRL Final Rule and under Sections 510(j)(2)(B) & 510(j)(2)(D) of the Food Drug And Cosmetic Act, drug product labelers must certify annually all drug product listings that have not already been updated during the calendar year. If there is no change in drug information for all listed products, establishments can submit a blanket no change certification SPL to FDA, which will consider as all product listings are current and updated, Listing update or blanket certification must submit every year during renewal period which is October 1st to December 31st. Drug listings which are not updated during renewal period will consider as inactive and FDA may remove from DailyMed website and NDC directory.

The new FDA requirement

Includes all human drug document/product types and marketing categories including:

• Finished and unfinished/bulk/API listings
• Approved and unapproved listings
• Rx and OTC listings
• Medical Gases, Homeopathic, Bulk drugs for human drug compounding
• PLD and contractor listings
• Repackaged and relabeled listings

 

Any NDC Product code for which a listing submission, new or updated, has been received during the calendar year is considered to be up-to-date and does not need to be certified. Only electronic (SPL) listings can be certified.  Any drug last updated in paper prior to June 2009 must first be submitted electronically.  (Which therefore counts as an update and satisfies the certification requirement)

Since the ultimate responsibility for submitting product listings lies with the registered establishment, certification of product listings is also the responsibility of the registered establishments.  Private Label Distributors (PLDs) and Contract Manufacturers (CMs) should work together to ensure that all NDCs involved in their business relationships are properly certified. US Agents, Importers, Consultants, and anyone acting as an authorized agent for a registrant may submit product listing certification SPL files.

For more information please visit Electronic Drug Registration and Listing Instructions and 21CFR Part 207

mdi Consultants Inc. can help you meet the FDA deadline and avoid any inconvenience to your firm and your product/s. Please let us know if you want mdi Consultants Inc. to update your annual product listing for the next Fiscal year 2018.

“Please do not wait till the last moment.  We value our clients and therefore it is our kind advice that you act promptly and let us know in advance so that we are on track and ahead of time and avoid unnecessary complications.”

 

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