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  1. Electronic Drug Registration and Listing System (eDRLS)

Electronic Registration and Listing Compliance Program

Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s mission. Several key programs inside and outside the agency such as inspections, commercial drug databases, electronic prescribing and reimbursement rely upon registration and listing information.

FDA employs automated validation rules in order to prevent inaccurate and incomplete data submission; however, not all the data screening can be automated. Our compliance program is designed to monitor the registration and listing data through surveillance methods, have manufacturers correct any data inaccuracies and ultimately remove inaccurate data from the public sites, if corrections are not made as required. Certain violations of federal law can result in further actions such as data inactivation and/or a warning letter.

Please contact [email protected] if you have questions about FDA’s registration and listing compliance program or any published registration or listing data.

FDA issued the following warning letters:

Warning Letter/Company

 Issue Date

 Closeout Date

ECI Pharmaceuticals,LLC 2/3/2022  

RPK Pharmaceuticals Inc.


Close Out Letter

Netcos Co., Ltd.


Close Out Letter

United Exchange Corporation


Close Out Letter

AMI Cosmetic Co., Ltd. 


 Close Out Letter 

Aphena Pharma Solutions-Tennessee, LLC



A-S Medication Solutions LLC.



Prestige Brands Holdings



Exact-Rx Inc



Targeted Medical Pharma, Inc. dba Physician Therapeutics



Wallace Cameron International Ltd



Pharmaceutical Associates Inc



RemedyRepack Inc.



Rebel Distributors Corp



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