U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Drug Registration and Listing System (DRLS and eDRLS)
  5. Electronic Registration and Listing Compliance Program
  1. Drug Registration and Listing System (DRLS and eDRLS)

Electronic Registration and Listing Compliance Program

Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL). Establishment registrations and drug listing data provide the agency with a list of all drug manufacturers currently manufacturing drugs for U.S. commercial distribution and a current inventory of all drugs in the U.S. commercial distribution. Part of this data is published online in the FDA National Drug Code Directory, FDA Label Repository, FDA Drug Establishment Current Registration Site and NIH’s DailyMed for public, health care professionals, and healthcare industry access.

Requirements for establishment registration and drug listing are outlined in section 510 of the Federal Food, Drug, and Cosmetic Act and part 207 of Title 21 of the Code of Federal Regulations (CFR), which was revised in 2016 and went into effect on November 29 of the same year.

Accuracy and integrity of establishment registration and drug listing data are essential to the FDA’s mission to minimize the exposure of the public to unsafe and ineffective drugs. Several key programs inside and outside the agency such as inspections and reimbursement rely upon registration and listing information. Although FDA has several automated validation rules in place to stop the submission of inaccurate and incomplete data at its entry point, many steps within the process cannot be automated.

Our compliance program focuses on ways to find inaccuracies in the data after it has been submitted to the agency. We subsequently take action to have firms correct those data inaccuracies and ultimately remove them from the public sites if corrections are not made as required. Certain violations of the FD&C Act can result in further actions such as a warning letter. To date, FDA has issued the following warning letters:

 Warning Letter/Company

 Issue Date

 Closeout Date

NuCare Pharmaceuticals 09/26/2019  
American Sales Company 7/11/2019  

Jessie Commodity Co., Ltd.

4/18/2019  

Close Out Letter
5/20/2019

ABC Compounding Company Inc.

4/18/2019

Close Out Letter
5/2/2019

Netcos Co., Ltd.

10/29/2018

Close Out Letter
11/30/2018

United Exchange Corporation

10/29/2018

Close Out Letter
11/30/2018

AMI Cosmetic Co., Ltd.

 6/12/2018

Close Out Letter
7/11/2018

Aphena Pharma Solutions-Tennessee, LLC

 12/5/2017

 1/31/2018

A-S Medication Solutions LLC.

 6/5/2017

Close Out Letter
2/25/2019

Prestige Brands Holdings

 6/1/2017

 7/5/2017

Exact-Rx Inc

 4/19/2017

 4/27/2017

Targeted Medical Pharma, Inc. dba Physician Therapeutics

 10/6/2016

 

Wallace Cameron International Ltd

 9/29/2016

 

Pharmaceutical Associates Inc

 3/23/2016

 5/6/2016

RemedyRepack Inc.

 3/31/2015

 5/21/2015

Rebel Distributors Corp

 3/31/2015

 

Changzhou Qianhong Bio-Pharma Co., Ltd

 6/4/2013

 7/9/2013

Quzhou Chemsyn Pharm Co Ltd

 9/6/2012

 

Peking Medicine Manufactory

 4/5/2012

 

Korea Pharma Company Ltd

 3/26/2012

 

Zhejiang Xianju Chemical Pharmaceutical Factory

 1/25/2012

 

Changzhou Jialing Medicine Industry Co Ltd

 12/29/2011

 

If you have any questions about our registration and listing compliance program, or if you believe our published registration or listing data includes any error, please contact us at eDRLS@fda.hhs.gov.

Back to Top

Resources for You