United States: FDA Finalizes Rule Governing Establishment Registration And Listing For Human Drugs


On August 31, 2016, the US Food and Drug Administration published "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs," finalizing a 2006 proposal to amend regulations governing drug establishment registration and listing.

In Depth

On August 31, 2016, the US Food and Drug Administration (FDA) published "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs" (Final Rule), finalizing a 2006 proposal (Proposed Rule) to amend regulations governing drug establishment registration and listing 71 Fed. Reg. 51,276 (Aug. 29, 2006). The Final Rule is effective November 29, 2016, and brings FDA's regulations governing drug establishment and listing in conformity with amendments to Section 510 of the Federal Food, Drug, and Cosmetic Act (FDCA) (described below), while modernizing submission requirements to maintain consistency with current electronic practices. These changes aim to improve efficiency and reliability. Under the Final Rule, establishment registration drug listing information is generally subject to inspection and public disclosure.

Notably, the Final Rule (1) gives FDA the authority to refuse a new drug application if it is manufactured in whole or in part in an establishment that is not registered or exempt under FDCA, and (2) requires holders of Biologics License Applications (BLA) to electronically report when they withdraw from the sale of licensed biological products.

After FDA issued the Proposed Rule, US Congress passed the Food and Drug Administration Amendments Act (FDAAA) in 2007, which required the electronic submission of drug establishment registration and listing information [Pub. L. 110–85 (2007)], and the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, which amended the deadline for and information required with an annual establishment registration [Pub. L. 112–144 (2012)]. FDA subsequently issued its "Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing" 74 Fed. Reg. 26, 248 (June 1, 2009) to explain electronic submissions of registration and listing information consistent with the FDAAA 71 Fed. Reg. 63,276 (Oct. 31, 2006).

The Final Rule includes few departures from the Proposed Rule. In response to comments, FDA did not include the requirement that FDA develop National Drug Codes (NDCs) to assign to listed drugs or the requirement that the NDC appear in human-readable form on the label of each listed drug. FDA indicated that it expects to address drug / device combination product registration and listing requirements in the future.

The remainder of this article highlights additional provisions.

Who Does the Rule Cover?

  • The Final Rule regulates domestic and foreign drug manufacturers, repackers, relabelers and salvagers, and requires annual electronic registration and listing, while carving out exemptions (e.g., certain "import for export" drugs). The Final Rule also covers establishments engaging in these activities under a BLA or human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated under Section 505 of the FDCA or under Section 351 of the Public Health Service Act.
  • FDA will accept registration and listing information from anyone properly authorized to act as an agent for the actual manufacturer, including private label distributors.
  • It is particularly important to note that the drug listing requirement applies to drugs manufactured, repacked, relabeled or salvaged for commercial distribution only, while the registration requirement applies to establishments where drugs are manufactured without regard to whether the drug is commercially distributed.

Content of Registration and Listing

  • The Final Rule includes specific content requirements for registration and listing. Pursuant to the FDASIA, the Final Rule amends the registration requirements to include a Unique Facility Identifier (UFI), which is currently a DUNS number, assigned and managed by Dun & Bradstreet. The FDASIA also requires establishments to provide a point-of-contact email address.
  • Because FDA's drug listing system cannot retrieve inactive ingredient information from approved applications, a registrant must provide the name of each inactive ingredient in a listed drug it manufactures—the drug's US application number will not suffice. Although FDA is not currently collecting advertisements as part of drug listing information, it may request a representative sampling of advertisements in the future.
  • The Final Rule includes additional NDC requirements, such as format, length, changes requiring a new NDC and restrictions.
  • Under the Final Rule, FDA's center directors may now approve additional standards or formats for bar code label requirements.

Effective Dates

  • Electronic registration and listing submissions under Part 207 have largely been implemented under FDA's Guidance. As of November 29, 2018, to purge outdated information, FDA will remove from the current database any previous registration and listing information submitted in the past on paper and not updated with a more recent electronic submission. However, FDA may grant firms waivers from the electronic submission requirement. The requirement for electronic registration and listing under Parts 607 and 1271 for drugs regulated under a BLA or HCT/Ps regulated under Section 505 of the FDCA or Section 351 of the Public Health Service Act, respectively, will be effective November 29, 2017.
  • FDA encourages establishments to submit listing updates at the time of any change affecting the previously submitted information, and at a minimum, each June and December. As part of the annual registration process, establishments also must submit a no-change certification if there are no changes to the previously submitted listings.

Addition and Clarification to Definitions

  • "Active pharmaceutical ingredient" has the same meaning as "bulk drug substance."
  • "Salvage" means "the act of segregating out those finished products that may have been subjected to improper storage conditions for the purpose of returning the products to the marketplace and includes applying manufacturing controls such as current good manufacturing practice (CGMP)."
  • Establishment registration number" means the number assigned by FDA to the establishment during the establishment registration process [currently, the FDA Establishment Identifier (FEI)] and is distinct from the "Unique Facility Identifier" required by the FDASIA).
  • Clarifying "commercial distribution" to exclude "active pharmaceutical ingredient" so internal or interplant transfers are not treated as commercial distribution. Transfers between a registered establishment and a marketing authorization holder pursuant to a contractual relationship still constitute commercial distribution.
  • Content labeling" is used to describe some, but not all, labeling that must be submitted with human and animal drug listing information.
  • A "private label distributor," whose label or trade name is on a commercially distributed drug, does not have to register or list as long as it does not manufacture, repack, relabel or salvage a drug. Private label distributors still must apply for a NDC labeler code.
  • A drug's "end marketing date" is the expiration date of the last lot manufactured, repacked, relabeled or salvaged and should be included when reporting that a listed drug has been discontinued.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Strasburger & Price, L.L.P.
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Strasburger & Price, L.L.P.
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions