Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

Registration of Drug Establishment/Labeler Code Assignment

Form FDA 2656

This form is used by all drug firms both domestic and foreign who are required to register and drug list products with the Food and Drug Administration.  This form is also used to provide updates in registration information annually or at the discretion of the registrant, when any changes occur.

Initial Registration - Form FDA 2656

Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment) is currently available on the Internet. This form can be obtained from www.hhs.gov/forms

F Print or type all entries in English.

F Use additional copies of this form for supplemental pages if necessary. Indicate sequential page numbers on the lower right hand corner, if additional pages are used.

F Supply the following data on all additional pages: Labeler Code and Registration Number (if previously assigned to your firm by the FDA), and the full name of the Reporting Firm.

F Complete Section D on all Forms and/or pages. (Forms will be returned if this section is not completed.)

F Do not write any information in the "FDA USE ONLY" fields.

F Submit Form in triplicate, when using Form from the Internet.

F All first time registrants must list (submit) product information (Form(s) FDA 2657, Drug Product Listing). If unable to list at this time, a letter must be submitted stating the reason(s) with a list of intended drug products.

F All foreign drug establishments required to register with the Food and Drug Administration (FDA) must identify a United States agent. A letter designating a United States agent should be submitted on the registrant's letterhead to the FDA. The United States agent�s letter must be included as part of their initial and updated registration information. Each registrant will designate only one United States agent and this agent should represent the registrant and all products that will be imported or offered for import into the United States by the registrant. 

Labeler Code - The Labeler Code is assigned by the FDA to all firms required to register and/or list with the FDA, i.e., manufacturers, repackers/relabelers or private label distributors. (Refer to regulation 21 CFR, Part 207, for specific drug firm requirements. A copy of this regulation is provided in Annex A, of this booklet.) Labeler Codes are all numeric. Some Veterinary Firms (depending upon their FDA registration requirements, e.g. Medicated Feed Mills) receive the pseudo Labeler Code 1900. Firms required to register with the FDA, but not drug list their products, e.g., Analytical Labs receive the pseudo Labeler Code 1500. If a Labeler Code has not been assigned, leave the field blank and a code will be assigned.

Registration Number - The Registration Number is assigned by the FDA (District Offices) to firms that are required to register. (Refer to regulation 21 CFR, Part 207.) Registration Numbers that are assigned by District Offices are all numeric. Pseudo registration numbers, which are assigned by this Office, e.g. Private Label Distributors, are assigned to firms required to list but not register. If a Registration Number has not been assigned, leave the field blank and an appropriate number will be assigned.

Section A - Site Information

F Reporting Firm Name - Enter the full name of the reporting firm. Punctuation is not permitted.

F State of Inc. - Enter the U.S. Postal Service two-letter abbreviation for the State of Incorporation of the reporting firm.

F Site Address - Enter the street number and name or rural route number of the actual location of the site. Post Office (PO) Box numbers are not acceptable for this field.

F Site Telephone Number - Enter the area code and telephone number of the site.

F City - Enter the city of the actual location of the site.

F State - Enter the state of the actual location of the site.

F Zip Code - Enter the zip code of the actual location of the site.

F Country - Enter the name of the country of actual location of the site.

F Business Category - Check the appropriate box, Human or Veterinary, or both if applicable.

F Site Mailing Address - Enter the street number and name, rural route number or Post Office Box number for the reporting firm, if this address is different from the site address above. This is the address where copy of the registration form FDA 2656 will be mailed back. Forms for foreign firms will be mailed to the US agents address.  

F City - Enter the city of the mailing address of the reporting firm.

F State - Enter the state of the mailing address of the reporting firm.

F Zip Code - Enter the zip code of the mailing address of the reporting firm.

F Country - Enter the name of the country of the mailing address of the reporting firm.

F Site Internet/E-mail Address - Enter the Site Internet/E-mail Address of the reporting firm.

F Doing Business As (DBA) Name of Firm - Enter the Trade name or other name(s) under which the reporting firm markets the product.

F Parent Company Name - If the reporting firm does not have a Parent Company, enter "NONE".

F Reason(s) For Submission - Check the reason(s) for submission of Form FDA 2656.

� Firm Registration - Firms registering for the first time must check this box. (Both the Labeler Code and Registration Number fields on the form are left blank.)

� Registration of Additional Site - An existing firm (with a Labeler Code) registering an additional site must check this box. (The Labeler Code field must be filled in, however the Registration Number field on the form is left blank.)

�Re-Registration � Firms that are submitting this form to meet their annual re-registration requirements should check this box.  The agency encourages submission of annul updates according to the schedule outlined in the current regulations (21 CFR 207.21(a). However, annual re-registration information must be submitted on or before December 31^st of each year, as required by section 510 of the Act.    

� LC Assignment - Firms that are not required to register but must drug list their products, i.e., private label distributors, must check this box. (Both the Labeler Code and Registration Number fields on the form are left blank.)

� Name Change - Firms that are changing their reporting firm name (not as a result of a merger or a buy out), where the change affects all of its sites, must check this box. A separate Form FDA 2656 must be submitted for each of the affected sites. (Both the Labeler Code and Registration Number fields on the form(s) must be filled in.)

� Address Change - Firms that are changing either one or more of their applicable addresses, i.e., site address, site mailing address and/or site Internet/e-mail mailing address, must check this box. (Both the Labeler Code and Registration Number fields on the form must be filled in.) If the Compliance mailing address, or Compliance Internet/e-mail address, is being changed no form is necessary (since it affects all sites), however a letter of such change must be submitted to the FDA.

� Merger/Buyout - Firms that are either acquiring or loosing site locations, and such action involves a change to Labeler Codes, must check this box. A separate Form FDA 2656 must be submitted for each site being affected. A letter of explanation, addressing all Labeler Codes involved, must accompany the form(s). (The Labeler Code field on the form(s) must be completed with the Labeler Code that is being retained. However, since the registration number of the affected sites will not change, the registration number field on each form must be filled in.)

� Reentry Into Business With Same Name - Firms previously engaged in drug activities, resuming operation after a period of non-operation, will check this box. The former Labeler Code will be assigned, providing the reentry into business occurs within five years. Since the registration number will not change, the former registration number should be provided in the registration field.

� Out of Business - A Firm no longer engaged in drug activities must check this box. Each site of the firm affected by this action must submit a separate Form FDA 2656. (Both the Labeler Code and Registration Number fields on each form must be filled in.) As a result, if the entire firm no longer exists the drug products will be discontinued and the Labeler Code will be rescinded.

F Type of Ownership - Check the box which indicates the type of ownership of the reporting firm.

F Person Submitting Data and Telephone - Print the name and telephone number, including area code, of person completing this form.

F Business Type - Check the appropriate box(es). If the "other" box is checked, indicate the business type and provide additional explanation on a separate sheet.

Section B - Firm Compliance Mailing Address

This address applies to the location of the individual knowledgeable about the firm�s products. This address can be the firms "Regulatory Affairs" Office, �Corporate Office� or an Office of the firm where an individual can be reached for matters affecting all sites and all drug products. Compliance address is also the address where all the drug listing deficiencies are mailed. However, all drug listing deficiencies for foreign firms will be mailed to the US agents address.  

F Number and Street... - Enter the street number and name, rural route number, or the PO Box of the Compliance Address of the reporting firm. Include the name of any specific individual, or internal Mail Code, to which mail should be directed.

F Telephone Number - Enter the area code and telephone number of the Compliance Address.

F City - Enter the city of the Compliance Address.

F State - Enter the state of the Compliance Address.

F Zip Code - Enter the zip code of the Compliance Address.

F Country - Enter the name of the country of the Compliance Address.

F Compliance Internet/E-mail Address - Enter the Compliance Internet/E-mail Address of the reporting firm.

Section C - Additional Firm and Site Information

F Name of Owners, Partners or Officers - Enter the name(s) of all reporting firm Owners, Partners and/or Officers, as reflected by the "Type of Ownership" listed above.

F Title - Legal and/or professional title of the individual listed, i.e., Mr., Ms., Mrs., Dr., Esq., etc.

F Position - Business title, within the firm, of the individual listed, i.e., Director, Associate Director, etc.

F Other Firms Doing Business At This Site - Firms listed here share the same registration numbers (i.e., same location) but different Labeler Codes. The two share a relationship, i.e., are affiliated with the same firm, physically located at the same location and are all engaged in drug activities. (The primary registrant, i.e., the reporting firm, for this site is responsible for the annual registration of the drug establishment site.)

� Labeler Code - If the "other" firm has an FDA assigned Labeler Code this field must be completed. However if the "other" firm does not have an FDA assigned Labeler Code, and would like to request a new Labeler code number, firm shall submit form(s) FDA 2657 and a letter requesting Labeler code number to the new firm name. 

� Firm Name - Name of the "other" affiliated firm.

Section D - Signature

F Signature of Authorizing Official - An authorized representative or agent of the reporting firm must sign this form in order for the form to be processed.

F Title - Business title, i.e., Director, Associate Director, etc. of an authorized representative or agent of the reporting firm, signing the form.

F Date - Enter the month, day and year in which the form is completed.

Distributor�s Certification

A Private Label Distributor who is submitting product listing information to the FDA, on their own behalf, must sign this certification. As a result, the Distributor must also forward a copy of this Form FDA 2656 to the appropriate Manufacturers of the products.

F Signature of Distributor - Signature of private label distributor submitting data to the FDA.

F Distributor�s Telephone Number - Telephone number of the private label distributor.

Note: If this field is not signed, a letter of confirmation from the distributor stating that the manufacturer is submitting product listing information to the FDA on behalf of the distributor shall be provided. This letter shall also include the manufacturer�s name. 

How to Update Registration Information

To submit annual re-registration information and to report any changes, registrants should complete the following fields on Form FDA 2656:

� Labeler Code

� Registration Number

� Reporting Firm Name

� Reason(s) for Submission (write in "ANNUAL" or "ANNUAL - NO CHANGE" if no changes made)

� Section D (signature, title, and, date)

� Other sections of the form where changes have occurred

Registrants should not complete any other sections where information has remained the same.

The Agency encourages submission of annual updates according to the schedule outlined in the current regulations (21 CFR 207.21(a)). However, annual re-registration information must be submitted on or before December 31 of each year, as required by section 510 of the Act. All other changes should be submitted at the discretion of the registrant, when any changes occur.