FDA Form 2656 Registration of Drug Establishment (New registration, in

Form Approved: OMB No. 0910-0045. Expiration Date: December 31, 2007.

See OMB Statement on Reverse.

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION REGISTRATION OF DRUG ESTABLISHMENT/ LABELER CODE ASSIGNMENT (In accordance with Public Law 92-387)

FDA USE ONLY      

FDA USE ONLY      

NOTICE: This report is required by law (21 C.F.R. 207.20). Failure to report can result in imprisonment for not more than one year or a fine of not more than $1,000, or both. (FD&C Act, Section 303).

LABELER CODE

REGISTRATION NUMBER

     

     

SECTION A - SITE INFORMATION

REPORTING FIRM NAME

STATE OF INC.

     

     

SITE ADDRESS (No P.O. Box)

SITE TELEPHONE NUMBER

     

(     )      

CITY

STATE

ZIP CODE

COUNTRY

BUSINESS CATEGORY

     

  

     

     

HUMAN VETERINARY

SITE MAILING ADDRESS (If different from site address)

     

CITY

STATE

ZIP CODE

COUNTRY

SITE INTERNET/EMAIL ADDRESS

     

  

     

     

     

DOING BUSINESS AS (DBA) NAME OF FIRM (if applicable)

     

PARENT COMPANY NAME

     

REASON(s) FOR SUBMISSION

TYPE OF OWNERSHIP

PERSON SUBMITTING DATA AND TELEPHONE

Firm Registration Address Change Registration of Merger/Buyout Additional Site Reentry into Business Re-Registration with Same Name LC Assignment Out of Business Name Change

Sole Proprietorship Partnership Coop. Assn. Corporation Other      

     

BUSINESS TYPE

Distributor* Manufacturer Foreign Country Repacker Analytical Lab Relabeler Other      

SECTION B - FIRM COMPLIANCE MAILING ADDRESS for Annual Listing Report and/or Firm Correspondence

NUMBER AND STREET AND/OR P.O. BOX and ATTENTION LINE and/or Internal Mail Code

TELEPHONE NUMBER

     

(     )      

CITY

STATE

ZIP CODE

COUNTRY

COMPLIANCE INTERNET/EMAIL

     

  

     

     

ADDRESS

     

SECTION C - ADDITIONAL FIRM AND SITE INFORMATION

NAME OF OWNER, PARTNERS OR OFFICERS

TITLE

POSITION

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

OTHER FIRMS DOING BUSINESS AT THIS SITE

LABELER CODE

FIRM NAME

LABELER CODE

FIRM NAME

     

     

     

     

     

     

     

     

SECTION D - SIGNATURE

SIGNATURE OF AUTHORIZING OFFICIAL

TITLE

DATE

     

     

*DISTRIBUTOR’S CERTIFICATION: As a, Distributor, I am submitting product listing information to the FDA on my own behalf. I have provided a copy of this certification (Form FDA 2656) to the registered manufacturer(s). My signature and phone number are listed below.

RETURN THIS FORM TO: FOOD AND DRUG ADMINISTRATION CDER/DRUG REGISTRATION AND LISTING (HFD-337) 5600 FISHERS LANE ROCKVILLE, MD 20857 INTERNET: [email protected]

SIGNATURE OF DISTRIBUTOR

DISTRIBUTOR’S TELEPHONE NUMBER

(     )      

If using Federal Express, DHL or any special carrier to return the forms, please use the following address:

(Please refer to the Drug Registration and Listing Instruction Booklet.)

When completing this form, please refer to the Drug Registration and Listing Instruction Booklet for assistance.

PLEASE PRINT IN ENGLISH USING BLACK INK.

Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

Food and Drug Administration CDER/Drug Registration and Listing (HFD-337) 5600 Fishers Lane Rockville, MD 20857

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

FDA 2656 (8/07) (FRONT) NOTE: Validation of this form is not to be construed as FDA approval of the establishment or its products.

PREVIOUS EDITION IS OBSOLETE PSC Graphics: (301) 443-1090 EF