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    The Food and Drug Licensing Group is within the Division for Regulatory Services. 
    P. O. Box 149347
    Austin, TX 78714-9347 
    (512) 834-6770

     


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Instructions for Applying for a Certificate of Free Sale and-or a Certificate of Origin - Food and Drug Licensing Group

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To receive a Certificate of Free Sale and/or a Certificate of Origin

Food manufacturers/distributors, medical device manufacturers/distributors, frozen dessert manufacturers/distributors, milk processors/distributors and wholesale distributors of drugs must be currently licensed with the Texas Department of State Health Services (DSHS). Certificates will be issued only for products that are regulated or inspected by DSHS. All establishments shall have a current compliant inspection as follows:

(1) For manufacturers, of food, drug, medical device products, within 12 months from the date of the application.

(2) For manufacturers, distributors, or wholesalers of cosmetic products, within 24 months from the date of the application.

(3) For distributors or wholesalers of foods, drugs, or medical devices, within 24 months from the date of the application.

(4) For producers, processors, and distributors of milk or dairy, frozen dessert, and molluscan shellfish products, within three (3) months from the date of the application.

If an inspection has not been done within the above timeframes, additional time will be required.

Return the completed application and nonrefundable fee to TEXAS DEPARTMENT OF STATE HEALTH SERVICES, P.O. BOX 12008, AUSTIN, TEXAS, 78711. Make check or money order payable to TEXAS DEPARTMENT OF STATE HEALTH SERVICES.


Fees for Certificates of Free Sale and/or Certificates of Origin are as follows:

(1) Original certificate. All applicants for certificates shall pay a nonrefundable fee based on the number of products to be listed on the certificate. Certificates shall not be reproduced or transferred from one person to another or from one establishment to another.

(2) Additional certificates. Each additional identical original certificate is about 10% of the base fee.

(3) The fee schedule.

$50 for 1 - 50 products per original certificate; $5 for each additional identical certificate

$60 for 51 - 200 products per original certificate; $6 for each additional identical certificate

$75 for 201 - 500 products per original certificate; $8 for each additional identical certificate

$100 for 501 - 1000 products per original certificate; $10 for each additional identical certificate

(4) Cosmetic products. For cosmetic establishments not required to be licensed by DSHS, and who do not have a current compliant inspection, a nonrefundable fee based on the number of products to be listed on the certificate and $400.00 for inspection conducted by DSHS staff will be required.

(5) Supplemental information review. For a supplemental information review, a separate invoice shall be mailed or sent via facsimile to the applicant. A nonrefundable fee of $72.00 per hour of review time will be charged. This fee must be paid prior to the certificate being issued. Failure to pay the review fee will result in denial of the certificate.


Products for manufacturers must be manufactured in the State of Texas.

Requests containing more than ten product items may be submitted on diskette or CD-ROM, in Word or Excel, along with the application.

If you have questions or desire additional information, please contact the Regulatory Licensing Unit Office at (512) 834-6626.

FOR INFORMATION ON EXPORTING MEAT AND/OR POULTRY PRODUCTS PLEASE CONTACT:
RICK HARRIES, DIRECTOR EXPORT PROGRAMS STAFF (USDA) TELEPHONE: 202.720.0082 FAX 202.720.7990

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Last updated January 12, 2011