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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER RISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION
RULE §229.302Definitions

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

  (1) Certificate of free sale and sanitation--A certificate issued by the department, which certifies that the distributor of the food, drugs, cosmetics, medical device products, dietary supplements, milk and dairy products, or molluscan shellfish products listed in the document is duly authorized to distribute the products and that the products can be sold freely to the public in Texas, and that the distributor is in substantial compliance with Texas Health and Safety Code, Chapters 431, 435, 436, or 440, depending on the product (the Acts), and with 25 Texas Administrative Code, Chapters 217, 229, or 241 (the Rules), as determined by the department.

  (2) Certificate of origin and sanitation--A certificate issued by the department, which certifies that the product(s) listed in the document originate from, are manufactured in, produced in or grown in the State of Texas and can only be issued to a Texas manufacturer.

  (3) Common or usual name--The common or usual name of a food shall accurately identify or describe in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The "common or usual name" shall comply with all state and federal regulations, including Title 21, Code of Federal Regulations (CFR), §102.5.

  (4) Current inspection--An official inspection of an establishment conducted within the time specified in §229.303(b) of this title (relating to Minimum Requirements), or immediately preceding a request for certificate of free sale and sanitation and/or a certificate of origin and sanitation.

  (5) Currently licensed--Establishments regulated by the department under the Texas Health and Safety Code (Texas Food, Drug, and Cosmetic Act, Texas Dairy Products Act, Texas Aquatic Life Act, and Frozen Desserts Manufacturer Licensing Act,) which possess a current, valid license.

  (6) Custom certificate--A certificate of free sale and sanitation or certificate of origin and sanitation with additional verbiage requested by the applicant. The verbiage may be specific to the requirements of the receiving country and/or specific information about the product(s) listed on the certificate(s).

  (7) Department--The Department of State Health Services.

  (8) Private Labeler--A firm that distributes a product under a custom label, trade name, private label, or its own label, and assumes full responsibility for compliance with all applicable laws and regulations, and the product is manufactured and labeled by another licensee and/or registered establishment. For purposes of this regulation, regardless of license type issued, a private labeler can only be issued a certificate of free sale and sanitation.

  (9) Properly labeled--Products in compliance with applicable state and federal statutes and regulations as listed in subparagraphs (A) - (D) of this paragraph and in accordance with the Texas Food, Drug and Cosmetic Act, Texas Health and Safety Code, Chapter 431.

    (A) Title 21, CFR, Part 101, Food labeling (relating to labeling of food, beverages, and dietary supplements).

    (B) Title 21, CFR, Part 201, Labeling (relating to labeling of drugs), and Title 21, CFR, Parts 310 and 328 - 369 (relating to monograph labeling requirements).

    (C) Title 21, CFR, Parts 701 and 740, Cosmetic labeling.

    (D) Title 21, CFR, Part 801, Labeling (relating to labeling of medical devices).


Source Note: The provisions of this §229.302 adopted to be effective March 15, 2001, 26 TexReg 2031; amended to be effective October 1, 2010, 35 TexReg 8500

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