Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter R - ISSUANCE OF CERTIFICATES OF FREE SALE AND SANITATION AND/OR CERTIFICATES OF ORIGIN AND SANITATION › Section 229.302 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
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).