reglab/statecodes huggingface dataset:
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter K - TEXAS FOOD ESTABLISHMENTS › Section 229.177 - Certification of Food Managers in Areas Under the Department of State Health Services Permitting Jurisdiction

Current through Reg. 49, No. 28; July 12, 2024
(a) Purpose. The
				  purpose of this section is to implement a food manager certification
				  requirement as authorized in the Texas Health and Safety Code, Chapter 437,
				  §437.0076(b). Certification of food managers after testing on food safety
				  principles reduces the risk of foodborne illness outbreaks caused by improper
				  food preparation and handling techniques.
(b) Food manager certification required. One
				  certified food manager must be employed by each food establishment permitted
				  under Texas Health and Safety Code, §
										437.0055.
				  Certification must be obtained by passing a department approved examination at
				  an approved examination site and meeting all requirements in Texas Health and
				  Safety Code, Chapter 438, Subchapter G, and §
										229.176 of this title (relating to
				  Certification of Food Managers).
(c) Food manager certification exemptions.
				  The following food establishments are exempt from the requirements in
				  subsection (b) of this section:
(1)
				  establishments that handle only prepackaged food and do not package food as
				  exempted in Texas Health and Safety Code, §
											437.0076(c);
(2) child care facilities as exempted by
				  Texas Health and Safety Code, §
											437.0076(f);
(3) establishments that do not prepare or
				  handle exposed Time/Temperature Control for Safety (TCS) food--(formerly
				  Potentially Hazardous Food (PHF)), as defined in 2017 FDA Food Code 1-201.10;
				  or
(4) nonprofit organizations as
				  defined in §
											229.371(9) of
				  this title (relating to Permitting Retail Food Establishments).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter L - LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS › Section 229.181 - 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) Direct seller--An
				  individual:
(A) who is not affiliated with a
				  permanent retail establishment and who engages in the business of:
(i) in-person sales of prepackaged
				  nonperishable foods, including dietary supplements, to a buyer on a buy-sell
				  basis, a deposit-commission basis, or a similar basis for resale in a home;
				  or
(ii) sales of prepackaged
				  nonperishable foods, including dietary supplements, in a home;
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter L - LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS › Section 229.183 - Minimum Standards for Licensure/Registration

Current through Reg. 49, No. 28; July 12, 2024
Food manufacturers, food wholesalers, and warehouse
					 operators.
(1) All food manufacturers,
				  and warehouse operators in Texas shall comply with §§
										229.211-
				  229.221 of
				  this title (relating to Current Good Manufacturing Practice and Good
				  Warehousing Practice in Manufacturing, Packing, or Holding Human Food) in
				  addition to the existing standards contained in the Health and Safety Code,
				  Chapters 431, 434, and 438.
(2) All
				  food wholesalers in Texas, including those food wholesalers registered under
				  §
										229.182
				  of this title (relating to Licensing/Registration Fees and Procedures), shall
				  comply with §§
										229.211-
				  229.219 of
				  this title, in addition to the existing standards contained in the Health and
				  Safety Code, Chapters 431, 434, and 438.
(3) Living areas. No manufacturing or holding
				  of foods for distribution shall be conducted in any room used as living or
				  sleeping quarters. All food manufacturing and storage shall be separated from
				  any living or sleeping quarters by complete partitioning.
(4) Food labeling. If a person, firm, or
				  corporation labels an article of food, the label shall meet the requirements of
				  the Health and Safety Code, Chapter 431.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter L - LICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS › Section 229.184 - Refusal, Revocation, or Suspension of Licensure/Registration

Current through Reg. 49, No. 28; July 12, 2024
(a) Basis. The
				  department may, after providing an opportunity for a hearing, refuse an
				  application for a license/registration from a food manufacturer, food
				  wholesaler, or warehouse operator, or may revoke or suspend a
				  license/registration for violations of the requirements in §
										229.182
				  of this title (relating to Licensing/Registration Fee and Procedures), and
				  §
										229.183
				  of this title (relating to Minimum Standards for Licensure/Registration), or
				  for interference with the department in the performance of its duty under these
				  rules.
(b) Hearings. Any hearings
				  for the refusal, revocation, or suspension of a license/registration are
				  governed by §§
										1.21,
				  1.23,
				  1.25, and
				  1.27 of
				  this title (relating to Formal Hearing Procedures).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.212 - Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food

Current through Reg. 49, No. 28; July 12, 2024
(a) Applicability.
(1) The management of an establishment must
				  ensure that all individuals who manufacture, process, pack, or hold food
				  subject to 21 Code of Federal Regulations Part 117 Subparts B and F are
				  qualified to perform their assigned duties.
(2) The owner, operator, or agent in charge
				  of a facility must ensure that all individuals who manufacture, process, pack,
				  or hold food subject to 21 Code of Federal Regulations Part 117 Subparts C, D,
				  E, F, or G are qualified to perform their assigned duties.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.213 - Exemptions

Current through Reg. 49, No. 28; July 12, 2024
(a) Except as
				  provided by 21 Code of Federal Regulations Part 117 Subparts E, C and G does
				  not apply to a qualified facility. Qualified facilities are subject to the
				  modified requirements in 21 Code of Federal Regulations,
				  §117.201.
(b) 21 Code of
				  Federal Regulations Part 117 Subparts C and G do not apply with respect to
				  activities that are subject to 21 Code of Federal Regulations Part 123, Fish
				  and Fishery Products, at a facility if you are required to comply with, and are
				  in compliance with, Part 123 with respect to such activities.
(c) 21 Code of Federal Regulations Part 117
				  Subparts C and G of this part do not apply with respect to activities that are
				  subject to 21 Code of Federal Regulations Part 120, Hazard Analysis and
				  Critical Control Point (HACCP) Systems, at a facility if you are required to
				  comply with, and are in compliance with, Part 120 with respect to such
				  activities.
(d) Thermally Processed
				  Low-Acid Foods Packaged in Hermetically Sealed Containers.
(1) 21 Code of Federal Regulations Part 117
				  Subparts C and G do not apply with respect to activities that are subject to 21
				  Code of Federal Regulations Part 113, Thermally Processed Low-Acid Foods
				  Packaged in Hermetically Sealed Containers, at a facility if you are required
				  to comply with, and are in compliance with 21 Code of Federal Regulations Part
				  113 with respect to such activities.
(2) The exemption in paragraph (1) of this
				  subsection is applicable only with respect to the microbiological hazards that
				  are regulated under 21 Code of Federal Regulations Part 113.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.214 - Applicability of 21 Code of Federal Regulations Part 117 Subparts C, D, and G to a Facility Solely Engaged in the Storage of Unexposed Packaged Food

Current through Reg. 49, No. 28; July 12, 2024
(a) Applicability
				  of 21 Code of Federal Regulations Part 117 Subparts C and G. 21 Code of Federal
				  Regulations Part 117 Subparts C and G do not apply to a facility solely engaged
				  in the storage of unexposed packaged food.
(b) Applicability of 21 Code of Federal
				  Regulations Part 117 Subpart D. A facility solely engaged in the storage of
				  unexposed packaged food, including unexposed packaged time/temperature
				  controlled for safety (TCS) food is subject to the modified requirements in 21
				  Code of Federal Regulations §117.206 for any unexposed packaged TCS
				  food.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.215 - Applicability of Subchapter N to the Off-Farm Packing and Holding of Raw Agricultural Commodities

Current through Reg. 49, No. 28; July 12, 2024
Subchapter N of this chapter applies to the off-farm
					 packaging, packing, and holding of raw agricultural commodities. Compliance
					 with this requirement for raw agricultural commodities that are produce as
					 defined in 21 Code of Federal Regulations Part 112 may be achieved by complying
					 with Subchapter N of this chapter or with the applicable requirements for
					 packing and holding in Part 112.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.216 - Records

Current through Reg. 49, No. 28; July 12, 2024
(a) Records that
				  document training required by §
										229.212(b)(2)
				  of this title (relating to Qualifications of Individuals Who Manufacture,
				  Process, Pack, or Hold Food) must be established and maintained.
(b) The records that must be established and
				  maintained are subject to the requirements of 21 Code of Federal Regulations
				  Part 117 Subpart F.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.218 - Plant and Grounds

Current through Reg. 49, No. 28; July 12, 2024
(a) Grounds.
				  The grounds about a food plant under the control of the operator must be kept
				  in a condition that will protect against the contamination of food. The methods
				  for adequate maintenance of grounds must include:
(1) properly storing equipment, removing
				  litter and waste, and cutting weeds or grass within the immediate vicinity of
				  the plant that may constitute an attractant, breeding place, or harborage for
				  pests;
(2) maintaining roads,
				  yards, and parking lots so that they do not constitute a source of
				  contamination in areas where food is exposed;
(3) adequately draining areas that may
				  contribute contamination to food by seepage, foot-borne filth, or providing a
				  breeding place for pests;
(4)
				  operating systems for waste treatment and disposal in an adequate manner so
				  that they do not constitute a source of contamination in areas where food is
				  exposed; and
(5) if the plant
				  grounds are bordered by grounds not under the operator's control and not
				  maintained in the manner described in paragraphs (1) through (4) of this
				  subsection, care must be exercised in the plant by inspection, extermination,
				  or other means to exclude pests, dirt, and filth that may be a source of food
				  contamination.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.219 - Sanitary Operations

Current through Reg. 49, No. 28; July 12, 2024
(a) General
				  maintenance. Buildings, fixtures, and other physical facilities of the plant
				  must be maintained in a clean and sanitary condition and must be kept in repair
				  to prevent food from becoming adulterated. Cleaning and sanitizing of utensils
				  and equipment must be conducted in a manner that protects against allergen
				  cross-contact and against contamination of food, food-contact surfaces, or
				  food-packaging materials.
(b)
				  Substances used in cleaning and sanitizing; storage of toxic materials.
(1) Cleaning compounds and sanitizing agents
				  used in cleaning and sanitizing procedures must be free from undesirable
				  microorganisms and must be safe and adequate under the conditions of use.
				  Compliance with this requirement may be verified by any effective means
				  including purchase of these substances under a supplier's guarantee or
				  certification, or examination of these substances for contamination. Only the
				  following toxic materials may be used or stored in a plant in areas where food
				  is processed or exposed:
(A) those required
				  to maintain clean and sanitary conditions;
(B) those necessary for use in laboratory
				  testing procedures;
(C) those
				  necessary for plant and equipment maintenance and operation; and;
(D) those necessary for use in the plant's
				  operations.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.220 - Sanitary Facilities and Controls

Current through Reg. 49, No. 28; July 12, 2024
Each plant must be equipped with adequate sanitary
					 facilities and accommodations including, but not limited to:
(1) Water supply. The water supply must be
				  adequate for the operations intended and must be derived from an approved
				  source.
(A) Requirements for approved source.
				  Sources in Texas must comply with the following requirements.
(i) Public water systems. Sources in Texas
				  which are public water systems must comply with the Texas Health and Safety
				  Code, Chapter 341, Subchapter C, drinking water standards and rules adopted by
				  the Texas Commission on Environmental Quality, 30 Texas Administrative Code
				  (TAC) Chapter 290.
(ii) Other
				  sources. Any other sources in Texas must comply with 30 TAC Chapter 290,
				  Subchapter F, concerning drinking water standards.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.221 - Equipment and Utensils

Current through Reg. 49, No. 28; July 12, 2024
(a) Design and
				  Construction.
(1) All plant equipment and
				  utensils used in manufacturing, processing, packing, or holding food must be so
				  designed and of such material and workmanship as to be cleanable, and must be
				  maintained to protect against allergen cross-contact and
				  contamination.
(2) Equipment and
				  utensils must be designed, constructed, and used appropriately to avoid the
				  adulteration or contamination of food.
(3) Equipment must be installed so as to
				  permit the cleaning and maintenance of the equipment and of adjacent
				  spaces.
(4) Food-contact surfaces
				  must be corrosion-resistant.
(5)
				  Food-contact surfaces must be made of nontoxic materials and designed to
				  withstand the environment of their intended use and the action of food,
				  cleaning compounds, sanitizing agents, and cleaning procedures.
(6) Food-contact surfaces must be maintained
				  to protect food from allergen cross-contact and from being contaminated by any
				  source.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.222 - Production and Process Controls

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  General.
(1) All operations in the
				  manufacturing, processing, packing, and holding of food (including operations
				  directed to receiving, inspections, transporting, and segregating) must be
				  conducted in accordance with adequate sanitation principles.
(2) Quality control operations must be
				  employed to ensure that food is suitable for human consumption and that
				  food-packaging materials are safe and suitable.
(3) Overall sanitation of the plant must be
				  under the supervision of one or more competent individuals assigned
				  responsibility for this function.
(4) Adequate precautions must be taken to
				  ensure that production procedures do not contribute to allergen cross-contact
				  and to contamination from any source.
(5) Chemical, microbial, or
				  extraneous-material testing procedures must be used where necessary to identify
				  sanitation failures or possible allergen cross-contact and food
				  contamination.
(6) All food that
				  has become contaminated to the extent that it is adulterated must be rejected,
				  treated or processed to eliminate the contamination.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.223 - Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard

Current through Reg. 49, No. 28; July 12, 2024
(a) Some foods,
				  even when produced under current good manufacturing practice, contain natural
				  or unavoidable defects that at low levels are not hazardous to health. The
				  United States Food and Drug Administration establishes maximum levels for these
				  defects in foods produced under current good manufacturing practice and uses
				  these levels in deciding whether to recommend regulatory action.
(b) Compliance with defect action levels does
				  not excuse violation of the requirement in the Texas Health and Safety Code,
				  §
										431.081(a)(3)
				  that food not be prepared, packed, or held under unsanitary conditions or the
				  requirements in this section that food manufacturers, distributors, and holders
				  must observe current good manufacturing practice. Evidence indicating that such
				  a violation exists causes the food to be adulterated, even though the amounts
				  of natural or unavoidable defects are lower than the currently established
				  defect action levels. The manufacturer, distributor, and holder of food must at
				  all times utilize quality control operations that reduce natural or unavoidable
				  defects to the lowest level currently feasible.
(c) The mixing of a food containing defects
				  above the current defect action level with another lot of food is not permitted
				  and renders the final food adulterated regardless of the defect level of the
				  final food.
(d) A compilation of
				  the current defect action levels for natural or unavoidable defects in food for
				  human use that present no health hazard may be obtained upon request from
				  foods.regulatory@dshs.state.tx.us or Texas Department of State Health Services
				  Foods Group, P.O. Box 149347, Mail Code 1987, Austin, Texas
				  78714-9347.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.224 - Good Warehousing Practice

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Plant and grounds.
(1) Storage and
				  transportation of food must be under conditions that will protect food against
				  physical, chemical, and microbial contamination as well as against
				  deterioration of the food and the container.
(2) Food storage facilities must be properly
				  constructed and maintained. All walls, ceilings, and floors must be intact to
				  preclude entry of vermin and environmental contaminants.
(3) Doors and loading docks must be
				  tight-fitting and kept closed at all times when not in use, or adequately
				  screened during normal operating hours to prevent entry of rodents, birds, or
				  other pests.
(4) Outer premises,
				  including trash receptacles, and non food storage areas must be kept clean and
				  free of odors, debris, high weeds, or standing water which could harbor or
				  attract vermin.
(5) Adequate
				  lighting of at least 108 lux (10 foot candles) must be provided to facilitate
				  cleaning and inspection of food storage areas.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter N - CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Section 229.225 - Enforcement

Current through Reg. 49, No. 28; July 12, 2024
(a) Criminal
				  penalties as provided in Texas Health and Safety Code, §
										431.059
				  may be assessed for violations of these sections.
(b) Civil penalties as provided in Texas
				  Health and Safety Code, §
										431.0585 may be
				  assessed for violations of these sections.
(c) Administrative penalties as provided in
				  Texas Health and Safety Code, §
										431.054,
				  §
										431.055,
				  §
										431.056,
				  §
										431.057,
				  §
										431.058,
				  and in §
										229.261
				  of this title (relating to Assessment of Administrative Penalties), may be
				  assessed for violation of these sections. If the person charged with the
				  violation does not request a hearing, the Commissioner of the Department of
				  State Health Services (Commissioner) or the Commissioner's designee may assess
				  a penalty after determining that a violation has occurred and the amount of the
				  penalty.
(d) Emergency orders as
				  provided in Texas Health and Safety Code, §
										431.045 may be
				  issued by the Commissioner or the Commissioner's designee.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.241 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
These sections provide for the minimum licensing standards
					 necessary to ensure the safety and efficacy of nonprescription drugs offered
					 for sale by wholesale distributors.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.243 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
The following words and terms, when used in this
					 subchapter, shall have the following meanings, unless the context clearly
					 indicates otherwise.
(1) Act--The
				  Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter
				  431.
(2) Adulterated drug--Has the
				  meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety
				  Code, Chapter 431, §431.111.
(3) Authorized agent--An employee of the
				  department who is designated by the commissioner to enforce the provisions of
				  the Act.
(4) Change of ownership--A
				  sole proprietor who transfers all or part of the facility's ownership to
				  another person or persons; the removal, addition, or substitution of a person
				  or persons as a partner in a facility owned by a partnership; a corporate sale,
				  transfer, reorganization, or merger of the corporation which owns the facility
				  if sale, transfer, reorganization, or merger causes a change in the facility's
				  ownership to another person or persons; or if any other type of association,
				  the removal, addition, or substitution of a person or persons as a principal of
				  such association.
(5)
				  Commissioner--Commissioner of the Department of State Health
				  Services.
(6) Cosmetic--Articles
				  intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or
				  otherwise applied to the human body or any part of the human body for cleaning,
				  beautifying, promoting attractiveness, or altering the appearance, and articles
				  intended for use as a component of those articles. The term does not include
				  soap.
(7) Department--The
				  Department of State Health Services.
(8) Device--An instrument, apparatus,
				  implement, machine, contrivance, implant, in vitro reagent, or other similar or
				  related article, including any component, part, or accessory, that is:
(A) recognized in the official United States
				  Pharmacopoeia National Formulary or any supplement to it;
(B) intended for use in the diagnosis of
				  disease or other conditions, or in the cure, mitigation, treatment, or
				  prevention of disease in man or other animals; or
(C) intended to affect the structure or any
				  function of the body of man or other animals and that does not achieve any of
				  its principal intended purposes through chemical action within or on the body
				  of man or other animals and is not dependent on metabolization for the
				  achievement of any of its principal intended purposes.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.244 - Sale of Nonprescription Drugs

Current through Reg. 49, No. 28; July 12, 2024
Any reference in these sections to the sale of
					 nonprescription drugs shall be considered to include the manufacture,
					 packaging, exposure, offer, possession, and holding of any nonprescription drug
					 for sale; the sale, dispensing, and giving of any nonprescription drug; and
					 supplying or applying of any nonprescription drug in the operation of any
					 nonprescription drug place of business.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.245 - Exemption

Current through Reg. 49, No. 28; July 12, 2024
(a) A person is
				  exempt from licensing a place of business in accordance with §
										229.246 of
				  this title (relating to Licensure Requirements) if the person holds a license
				  for the place of business issued by the department under Subchapter W of this
				  chapter (relating to Licensing of Wholesale Distributors of Prescription
				  Drugs--Including Good Manufacturing Practices).
(b) An exemption from the licensing
				  requirement granted in subsection (a) of this section does not constitute an
				  exemption from other applicable requirements for nonprescription drugs in these
				  sections or under the Texas Food, Drug, and Cosmetic Act, Health and Safety
				  Code, Chapter 431.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.247 - Licensing Procedures

Current through Reg. 49, No. 28; July 12, 2024
(a) License
				  application forms. License application forms may be obtained from the
				  department, 1100 West 49th Street, Austin, Texas, 78756, or online at
				  http://www.dshs.state.tx.us/license.shtm.
(b) Contents of license application. The
				  application for licensure as a wholesale distributor of nonprescription drugs
				  shall be signed and verified, submitted on a license application form furnished
				  by the department, and contain the following information:
(1) the name of the legal entity to be
				  licensed, including the name under which the business is conducted;
(2) the address of each place of business
				  that is licensed;
(3) if a
				  proprietorship, the name and residence address of the proprietor; if a
				  partnership, the names and residence addresses of all partners; if a
				  corporation, the date and place of incorporation and name and address of its
				  registered agent in the state and corporation charter number; or if any other
				  type of association, the names of the principals of such association;
(4) the name, residence address, and valid
				  driver license number for each individual in an actual administrative capacity
				  which, in the case of proprietorship, shall be the managing proprietor;
				  partnership, the managing partner; corporation, the officers and directors; or
				  those in a managerial capacity in any other type of association;
(5) for each place of business, the residence
				  address of the individual in charge thereof;
(6) a list of categories which must be marked
				  and adhered to in the determination and payment of the fee; and
(7) a statement verified by the applicant's
				  signature that acknowledges the applicant has read, understood, and agrees to
				  abide by the provisions of these sections and those of the Texas Food, Drug,
				  and Cosmetic Act, Health and Safety Code, Chapter 431.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.248 - Report of Changes

Current through Reg. 49, No. 28; July 12, 2024
(a) Change in the
				  content of a license application. The license holder shall notify the
				  department in writing within ten days of any change which would render the
				  information contained in the application for the license, reported pursuant to
				  §
										229.247 of
				  this title (relating to Licensing Procedures), no longer accurate. Failure to
				  inform the department no later than ten days of a change in the information
				  required in the application for a license may result in a suspension or
				  revocation of the license.
(b)
				  Change in location of place of business. Not fewer than 30 days in advance of
				  the change, the licensee shall notify the department in writing of the
				  licensee's intent to change the location of a licensed place of business. The
				  notice shall include the address of the new location, and the name and
				  residence address of the individual in charge of the business at the new
				  location. Not more than 10 days after the completion of the change of location,
				  the licensee shall notify the department in writing to confirm the completion
				  of the change of location, and provide verification of the information
				  previously provided or correct and confirm any information that has changed
				  since providing the notice of intent. The notice and confirmation required by
				  this subsection will be deemed adequate if the licensee sends the notices by
				  certified mail, return receipt requested, to the department at 1100 West 49th
				  Street, Austin, Texas 78756, or submits them electronically through the Texas
				  Online Internet website.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.249 - Licensure Fees

Current through Reg. 49, No. 28; July 12, 2024
(a) License fee.
				  Except as provided by §
										229.245 of
				  this title (relating to Exemption), no person may operate or conduct business
				  as a wholesale distributor of nonprescription drugs without first obtaining a
				  license from the department. All applicants for an initial wholesale
				  distributor of nonprescription drugs license or a renewal license shall pay a
				  licensing fee unless otherwise exempt as provided by subsection (c) of this
				  section. All fees are nonrefundable. Licenses are issued for two-year terms. A
				  license shall only be issued when all past due license fees and delinquency
				  fees are paid.
(1) In-state wholesale
				  distributors of nonprescription drugs who are not manufacturers shall pay a
				  two-year license fee based on the gross annual sales of all nonprescription
				  drugs.
(A) For a wholesale distributor with
				  gross annual nonprescription drug sales of $0 - $199,999.99, the fees are:
(i) $1,040 for a two-year license;
(ii) $1,040 for a two-year license that is
				  amended due to a change of ownership; and
(iii) $520 for a license that is amended
				  during the current licensure period due to minor changes.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.250 - Refusal, Cancellation, Suspension or Revocation of License

Current through Reg. 49, No. 28; July 12, 2024
(a) The
				  commissioner may refuse an application for a wholesale distributor of
				  nonprescription drugs license or may suspend or revoke such a license if the
				  applicant or licensee:
(1) has been convicted
				  of a felony or misdemeanor that involves moral turpitude;
(2) is an association, partnership, or
				  corporation and the managing officer and/or any officer or director of the
				  corporation has been convicted of a felony or misdemeanor that involves moral
				  turpitude;
(3) is an association,
				  partnership, or corporation and the managing officer and/or any officer or
				  director of the corporation has been convicted of a felony or misdemeanor
				  involving the illegal use, sale, or transportation of intoxicating liquors,
				  narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or
				  derivatives, or any other dangerous or habit-forming drugs;
(4) has violated any of the provisions of the
				  Texas, Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act)
				  or these sections;
(5) has violated
				  the Health and Safety Code, §
											431.021(1)(3),
				  concerning the counterfeiting of a drug or the sale or holding for sale of a
				  counterfeit drug;
(6) has violated
				  the Health and Safety Code, Chapter 481 (Texas Controlled Substance Act), or
				  the Health and Safety Code, Chapter 483 (Dangerous Drug Act);
(7) has violated the rules of the director of
				  the Department of Public Safety, including being responsible for a significant
				  discrepancy in the records that state law requires the applicant or licensee to
				  maintain;
(8) has failed to
				  complete a license application or submits an application that contains false,
				  misleading, or incorrect information or contains information that cannot be
				  verified by the department;
(9) has
				  failed to pay a license fee or a renewal fee for a license; or
(10) has obtained or attempted to obtain a
				  license by fraud or deception.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.252 - Enforcement and Penalties

Current through Reg. 49, No. 28; July 12, 2024
(a) Inspection.
				  To enforce these sections or the Texas Food, Drug, and Cosmetic Act, Health and
				  Safety Code, Chapter 431 (Act), the commissioner, an authorized agent, or a
				  health authority may, on presenting appropriate credentials to the owner,
				  operator, or agent in charge of a place of business:
(1) enter at reasonable times a place of
				  business, including a factory or warehouse, in which a nonprescription drug is
				  manufactured, packed, or held for introduction into commerce or held after the
				  introduction;
(2) enter a vehicle
				  being used to transport or hold a nonprescription drug in commerce;
				  or
(3) inspect at reasonable times,
				  within reasonable limits, and in a reasonable manner, the place of business or
				  vehicle and all equipment, finished and unfinished materials, containers, and
				  labeling of any item, and obtain samples necessary for the enforcement of these
				  sections or the Act.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter P - ASSESSMENT OF ADMINISTRATIVE PENALTIES › Section 229.261 - Assessment of Administrative Penalties

Current through Reg. 49, No. 28; July 12, 2024
(a) Proposals for assessment of
				  administrative penalties. The department shall propose to assess administrative
				  penalties in accordance with the requirements of the Texas Health and Safety
				  Code, Chapter 146 concerning Tattoo and Certain Body Piercing Studios; Chapter
				  431 concerning Texas Food, Drug, and Cosmetic Act; Chapter 432 concerning Texas
				  Food, Drug, Device, and Cosmetic Salvage Act; and Chapter 437 concerning
				  Regulation of Food Service Establishments, Retail Food Stores, Mobile Food
				  Units, and Roadside Food Vendors .
(b) Assessment of administrative penalties
				  and conduct of hearings. The department shall assess administrative penalties
				  and conduct hearings pursuant to those administrative penalties in accordance
				  with the appropriate statute in subsection (a) of this section and rules
				  adopted under it; the Administrative Procedure Act, Texas Government Code,
				  Chapter 2001 ; and the department's formal hearing procedures in §§
										1.21,
				  1.23,
				  1.25, and
				  1.27 of
				  this title (relating to Formal Hearing Procedures).
(c) Criteria for the assessment of
				  administrative penalties. The department shall assess administrative penalties
				  based upon one or more of the following criteria:
(1) history of previous violations;
(2) seriousness of the violation;
(3) hazard to the health and safety of the
				  public;
(4) demonstrated good faith
				  efforts to correct;
(5) economic
				  harm to property or the environment;
(6) amounts necessary to deter future
				  violations;
(7) enforcement costs
				  relating to the violation; and
(8)
				  any other matter justice may require.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Q - LICENSE/PERMIT APPLICATIONS › Section 229.281 - Processing License/Permit Applications Relating to Food and Drug Operations

Current through Reg. 49, No. 28; July 12, 2024
(a) Definition.
				  For purposes of this section, license means a license, permit, registration, or
				  certificate issued by the Texas Department of Health (department) for a food
				  wholesaler and manufacturer, wholesale drug manufacturer and distributor,
				  device manufacturer and distributor, tanning facility, tattoo studio, body
				  piercing studio, salvage broker, salvage establishment, retail food
				  establishment, or narcotic treatment program. This subchapter is not applicable
				  to food manager certification.
(b)
				  General. Time periods for processing and issuing a license.
(1) The date a license application is
				  received by the Bureau of Food and Drug Safety, Texas Department of Health, is
				  the date the original application reaches the department.
(2) An application for a license is complete
				  when the department has received, reviewed, and found acceptable the
				  application information and fee required by the appropriate sections of this
				  title (25 Texas Administrative Code (TAC), Chapter 229, Food and Drug, relating
				  to Licensing Fees, Procedures, Requirements).
(3) An application for an annual renewal of a
				  license is complete when the department has received, reviewed and found
				  acceptable the application information and fee required by the appropriate
				  section of this title (25 TAC, Chapter 229, Food and Drug, relating to
				  Licensing Fees, Procedures, Requirements).
(4) An application for an amendment of a
				  license is complete when the department has received, reviewed, and found
				  acceptable the application information and fee required by the appropriate
				  section of this title (25 TAC, Chapter 229, Food and Drug relating to Licensing
				  Fees, Procedures, Requirements).
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 229.301 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
These sections set out the requirements for the Department
					 of State Health Services (department) to issue a certificate of free sale and
					 sanitation and/or a certificate of origin and sanitation. Certificates are
					 issued only to Texas licensed manufacturers and/or distributors with product
					 physically present in Texas (and therefore available for inspection by the
					 department) for the purpose of exporting products from the United States into
					 other countries. Products shall be manufactured in Texas and/or distributed,
					 warehoused, and sold from Texas. Certificates for cosmetics can only be issued
					 after the department has inspected the Texas manufacturing and/or warehousing
					 facility. Certificates for meat and poultry products can only be issued by the
					 United States Department of Agriculture (USDA).
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 229.303 - Minimum Requirements

Current through Reg. 49, No. 28; July 12, 2024
(a) Current
				  license. All establishments, except those exempt from licensing by law, shall
				  be currently licensed by the department and shall be in substantial compliance
				  with the Acts and the Rules as they apply to each specific type of
				  operation.
(b) Current compliant
				  inspection. All establishments shall have a current compliant inspection as
				  follows:
(1) distributors or wholesalers of
				  foods, drugs, or medical devices, within 24 months of application;
(2) manufacturers of foods, drugs, or medical
				  devices, within 12 months of application;
(3) manufacturers, distributors, or
				  wholesalers of cosmetic products, within 24 months of application;
(4) producers, processors, and distributors
				  of milk or dairy products, within 3 months of application; and
(5) producers or distributors of molluscan
				  shellfish, within 3 months of application.
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 229.304 - Application for Certificate

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Application form. Application forms may be obtained from the Department of
				  State Health Services, or at the website,
				  www.dshs.state.tx.us/fdlicense.
(b)
				  Application information. The application shall be signed and verified, shall be
				  made on an application form authorized by the department, and shall contain the
				  following information:
(1) the name under
				  which the business is conducted and/or licensed;
(2) the address where the business is
				  conducted;
(3) the type of
				  operation conducted by the requesting establishment;
(4) the type of certificate requested;
				  and
(5) the product(s) specified on
				  the application to include the full, common or usual name of the product, the
				  name of the manufacturer and the size of the product. Each product size shall
				  be submitted as a separate product. Products on the certificate will be listed
				  exactly as submitted.
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 229.305 - Time Frames

Current through Reg. 49, No. 28; July 12, 2024
(a) Time frames for
				  issuing a certificate. The time frames for issuing a certificate shall be as
				  follows.
(1) No later than 15 business days of
				  receipt of a completed application, the department shall issue a certificate,
				  deny a certificate, schedule an inspection, and/or request supplemental
				  information. Time frames are suspended any time the applicant is requested to
				  submit additional information, the applicant submits additional information, or
				  the applicant requests a custom certificate.
(2) No later than 45 business days of receipt
				  of a completed application, the department shall inspect an establishment
				  needing a current compliant inspection, and shall issue the certificate if
				  there is no substantive violation of the Acts or the Rules. If substantive
				  violations exist, the department shall notify the applicant. Time frames are
				  suspended any time substantive violations exist.
(3) No later than 30 business days of receipt
				  of requested supplemental information or acceptable documentation of correction
				  of substantive violations, the department shall review all information for
				  compliance with state and federal regulations. If the information meets the
				  requirements of the state and federal law, the establishment has a current
				  compliant inspection, and all fees have been received, the department shall
				  issue the certificate. Time frames are suspended any time the applicant is
				  requested to submit supplemental information.
(4) If any time frame is suspended for 60
				  business days or more with no response from the applicant, the application is
				  considered withdrawn.