reglab/statecodes huggingface dataset:
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.426 - 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
				  §
										229.425 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 must 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 subchapter will be
				  deemed adequate if the licensee sends the notices by certified mail, return
				  receipt requested, to the department at P.O. Box 149347, Austin, Texas
				  78714-9347, or submits them electronically through texas.gov at
				  www.texas.gov.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.427 - Licensure Fees

Current through Reg. 49, No. 28; July 12, 2024
(a) License fee.
				  Except as provided by §
										229.423 of
				  this title (relating to Exemptions), no person may operate or conduct business
				  as a wholesale distributor of prescription drugs without first obtaining a
				  license from the department. All applicants for an initial wholesale
				  distributor of prescription 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 and out-of-state
				  wholesale distributors of prescription drugs who are not manufacturers shall
				  pay a two-year license fee based on the gross annual sales of all drugs.
(A) For a wholesale distributor of only
				  medical gases, the fees are:
(i) $675 for a
				  two-year license;
(ii) $675 for a
				  two-year license that is due to a change of ownership; and
(iii) $337 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 W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.428 - 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
				  prescription 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 a
				  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 a 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 this subchapter;
(5) has
				  violated the Health and Safety Code, §
											431.021(l)(3),
				  (jj), and (kk) concerning the counterfeiting
				  of a drug or the sale or holding for sale of a counterfeit drug;
(6) has violated the Texas Controlled
				  Substances Act, Health and Safety Code, Chapter 481, or the Texas Dangerous
				  Drug Act, Health and Safety Code, Chapter 483;
(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) fails 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 furnished false
				  or fraudulent information in any application made in connection with drug
				  manufacturing or distribution;
(10)
				  has failed to pay a license fee or a renewal fee for a license; or
(11) 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 W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS - INCLUDING GOOD MANUFACTURING PRACTICES › Section 229.430 - Enforcement and Penalties

Current through Reg. 49, No. 28; July 12, 2024
(a) Inspection.
(1) To enforce this subchapter 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:
(A) enter at reasonable times a
				  place of business, including a factory or warehouse, in which a prescription
				  drug is manufactured, packed, or held for introduction into commerce or held
				  after the introduction;
(B) enter a
				  vehicle being used to transport or hold a prescription drug in commerce;
				  or
(C) 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 this
				  subchapter or the Act.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.431 - 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 devices distributed by device
					 distributors and manufacturers.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.432 - Applicable Laws and Regulations

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  The department adopts by reference the following laws and regulations:
(1) Federal Food, Drug, and Cosmetic Act, 21
				  United States Code, et seq., as amended;
(2) 21 Code of Federal Regulations (CFR),
				  Part 801, Labeling, as amended;
(3)
				  21 CFR, Part 803, Medical Device Reporting, as amended;
(4) 21 CFR, Part 807, Establishment
				  Registration and Device Listing for Manufacturers and Initial Importers of
				  Devices, as amended;
(5) 21 CFR,
				  Part 814, Premarket Approval of Medical Devices, as amended;
(6) 21 CFR, Part 820, Quality System
				  Regulation, as amended; and
(7) 21
				  CFR, Subchapter J--Radiological Health, as amended.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.433 - 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) Act--The Texas Food,
				  Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.
(2) Adulterated Device--Has the meaning
				  specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code,
				  Chapter 431, §431.111.
(3)
				  Advertising--All representations disseminated in any manner or by any means,
				  other than by labeling, for the purpose of inducing, or that are likely to
				  induce, directly or indirectly, the purchase of food, drugs, devices, or
				  cosmetics.
(4) Authorized agent--An
				  employee of the department who is designated by the commissioner to enforce the
				  provisions of this chapter.
(5)
				  Commissioner--The Commissioner of Health or his successor.
(6) Department--The Department of State
				  Health Services.
(7) 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 X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.434 - Exemptions

Current through Reg. 49, No. 28; July 12, 2024
(a) A person is
				  exempt from licensing under §
										229.435 of
				  this title (relating to Licensure Requirements) if the person engages only in
				  the following types of device distribution:
(1) intracompany sales;
(2) distribution from a place of business
				  located outside the State of Texas; or
(3) the sale, purchase, or trade of a
				  distressed or reconditioned device by a salvage broker or a salvage operator
				  licensed under §
											229.605
				  of this title (relating to Licensing Requirements and Procedures).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.436 - 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://dshs.state.tx.us/license.shtm.
(b) Contents of license application. The
				  application for licensure as a device distributor or manufacturer 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, then 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 X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.437 - Report of Changes

Current through Reg. 49, No. 28; July 12, 2024
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 §
										229.436 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.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.439 - Licensure Fees

Current through Reg. 49, No. 28; July 12, 2024
(a) License fee.
(1) No person may operate or conduct business
				  as a device distributor without first obtaining a license from the department.
				  All applicants for a device distributor license or a renewal license shall pay
				  a licensing fee. All fees are nonrefundable. Licenses are issued for two-year
				  terms. A license shall only be issued when all past due fees and delinquency
				  fees are paid. License fees are based on gross annual device sales.
(A) For a distributor with gross annual
				  device sales of $0 - $499,999.99, the fees are:
(i) $480 for a two-year license;
(ii) $480 for a two-year license that is
				  amended due to a change of ownership; and
(iii) $240 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 X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.440 - Refusal, Cancellation, Suspension, or Revocation of License

Current through Reg. 49, No. 28; July 12, 2024
(a) The
				  commissioner may refuse an application or may suspend or revoke 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 has been convicted of a felony or
				  misdemeanor that involves moral turpitude;
(3) has been convicted in a state or federal
				  court of 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) is an association, partnership, or
				  corporation and the managing officer has been convicted in state or federal
				  court of 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;
(5) has violated any of the provisions of the
				  Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act)
				  or these sections;
(6) has failed
				  to pay a license fee or a renewal fee for a license; or
(7) 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 X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.442 - Advertising

Current through Reg. 49, No. 28; July 12, 2024
(a) An
				  advertisement of a device shall be deemed to be false if it is false or
				  misleading in any particular.
(b)
				  An advertisement of a device is false if the advertisement represents that the
				  device affects:
(1) infectious and parasitic
				  diseases;
(2) neoplasms;
(3) endocrine, nutritional, and metabolic
				  diseases and immunity disorders;
(4) diseases of blood and blood-forming
				  organs;
(5) mental
				  disorders;
(6) diseases of the
				  nervous system and sense organs;
(7) diseases of the circulatory
				  system;
(8) diseases of the
				  respiratory system;
(9) diseases of
				  the digestive system;
(10) diseases
				  of the genitourinary system;
(11)
				  complications of pregnancy, childbirth, and the puerperium;
(12) diseases of the skin and subcutaneous
				  tissue;
(13) diseases of the
				  musculoskeletal system and connective tissue;
(14) congenital anomalies;
(15) certain conditions originating in the
				  perinatal period;
(16) symptoms,
				  signs, and ill-defined conditions; or
(17) injury and poisoning.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.443 - Enforcement and Penalties

Current through Reg. 49, No. 28; July 12, 2024
(a) Inspection.
(1) To enforce these sections or the Texas
				  Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act), the
				  Commissioner of the Department of State Health Services (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:
(A) enter at reasonable times a place of
				  business, including a factory or warehouse, in which a device is manufactured,
				  assembled, packed, or held for introduction into commerce or held after the
				  introduction;
(B) enter a vehicle
				  being used to transport or hold a device in commerce; or
(C) 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 X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS › Section 229.444 - Device Distributors and Manufacturers Advisory Committee

Current through Reg. 49, No. 28; July 12, 2024
(a) The committee.
				  An advisory committee shall be appointed under and governed by this section.
(1) The name of the committee shall be the
				  Device Distributors and Manufacturers Advisory Committee (committee).
(2) The committee is required to be
				  established by the Executive Commissioner of the Health and Human Services
				  Commission by Health and Safety Code, §
											431.275 and is subject
				  to the Health and Safety Code, §
											11.016.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Y - REGULATIONS TO PROHIBIT THE SALE OF DIETARY SUPPLEMENTS CONTAINING EPHEDRINE GROUP ALKALOIDS; AND TO RESTRICT THE SALE AND DISTRIBUTION OF CERTAIN PRODUCTS CONTAINING EPHEDRINE › Section 229.461 - Regulations to Prohibit the Sale and Distribution of Dietary Supplements Containing Ephedrine Group Alkaloids

Current through Reg. 49, No. 28; July 12, 2024
The sale or distribution of any dietary supplement
					 containing ephedrine group alkaloids is prohibited.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Y - REGULATIONS TO PROHIBIT THE SALE OF DIETARY SUPPLEMENTS CONTAINING EPHEDRINE GROUP ALKALOIDS; AND TO RESTRICT THE SALE AND DISTRIBUTION OF CERTAIN PRODUCTS CONTAINING EPHEDRINE › Section 229.464 - Regulations to Restrict the Sale and Distribution of Certain Drug Products Containing Ephedrine

Current through Reg. 49, No. 28; July 12, 2024
(a) Drug products
				  containing single ingredient ephedrine, its salts, optical isomers or salts of
				  optical isomers, are dangerous drugs as defined in the Health and Safety Code,
				  Chapter 483, relating to Dangerous Drugs.
(b) Drug products that contain
				  pseudoephedrine are exempt from the designation as dangerous drugs if the drug
				  product is labeled in accordance with the U.S. Food and Drug Administration's
				  final monograph.
(c) Any drug
				  product containing ephedrine, its salts, optical isomers or salts of optical
				  isomers shall not be sold, distributed, introduced into commerce, manufactured,
				  produced, packaged, exposed, offered, possessed or held for sale, dispensed or
				  given away in this state except as dispensed upon the prescription of a
				  licensed practitioner.
(d) The
				  following formulations are exempt from the designation as dangerous drugs under
				  subsection (a) of this section, and the dispensing restrictions under
				  subsection (c) of this section:
(1) solid
				  dosage forms that combine active ingredients must be in the following ranges
				  for each recommended dose: ephedrine, its salts, optical isomers or salts of
				  optical isomers not to exceed 12.5 milligrams (mg) combined with at least 200
				  mg guiafenesin; ephedrine, its salts, optical isomers or salts of optical
				  isomers not to exceed 25 mg combined with at least 400 mg
				  guiafenesin;
(2) liquid oral dosage
				  forms that combine active ingredients in the following ranges for each 5
				  milliliter (ml) dose: dextromethorphan HBr (not more than 10 mg),
				  chlorpheniramine maleate (not more than 2 mg), ephedrine HCl (not more than 5
				  mg), phenylephrine (not more than 5 mg), ammonium chloride (not more than 40
				  mg), ipecac fluidextract (not more than 0.005 ml);
(3) anorectal preparations containing less
				  than 5.0% ephedrine;
(4) nasal
				  decongestant preparations containing 0.5% or less ephedrine; and
(5) any ephedrine-containing drug product
				  that is marketed pursuant to an approved new drug application under the Federal
				  Food, Drug, and Cosmetic Act,
				  21
				  U.S.C. §§301,
et
				  seq.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Z - INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS › Section 229.470 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
The purpose of these sections is to implement Texas Health
					 and Safety Code, Chapter 437, which authorizes the department to collect fees
					 to conduct inspections requested or required by certain food establishments
					 when exempted from permitting by the department.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Z - INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS › Section 229.471 - 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) Child care center--Any
				  facility licensed by the regulatory authority to receive 13 or more children
				  for child care which prepares food for on-site consumption. A child care center
				  is classified as a food establishment.
(2) Department--The Department of State
				  Health Services.
(3) Food--A raw,
				  cooked, or processed edible substance, ice, beverage or ingredient used or
				  intended for use or for sale in whole or in part for human consumption, or
				  chewing gum.
(4) Food employee--An
				  individual working with unpackaged food, food equipment or utensils, or
				  food-contact surfaces.
(5) Food
				  establishment--
(A) Food establishment means
				  an operation that stores, prepares, packages, serves, vends, or otherwise
				  provides food for human consumption:
(i) such
				  as a restaurant; retail food store; satellite or catered feeding location;
				  catering operation if the operation provides food directly to a consumer or to
				  a conveyance used to transport people; market; vending location; conveyance
				  used to transport people; institution; or food bank; and
(ii) that relinquishes possession of food to
				  a consumer directly, or indirectly through a delivery service such as home
				  delivery of grocery orders or restaurant takeout orders, or delivery service
				  that is provided by common carriers.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Z - INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS › Section 229.472 - Inspection Fees and Procedures

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Inspection fees. A person who operates a non-permitted food establishment, that
				  requests an inspection be conducted by the department, shall pay an inspection
				  fee for each inspection of the establishment. All inspection fees are
				  nonrefundable.
(1) A school food
				  establishment that requests two inspections per year shall pay for both
				  inspections before the first inspection is conducted by the department.
(A) The school food establishment fee is $300
				  for two inspections.
(B) An
				  application and inspection fee must be submitted between September 15 and
				  October 31 annually.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Z - INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS › Section 229.473 - Minimum Standards for Permitting and Operation

Current through Reg. 49, No. 28; July 12, 2024
All food establishments shall be operated in accordance
					 with the requirements specified in Chapter 228 of this title (relating to
					 Retail Food). Copies may be obtained from the department, 1100 West 49th
					 Street, Austin, Texas 78756-3182, or may be downloaded from the following
					 website:
www.dshs.texas.gov/foodestablishments
.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter Z - INSPECTION FEES FOR RETAIL FOOD ESTABLISHMENTS › Section 229.474 - Refusal of Inspection Request; Administrative Penalties

Current through Reg. 49, No. 28; July 12, 2024
(a) Basis. The
				  department may refuse an application for an inspection for violations of the
				  requirements of §
										229.472
				  of this title (relating to Inspection Fees and Procedures) or §
										229.473
				  of this title (relating to Minimum Standards for Permitting and Operation), or
				  for interference with a department representative in the performance of their
				  duties under these sections.
(b)
				  Hearings. Any hearings for the refusal of an inspection are governed by
				  §§
										1.21,
				  1.23,
				  1.25, and
				  1.27 of
				  this title (relating to Formal Hearing Procedures) or under the provisions of
				  the Government Code, Chapter 2001, the Administrative Procedures Act.
(c) Administrative penalties. Administrative
				  penalties, as provided in the Health and Safety Code, §
										437.018,
				  and in §
										229.261
				  of this title (relating to Assessment of Administrative Penalties), may be
				  assessed for violation of these sections or requirements specified in Chapter
				  228 of this title (relating to Retail Food).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.541 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
These sections provide for the licensing and regulation of
					 food salvage establishments and brokers to prevent the sale or distribution of
					 adulterated or misbranded foods to consumers.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.542 - Applicable Laws and Regulations

Current through Reg. 49, No. 28; July 12, 2024
(a) A
				  salvage establishment or salvage broker who is subject to these sections and
				  who is also involved in the reconditioning, sale, or distribution of distressed
				  or salvaged medical devices, drugs, or cosmetics must comply with the
				  applicable requirements in Subchapter BB of this chapter (relating to
				  Regulation of Drug Salvage Establishments and Brokers), Subchapter CC of this
				  chapter (relating to Regulation of Device Salvage Establishments and Brokers),
				  and Subchapter DD of this chapter (relating to Regulation of Cosmetic Salvage
				  Establishments and Brokers).
(b)
				  The Department of State Health Services (department) adopts by reference the
				  following federal laws and regulations:
(1)
				  Federal Food, Drug, and Cosmetic Act, 21 United States Code (U.S.C.), §301
				  et seq. as amended;
(2) Fair
				  Packaging and Labeling Act, 15 U.S.C.. §1451 et seq. as amended;
(3) Section 501(c)(3), Internal Revenue Code
				  of 1986, as amended; and
(4) 21
				  Code of Federal Regulations (CFR), Part 178, Indirect Food Additives:
				  Adjuvants, Production Aids, and Sanitizers, as amended.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.543 - 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) Act--The Texas Food,
				  Drug, Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter
				  432.
(2) Adulterated food--Has the
				  meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and Safety
				  Code, Chapter 431, §431.081.
(3) Authorized Agent--An employee of the
				  department who is designated by the commissioner to enforce the provisions of
				  this chapter.
(4) Change of
				  ownership--A sole proprietor who transfers all or part of the salvage
				  establishment or salvage broker business to another person or persons; the
				  removal, addition, or substitution of a person or persons as a partner in a
				  salvage establishment or salvage broker business owned by a partnership; a
				  corporate sale, transfer; reorganization; or merger of the corporation which
				  owns the salvage establishment or salvage broker business if the sale,
				  transfer, reorganization, or merger causes a change in the salvage
				  establishment's or salvage broker business' 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--The
				  Commissioner of Health or his successor.
(6) Department--The Department of State
				  Health Services.
(7) 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 AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.544 - Exemptions and Applicability

Current through Reg. 49, No. 28; July 12, 2024
(a) A person is
				  exempt from licensing under these sections if the person is:
(1) a manufacturer, distributor, or processor
				  of a food who in the normal course of business engages in the activities of
				  reconditioning the items manufactured, distributed, or processed by or for that
				  person and not purchased by that person solely for the purpose of
				  reconditioning and sale;
(2) a
				  common carrier or a common carrier's agent who disposes of or otherwise
				  transfers undamaged or distressed foods to a person who is exempt under this
				  section or to a currently licensed salvage broker or salvage
				  operator;
(3) a person who
				  transfers distressed food to a licensed salvage broker or salvage operator;
				  or
(4) a nonprofit organization
				  that distributes food to the needy under the provisions of the Good Faith Donor
				  Act, Civil Practice and Remedies Code, Chapter 76, but does not recondition
				  such food.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.546 - Licensing Fees

Current through Reg. 49, No. 28; July 12, 2024
(a) Licensing fees.
(1) All applicants for a license or a renewal
				  license must pay a licensing fee. All fees are nonrefundable. License fees are
				  as follows:
(A) $600 for a one-year license;
				  or
(B) $1,200 for a two-year
				  license.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.547 - Personnel

Current through Reg. 49, No. 28; July 12, 2024
(a) Employee health
				  requirements. No person known to be or suspected of being affected with any
				  disease in a communicable form, or while a carrier of such disease, or while
				  afflicted with boils, infected wounds, sores, or respiratory infection, shall
				  work in an area of a salvage establishment or for a salvage broker in any
				  capacity in which there is any possibility of such person contaminating
				  salvageable or salvaged food with pathogenic organisms, or transmitting disease
				  to other individuals.
(b) Personal
				  cleanliness.
(1) All personnel while working
				  in direct contact with salvageable food or while engaged in reconditioning,
				  repacking, or otherwise handling any ingredients or components of salvageable
				  food shall wear clean outer garments, maintain a high degree of personal
				  cleanliness, and conform to hygienic practices while on duty.
(2) Personnel engaged in reconditioning
				  salvageable food shall wash their hands thoroughly in a department approved
				  hand-washing facility before starting work and as often as may be necessary to
				  remove soil and contamination.
(3)
				  No person shall resume work after visiting the toilet room without first
				  washing their hands.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.548 - Construction and Maintenance of Physical Facilities

Current through Reg. 49, No. 28; July 12, 2024
(a) Buildings. Buildings used by salvage
				  establishments and salvage brokers shall be of suitable design and contain
				  sufficient space to perform necessary operations, prevent mix-ups, and assure
				  orderly handling.
(b) Floor
				  construction.
(1) The floor surfaces in all
				  rooms and areas in which salvageable or salvaged food is stored or processed
				  and in which utensils are washed, and walk-in refrigerators, dressing or locker
				  rooms, and toilet rooms, shall be constructed to be smooth and easily
				  cleanable.
(2) Any floor that is
				  exposed to water or liquids shall be constructed and maintained to be
				  nonabsorbent
(3) All floors shall
				  be kept clean and in good repair.
(4) Floor drains shall be provided in all
				  rooms where floors are subjected to flooding-type cleaning or where normal
				  operations release or discharge water or other liquid waste on the
				  floor.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.549 - Sanitary Facilities and Controls

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Water supply. The water supply shall be adequate, of a safe sanitary quality,
				  and from a source constructed and operated in accordance with the Minimum
				  Standards of Sanitation and Health Protection, Health and Safety Code, Chapter
				  341, and rules promulgated under this chapter.
(b) Sewage. All sewage, including liquid
				  waste, shall be disposed of in a public sewerage system or, in the absence
				  thereof, in a manner applicable with the Minimum Standards of Sanitation and
				  Health Protection, Health and Safety Code, Chapter 341, and rules promulgated
				  under this chapter.
(c) Plumbing.
				  Plumbing shall be sized, installed, and maintained in accordance with
				  applicable state and local plumbing codes.
(d) Toilet facilities.
(1) Each salvage establishment shall provide
				  its employees with adequate and conveniently located toilet
				  facilities.
(2) Toilet facilities,
				  including rooms and fixtures, shall be kept in a clean condition and in good
				  repair at all times.
(3) The doors
				  of all toilet rooms shall be self-closing.
(4) Toilet tissue shall be
				  provided.
(5) Easily cleanable
				  receptacles shall be provided for waste materials, and such receptacles in
				  toilet rooms for women shall be covered.
(6) Where the use of non-water-carried sewage
				  disposal facilities are approved by the department, they shall be located at
				  least 100 linear feet from the salvage establishment and from any well or
				  stream.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.550 - General Provisions for Handling and Movement of Distressed Food

Current through Reg. 49, No. 28; July 12, 2024
(a) Notice to the
				  department.
(1) When the source of distressed
				  food is the result of a natural disaster, accident, power failure, or other
				  emergency, the salvage establishment or salvage broker shall make contact with
				  the department's Bureau of Food and Drug Safety within 24 hours after their
				  initial awareness of the emergency and prior to any removal of distressed food
				  from the place at which it was located when it became distressed.
(2) If emergency removal of distressed food
				  referenced in subsection (a)(1) of this section is required, notice to the
				  department shall be made as soon thereafter as possible. It shall be the duty
				  of the salvage establishment or salvage broker to make contact with the
				  department's Bureau of Food and Drug Safety within 48 hours whenever distressed
				  foods subject to the provisions of this subsection are obtained.
(3) Distressed food shall not be moved out of
				  the State of Texas without prior approval of the department and the responsible
				  state agency in the state to receive the food. Concurrence shall also be
				  obtained from the U.S. Food and Drug Administration, or U.S. Department of
				  Agriculture, Food Safety and Inspection Service, prior to interstate
				  movement.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.551 - Handling Distressed Food

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Good manufacturing practices. A person must follow and comply with the
				  requirements of §§
										229.211-
				  229.222
				  of this title (relating to Current Good Manufacturing Practice and Good
				  Warehousing Practice in Manufacturing, Packing, or Holding Human Food) in the
				  handling and reconditioning of all distressed and/or salvaged food.
(b) Perishable foods. All perishable foods
				  shall be kept at a temperature that will provide protection against
				  spoilage.
(c) Potentially hazardous
				  foods. All potentially hazardous foods shall be maintained at a safe
				  temperature, 41 degrees Fahrenheit (5 degrees Celsius) or below; 140 degrees
				  Fahrenheit (60 degrees Celsius) or above.
(d) Frozen Foods. Frozen foods shall be kept
				  frozen at all times.
(e) Distressed
				  or nonsalvageable food.
(1) All metal cans of
				  food offered for sale or distribution shall be essentially free from rust
				  (pitting) and dents (especially at rim, end double seams, and/or side
				  seams).
(2) Leakers, springers,
				  flippers, and swells shall be deemed unfit for sale or distribution.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.552 - Records

Current through Reg. 49, No. 28; July 12, 2024
(a) Inventory
				  records without department approved written Standard Operating Procedures
				  (SOPs). A written record or receipt of distressed, salvageable, and salvaged
				  food shall be maintained by the salvage establishment or salvage broker and
				  shall include:
(1) the common name including
				  brand name or manufacturer and quantity of the food received;
(2) the source of the distressed
				  food;
(3) the date
				  received;
(4) a brief description
				  of the type of damage (fire, flood, warehouse damage, overstock, etc.);
				  and
(5) the name of the individual
				  or business that purchases any such food for the purpose of sale or
				  distribution and the date of any such transaction.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.553 - Inspection

Current through Reg. 49, No. 28; July 12, 2024
(a) Inspection. To
				  enforce these sections of the 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 the place of
				  business of a salvage establishment or salvage broker;
(2) enter a salvage warehouse used to store
				  or hold distressed or salvaged food;
(3) enter a vehicle being used to transport
				  or hold distressed or salvaged food; or
(4) inspect at reasonable times, any place of
				  business of a salvage establishment or salvage broker, salvage warehouse, 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 AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.554 - Standard Operating Procedures

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Standard Operating Procedures. Each establishment should have and implement
				  written standard operating procedures (herein referred to as SOP) to ensure
				  conformance with conditions and practices as specified in this subchapter and
				  applicable §§
										229.211-
				  229.222
				  of this title (relating to Current Good Manufacturing Practice and Good
				  Warehousing Practice in Manufacturing, Packing, or Holding Human Food). The SOP
				  should specify how the establishment will meet these conditions and
				  practices.
(b) Monitoring of SOPs.
				  Each processor should monitor the conditions and practices described in the SOP
				  with sufficient frequency to ensure, at a minimum, conformance with conditions
				  and practices specified in this subchapter and applicable §§
										229.211-
				  229.222
				  of this title appropriate to the facility and that relate to the following:
(1) personnel practices and
				  training;
(2) construction and
				  maintenance of facilities;
(3)
				  sanitary controls;
(4)
				  transportation of distressed and/or reconditioned product;
(5) product evaluation and
				  reconditioning;
(6) disposal of
				  nonsalvageable food; and
(7)
				  records.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter AA - REGULATION OF FOOD SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.555 - Enforcement and Penalties

Current through Reg. 49, No. 28; July 12, 2024
(a) General
				  license actions. The department may deny, suspend, or revoke the license of an
				  applicant or licensee who fails to comply with any one of the following:
(1) failure to comply with the Act or these
				  sections;
(2) falsification of
				  information provided in an application for a license;
(3) refusal to allow the department to
				  conduct an inspection or collect samples;
(4) interference with the department in the
				  performance of its duties;
(5)
				  removal or disposal of a detained food in violation of the Texas Food, Drug,
				  and Cosmetic Act, Health and Safety Code, §
											431.021;
				  or
(6) failure to information the
				  department of any salvage warehouse(s) at the time of an inspection or when
				  requested by the department.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.571 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
These sections provide for the licensing and regulation of
					 drug salvage establishments and brokers in order to prevent the sale or
					 distribution of adulterated or misbranded drugs to consumers.