reglab/statecodes huggingface dataset:
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 229.572 - 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, foods, or cosmetics must comply with the
				  applicable requirements in Subchapter AA of this chapter (relating to
				  Regulation of Food 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
				  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;
(4) 21 Code of
				  Federal Regulations (CFR), Part 205, §§205.1 - 205.50, titled
				  "Guidelines for State Licensing of Wholesale Prescription Drug Distributors,"
				  as amended;
(5) 21 CFR Part 210,
				  §§210.1 - 210.3, titled "Current Good Manufacturing, Processing,
				  Packing, or Holding of Drugs" as amended, and §§211.1 - 211.208,
				  titled "Current Good Manufacturing Practice for Finished Pharmaceuticals" as
				  amended.
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 229.573 - 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 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
				  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'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--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 manor 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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.574 - 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 drug 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 drugs to a person who is exempt under this
				  section or to a currently licensed salvage broker or salvage operator;
				  or
(3) a person who transfers
				  distressed drugs to a licensed salvage broker or salvage operator.
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 229.575 - Licensing Requirements and Procedures

Current through Reg. 49, No. 28; July 12, 2024
(a) General. Except as provided by §
										229.574
				  of this title (relating to Exemptions and Applicability), it shall be unlawful
				  for any person to operate a salvage establishment or operate as a salvage
				  broker within the State of Texas, who does not possess a current and valid
				  license issued by the department.
(b) Licensing of out-of-state salvage
				  establishments and brokers. A person who operates a salvage establishment or
				  acts as a salvage broker outside this state may not sell, distribute, or
				  otherwise traffic in distressed or salvaged food, drugs, devices, or cosmetics
				  within this state unless the person holds a license from the
				  department.
(c) Reports from other
				  jurisdictions. The department may accept reports from authorities in other
				  jurisdictions to determine the extent of compliance with these sections and
				  with the provisions of the Act.
(d)
				  New place of business. Each person acquiring or establishing a place of
				  business for the purpose of operating a salvage establishment or operating as a
				  salvage broker shall apply for and obtain a license of such business prior to
				  beginning operations.
(e) Two or
				  more places of business. If the salvage establishment or salvage broker
				  operates more than one place of business, the salvage establishment or salvage
				  broker shall license each place of business separately.
(f) License application. 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.
(g) Contents of license application. The
				  salvage establishment or salvage broker license application shall be signed and
				  verified, submitted on a license application form furnished by the department,
				  and shall include 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 the place of business to
				  be licensed and the mailing address if different;
(3) the address of any salvage warehouse used
				  by a salvage establishment or salvage broker;
(4) if a sole proprietorship, the name of the
				  proprietor; if a partnership, the names of all partners; if a corporation, the
				  names and titles of all officers; in any other association, those in a
				  managerial capacity; and
(5) a
				  statement signed and verified by the sole proprietor, managing partner,
				  corporate officer, or person in a managerial capacity for an association that
				  acknowledges the applicant has read, understood, and agrees to abide by the
				  provisions of these sections and those of the Act.
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 229.576 - 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. The 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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.577 - 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
				  communicable disease, 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 when
				  there is any possibility of such person contaminating salvageable or salvaged
				  drugs with pathogenic organisms, or transmitting disease to other
				  individuals.
(b) Personal
				  cleanliness.
(1) All personnel while working
				  in direct contact with salvageable drugs or while engaged in reconditioning,
				  repacking, or otherwise handling any ingredients or components of salvageable
				  drugs 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 drugs 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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.578 - 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 drugs are 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 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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.579 - 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 and 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) All toilet
				  room doors shall be self-closing.
(4) Toilet tissue shall be
				  provided.
(5) Easily cleanable
				  covered receptacles shall be provided for waste materials in all toilet
				  rooms.
(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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.580 - General Provisions for Handling and Movement of Distressed Drugs

Current through Reg. 49, No. 28; July 12, 2024
(a) Notice to the
				  department.
(1) When the source of distressed
				  drugs 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 within 24 hours after their initial awareness of the emergency
				  and prior to any removal of distressed drugs from the place at which it was
				  located when it became distressed.
(2) If emergency removal of distressed drugs
				  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 within 48 hours whenever distressed drugs subject to the provisions
				  of this subsection are obtained.
(3) Distressed drugs referenced in this
				  subsection 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
				  drugs. 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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.581 - Handling Distressed Drugs

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Good manufacturing practices. A person must follow and comply with the
				  requirements in 21 CFR, Parts 205, §§205.1 - 205.50, titled
				  "Guidelines for State Licensing of Wholesale Prescription Drug Distributors,"
				  as amended, 21 CFR Part 210, §§210.1 - 210.3, titled "Current Good
				  Manufacturing, Processing, Packing, or Holding of Drugs" as amended, and
				  §§211.1 - 211.208, titled "Current Good Manufacturing Practice for
				  Finished Pharmaceuticals" as amended, in the handling and reconditioning of all
				  salvaged drugs.
(b) Distressed or
				  nonsalvageable drugs. All distressed or nonsalvageable drugs shall be disposed
				  of in accordance with §
										229.579(f)
				  of this title (relating to Sanitary Facilities and Controls).
(c) Relabeling. All salvaged drugs in
				  containers shall be provided with labels meeting the requirements in §
										229.580(i)
				  of this title (relating to General Provisions for Handling and Movement of
				  Distressed Drugs). When original labels are removed from containers that are to
				  be resold or redistributed, the replacement labels must show the name and
				  address of the salvage establishment.
(d) Procedures. All salvage establishments
				  shall have written procedure for identifying and retrieving over-the-counter
				  and prescription drug products that are subject to recall.
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 229.582 - Records

Current through Reg. 49, No. 28; July 12, 2024
(a) Inventory
				  Records. A written record or receipt of distressed, salvageable, and salvaged
				  drugs shall be maintained by the salvage establishment or salvage broker and
				  shall include:
(1) the common name and brand
				  name or manufacturer and quantity of the drugs received;
(2) the source of the distressed,
				  salvageable, and salvaged drugs;
(3) the date received;
(4) a brief description of the type or cause
				  of damage (fire, flood, wreck, prolonged storage, warehouse damage, etc.);
				  and
(5) the name of the individual
				  or business that purchases any such drugs 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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.583 - Inspection

Current through Reg. 49, No. 28; July 12, 2024
(a) Inspection. To
				  enforce these sections or 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 drug;
(3) enter a vehicle being used to transport
				  or hold distressed or salvaged drug; 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 BB - REGULATION OF DRUG SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.584 - 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 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) refuses to allow the department to
				  conduct an inspection or collect samples;
(4) interferes with the department in the
				  performance of its duties;
(5)
				  removes or disposes of a detained drugs in violation of the Texas Food, Drug,
				  and Cosmetic Act, Health and Safety Code, §
											431.021;
				  or
(6) fails to inform 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 CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.601 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
These sections provide for the licensing and regulation of
					 device salvage establishments and brokers to prevent the sale or distribution
					 of adulterated or misbranded devices to consumers.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.602 - 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 food, drugs, or cosmetics must comply with the applicable
				  requirements in Subchapter AA of this chapter (relating to Regulation of Food
				  Salvage Establishments and Brokers), Subchapter BB of this chapter (relating to
				  Regulation of Drug 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) Fair Packaging and
				  Labeling Act, 15 United States Code (U.S.C.), §1451 et seq., as
				  amended;
(2) Federal Food, Drug,
				  and Cosmetic Act,
				  21
				  U.S.C., §301 et seq., as
				  amended;
(3)
											§501(c)(3),
				  Internal Revenue Code of 1986, as amended;
(4) 21 Code of Federal Regulations (CFR),
				  Part 801, as amended;
(5) 21 CFR,
				  Subchapter J, Radiological Health, as amended; and
(6) 21 CFR, Part 820, Quality System
				  Regulation, as amended.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.604 - 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 or distributor of a device
				  who in the normal course of business engages in the activities of
				  reconditioning the device manufactured or distributed by or for that person and
				  not purchased by that person solely for the purpose of reconditioning and
				  sale;
(2) a person who is a common
				  carrier or the common carrier's agent, who disposes of or otherwise transfers
				  an undamaged or distressed device to a person who is exempt under this section
				  or to a licensed salvage broker or salvage operator; or
(3) a person who transfers a distressed
				  device to a licensed salvage broker or salvage operator.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.606 - 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 license fee. All fees are nonrefundable. The 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 CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.607 - 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 devices with pathogenic organisms, or transmitting
				  disease to other individuals.
(b)
				  Personal cleanliness.
(1) All personnel while
				  working in direct contact with salvageable devices or while engaged in
				  reconditioning, repacking, or otherwise handling any components or accessories
				  of salvageable devices 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 devices 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 CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.608 - 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 devices are stored or
				  processed and in which tools or equipment 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 CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.609 - 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 personnel 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 CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.610 - General Provisions for Handling and Movement of Distressed Devices

Current through Reg. 49, No. 28; July 12, 2024
(a) Notice to the
				  department.
(1) When the source of distressed
				  devices 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
				  devices from the place at which it was located when it became
				  distressed.
(2) If emergency
				  removal of distressed devices referenced in subsection (a)(1) 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 devices subject to the provisions of this subsection are
				  obtained.
(3) Distressed devices
				  referenced in subsection (a)(1) shall not be moved out of the State of Texas
				  without the prior approval of the department and the responsible state agency
				  in the state to receive the devices. Concurrence shall also be obtained from
				  the U.S. Food and Drug Administration prior to interstate movement.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.611 - Reconditioning Distressed Devices

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Salvageable devices. All salvageable devices shall be reconditioned prior to
				  sale or distribution except for such sale or distribution to a person holding a
				  valid license to engage in a salvage operation or as provided for in subsection
				  (o) of this section.
(b)
				  Reconditioned devices. All reconditioned devices must be in compliance with the
				  Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter
				  431.
(c) General labeling. All
				  salvaged devices must be labeled in accordance with the requirements of the
				  Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431; the
				  Federal Food, Drug, and Cosmetic Act,
				  21
				  U.S.C., §301 et seq., as amended; the
				  Fair Packaging and Labeling Act,
				  15 U.S.C.,
				  §1451 et seq., as amended; and the
				  federal regulations promulgated under those Acts.
(d) Reconditioned Labeling. In addition to
				  the general labeling requirements found in subsection (c) of this section, all
				  reconditioned devices shall be labeled with the statement "Reconditioned by
				  (name and business address of the salvage establishment responsible for the
				  reconditioning of the device)."
(e)
				  Salvage warehouses. A person may not use a salvage warehouse to recondition
				  devices or sell to consumers.
(f)
				  Personnel. Each salvage establishment that engages in the reconditioning of
				  devices shall have sufficient personnel with the necessary education,
				  background, training, and experience to assure that all reconditioning
				  activities are correctly performed. With the exception of class I exempt
				  devices, training of personnel engaged in the reconditioning of class I, II, or
				  III devices shall be documented.
(g) Operating procedures. Each salvage
				  establishment that engages in the reconditioning of devices shall establish,
				  maintain, and implement written procedures for identifying devices during all
				  stages of receipt, reconditioning, distribution, and installation to prevent
				  mixups.
(h) Inspection, measuring,
				  and test equipment.
(1) Each salvage
				  establishment that engages in the reconditioning of devices shall ensure that
				  all inspection, measuring, and test equipment used in the reconditioning of
				  devices is:
(A) suitable for its intended
				  purpose and capable of producing valid results; and
(B) routinely calibrated, inspected, checked,
				  and maintained.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.612 - Records

Current through Reg. 49, No. 28; July 12, 2024
(a) Inventory
				  Records. A written record or receipt of all distressed, salvageable, and
				  salvaged devices shall be maintained by the salvage establishment or salvage
				  broker and shall include:
(1) the common
				  name, the brand name or manufacturer, and quantity of the device
				  received;
(2) the source of the
				  distressed device;
(3) the date
				  received;
(4) a brief description
				  of the type or cause of damage (fire, flood, wreck, prolonged storage,
				  warehouse damage, etc.);
(5) the
				  name of the individual or business that purchases any such device for the
				  purpose of sale or distribution and the date of any such transaction;
				  and
(6) the date and final
				  disposition of the device (reconditioned, unreconditioned, destroyed,
				  etc.).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.613 - Inspection

Current through Reg. 49, No. 28; July 12, 2024
(a) Inspection. To
				  enforce these sections or the Act, the commissioner or an authorized agent 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 devices;
(3) enter a vehicle being used to transport
				  or hold distressed or salvaged devices; 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 CC - REGULATION OF DEVICE SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.614 - 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 inform 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 DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.631 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
These sections provide for the licensing and regulation of
					 cosmetic salvage establishments and brokers in order to prevent the sale or
					 distribution of adulterated or misbranded cosmetics to
					 consumers.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.632 - 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 food, drugs, or devices must comply with the applicable
				  requirements in Subchapter AA of this chapter (relating to Regulation of Food
				  Salvage Establishments and Brokers), Subchapter BB of this chapter (relating to
				  Regulation of Drug Salvage Establishments and Brokers), and Subchapter CC of
				  this chapter (relating to Regulation of Device Salvage Establishments and
				  Brokers).
(b) The Department of
				  State Health Services (department) adopts by reference the following federal
				  laws and regulations:
(1) Fair Packaging and
				  Labeling Act, 15 United States Code (U.S.C.), §1451 et seq. as
				  amended;
(2) Federal Food, Drug,
				  and Cosmetic Act,
				  21
				  U.S.C., §301 et seq. as
				  amended;
(3)
											§501(c)(3),
				  Internal Revenue Code of 1986, as amended;
(4) 21 Code of Federal Regulations (CFR),
				  Parts 701 & 740, as amended;
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.633 - 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 cosmetic--Has
				  the meaning specified in the Texas Food, Drug, and Cosmetic Act, Health and
				  Safety Code, Chapter 431, §431.141.
(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'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--The
				  Commissioner of Health or his successor.
(6) Cosmetic--Any article or substance
				  intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or
				  otherwise applied to the human body for cleansing, beautifying, promoting
				  attractiveness, or altering appearances; or an article or substance for use as
				  a component of such an article, except that the term does not include
				  soap.
(7) Cosmetic
				  manufacturer--Includes a person who represents himself as responsible for the
				  purity and proper labeling of a cosmetic.
(8) Department--The Department of State
				  Health Services.
(9) 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 DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.634 - 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 or distributor of a
				  cosmetic who in the normal course of business engages in the activities of
				  reconditioning the cosmetic manufactured or distributed by or for that person
				  and not purchased by that person solely for the purpose of reconditioning and
				  sale;
(2) a person who is a common
				  carrier or a common carrier's agent, who disposes of or otherwise transfers an
				  undamaged or distressed cosmetic to a person who is exempt under this section
				  or to a currently licensed salvage broker or salvage operator; or
(3) a person who transfers a distressed
				  cosmetic to a licensed salvage broker or salvage operator.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.636 - 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 license fee. All fees are nonrefundable. The 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 DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.637 - 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
				  communicable disease, 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 when
				  there is any possibility of such person contaminating salvageable or salvaged
				  cosmetics with pathogenic organisms, or transmitting disease to other
				  individuals.
(b) Personal
				  cleanliness.
(1) All personnel while working
				  in direct contact with salvageable cosmetics or while engaged in
				  reconditioning, repacking, or otherwise handling any components or accessories
				  of salvageable cosmetics 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 cosmetics 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 DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.638 - 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 cosmetics are stored or
				  processed and in which tools or equipment 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 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 DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.639 - 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 and 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 personnel 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) All toilet
				  rooms shall be self-closing.
(4)
				  Toilet tissue shall be provided.
(5) Easily cleanable covered receptacles
				  shall be provided for waste materials in all toilet rooms.
(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 DD - REGULATION OF COSMETIC SALVAGE ESTABLISHMENTS AND BROKERS › Section 229.640 - General Provisions for Handling and Movement of Distressed Cosmetics

Current through Reg. 49, No. 28; July 12, 2024
(a) Notice to the
				  department.
(1) When the source of distressed
				  cosmetics 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 within 24 hours after their initial awareness of the
				  emergency and prior to any removal of distressed cosmetics from the place at
				  which it was located when it became distressed.
(2) If emergency removal of distressed
				  cosmetics 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 within 48 hours whenever distressed cosmetics subject to the
				  provisions subsection (a)(1) of this section are obtained.
(3) Distressed cosmetics referenced in this
				  subsection 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
				  cosmetics. Concurrence shall also be obtained from the U.S. Food and Drug
				  Administration prior to interstate movement.