reglab/statecodes huggingface dataset:
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter B - DONATION OF UNUSED DRUGS › Section 229.22 - Donation of Drugs to Charitable Medical Clinics

Current through Reg. 49, No. 28; July 12, 2024
A charitable medical clinic may receive a drug donated by a
					 charitable drug donor for dispensing to a patient of the charitable medical
					 clinic, provided that the following requirements are met.
(1) The charitable drug donor must be
				  licensed with the department as a wholesale drug distributor. Manufacturers who
				  participate in a patient assistance program and physicians who donate samples
				  will not be required to license with the department.
(2) The donated drugs must be dangerous drugs
				  as defined in Health and Safety Code, Chapter 483, entitled "Texas Dangerous
				  Drug Act."
(3) Donated drugs may
				  not be controlled substances as defined in Health and Safety Code, Chapter 481,
				  entitled "Texas Controlled Substances Act."
(4) All donated drugs must be approved by the
				  Food and Drug Administration (FDA) and intended for human use.
(5) Donation of drug samples must comply with
				  Title 21, Code of Federal Regulations (CFR), §203.39.
(6) Previously dispensed drugs shall not be
				  donated.
(7) The charitable drug
				  donor must verify that the requesting charity is legitimate.
(A) Verification shall include copies of
				  documents proving the charitable medical clinic's status as exempt from federal
				  income tax; address, telephone number, and name of contact person at the
				  charitable medical clinic.
(B)
				  Documentation of verification must be retained by the charitable drug donor for
				  three years.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter B - DONATION OF UNUSED DRUGS › Section 229.23 - Donation of Drugs From Nursing Homes to Foreign Countries

Current through Reg. 49, No. 28; July 12, 2024
A nursing home may donate certain drugs or drug samples,
					 due for destruction, to a foreign country provided the following requirements
					 are met.
(1) The drugs to be donated
				  are in the manufacturer's unopened original tamper-evident packaging with its
				  labeling intact.
(2) Previously
				  dispensed drugs shall not be donated.
(3) Controlled substances as defined in
				  Health and Safety Code, Chapter 481, entitled "Texas Controlled Substances
				  Act," shall not be donated.
(4) A
				  drug shall not be shipped to a foreign country until it has been examined by a
				  registered pharmacist at the nursing home to confirm, in his or her
				  professional judgment, that it is not adulterated or misbranded for any reason
				  including, but not limited to, the following:
(A) the drug is out of date;
(B) the labeling has become mutilated,
				  obscured, or detached from the drug packaging;
(C) the drug shows evidence of having been
				  stored or shipped under conditions that might adversely affect its stability,
				  integrity, or effectiveness;
(D)
				  the drug has been recalled or is no longer marketed; or
(E) the drug is otherwise possibly
				  contaminated, deteriorated, or adulterated.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter B - DONATION OF UNUSED DRUGS › Section 229.24 - Dispensing of Drugs From Charitable Medical Clinics

Current through Reg. 49, No. 28; July 12, 2024
All charitable medical clinics (including licensed
					 pharmacies that are a community pharmaceutical access program provider as
					 defined at §
										229.21(3)
					 of this title (relating to Definitions) shall comply with the laws and rules
					 pertaining to dispensing of prescription drugs as contained in the Occupations
					 Code, Chapters 551- 566, and 569 (relating to the Texas Pharmacy Act); and 22
					 Texas Administrative Code, Chapters 281- 311 (relating to the Texas State Board
					 of Pharmacy).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter B - DONATION OF UNUSED DRUGS › Section 229.25 - Minimum Requirements for Licensing as a Charitable Drug Donor

Current through Reg. 49, No. 28; July 12, 2024
(a) All charitable
				  drug donors in Texas shall obtain a wholesale drug distributor license annually
				  with the department.
(b) Charitable
				  drug donors are exempt from the license fee, but otherwise are subject to and
				  must comply with the requirements of this chapter.
(c) If the United States Food and Drug
				  Administration (FDA) determines, with respect to a product that is a
				  combination of a drug and a device that the primary mode of action of the
				  product is as a drug, a person who engages in donation of the product is
				  subject to licensing as described in this section.
(d) License forms. License application forms
				  may be obtained from the department at 1100 West 49th Street, Austin, Texas
				  78756 or online at http://www.dshs.state.tx.us/license.shtm.
(e) License statement. The charitable drug
				  donors' licensing statement shall be signed and verified by the owner, partner,
				  president, or corporate designee (authorized person), shall be made on the
				  department furnished license form, and shall contain the following information:
(1) the legal 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; or if
				  any other type of association, then the names of the principals of such
				  association;
(4) the names,
				  residence addresses, and valid driver's license of those individuals 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; and
(5) for each place
				  of business, the residence addresses of the individuals in charge
				  thereof.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter B - DONATION OF UNUSED DRUGS › Section 229.26 - Enforcement - Refusal, Revocation, or Suspension of License

Current through Reg. 49, No. 28; July 12, 2024
(a) The department may, after providing an
				  opportunity for a hearing, refuse to license a charitable drug donor, or may
				  revoke or suspend the license for violations of the requirements in
				  §§
										229.21-
				  229.25
				  of this title (relating to Donation of Unused Drugs), §
										229.251
				  and §
										229.429
				  of this title (relating to Minimum Standards for Licensure), and for violations
				  of Health and Safety Code, Chapter 431, including §431.021 (prohibited
				  acts).
(b) Hearing. Any hearing for
				  the refusal, revocation, or suspension of a license is governed by the
				  department's formal hearing procedures in Chapter 1 of this title (relating to
				  Texas Board of Health) and the Government Code, Chapter 2001, Administrative
				  Procedure Act.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter C - PURCHASE OF DOMESTIC BEEF › Section 229.31 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
The following words and terms, when used in this chapter,
					 shall have the following meanings, unless the context clearly indicates
					 otherwise:
(1) Products consisting
				  substantially of beef--A meat food product consisting of 5.0% or more of beef,
				  and/or having visible beef of any quantity, shall be considered as consisting
				  substantially of beef and hereinafter referred to as beef product.
(2) State agency--Any agency, department,
				  board, or commission of the state or any state eleemosynary, educational,
				  rehabilitative, correctional, or custodial facility.
(3) Subdivision--Any county, incorporated
				  city, or town, or any school, junior-college, water, hospital, reclamation, or
				  other special-purpose district.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter C - PURCHASE OF DOMESTIC BEEF › Section 229.32 - Records

Current through Reg. 49, No. 28; July 12, 2024
(a) Purchasing
				  officials of state agencies and subdivisions shall require affidavits or
				  certification by the vendor that the beef or beef product purchased is not
				  imported from outside the United States of America.
(1) Such affidavits or certification shall
				  have attached an affidavit or certification from each previous buyer or seller
				  of the beef product sold to the state agency or subdivision stating that each
				  beef product was derived exclusively from domestic beef.
(2) Where the beef product is canned, an
				  attached affidavit or certification from the packer or manufacturer of the beef
				  product stating that such beef product was derived exclusively from domestic
				  beef shall constitute compliance with paragraph (1) of this
				  subsection.
(3) The vendor
				  affidavits or certification shall include a statement that the beef product
				  sold and delivered is that to which the attached affidavit(s) or
				  certification(s) refer.
(4) The
				  affidavits or certification required of the vendor by this section may be
				  contained within a signed bid under circumstances where a bid is
				  required.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter C - PURCHASE OF DOMESTIC BEEF › Section 229.33 - Reporting Violations

Current through Reg. 49, No. 28; July 12, 2024
State agencies and subdivisions having cause to believe
					 beef and/or beef products purchased and delivered are not in compliance with
					 the requirements of Texas Civil Statutes Article 4476-3(b), and these
					 regulations, shall immediately and any other individual may report the same to
					 the Division of Food and Drugs, Bureau of Consumer Health Protection, Texas
					 Department of Health Resources, 1100 West 49th Street, Austin, Texas 78756,
					 giving full particulars.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter D - REGULATION OF COSMETICS › Section 229.40 - Purpose

Current through Reg. 49, No. 28; July 12, 2024
(a) These sections
				  set forth the requirements for the sale of cosmetics in this state.
(b) A "cosmetic" means articles intended to
				  be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise
				  applied to the human body or any part of the human body for cleaning,
				  beautifying, promoting attractiveness, or altering the appearance, and articles
				  intended for use as a component of those articles. The term does not include
				  soap.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter D - REGULATION OF COSMETICS › Section 229.41 - 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 700, General, as amended;
(3)
				  21 CFR, Part 701, Cosmetic Labeling, as amended; and
(4) 21 CFR, Part 740, Cosmetic Product
				  Warning Statements, as amended.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.82 - Sampling

Current through Reg. 49, No. 28; July 12, 2024
Bottled water must be sampled in accordance with the
					 compliance procedures of Title 21, Code of Federal Regulations, Part 129. All
					 required analyses must be performed by a laboratory acceptable to the
					 department, certified by the U.S. Environmental Protection Agency (EPA), or
					 certified by the primacy enforcement authority in any state which has been
					 granted primacy by EPA or certified by a third party organization acceptable to
					 a primacy state.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.83 - Water Hauling

Current through Reg. 49, No. 28; July 12, 2024
(a) Water that is
				  distributed by truck or trailer in lieu of distribution piping, shall comply
				  with the Health and Safety Code, Chapter 431, Subchapter C, concerning drinking
				  water standards and rules adopted thereunder by the Texas Commission on
				  Environmental Quality, 30 Texas Administrative Code (TAC),
				  §§290.44(i) (relating to Water Distribution).
(b) A person receiving water transported by
				  truck or trailer shall test and record the chlorine residual for compliance
				  with the required minimum chlorine residual (30 TAC, §
										290.44(i)(2)(K)).
(c) Operational records detailing the amount
				  of water received, the source of the water, and the chlorine residual readings,
				  shall be maintained by the person receiving water that has been transported by
				  truck or trailer. The records shall be kept at the receiving facility for a
				  period of two years and be available for inspection upon request.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.84 - Standards for Microbiological Control

Current through Reg. 49, No. 28; July 12, 2024
Bottled and vended water production including transporting,
					 processing, packaging, and storage, shall be conducted under such standards and
					 controls as are necessary to minimize the potential for microbiological
					 contamination of the finished product. These standards and controls shall
					 include the following.
(1) Bottled and
				  vended water shall be subject to effective germicidal treatment by ozonation,
				  chlorination, exposure to ultraviolet light, or other equivalent disinfection
				  approved by the department.
(2)
				  Bottled and vended water shall not be transported or stored in bulk tanks or
				  processed through equipment or lines used for any non-food product.
(3) In order to minimize the potential for
				  microbiological contamination of the finished product, non-carbonated bottled
				  water shall not be transported, stored, processed, or bottled in or through
				  lines through which has passed milk, fruit juice, or other food products likely
				  to contribute nutrients for microbial growth. However, multifood fillers may be
				  used for the filling of bottled water as long as the fillers are properly
				  cleaned and sanitized prior to the bottling of water, and provided that they
				  are in compliance with Title 21, Code of Federal Regulations, §129.80. Any
				  parts which are not designed to be cleaned-in-place shall be disassembled and
				  removed, and shall be cleaned and sanitized prior to reassembly.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.85 - Labeling and Advertising

Current through Reg. 49, No. 28; July 12, 2024
(a) Claims of
				  medicinal and health-giving properties shall not be placed on labels and
				  references shall not be made to bacterial purity or to laboratory examinations
				  which may have been made by department laboratories.
(b) The label must state the source of all
				  artesian water, spring water, mineral water, well water, or drinking water
				  sold. Source refers to the point of origin. Examples: Brook Hollow Spring Water
				  from Buck Hollow, Arkansas; drinking water obtained from Austin municipal water
				  supply, Austin, Texas; well water from Bandera, Texas. Except that water
				  processed by distillation, deionization, reverse osmosis, or other suitable
				  process that alters the water's physical properties enabling it to meet the
				  definition of purified as defined in §
										229.81(c)(11)
				  of this title (relating to General Provisions) is not required to state the
				  source. This exception only applies if all the water used in the finished
				  product is processed to meet the definition of purified.
(c) Other label statements.
(1) If the Total Dissolved Solids (TDS)
				  content of Mineral water is below 500 ppm, or if it is greater than 1,500 ppm,
				  the statement "low mineral content" or the statement "high mineral content,"
				  respectively, shall appear on the principal display panel following the
				  statement of identity in type size at least one-half the size of the statement
				  of identity but in no case less that one-sixteenth of an inch. If the TDS of
				  mineral water is between 500 and 1,500 ppm, no additional statement need
				  appear.
(2) When the label or
				  labeling of a bottled water product states or implies (e.g., through label
				  statements or vignettes with reference to infants) that the bottled water is
				  for use in feeding infants, and the product is not commercially sterile, the
				  product label shall bear conspicuously and on the principal display panel the
				  statement "Not sterile. Use as directed by physician or by labeling directions
				  for use of infant formula."
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.86 - Processing of Vended Water

Current through Reg. 49, No. 28; July 12, 2024
(a) Water
				  dispensing device requirements are as follows.
(1) Any device from which any operator or
				  consumer dispenses servings of water in bulk shall comply with Title 21, Code
				  of Federal Regulations (CFR), §129.40, Equipment and Procedures, and
				  §165.110, Requirements for Specific Standardized Beverages. Except
				  §129.40, the provision pertaining to the cleaning, sanitizing, filling,
				  and capping or sealing of containers shall not apply to containers furnished by
				  the consumer.
(2) Water dispensing
				  devices shall:
(A) be designed and
				  constructed to permit thorough cleaning, sanitization, and maintenance of all
				  exterior and interior surfaces and component parts;
(B) have all parts and surfaces that come
				  into contact with the water constructed of corrosion-resistant, and
				  nonabsorbent material acceptable to the department and capable of withstanding
				  repeated cleaning and sanitizing treatment;
(C) be designed so all treatment of the water
				  by distillation, ion-exchange, filtration, ultraviolet light, reverse osmosis,
				  mineral addition, or any other acceptable process is done in an effective
				  manner;
(D) have an effective
				  system of collection and handling of drip, spillage, and overflow of
				  water;
(E) have a backflow
				  prevention device approved by the department or local authority for all
				  connections with the water supply;
(F) disinfect water by ultraviolet light or
				  other method approved by the department immediately prior to delivery into the
				  customer's container;
(G) comply
				  with the American Water Works Association (AWWA) specifications for granular
				  activated carbon if used in the treatment of potable water (AWWA
				  B604-74);
(H) be maintained in a
				  clean and sanitary condition; and
(I) be free from dirt and vermin.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.87 - Requirements for Approved Sources

Current through Reg. 49, No. 28; July 12, 2024
Sources in Texas shall comply with the following
					 requirements.
(1) Public water
				  systems. Sources in Texas which are public water systems shall comply with the
				  Texas Health and Safety Code, Chapter 341, Subchapter C, concerning drinking
				  water standards and rules adopted by the Texas Commission on Environmental
				  Quality, at 30 Texas Administrative Code (TAC), §§290.101 - 290.122
				  (relating to Drinking Water Standards Governing Drinking Water Quality and
				  Reporting Requirements for Public Water Supply Systems), and §§290.38
				  - 290.47 (relating to Rules and Regulations for Public Water
				  Systems).
(2) Other sources. Any
				  other sources in Texas shall comply with 30 TAC §§
										290.101-
				  290.121
				  concerning drinking water standards, and 30 TAC §§
										290.38-
				  290.43
				  and
				  290.46concerning
				  rules and regulations for public water systems, except where variances are
				  permitted in §
										229.81 of this
				  title (relating to General Provisions).
(3) Compliance with these sections is
				  required as if the source were a public water system.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.88 - Certificates of Competency

Current through Reg. 49, No. 28; July 12, 2024
A person may not furnish bottled or vended water to the
					 public or for distribution to the public unless the bottled or vended water
					 operator holds a certificate under this chapter.
(1) A person may not furnish bottled water to
				  the public or for distribution to the public unless the processing, bottling
				  and distribution of the bottled water is performed by or under the full-time
				  supervision of a bottled and vended water operator who holds a certificate
				  under this chapter.
(2) A person
				  may not furnish vended water to the public or for distribution to the public
				  unless the processing, bottling and distribution of the vended water is
				  performed by or under the guidance and control of a bottled and vended water
				  operator who holds a certificate under this chapter.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.89 - Examination

Current through Reg. 49, No. 28; July 12, 2024
(a) After payment
				  of the required fee, an applicant shall pass a written examination prescribed
				  by the department. To pass the examination for a certificate, the applicant
				  must achieve a score of 70% or more on the examination.
(1) The examination must be taken within 90
				  days of the date the department receives the fee. If the 90-day time frame
				  lapses without the applicant taking the examination, the applicant must submit
				  a new application and fee in order to take the examination.
(2) If the applicant fails the examination,
				  the applicant may repeat the examination 30 days after the failed examination.
				  The applicant must reapply and pay a re-application fee of $50.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.90 - Certification and Renewal Fees

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  This subsection applies to all new and renewal applications.
(1) Certification fee--$100.
(2) Renewal fee--$100.
(3) A certificate can be obtained by
				  submitting an application with the $100 certification fee and receiving a
				  passing score on the examination. Certificates can be renewed by submitting a
				  completed application with the $100 renewal fee. Certificates are valid for two
				  years from the date of issuance or renewal. Certificates expire two years from
				  the date of issuance. Fees will not be prorated. If the department has not
				  received a completed application for renewal within 60 days following the
				  expiration date, the certificate holder shall submit a new application and
				  retake the examination.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter F - PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER › Section 229.91 - Suspension, Denial, or Revocation of Certificate

Current through Reg. 49, No. 28; July 12, 2024
(a) Basis for suspension. The certificate
				  shall be suspended if the operator practices fraud or deceit against the
				  department or the public; or fails to use reasonable care, judgment or
				  application of knowledge in the performance of their duties.
(b) Basis for denial. The certificate shall
				  be denied if it is found:
(1) that the
				  application is incomplete or false;
(2) that the operator obtained the
				  certificate through fraud or deceit; or
(3) that the operator practiced fraud or
				  deceit; or failed to use reasonable care, judgment or application of knowledge
				  in the performance of their duties.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter G - MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE › Section 229.111 - General Provisions

Current through Reg. 49, No. 28; July 12, 2024
These sections supplement §§
										229.181-
					 229.184
					 of this title (relating to Licensure of Food Manufacturers and Food Wholesalers
					 - Including Good Manufacturing Practices and Good Warehousing Practices in
					 Manufacturing, Packing and Holding Human Food) and §§
										229.211-
					 229.222
					 of this title (relating to Current Good Manufacturing Practice and Good
					 Warehousing Practice in Manufacturing, Packing or Holding Human
					 Food).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter G - MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE › Section 229.112 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
The following words and terms, when used in these sections,
					 have the following meanings unless the context clearly indicates
					 otherwise.
(1) Approved laboratory--An
				  approved laboratory is one which is acceptable to the department, certified by
				  the U.S. Environmental Protection Agency (EPA) or certified by the primacy
				  enforcement authority in any state which has been granted primacy by EPA or
				  certified by a third party organization acceptable to a primacy
				  state.
(2) Approved source (when
				  used in reference to a plant's product water or operations water)--A source of
				  water and the water there from, whether it be from a spring, artesian well,
				  drilled well, municipal water supply or any source, that has been inspected and
				  the water sampled, analyzed and found to be safe and sanitary quality according
				  to applicable laws and regulations of State and local government agencies
				  having jurisdiction. The presence in the plant of current certificates or
				  notifications of approval from the government agency or agencies having
				  jurisdiction constitutes approval of the source and the water supply.
(3) Department--Department of State Health
				  Services (DSHS).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter G - MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE › Section 229.113 - Source Water

Current through Reg. 49, No. 28; July 12, 2024
(a) Requirements
				  for approved source. Sources in Texas shall comply with the following
				  requirements:
(1) Public water systems.
				  Sources in Texas which are public water systems shall comply with the Texas
				  Health and Safety Code, Chapter 341, Subchapter C, concerning drinking water
				  standards and rules adopted by the Texas Commission for Environmental Quality,
				  at 30 Texas Administrative Code (TAC), §§290.101 - 290.122 (relating
				  to Drinking Water Standards Governing Drinking Water Quality and Reporting
				  Requirements for Public Water Supply Systems), and 30 TAC, §§
											290.38-
				  290.47
				  (relating to Rules and Regulations for Public Water Systems);
(2) Other sources. Any other sources in Texas
				  shall comply with 30 TAC, §§
											290.101-
				  290.122
				  concerning drinking water standards and 30 TAC, §§
											290.38-
				  290.43
				  and §
											290.46concerning
				  rules and regulations for public water systems.
(3) Compliance with these sections is
				  required as if the source were a public water system.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter G - MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE › Section 229.114 - Labeling of Packaged Ice

Current through Reg. 49, No. 28; July 12, 2024
(a) Packaged
				  ice shall be labeled according to Health and Safety Code, Chapter 431, and
				  Title 21, Code of Federal Regulations, Part 101, Food Labeling.
(b) Label information shall include:
(1) the common name of the food;
(2) the accurate declaration of the net
				  weight; and
(3) the name and place
				  of business of the manufacturer, packer, or distributor.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter G - MANUFACTURE, STORAGE, AND DISTRIBUTION OF ICE SOLD FOR HUMAN CONSUMPTION, INCLUDING ICE PRODUCED AT POINT OF USE › Section 229.115 - Ice Equipment

Current through Reg. 49, No. 28; July 12, 2024
(a) Ice equipment.
				  Equipment used in ice plants or as part of the facilities producing ice at
				  point of use including, but not limited to, portable can fillers, core sucking
				  devices, drop tubes, tank lids, ice cans, ice manufacturing and ice dispensers
				  shall be handled and maintained in such a manner as to prevent contamination.
				  Equipment shall be located away from areas that could cause contamination such
				  as toilets, vestibules and openings to the outside. If at any time equipment is
				  suspected as having been contaminated by improper handling, this equipment
				  shall be sanitized.
(b) Block ice
				  facilities.
(1) In order to minimize the
				  possibility of contamination of ice during freezing, the operator employed on
				  the tank floor shall use footwear which is limited to use only on the tank room
				  floor. This footwear cannot be worn when leaving the tank room floor for any
				  purpose. Only authorized persons are to be permitted on the tank room floor or
				  within the ice storage rooms. Signs shall be posted stating that only
				  authorized persons are allowed on the tank room floor and in ice storage
				  vaults.
(2) Ice storage vaults. Ice
				  storage vaults must be kept under sanitary conditions and shall be maintained
				  in such a condition as to prevent possible flooding of rooms with waste
				  material. All vaults shall be provided with suitable drains. To prevent
				  possible contamination of ice, all accumulations of rust, fungus growth, mold
				  or slime shall be controlled.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.141 - General Provisions

Current through Reg. 49, No. 28; July 12, 2024
The purpose of the sections in this chapter is to provide
					 assurance that facilities holding an approved narcotic drug permit are
					 regulated under a set of minimum standards for the establishment and operation
					 of a narcotic treatment program pursuant to Texas Health and Safety Code,
					 Chapter 466. Each facility shall be approved and monitored by the department at
					 1100 West 49th Street, Austin, Texas 78756.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.143 - Organization

Current through Reg. 49, No. 28; July 12, 2024
(a) Organization
				  types. A narcotic treatment program (NTP) may be organized as an independent
				  single program or may be a part of a centralized organization. Each location
				  site must receive independent approval and, upon approval, be issued an
				  approved narcotic drug permit. If an applicant is a partnership or a
				  corporation, all individuals having a majority or management interest in such
				  corporation or partnership must be identified.
(b) Persons responsible. Where two or more
				  NTPs share a central administration (e.g., a city or statewide organization),
				  the person responsible for the organization is required to be listed as the
				  permit holder for each separate participating program. An individual shall
				  indicate participation in the central organization at the time of the
				  application. The permit holder shall fulfill all recordkeeping and reporting
				  requirements for these programs, but each program must continue to receive
				  separate approval. If a physician assumes medical responsibility for more than
				  one NTP, a statement describing how medical services will be provided to each
				  NTP shall be submitted to the department.
(c) Medication unit. A program may establish
				  a medication unit to facilitate the needs of patients who are stabilized on an
				  optimal dosage level. A medication unit is limited to administering or
				  dispensing a narcotic drug and collecting samples for drug testing or analysis
				  for narcotic drugs in accordance with §229.148(h)(1). The only patients
				  who shall be referred to a medication unit are those not in need of frequent
				  counseling, rehabilitative, or other services. The physician shall be
				  responsible for making this determination and documenting the patient's record.
				  If a private practitioner wishes to provide other services besides
				  administering or dispensing a narcotic drug and collecting samples for drug
				  testing or analysis for narcotic drugs, he or she must submit an application
				  for separate approval as an NTP.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.144 - State and Federal Statutes and Regulations

Current through Reg. 49, No. 28; July 12, 2024
(a) A permit holder shall assure that the
				  narcotic treatment program (NTP) is in compliance with all State of Texas laws
				  and rules regulating chemical dependency treatment facilities including, but
				  not limited to, the following laws: Health and Safety Code, Chapters 464 and
				  466; the Medical Practice Act, Occupations Code, Chapters 151-160, and 162-165;
				  the Nurse Practice Act, Occupations Code, Chapter 301; the Texas Pharmacy Act,
				  Occupations Code, Chapters 551-566; and the Licensed Professional Counselor
				  Act, Occupations Code, Chapter 503.
(b) The permit holder shall assure the NTP is
				  in compliance with Title 42, Code of Federal Regulations, Part 8, titled,
				  "Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction."
				  To the extent that the Code of Federal Regulation conflicts with these
				  sections, these sections shall prevail.
(c) Balance Billing.
(1) An NTP may not violate a law that
				  prohibits the NTP from billing a patient who is an insured, participant, or
				  enrollee in a managed care plan an amount greater than an applicable copayment,
				  coinsurance, and deductible under the insured's, participant's, or enrollee's
				  managed care plan or that imposes a requirement related to that
				  prohibition.
(2) An NTP shall
				  comply with Senate Bill 1264, 86th Legislature, Regular Session, 2019, and with
				  related Texas Department of Insurance rules at 28 TAC Chapter 21, Subchapter
				  OO, §§21.4901 -21.4904 (relating to Disclosures by Out-of-Network
				  Providers) to the extent this subchapter applies to the NTP.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.146 - Failure to Comply

Current through Reg. 49, No. 28; July 12, 2024
(a) The department
				  may take any action provided in the Texas Health and Safety Code (code),
				  Chapter 466, including emergency orders when it appears that a person violated,
				  is violating, or is threatening to violate the code, these sections, or an
				  order or permit issued pursuant to the code.
(b) If an emergency order is issued to
				  suspend or revoke the permit of a narcotic treatment program (NTP), the
				  department may notify other NTPs to expect patients so that treatment services
				  for the patients are maintained.
(c) The department will assess administrative
				  penalties in accordance with the provisions in §
										229.261
				  of this title (relating to Assessment of Administrative Penalties).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.147 - Denial of Application; Suspension or Revocation of a Narcotic Drug Permit

Current through Reg. 49, No. 28; July 12, 2024
(a) Failure to
				  comply with Chapter 466 or any of these sections shall be grounds for denial,
				  suspension, or revocation of a narcotic drug permit.
(b) The department may deny an application
				  for a license 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 of a felony or
				  misdemeanor in a state or federal court for the illegal use, sale or
				  transportation of narcotic drugs, barbiturates, amphetamines, or any other
				  dangerous or habit-forming drugs;
(4) is an association, partnership, or
				  corporation and the managing officer has been convicted of a felony or
				  misdemeanor in a state or federal court for the illegal use, sale, or
				  transportation of narcotic drugs, barbiturates, amphetamines, or any other
				  dangerous or habit-forming drugs;
(5) has had a permit to operate a narcotic
				  treatment program denied, revoked, surrendered, and/or suspended by the
				  department, Drug Enforcement Administration (DEA), Food and Drug Administration
				  (FDA), and/or Substance Abuse and Mental Health Services Administration
				  (SAMHSA); or
(6) 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 J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.148 - State Operational Requirements

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Management and administration.
(1) Human
				  resources management.
(A) The narcotic
				  treatment program (NTP) shall employ a sufficient number of qualified personnel
				  to fulfill the service objectives of the program and to satisfy the intent of
				  this section.
(B) Each NTP shall
				  notify the State Methadone Authority (SMA) within seven days, in writing, of
				  any change in the employment status of any of its program personnel. For new
				  hires, the employee's home address and telephone number, copies of a current
				  Texas driver's license and verification of professional licensure shall be
				  provided with this notification. In addition, copies of a curriculum vitae,
				  physician permit, Drug Enforcement Administration (DEA) certificate, and Texas
				  Department of Public Safety registrations shall be provided for physicians.
				  Notice of change of medical director or program sponsor must be given prior to
				  the change or on the date the change occurs.
(C) Employees who are currently or formerly
				  addicted within the past two years to drugs of abuse and/or opiates (including
				  methadone) or alcohol are considered risks to the security of drug stocks and
				  shall not have access to the drug stocks or to the drug dispensing
				  area.
(D) The NTP shall develop job
				  descriptions for all staff members which include job duties and
				  responsibilities, dates of regular review for continuing appropriateness, and
				  documentation that the descriptions are provided to the individual staff
				  member.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.149 - Inspections and Monitoring

Current through Reg. 49, No. 28; July 12, 2024
In order to determine compliance with the sections in this
					 chapter and related statutes, the department may enter and inspect the location
					 of an applicant or a permit holder at any reasonable time without prior
					 notification. This unannounced monitoring may include inspection of relevant
					 records and/or interviews with patients, narcotic treatment program (NTP)
					 personnel and prospective NTP personnel, to determine knowledge of and
					 compliance with the rules and statutes governing the operation of an NTP.
					 Inspection and monitoring can occur at unspecified frequencies and are subject
					 to the provisions of the Code of Federal Regulations, Title 42, Part
					 2.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.151 - Approved Hospital Narcotic Drug Detoxification Treatment

Current through Reg. 49, No. 28; July 12, 2024
(a) Application.
(1) The hospital administrator must submit a
				  complete hospital narcotic drug detoxification treatment application provided
				  by the department, a copy of federal form SMA -162 filed with the Substance
				  Abuse and Mental Health Services Administration (SAMHSA), and a copy of federal
				  form DEA 363 filed with the Drug Enforcement Agency (DEA), to apply for an
				  approved narcotic drug permit for inpatient narcotic drug
				  detoxification.
(2) The hospital
				  administrator shall submit to the department the name of the individual (e.g.,
				  pharmacist) responsible for receiving and securing supplies of narcotic drugs
				  for the treatment of narcotic addicts. The individuals responsible for supplies
				  of narcotic drugs must be authorized to do so by federal or state
				  law.
(3) The hospital administrator
				  shall submit to the department a general description of the hospital including
				  the number of beds, specialized treatment facilities for drug dependence, and
				  nature of patient care undertaken.
(4) The hospital pharmacist shall submit to
				  the department the quantity of narcotic drugs anticipated to be used per year
				  for narcotic addiction detoxification treatment.
(5) A member of the hospital medical staff
				  shall be named by the administrator or chief of medical staff as the
				  responsible physician for the narcotic drug detoxification treatment.
(6) A hospital pharmacy registered by the
				  Texas State Board of Pharmacy must be registered as a narcotic treatment
				  program (NTP) for detoxification by the DEA.
(7) A complete application filed in
				  accordance with this subsection for an NTP will be reviewed and evaluated by
				  the department in accordance with §
											229.281
				  of this title (relating to Processing Permit Applications Related to Food and
				  Drug Operations). Denial of application shall be in accordance with §
											229.147
				  of this title (relating to Denial of Application; Suspension or Revocation of a
				  Narcotic Drug Permit).
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.152 - Federal Regulations

Current through Reg. 49, No. 28; July 12, 2024
The department adopts by reference the federal regulations
					 on "Opioid Drugs in Maintenance and Detoxification Treatment of Opiate
					 Addiction" found in Title 42, Code of Federal Regulations, Part 8. A copy of
					 these regulations is indexed and filed at the department, located at 1100 West
					 49th Street, Austin, Texas 78756.
Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.153 - Enforcement

Current through Reg. 49, No. 28; July 12, 2024
(a) Denial,
				  Suspension or Revocation of Permit. Except for Emergency Orders under the
				  Health and Safety Code, §
										466.041, after
				  notice to an applicant or a permit holder and after the opportunity for a
				  hearing, the department may:
(1) deny an
				  application of the person if the person fails to comply with this chapter or
				  the rules establishing minimum standards for the issuance of a permit adopted
				  under this chapter; or
(2) suspend
				  or revoke the permit of a person who has committed a Level I, II, or III
				  violation as defined in subsection (d) of this section.