ADOPTED RULES 
 
 An agency may take final action on a section 30 days after a proposal has been 
published in the  Texas Register. The section becomes effective 20 days after 
the agency files the correct document with the  Texas Register, unless a later 
date is specified or unless a federal statute or regulation requires 
implementation of the action on shorter notice. 
 If an agency adopts the section without any changes to the proposed text, only 
the preamble of the notice and statement of legal authority will be published. 
If an agency adopts the section with changes to the proposed text, the proposal 
will be republished with the changes. 
 
   
  TITLE 4. AGRICULTURE 
 Part I. Texas Department of Agriculture 
  Chapter 15. Consumer Services Division 
  
  Texas Grain Warehouse 
 
  4 TAC sec.15.78 
 
  The Texas Department of Agriculture (the department) adopts new sec.15.78, 
concerning regulation of warehouse receipts that are ten years old or more, 
without changes to the proposed text as published in the June 14, 1994, issue of 
the Texas Register (19 TexReg 4605). 
 The new section is adopted to provide procedures to implement the Texas 
Agriculture Code, sec.14.017. 
 The new section allows the department to limit the negotiability of warehouse 
receipts. 
 No comments were received regarding adoption of the new section. 
 The new section is adopted under the Texas Agriculture Code, sec.14.003, 
(Vernon 1982), which provides the Texas Department of Agriculture with the 
authority to establish rules necessary to regulate Public Grain Warehouses. 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's legal authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447302 
  Dolores Alvarado Hibbs 
 Chief Administrative Law Judge 
 Texas Department of Agriculture 
    Effective date: September 19, 1994 
 Proposal publication date: June 14, 1994 
 For further information, please call: (512) 463-7583 
         
               
  TITLE 25. HEALTH SERVICES 
 Part I. Texas Department of Health 
  Chapter 14. County Indigent Health Care Program 
  
  Subchapter C. Providing Services 
 
  25 TAC sec.14.202 
 
  The Texas Department of Health (department) adopts an amendment to sec.14. 
202, concerning exclusions and limitations, without changes to the proposed text 
as published in the June 10, 1994, issue of the Texas Register (19 TexReg 4479). 
 The amendment is being adopted to comply with the Indigent Health Care and 
Treatment Act, Chapter 61, Health and Safety Code, which specifies that the 
department must define the services and establish the payment standards to 
correspond with department rules relating to the AFDC-Medicaid program. This 
amendment corresponds to a recent change to the Medicaid program. 
 The amendment limits psychiatric services or supplies provided to a patient who 
is not confined as a bed patient in a hospital to 30 visits instead of a 
specified amount of $312.50 during any one calendar year. 
 Two comments were received on the proposed amendment during the comment period. 
Both commenters opposed the amendment because they perceived an increase in cost 
to counties. The department's response is that the amendment will be cost 
effective because it will encourage outpatient psychiatric services over more 
expensive inpatient psychiatric services. No changes were made as a result of 
the comments. 
 The amendment is adopted under Chapter 61 of the Health and Safety Code and 
Chapters 22 and 32 of Human Resources Code. The authority to administer the 
County Indigent Health Care Program was transferred to the Texas Department of 
Health under Chapter 15, sec.1.07, Acts of the 72nd Legislature, First Called 
Session (1991). 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447292 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: September 19, 1994 
 Proposal publication date: June 10, 1994 
 For further information, please call: (512) 338-6458 
         
           Chapter 31. Special Supplemental Food Program for Women, Infants, and 
Children (WIC) 
  
  25 TAC sec.sec.31.1-31.3 
 
  The Texas Department of Health (department) adopts under federal mandate 
amendments to sec.sec.31.1-31.3, concerning the Special Supplemental Food 
Program for Women, Infants and Children (WIC). Section 31.1 adopts by reference 
the amendments to federal regulations. Section 31.2 adopts by reference the 
Fiscal Year 1994 WIC State Plan of Operations. Section 31.3 adopts by reference 
the WIC Policy and Procedure Manual as part of the WIC State Plan of Operations 
which the United States Department of Agriculture (USDA) approves under 
authority of 7 Code of Federal Regulations (CFR), Part 246. The manual 
incorporates all of the requirements of the federal regulations and federal 
management circulars into state policies and procedures. The manual is provided 
to and serves as the operating manual for the local health agencies that have 
contracted with the department to provide WIC services. The amendments modify 
the text of the sections and also the materials which are adopted by reference 
in the sections. 
 Concerning sec.31.1, the amendments to the federal regulations are as follows. 
The first amendment is to the federal regulations which were initially 
promulgated by the USDA and published in 7 CFR, Part 246, on February 13, 1985. 
The first amendment implements a revision to the food funds allocation formula 
for the Special Supplemental Food Program for WIC to remove the provision 
limiting any state agency to a 15% increase in food funding. The change will 
ensure that all funds appropriated for Fiscal Year 1994 and subsequent years are 
allocated to state agencies most in need. The final rule was published in the 
Federal Register, Volume 58, Number 190, dated Monday, October 4, 1993. The 
second amendment provides final revisions to Office of Management and Budget 
(OMB) Circular A-110, which provides standards for achieving consistency and 
uniformity among federal agencies in the administration of grants and agreements 
with institutions of higher education, hospitals, and other non-profit 
organizations. The revisions were published in the Federal Register, Volume 58, 
Number 227, dated Monday, November 29, 1993. The third amendment provides notice 
of adjusted poverty income guidelines to be used by state agencies in 
determining the income eligibility of persons applying to participate in the WIC 
Program. These poverty income guidelines are to be used in conjunction with the 
WIC regulations. The guidelines were published in the Federal Register , Volume 
59, Number 47, dated Thursday, March 10, 1994. Since the poverty guidelines are 
adopted by reference in subsection (a), the second reference in subsection (c) 
is being deleted. The fourth amendment implements a final rule amending 
regulations governing the WIC Program to comply with the mandates of sec.123 and 
sec.213 of the Child Nutrition and WIC Reauthorization Act of 1989, enacted on 
November 10, 1989. This final rule contains both funding and nonfunding 
provisions. The major nonfunding provisions in this final rule include: 
extending adjunct or automatic income eligibility to certain family members; 
enhancing outreach efforts and program access; defining breastfeeding and 
establishing breastfeeding promotion activities; referring and providing 
participants with information about other health and welfare programs; 
permitting state agencies the option to establish alternative means of issuing 
food instruments, such as mailing them to participants; and reducing the 
frequency with which state agencies must review their local agencies. This final 
rule also incorporates other legislative mandates, such as governmentwide 
debarment and suspension (nonprocurement) requirements, a drug-free workplace, 
and new restrictions on lobbying. This federal rule became effective on March 
11, 1994, except that the nondiscretionary funding provisions set forth in 7 
CFR, sec.246.14 and sec.246.16 were, by law, effective October 1, 1989. State 
agencies must implement all other provisions no later than October 1, 1994. 
 Concerning sec.31.2, the amendments to federal regulations in 7 CFR, Part 246, 
require the USDA to approve an annual update of the WIC State Plan of 
Operations. The amendment covers the annual update for the fiscal year 1994, 
which was approved by the USDA effective October 1, 1993. The update covers the 
outline of the state agency's goals and objectives for improving program 
operations; the affirmative action plan; and local agency identification -WIC 
project information. 
 Concerning sec.31.3, the amendments to the WIC Policy and Procedure Manual 
incorporate into the manual new and revised USDA policies, which became 
effective when the federal regulations and federal circulars became effective, 
and are incorporated into policies that are approved by USDA. The latest federal 
requirements which are being incorporated into the Policy and Procedure Manual 
by the amendments to sec.31.3 cover the following: allowable costs-peer 
counselors; nutrition education expenditures; repair of computer equipment; food 
instrument inventories for automated sites; breastfeeding promotion standards; 
local breastfeeding coordinator; breastfeeding peer counselor; breastfeeding 
training; issuance of formula to breastfeeding mothers; nondiscrimination; 
providing oral and written program information to non-English or limited English 
speaking persons; civil rights training; collection of racial/ethnic data; 
eligibility criteria for program participation; appointment log; notification of 
ineligibility; notification of certification expiration; caseload management; 
adjunctive income eligibility for participants of AFDC, food stamps, and 
Medicaid; Texas WIC income guidelines; documentation of a complete nutritional 
assessment; criteria for identifying nutritional risk conditions; procedures for 
weighing and measuring; measuring equipment; weighing equipment; determination 
of hematocrit/hemoglobin; hematocrits/hemoglobins on infants; equipment for 
determination of hemoglobin/hematocrits; calibration of hematocrit/hemoglobin 
equipment; assessment of dietary pattern; assessment of medical/prenatal 
history; use of medical data taken prior to the time eligibility is determined; 
enrollment of transferring participants; completion and issuance of food 
instruments; triple issuance of WIC food vouchers; food packages/allowable 
foods; vendor abuse; access to appointments; vaccine administration schedule; 
emergency procedures; immunization tracking; local nutrition education 
coordinator; definition of nutrition education contact; standards for nutrition 
education contacts; standards for group classes; standards for individual 
counseling; nutrition education lessons; documentation of nutrition education 
attendance/nonattendance; nutrition education audiovisuals; distributed or 
loaned nutrition education materials; local outreach coordinator; in-service 
orientation to new local agencies; orientation/training of local agency 
directors; local training coordinator; and required local agency/clinic staff 
training. 
 The amendments are adopted under federal mandate for the following reasons. 
Under federal and state enabling legislation (the Child Nutrition Act of 1966, 
Title 42, United States Code, sec.1786; and the Texas Omnibus Hunger Act of 
1985, Acts 1985, 69th Legislature, Chapter 150, Title II), the WIC Program is 
99% federally funded and governed by federal regulations. Funds are made 
available to the department by a federal grant. The federal statute (42 United 
States Code, sec.1786), federal regulations (7 CFR, Part 246), and the federal 
grant (Federal-State Special Supplemental Food Program Agreement) authorize the 
USDA to make the funds available to the department to administer the WIC Program 
in the State of Texas, provided that the department administers the program in 
accordance with the federal regulations. Therefore, the department under federal 
mandate adopts the amendments, effective on October 1, 1994. 
 The amendments are adopted under Health and Safety Code,  sec.12.001(b), which 
provides the Texas Board of Health (board) with authority to adopt rules for the 
performance of every duty imposed by law upon the board, the department, and the 
commissioner of health. 
 
 
  sec.31.1. Federal Regulations on Special Supplemental Food Program for Women, 
Infants, and Children (WIC). 
 
  (a) The Texas Department of Health adopts by reference the United States 
Department of Agriculture regulations on the Special Supplemental Food Program 
for Women, Infants, and Children (WIC). These regulations are contained in the 
Federal Register publication entitled "Special Supplemental Food Program for 
Women, Infants, and Children" dated February 13, 1985, as amended October 4, 
1993, November 29, 1993, March 10, 1994, and March 11, 1994. 
   
  (b) Copies of the regulations described in subsection (a) of this section are 
filed in the department's Bureau of Nutrition Services-Women, Infants, and 
Children (WIC) Program, Texas Department of Health, 1100 West 49th Street, 
Austin, Texas 78756, and are available for public inspection during regular 
working hours. 
 
     
  sec.31.2. WIC State Plan of Operations. 
 
  (a) The Texas Department of Health (department) adopts by reference the United 
States Department of Agriculture regulations on the Special Supplemental Food 
Program for Women, Infants, and Children (WIC). The regulations are contained in 
the Federal Register publication titled "Special Supplemental Food Program for 
Women, Infants, and Children" dated February 13, 1985, as amended in October 
1993. 
   
  (b) Copies of the state plan are filed in the department's Bureau of Nutrition 
Services-Women, Infants, and Children (WIC) Program, Texas Department of Health, 
1100 West 49th Street, Austin, Texas 78756, and are available for public 
inspection during regular working hours. 
 
     
  sec.31.3. WIC Policy and Procedure Manual. 
 
  (a) The Texas Department of Health (department) adopts by reference the 
publication titled, "WIC Policy and Procedure Manual," which the department 
developed, as amended May 1, 1994. This policy and procedure manual has been 
developed by the department's WIC Program and approved by the United States 
Department of Agriculture. 
   
  (b) Copies of the manual are filed in the department's Bureau of Nutrition 
Services-Women, Infants, and Children (WIC) Program, Texas Department of Health, 
1100 West 49th Street, Austin, Texas 78756, and are available for public 
inspection during regular working hours. 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447296 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: August 29, 1994 
 Proposal publication date: N/A 
 For further information, please call: (512) 458-7444 
         
             Chapter 98. HIV and STD Control 
  
  Subchapter C. Texas HIV Medication Program 
 
  General Provisions 
 
  25 TAC sec.98.104, sec.98.105 
 
  The Texas Department of Health (department) adopts amendments to sec.98. 104 
and sec.98.105, concerning the Texas HIV Medication Program, without changes to 
the proposed text as published in July 5, 1994, issue of the Texas Register  (19 
TexReg 5139). The sections implement the provisions of the "Communicable Disease 
Prevention and Control Act," Health and Safety Code, Chapter 85.063, Subchapter 
C, concerning the Texas HIV Medication Program. The program assists hospital 
districts, local health departments, public or nonprofit hospitals and clinics, 
nonprofit community organizations, and HIV infected individuals in the purchase 
of medications approved by the board that have been shown to be effective in 
reducing hospitalizations due to HIV related conditions. Generally, the sections 
cover eligibility for participation and medication coverage. Coverage of the 
program has been expanded to include Dapsone; the existing coverage for 
Didanosine, Zalcitabine, SMZ-TMP, Fluconazole, and Itraconazole for eligible 
participants has been amended; and the eligibility criteria for Zidovudine has 
been expanded to include pregnant women. 
 No comments were received regarding adoption of the amendments. 
 The amendments are adopted under the Health and Safety Code, sec.85.063, which 
provides the Texas Board of Health with the authority to adopt rules concerning 
a Texas HIV Medication Program; and Health and Safety Code, sec.12. 001, which 
provides the Texas Board of Health with the authority to adopt rules for the 
performance of every duty imposed by law on the Texas Board of Health, the Texas 
Department of Health, and the Commissioner of Health. 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447328 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: September 20, 1994 
 Proposal publication date: July 5, 1994 
 For further information, please call: (512) 458-7500 
         
             Chapter 129. Opticians' Registry 
  
  25 TAC sec.sec.129.3, 129.5, 129.8, 129.9, 129.11, 129.13 
 
  The Texas Department of Health adopts amendments to sec. sec.129.3, 129.5, 
129.8, 129.9, 129.11, and 129.13 without changes to the proposed text as 
published in the May 6, 1994, issue of the Texas Register (19 TexReg 3417). 
 The amendments define committee duties; delete requirements under the expired 
grandfather clause; lower the annual requirement for continuing education 
credits; add consumer information provisions; define deceptive advertising; add 
criminal convictions related to the profession of opticianry; and add minor 
changes which clarify meaning without substantial change, improve grammar and 
style, and clarify inconsistencies in the rules. The amendments implement the 
provisions of Texas Civil Statutes, Article 4512p, and update existing sections. 
 The amendments assure the regulation of opticians continues to identify 
competent practitioners. 
 No comments were received regarding adoption of the amendments. 
 The amendments are adopted under Texas Civil Statutes, Article 4551-1, which 
provide the Texas Department of Health with authority to adopt rules concerning 
the registration of opticians; and the Health and Safety Code, sec.12.001, which 
provides the Texas Board of Health with the authority to adopt rules for the 
performance of every duty imposed by law on the Texas Board of Health, the Texas 
Department of Health, and the commissioner of health. 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447293 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: September 19, 1994 
 Proposal publication date: May 6, 1994 
 For further information, please call: (512) 834-6661 
         
         Chapter 130. Code Enforcers 
  
  The Texas Department of Health (department) adopts amendments to 
sec.sec.130.2, 130.3, 130.5-130.7, 130.9, 130.10, 130.12; repeal of existing 
sec.130.8; and new sec.130.8 and sec.130.18 without changes to the proposed text 
as published in the April 5, 1994, issue of the Texas Register  (19 TexReg 2360) 
and a notice of correction to the proposed rules as filed was published in the 
April 29, 1994, issue of the Texas Register (19 TexReg 3279). The sections will 
not be republished. 
 The amendments update requirements pertaining to the registration of code 
enforcement officers. Specifically, the amendments alter the definitions; define 
committee duties; delete requirements under the expired grandfather clause; 
address renewal of a registration as a code enforcement officer in training; and 
add minor changes which clarify meaning without substantial change, improve 
grammar and style, and clarify inconsistencies in the rules. The repeal of 
existing sec.130.8 removes the examination procedures. New sec.130. 8 replaces 
the examination procedures with updated information concerning the examination 
process. The new sec.130.18 defines improper advertising as it is related to 
code enforcement officers by using the language from Texas Civil Statutes, 
Article 4512p, sec.4. 
 The registration of code enforcement officers will safeguard public health, 
safety, and welfare by providing a means by which the public can identify code 
enforcement officers that meet minimum standards of competence. The regulation 
of code enforcement officers creates a means to better serve the public. 
 No comments were received regarding the proposal of these rules. 
   
  25 TAC sec.sec.130.2, 130.3, 130.5-130.10, 130.12, 130.18 
 
  The amendments and new sections are adopted under Texas Civil Statutes, 
Article 4447bb, which provide the Texas Department of Health with authority to 
adopt rules concerning the registration of code enforcement officers; and Health 
and Safety Code,  sec.12.001, which provides the Texas Board of Health with the 
authority to adopt rules for the performance of every duty imposed by law on the 
Texas Board of Health, the Texas Department of Health and the commissioner of 
health. 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447294 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: September 19, 1994 
 Proposal publication date: April 5, 1994 
 For further information, please call: (512) 834-6659 
         
       
  25 TAC sec.130.8 
 
  The repeal is adopted under Texas Civil Statutes, Article 4447bb, which 
provide the Texas Department of Health with authority to adopt rules concerning 
the registration of code enforcement officers; and Health and Safety Code, 
sec.12.001, which provides the Texas Board of Health with the authority to adopt 
rules for the performance of every duty imposed by law on the Texas Board of 
Health, the Texas Department of Health and the commissioner of health. 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447295 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: September 19, 1994 
 Proposal publication date: April 5, 1994 
 For further information, please call: (512) 834-6659 
         
         Chapter 289. Radiation Control 
  
  Texas Regulation for Control of Radiation 
 
  25 TAC sec.289.121 
 
  The Texas Department of Health (department) adopts an amendment to sec.289. 
121, concerning licensing of radioactive material, with changes to the proposed 
text as published in the May 3, 1994, issue of the Texas Register  (19 TexReg 
3336) and with changes to the material the section adopts by reference. The only 
change made to the text of sec.289.121 from the proposed text was that the 
amended date was changed to reflect the effective date of the amendment. 
 Section 289.121 adopts by reference Part 41 of the Texas Regulations for 
Control of Radiation (TRCR) titled, "Licensing of Radioactive Material." 
 TRCR Part 41 was amended to allow licensees who process and prepare 
radiopharmaceuticals for human use to deviate from instructions accompanying the 
radioactive material if such processing and preparation is done according to 
procedures approved by the department or according to the provisions of the 
practice of pharmacy as recognized by the Texas State Board of Pharmacy. The 
amendment also identifies training and experience requirements for a nuclear 
pharmacist. 
 The amendments will ensure appropriate and adequate regulatory control of the 
use of radioactive materials in the preparation of radiopharmaceuticals. 
 Department staff made the following changes for clarification purposes: 
 The reference was changed in Part 41.26(b)(2)(v) because the rule applies 
specifically to all of Part 41.26(b)(7) and not only to Part 41.26(b)(7)(ii) and 
(iii). 
 In Part 41.26(b)(7)(i), the words "...and dispense..." were added to further 
clarify the intent of the rule. Also, in Part 41.26(b)(7)(i), the words "...this 
section..." were added in place of "... Part 41.26(b)(7)(i)" to comply with 
standard rule format. 
 The following comments were received concerning the proposed amendment to TRCR 
Part 41. 
 Comment: Concerning Part 41.26(b)(7), five commenters expressed concern that 
the rule does not include radiochemists and that radiochemists with suitable 
experience and qualifications should be allowed to prepare radiopharmaceuticals 
for human use. Such restrictions may affect research institutes that prepare 
medical radioisotopes for human use. One of the five commenters stated that the 
rule should allow the same flexibility to other approved users and cited, as an 
example, that such an exception could be authorized by a radiation safety 
committee and by a physician certified by the American Board of Nuclear 
Medicine, and executed by a certified nuclear medicine technologist in 
accordance with the physician's directive. 
 Response: The rule is not intended to permit radiochemists to deviate from 
package inserts. The rule concerns those entities (e.g., nuclear pharmacies) 
that have a specific license to prepare and dispense radiopharmaceuticals for 
human use. Such licensees must have a nuclear pharmacist identified as an 
authorized user on the license. The rule applies to licenses issued pursuant to 
Part 41.26(b)(7) and does not intrude upon the purview of the broad medical 
license issued pursuant to Part 41.26(a). The department made no change to the 
rule as a result of the comments. 
 Comment: Concerning Part 41.26(b), one commenter stated that the changes are a 
constructive step and should be endorsed. 
 Response: The department acknowledged the commenter's opinion and made no 
change to the rule as a result of the comment. 
 Comment: Concerning Part 41.26(a)(4)(ii), one commenter noted that the rule 
appeared to require an institute that holds a specific license for the human use 
of radioactive material to have an appointed radiation safety committee and 
suggested that the wording be changed to clarify as to when a radiation safety 
committee is required. 
 Response: As stated in Part 41.26(a)(3) and (4), a radiation safety committee 
is required for a license authorizing unspecified forms and/or multiple types of 
radioactive material for medical research, diagnosis and therapy (i.e., a broad 
medical license). A radiation safety committee is not required for licenses 
issued pursuant to Part 41.26(b). The department made no change to the rule as a 
result of the comment. 
 Comment: Concerning Part 41.26(b)(2)(iv), one commenter suggested removing the 
wording, "...and recommendations." because it is an unnecessary constraint on 
the practice of medicine and pharmacy. The commenter noted that the only 
recommendations in the package insert are the dose ranges and these are not 
specified by the manufacturer but are suggested, as they understand the final 
dosage determination is the purview of the physician, not a regulatory body nor 
the manufacturer. 
 Response: Package inserts also contain recommendations concerning quality 
assurance and quality control. The department made no change to the rule as a 
result of the comment. 
 Comment: Concerning Part 41.26(b)(7)(i), one commenter suggested the wording in 
the first sentence of Part 41.26(b)(7)(i) be changed to reflect the area being 
addressed. Since the rule is addressing the uses by a radiopharmacist and 
centralized radiopharmacies, the wording more correctly should be, "...in Part 
41.25, an application for a specific license for nuclear pharmacy services..." 
Otherwise all human use licenses currently in place or hereafter issued that 
authorize the reconstitution of reagent kits will require that a facility hire a 
nuclear pharmacist. 
 Response: A license issued pursuant to Part 41.26(b)(7) has an authorization to 
prepare and dispense radiopharmaceuticals for human use. To limit the 
authorization to "nuclear pharmacy services" would be too restrictive. The 
department added the words "...and dispense..." after "... prepare..." to 
further clarify the intent of the rule. 
 Comment: Concerning Part 41.26(b)(7)(ii), one commenter stated that the 
language is confusing. The commenter also stated that it appears that the 
department is assuming the role of the United States Food and Drug 
Administration and the State Board of Pharmacy. The commenter stated that if the 
intent is to allow licensees additional latitude, it should be clearly set 
forth. The commenter noted that it is unclear what the difference is between 
"instructions" and "procedures" and questioned whether the State of Texas is 
willing to allow another Agreement State to set the standards of practice in 
Texas. The commenter asked what the definition of "Licensing State" is and how 
it differs from an "Agreement State." The commenter suggested that Part 41. 
26(b)(7)(ii) might be more appropriately constructed as follows: (1) The 
instructions that are furnished by the manufacturer on the label attached to a 
generator or reagent kit, or contained in the accompanying leaflet or brochure; 
(2) Procedures approved by the Agency; or (3) The provisions of the practice of 
pharmacy, as recognized by the Texas State Board of Pharmacy, by an authorized 
nuclear pharmacist. 
 The commenter noted that if constructed this way, the agency can then decide 
under (2) what it will and will not approve. This would include items from "the 
Commission, and Agreement State, or a Licensing State," but require those be 
submitted and approved by the Agency prior to their use in Texas. 
 Response: Concerning Part 41.26(b)(7)(ii) gives a licensee who processes and 
prepares radiopharmaceuticals for human use three options for doing so. Part 
41.26(b)(7)(ii)(1) concerns instructions that are intended for manufacturers and 
that have been approved by the department, an Agreement State, or a Licensing 
State. Part 41.26(b)(7)(ii)(2) concerns procedures for end-users that are not 
covered in the manufacturers' instructions and that are approved by the 
department on a case-by-case basis. The department does not believe further 
clarification of the rule is necessary. An Agreement State is any state with 
which the United States Nuclear Regulatory Commission has entered into an 
effective agreement under sec.274.b of the Atomic Energy Act of 1954, as amended 
(73 Stat. 689). A Licensing State means any state with rules equivalent to the 
Suggested State Regulations for Control of Radiation relating to, and having an 
effective program for, the regulatory control of naturally occurring or 
accelerator produced radioactive material and has been designated as such by the 
Conference of Radiation Control Program Directors, Inc. The department made no 
change to the rule as a result of the comment. 
 Representatives from MASI Healthcare Services of Fort Worth, The University of 
Texas Health Science Center at Houston, The University of Texas M.D. Anderson 
Cancer Center of Houston, and St. Luke's Episcopal Hospital of Houston presented 
comments, questions, and suggestions for changes to the proposed amendment as 
discussed in the summary of comments. 
 The amendment is adopted under the Health and Safety Code, Chapter 401, which 
provides the Board of Health with the authority to adopt rules and guidelines 
relating to the control of radiation; and sec.12.001, which authorizes the board 
to adopt rules for the performance of every duty imposed by law on the board, 
the department, and the commissioner of health. 
 
 
  sec.289.121. Licensing of Radioactive Material. 
 
  (a) The Texas Department of Health adopts by reference Part 41, "Licensing of 
Radioactive Material" of the Department's document titled Texas Regulations for 
Control of Radiation, as amended in October, 1994. 
   
  (b) (No change.) 
 
  This agency hereby certifies that the rule as adopted has been reviewed by 
legal counsel and found to be a valid exercise of the agency's authority. 
 Issued in Austin, Texas, on August 29, 1994. 
 TRD-9447317 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: October 1, 1994 
 Proposal publication date: May 3, 1994 
 For further information, please call: (512) 834-6688