Adopted Sections 
 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 22. EXAMINING BOARDS 
 Part IX. Texas State Board of Medical Examiners 
  Chapter 161. General Provisions 
  
  22 TAC sec.161.1 
 
  The Texas State Board of Medical Examiners adopts an amendment to sec.161. 1, 
without changes to the proposed text as published in the May 18, 1993, issue of 
the Texas Register  (18 TexReg 3238). 
 The amendment will clarify the duties of the Board committees. 
 The amendment will function by providing guidelines for committee members. 
 No comments were received regarding adoption of the amendment. 
 The amendment is adopted under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations, and bylaws not inconsistent with this Act as may be 
necessary for the governing of its own proceedings, the performance of its 
duties, the regulation of the practice of medicine in this state, and the 
enforcement of this Act. 
 
  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 June 21, 1993. 
 TRD-9324960 
  Homer R. Goehrs, M.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Effective date: July 20, 1993 
 Proposal publication date: May 18, 1993 
 For further information, please call: (512) 834-4502 
         
         Chapter 163. Licensure 
  
  22 TAC sec.163.9 
 
  The Texas State Board of Medical Examiners adopts an amendment to sec.163. 9, 
without changes to the proposed text as published in the April 20, 1993, issue 
of the Texas Register  (18 TexReg 2510). 
 The amendment allows an additional examination to be considered in lieu of the 
Special Purpose Examination for reciprocal endorsement applicants not examined 
within the past ten years. 
 The amendment will function by allowing physicians who have training equal to 
that required for specialty certification to be considered for licensure, 
without the necessity of taking the Special Purpose Examination. 
 No comments were received regarding adoption of the amendment. 
 The amendment is adopted under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations, and bylaws not inconsistent with this Act as may be 
necessary for the governing of its own proceedings, the performance of its 
duties, the regulation of the practice of medicine in this state, and the 
enforcement of this Act. 
 
  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 June 21, 1993. 
 TRD-9324959 
  Homer R. Goehrs, M.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Effective date: July 20, 1993 
 Proposal publication date: April 20, 1993 
 For further information, please call: (512) 834-4502 
         
         Chapter 179. Investigation Files 
  
  22 TAC sec.179.2 
 
  The Texas State Board of Medical Examiners adopts an amendment to sec.179. 2, 
without changes to the proposed text as published in the May 18, 1993, issue of 
the Texas Register  (18 TexReg 3240). 
 The adopted amendment will clarify the rules regarding information needed for 
investigation files. 
 The amendment will function by clearly defining the information to be submitted 
by physicians regarding medical records. 
 No comments were received regarding adoption of the amendment. 
 The amendment is adopted under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations, and bylaws not inconsistent with this Act as may be 
necessary for the governing of its own proceedings, the performance of its 
duties, the regulation of the practice of medicine in this state, and the 
enforcement of this Act. 
 
  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 June 21, 1993. 
 TRD-9324961 
  Homer R. Goehrs, M.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Effective date: July 20, 1993 
 Proposal publication date: May 18, 1993 
 For further information, please call: (512) 834-4502 
         
       
  22 TAC sec.179.6 
 
  The Texas State Board of Medical Examiners adopts an amendment to sec.179. 6, 
without changes to the proposed text as published in the April 20, 1993, issue 
of the Texas Register  (18 TexReg 2511). 
 The amendment will clarify the physician's responsibility in reporting 
professional liability claims. 
 The amendment will function by giving examples of those claims that are not 
required to be reported and by reducing the amount of paperwork regarding the 
reporting of unnecessary claims. 
 One comment was received proposing a future amendment to this section; however, 
the comment did not relate to the current amendment. 
 The amendment is adopted under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations, and bylaws not inconsistent with this Act as may be 
necessary for the governing of its own proceedings, the performance of its 
duties, the regulation of the practice of medicine in this state, and the 
enforcement of this Act. 
 
  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 June 21, 1993. 
 TRD-9324962 
  Homer R. Goehrs, M.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Effective date: July 20, 1993 
 Proposal publication date: April 20, 1993 
 For further information, please call: (512) 834-4502 
         
         Chapter 187. Procedure 
  
  Subchapter D. Posthearing 
 
  22 TAC sec.sec.187.31, 187.32, 187.34, 187.36 
 
  The Texas State Board of Medical Examiners adopts amendments to sec.sec.187. 
31, 187.32, 187.34, and 187.36, without changes to the proposed text as 
published in the April 20, 1993, issue of the Texas Register (18 TexReg 2513). 
 The amendments will allow the Board flexibility in rendering a decision on 
disciplinary matters when it is in the best interest of the public. 
 The amendments will establish policy reasons, or legal grounds, to enable the 
Board to disagree with the recommendation of the administrative law judge on 
proposals for decision. 
 One comments was received questioning the necessity of the change in sec.187. 
34(d). 
 An attorney commented against the adoption of sec.187.34(d). 
 The agency disagreed with the comment because it amounted to criticism of form 
of rule and not substance. The substance of the rule is significant enough to 
avoid delay based on a criticism of the form of the rule, and no action was 
taken as a result of the comment. 
 The amendments are adopted under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations, and bylaw not inconsistent with this Act as may be necessary 
for the governing of its own proceedings, the performance of its duties, the 
regulation of the practice of medicine in this state, and the enforcement of 
this Act. 
 
  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 June 21, 1993. 
 TRD-9324963 
  Homer R. Goehrs, M.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Effective date: July 20, 1993 
 Proposal publication date: April 20, 1993 
 For further information, please call: (512) 834-4502 
         
           Chapter 199. Disciplinary Hearings Panels 
  
  22 TAC sec.sec.199.1-199.5 
 
  The Texas State Board of Medical Examiners adopts the repeal of sec.sec.199. 
1-199.5, without changes to the proposed text as published in the April 20, 
1993, issue of the Texas Register (18 TexReg 2514). 
 The adopted repeal is necessary due to a change in law establishing the State 
Office Administrative Hearings to handle all contested cases. 
 The section will function by deletion. 
 No comments were received regarding adoption of the repeals. 
 The repeals are adopted under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations, and bylaws not inconsistent with this Act as may be 
necessary for the governing of its own proceedings, the performance of its 
duties, the regulation of the practice of medicine in this state, and the 
enforcement of this Act. 
 
  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 June 21, 1993. 
 TRD-9324964 
  Homer R. Goehrs, M.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Effective date: July 20, 1993 
 Proposal publication date: April 20, 1993 
 For further information, please call: (512) 834-4502 
         
             
  TITLE 25. HEALTH SERVICES 
 Part I. Texas Department of Health 
  Chapter 229. Food and Drug 
  
  Synthetic Narcotic Drugs in the Treatment of Drug Dependent Persons 
 
  25 TAC sec.229.148 
 
  The Texas Department of Health (department) adopts an amendment to 
sec.229.148, concerning Minimum Standards for Approved Drug Treatment Programs, 
with changes to the proposed text as published in the May 11, 1993, issue of the 
Texas Register  (18 TexReg 3014). 
 The amendment establishes licensing and operating requirements for narcotic 
treatment programs pursuant to the requirements of Chapter 466 of the Texas 
Health and Safety Code and the rules adopted thereunder entitled "Minimum 
Standards for Approved Narcotic Drug Treatment Programs." The amendment will 
require yearly tuberculosis screening tests utilizing the Mantoux technique for 
narcotic treatment program patients and employees. 
 The following comments were received relating to the proposed amendments. 
 COMMENT: Several commenters stated that HIV-positive patients who have a 
negative reaction to the tuberculin screening test should receive anergy 
screening. 
 RESPONSE: The department agrees and has made changes to the final sec.229. 
148(u). 
 COMMENT: Several commenters stated that tuberculosis screening tests should be 
required every 6 months. 
 RESPONSE: The department feels that annual testing is sufficient but will 
reevaluate this recommendation after 1 year to determine if semi-annual testing 
would be advantageous. 
 COMMENT: One commenter stated that anergy testing should be required for all 
patients who are found to be tuberculin-negative because of the increased 
incidence of anergy among IV drug users and the unknown incidence of HIV 
infection among program patients. 
 RESPONSE: The department has insufficient data at this time to amend the 
section to reflect this change but will gather information relevant to this 
request in order to assess feasibility of this requirement. 
 The commenters were the Bureau of Disease Control and Epidemiology at the Texas 
Department of Health, the University of Texas Health Science Center at Houston, 
and several individuals. None of the commenters were totally for or against the 
sections, but they had concerns, recommendations, and questions. 
 The amendments are adopted under Texas Health and Safety Code, sec.466.004, 
which provides the department with the authority to adopt necessary regulations 
pursuant to the enforcement of this Chapter; and 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. 
 
 
  sec.229.148. State Operational Requirements. 
 
  (a)-(t) (No change.) 
   
  (u) Upon admission, each patient must receive an intradermal skin test using 
the Mantoux technique, or, when available, a procedure of equal or better 
sensitivity. A patient is not required to be retested at each admission if he or 
she can provide documentation that a Mantoux test was performed within the 
previous 12 months. Patients who had negative tuberculin skin tests on admission 
must be retested each year. Patients with a positive skin test result of five 
millimeters or greater must be referred for diagnostic evaluation. HIV 
seropositive patients found to be tuberculin-negative must be tested for anergy. 
Anergic HIV-positive patients must be referred for clinical assessment and 
possible preventative therapy. 
   
  (v) Each employee working in a narcotic treatment program must receive an 
intradermal skin test using the Mantoux technique at the start of employment and 
annually thereafter, or present a certificate signed by a physician that states 
that: 
 
  (1) the employee has been tested for tuberculosis infection within the 
previous 90 days; and 
   
  (2) the results of the test indicates that the person does not have 
tuberculosis. 
     
  (w) In lieu of a screening test an employee with a history of a positive 
screening test must provide: 
 
  (1) documentation of that positive test result and of any diagnostic and 
therapeutic follow-up; and 
   
  (2) a certificate signed by a physician that states that the person does not 
have tuberculosis. 
     
  (x) All notations by NTP personnel on patient files and other files kept by 
the NTP for purposes of this chapter shall be typed, printed, or legibly 
handwritten so that any regulatory authority could read the writing. 
   
  (y) A NTP may not refuse to allow an inspection or otherwise interfere with 
personnel of the State Methadone Authority in the performance of their duties, 
including the photocopying of patient records during an inspection. It is a 
violation for a NTP not to fully cooperate in any inspection by the State 
Methadone Authority. 
   
  (z)  Each NTP shall notify the State Methadone Authority in writing of any 
change in the employment status of any of its program personnel. This notice 
shall be provided within 20 days of the event. 
   
  (aa) NTP counselors not exempted must be licensed by the Texas Commission on 
Alcohol and Drug Abuse (TCADA). 
   
  (bb) Any theft from or illegal break-in to the clinic must be reported in 
writing to the State Methadone Authority within 10 days of the event. 
 
  This agency hereby certifies that rule as adopted has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 28, 1993. 
 TRD-9324915 
  Robert A. MacLean, M.D. 
 Deputy Commissioner 
 Texas Department of Health 
    Effective date: July 29, 1993 
 For further information, please call: (512) 458-7248 
         
             
  Registration of Manufacturers of Food-Including Good Manufacturing Practices 
 
  25 TAC sec.229.182, sec.229.183 
 
  The Texas Department of Health (department) adopts amendments to sec.229.182 
and sec.229. 183, concerning registration fee and procedures; and minimum 
standards for registration of manufacturing of food-including good manufacturing 
practices, without change to the proposed text as published in the May 11, 1993, 
issue of the Texas Register  (18 TexReg 3015). 
 The amendments will enable the department to register and regulate 
manufacturers of food so as to ensure compliance with the federal regulations 
titled "Current Good Manufacturing Practice in Manufacturing, Packing, or 
Holding Human Food." The changed deadlines will enable the department to process 
the registrations in a more timely manner, help reduce the massive peak workload 
which results from processing over 9,200 food and drug applications at the same 
time, eliminate the need for temporary workers to assist with registration, and 
afford the department more time to follow up on firms that are delinquent in fee 
payment. 
 No comments were received relating to the proposed amendments. 
 The amendments are adopted under the Texas Health and Safety Code, sec.431. 
241, which provides the department with the authority to adopt necessary 
regulations pursuant to the enforcement of this chapter; sec.431.225, which 
provides the Board the authority to adopt regulations to provide that 
registrations may expire at different dates during the year and to prorate 
registration fees payable on or before September 1 so that each registrant is 
required to pay only that portion of the registration fee allocable to the 
number of months during which the registration is valid ; and 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 legal authority. 
 Issued in Austin, Texas, on June 28, 1993. 
 TRD-9324977 
  Robert A. MacLean, M.D. 
 Deputy Commissioner 
 Texas Department of Health 
    Effective date: July 20, 1993 
 Proposal publication date: May 11, 1993 
 For further information, please call: (512) 458-7248 
         
         
  Licensing of Wholesale Distributors of Drugs-Including Good Manufacturing 
Practices 
 
  25 TAC sec.229.252 
 
  The Texas Department of Health (department) adopts an amendment to 
sec.229.252, concerning licensing fees and procedures for wholesale distributors 
of drugs-including good manufacturing practices, with changes to the proposed 
text as published in the May 11, 1993, issue of the Texas Register  (18 TexReg 
3016). 
 The amendment will enable the department to license and regulate wholesale 
distributors of drugs so as to ensure compliance with the federal regulations 
entitled "Current Good Manufacturing Practice in Manufacturing, Processing, 
Packing, or Holding of Drugs; General." The changed deadlines will enable the 
department to process the applications in a more timely and efficient manner, 
help reduce the massive peak workload which results from processing over 1,600 
drug applications at the same time, eliminate the need for temporary workers to 
assist with registration, and afford the department more time to follow up on 
firms that are delinquent in fee payment. 
 No comments were received; however, the department felt clarification was 
needed as to the requirements necessary to amend licenses. The department has 
included the necessary language in sec.229.252(g)(3)(A) which will clarify the 
intent of the statute. 
 The amendment is adopted under the Texas Health and Safety Code, sec.431.241, 
which provides the department with the authority to adopt necessary regulations 
pursuant to the enforcement of this chapter; sec.431.205, which provides the 
Board the authority to adopt regulations to provide that licenses may expire on 
different dates during the year and to prorate license fees payable on or before 
September 1 so that the licensee is required to pay only that portion of the fee 
that is allocable to the number of months during which the license is valid; and 
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. 
 
 
  sec.229.252. Licensing Fee and Procedures. 
 
  (a) License fee. All wholesale distributors of drugs who sell drugs in Texas 
shall obtain a license annually with the Texas Department of Health (department) 
and shall pay a licensing fee for each wholesale distribution place of business 
operated as follows: 
 
  (1)-(5) (No change.) 
     
  (b)-(e) (No change.) 
   
  (f) Issuance of license. The department may license a wholesale distributor of 
drugs who meets the requirements of this section and sec.229.253 of this title 
(relating to Minimum Standards for Licensing). 
 
  (1) The initial license shall be valid for one year from the date of issuance 
which becomes the anniversary date. 
   
  (2) The renewal license shall be valid for one year from the anniversary date. 
     
  (g) Renewal of license. 
 
  (1) Each year, the wholesale distributor of drugs shall renew its license 
following the requirements of this section and sec.229.253 of this title 
(relating to Minimum Standards for Licensing). 
   
  (2) A person who holds a license issued by the department under the Health and 
Safety Code shall renew the license by filing an application for renewal on a 
form prescribed by the Department, accompanied by the appropriate licensure fee. 
A licensee must file for renewal before the expiration date of the current 
license. A person who files a renewal application after the expiration date must 
pay an additional $100 as a delinquency fee. 
   
  (3) Failure to submit the renewal annually may subject the wholesale 
distributor of drugs to the enforcement provisions under Health and Safety Code, 
Chapter 431, and to the provisions of sec.229.254 of this title (relating to 
Refusal, Revocation, or Suspension of License). 
 
  (A) Amendment of license. A license that is amended, including a change of 
name, ownership, or a notification of a change in the location of a licensed 
place of business required under the Health and Safety Code, sec.431.206, will 
require submission of fees as outlined in subsection (a) of this section. 
   
  (B) Notification of change of location of place of business. Not fewer than 30 
days in advance of the change, the licensee shall notify the Commissioner of 
Health (commissioner) or the commissioner's designee in writing of the 
licensee's intent to change the location of a licensed place of business. The 
notice shall include the address of the new location, and the name and residence 
address of the individual in charge of the business at the new location. Not 
more than 10 days after the completion of the change of location, the licensee 
shall notify the commissioner or the commissioner's designee in writing to 
verify the change of location, the address of the new location, and the name and 
residence address of the individual in charge of the business at the new 
address. Notice will be deemed adequate if the licensee provides the intent and 
verification notices to the commissioner or the commissioner's designee by 
certified mail, return receipt requested, mailed to the Texas Department of 
Health, 1100 West 49th Street, Austin. 
       
  (h) Exemption from licensing. Persons who engage only in the following types 
of wholesale drug distribution are exempt from the licensing requirements of 
this undesignated head, to the extent that it does not violate provisions of the 
Texas Dangerous Drug Act or the Texas Controlled Substances Act, the Health and 
Safety Code: 
 
  (1)  intracompany sales; 
   
  (2) the purchase or acquisition by a hospital or other health care entity that 
is a member of a group purchasing organization of a drug for its own use from 
the group purchasing organization or from other hospitals or health care 
entities that are members of such organizations; 
   
  (3) the sale, purchase, or trade of a drug or an offer to sell, purchase, or 
trade a drug by a charitable organization, as described in the Internal Revenue 
Code of 1986, sec.501(c)(3), to a nonprofit affiliate of the organization to the 
extent otherwise permitted by law; 
   
  (4) the sale, purchase, or trade of a drug or an offer to sell, purchase, or 
trade a drug among hospitals or other health care entities that are under common 
control. For the purpose of this subsection, "common control" means the power to 
direct or cause the direction of the management and policies of a person or an 
organization, whether by ownership of stock, voting rights, contract, or 
otherwise; 
   
  (5) the sale, purchase, or trade of a drug or an offer to sell, purchase, or 
trade a drug for emergency medical reasons. For purposes of this section, 
"emergency medical reasons" includes transfers of prescription drugs by a retail 
pharmacy to another retail pharmacy to alleviate a temporary shortage; 
   
  (6) the sale, purchase, or trade of a drug, an offer to sell, purchase, or 
trade a drug, or the dispensing of a drug pursuant to a prescription; 
   
  (7) the distribution of drug samples by manufacturers' representatives or 
distributors' representatives; or 
   
  (8) the sale, purchase, or trade of blood and blood components intended for 
transfusion. 
 
  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 June 29, 1993. 
 TRD-9324976 
  Robert A. MacLean, M.D. 
 Deputy Commissioner 
 Texas Department of Health 
    Effective date: July 20, 1993 
 Proposal publication date: May 11, 1993 
 For further information, please call: (512) 458-7248