PART 1. TEXAS DEPARTMENT OF PUBLIC SAFETY
CHAPTER 13. CONTROLLED SUBSTANCES
SUBCHAPTER A. GENERAL PROVISIONS
The Texas Department of Public Safety (the department) adopts amendments to §13.1, concerning Definitions. The amendments are adopted without changes to the proposed text as published in the March 8, 2013, issue of the Texas Register (38 TexReg 1661) and will not be republished.
The amendments are necessary to reorganize and consolidate the rules governing definitions and to generally improve the clarity of the related rules.
No comments were received regarding the adoption of the amendments.
The amendments are adopted pursuant to Texas Government Code, §411.004(3), which authorizes the Public Safety Commission to adopt rules considered necessary for carrying out the department's work, and Texas Health and Safety Code, §481.003, which authorizes the department to adopt rules to enforce Chapter 481 of the Texas Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on April 19, 2013.
TRD-201301593
D. Phillip Adkins
General Counsel
Texas Department of Public Safety
Effective date: May 9, 2013
Proposal publication date: March 8, 2013
For further information, please call: (512) 424-5848
The Texas Department of Public Safety (the department) adopts the repeal of §§13.2 - 13.11, concerning General Provisions. The repeal is adopted without changes to the proposal as published in the March 8, 2013, issue of the Texas Register (38 TexReg 1662) and will not be republished.
The repeal is necessary to reorganize and consolidate the rules governing definitions and to generally improve the clarity of the related rules.
No comments were received regarding the adoption of the repeal.
The repeal is adopted pursuant to Texas Government Code, §411.004(3), which authorizes the Public Safety Commission to adopt rules considered necessary for carrying out the department's work, and Texas Health and Safety Code, §481.003, which authorizes the department to adopt rules to enforce Chapter 481 of the Texas Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on April 19, 2013.
TRD-201301594
D. Phillip Adkins
General Counsel
Texas Department of Public Safety
Effective date: May 9, 2013
Proposal publication date: March 8, 2013
For further information, please call: (512) 424-5848
The Texas Department of Public Safety (the department) adopts the repeal of §§13.21 - 13.33, concerning Registration. The repeal is adopted without changes to the proposal as published in the March 8, 2013, issue of the Texas Register (38 TexReg 1663) and will not be republished.
The repeal of this subchapter is necessary to reorganize and consolidate the rules governing registration requirements and procedures and to generally improve the clarity of the related rules.
No comments were received regarding the adoption of the repeal.
The repeal is adopted pursuant to Texas Government Code, §411.004(3), which authorizes the Public Safety Commission to adopt rules considered necessary for carrying out the department's work, and Texas Health and Safety Code, §481.003, which authorizes the department to adopt rules to enforce Chapter 481 of the Texas Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on April 19, 2013.
TRD-201301595
D. Phillip Adkins
General Counsel
Texas Department of Public Safety
Effective date: May 9, 2013
Proposal publication date: March 8, 2013
For further information, please call: (512) 424-5848
The Texas Department of Public Safety (the department) adopts new §§13.21 - 13.27, concerning Registration. Section 13.26 and §13.27 are adopted with changes to the proposed text as published in the March 8, 2013, issue of the Texas Register (38 TexReg 1664) and will be republished. Sections 13.21 - 13.25 are adopted without changes and will not be republished.
The adopted new Subchapter B is necessary to reorganize and consolidate the rules governing registration requirements and procedures and to generally improve the clarity of the related rules.
The department accepted comment on the proposed rules through April 8, 2013. Written comments were submitted by Katherine Thomas, Executive Director of the Texas Board of Nursing, and by Lynda Woolbert, Regulatory Consultant for the Coalition for Nurses in Advanced Practice. Changes were made to proposed new §13.27 based on the comments received by the department. Substantive comments received, as well as the department's responses thereto, are summarized below:
COMMENT: Regarding §13.27(e), both Ms. Thomas and Ms. Woolbert commented on certain inconsistencies between the language in this subsection and the statutory provisions of Texas Occupations Code, §157.054, relating to the delegation of authority to prescribe controlled substances.
RESPONSE: The department agrees with these comments and has revised the proposal accordingly, deleting text in §13.27(e) to remove inconsistencies with statute.
COMMENT: Regarding §13.27 generally, Ms. Woolbert commented on the proposal's use of the term "supervising physician" and proposed the substitution of the term "delegating physician" throughout the section to be consistent with Texas Medical Board rules.
RESPONSE: The department agrees with this recommendation and has revised the adoption accordingly.
The new sections are adopted pursuant to Texas Government Code, §411.004(3), which authorizes the Public Safety Commission to adopt rules considered necessary for carrying out the department's work, and Texas Health and Safety Code, §481.003, which authorizes the department to adopt rules to enforce Chapter 481 of the Texas Health and Safety Code.
§13.26.Requirement to Update Information.
(a) An applicant for or holder of a registration, a temporary registration, or an annual permit must notify the department before the seventh day after any modification or change in the person's business name, address, physician delegating prescriptive authority, telephone number or other information required on the application, registration, or permit.
(b) The notification must be in writing and include the signature of the registrant or other person who is authorized to sign an original application.
(c) If changing a delegating physician's prescriptive authority, the notification must include the physician's:
(1) name;
(2) Texas Medical Board license number;
(3) DPS registration number;
(4) signature; and
(5) date of signature.
(d) A request for modification of a registration may be denied if the modification does not meet the requirements under this section, or if there exists an applicable basis for the denial of an application as described in the Act, §481.063(e).
(e) A registrant may not transfer or assign a registration certificate or an authority conferred by the registration.
§13.27.Mid-level Practitioner.
(a) A mid-level practitioner must have a delegating physician with prescriptive authority as required by the Act, §481.002(39)(D). Each physician must certify the authorizing delegation on the mid-level practitioner's application and include the physician's:
(1) name;
(2) Texas Medical Board license number;
(3) DPS registration number;
(4) signature; and
(5) date of signature.
(b) A physician who signs a mid-level practitioner's application as the delegating physician assumes responsibility for ensuring the mid-level practitioner practices under the laws of this state related to controlled substances prescribing activities. A physician who fails to properly monitor the mid-level practitioner's activities may be subject to disciplinary action.
(c) A delegating physician must have an unrestricted and active DPS registration and Texas Medical Board license number.
(d) Modification or change of delegating physician.
(1) A change of delegating physician must be submitted in writing as required by this chapter.
(2) A delegating physician must notify the department in writing to terminate delegation with a mid-level practitioner.
(e) Accurate and timely internal institutional records listing the name and license number of the physician must be made available to the department within 24 hours of a request.
(f) The physician is limited to the extent and number of mid-level practitioners the physician delegated as outlined in Texas Occupations Code, Chapter 157.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on April 19, 2013.
TRD-201301596
D. Phillip Adkins
General Counsel
Texas Department of Public Safety
Effective date: May 9, 2013
Proposal publication date: March 8, 2013
For further information, please call: (512) 424-5848
The Texas Department of Public Safety (the department) adopts the repeal of §§13.71 - 13.99, concerning Texas Prescription Program. The repeal is adopted without changes to the proposal as published in the March 8, 2013, issue of the Texas Register (38 TexReg 1666) and will not be republished.
The repeal of this subchapter is necessary to reorganize and consolidate the rules governing the Texas Prescription Program's reporting requirements and procedures and to generally improve the clarity of the related rules.
No comments were received regarding the adoption of the repeal.
The repeal is adopted pursuant to Texas Government Code, §411.004(3), which authorizes the Public Safety Commission to adopt rules considered necessary for carrying out the department's work, and Texas Health and Safety Code, §481.003, which authorizes the department to adopt rules to enforce Chapter 481 of the Texas Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on April 19, 2013.
TRD-201301597
D. Phillip Adkins
General Counsel
Texas Department of Public Safety
Effective date: May 9, 2013
Proposal publication date: March 8, 2013
For further information, please call: (512) 424-5848
The Texas Department of Public Safety (the department) adopts new §§13.71 - 13.83, concerning Texas Prescription Program. The new sections are adopted without changes to the proposed text as published in the March 8, 2013, issue of the Texas Register (38 TexReg 1667) and will not be republished.
The adopted new Subchapter D is necessary to reorganize and consolidate the rules governing the Texas Prescription Program's reporting requirements and procedures and to generally improve the clarity of the related rules.
The department accepted comment on the proposed rules through April 8, 2013. Written comments were submitted by Mary Staples representing National Association of Chain Drug Stores (NACDS). Substantive comments received, as well as the department's responses thereto, are summarized below:
COMMENT: Regarding §13.75(3), NACDS recommends the department either eliminate the requirement to report the department's "designated placeholder" for schedule II electronic prescriptions or waive the requirement to report this particular data element until twelve months after the department provides pharmacies with the appropriate default value to report for this purpose.
RESPONSE: The department disagrees with these recommendations. The submission of the data element at issue is a requirement of the department's prescription database software application. Waiver or elimination of the requirement would cause the system to reject the electronic submission, resulting in additional administrative burdens on the dispenser and the need for manual processing by the department. In addition, no specific data element has been established at this time. It is the department's intent to establish a "placeholder" value that will have minimal or no impact on the dispenser.
The new sections are adopted pursuant to Texas Government Code, §411.004(3), which authorizes the Public Safety Commission to adopt rules considered necessary for carrying out the department's work, and Texas Health and Safety Code, §481.003, which authorizes the department to adopt rules to enforce Chapter 481 of the Texas Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on April 19, 2013.
TRD-201301598
D. Phillip Adkins
General Counsel
Texas Department of Public Safety
Effective date: May 9, 2013
Proposal publication date: March 8, 2013
For further information, please call: (512) 424-5848
The Texas Department of Public Safety (the department) adopts the repeal of §§13.131 - 13.137, concerning Application. The repeal is adopted without changes to the proposal as published in the March 8, 2013, issue of the Texas Register (38 TexReg 1670) and will not be republished.
The repeal of this subchapter is necessary to reorganize and consolidate the rules governing the application requirements and procedures for registration under the Controlled Substances Act, Texas Health and Safety Code Chapter 481 and to generally improve the clarity of the related rules.
No comments were received regarding the adoption of the repeal.
The repeal is adopted pursuant to Texas Government Code, §411.004(3), which authorizes the Public Safety Commission to adopt rules considered necessary for carrying out the department's work, and Texas Health and Safety Code, §481.003, which authorizes the department to adopt rules to enforce Chapter 481 of the Texas Health and Safety Code.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on April 19, 2013.
TRD-201301599
D. Phillip Adkins
General Counsel
Texas Department of Public Safety
Effective date: May 9, 2013
Proposal publication date: March 8, 2013
For further information, please call: (512) 424-5848