TITLE 25.HEALTH SERVICES

Part 1. DEPARTMENT OF STATE HEALTH SERVICES

Chapter 140. HEALTH PROFESSIONS REGULATION

Subchapter B. PERSONAL EMERGENCY RESPONSE SYSTEM PROVIDERS

25 TAC §§140.30 - 140.47

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), adopts new §§140.30 - 140.47, concerning the regulation and licensing of personal emergency response system (PERS) providers without changes to the proposed text as published in the July 21, 2006, issue of the Texas Register (31 TexReg 5753) and, therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

The passage of Senate Bill 568 in the 79th Regular Session of the Texas Legislature, 2005, created new Health and Safety Code, Chapter 781, exclusively focusing on the licensing and regulation of personal emergency response system (PERS) providers. It is the purpose of these rules to implement and administer Health and Safety Code, Chapter 781.

A "personal emergency response system" is one that is "installed in the residence of a person; monitored by an alarm company; designed only to permit the person to signal the occurrence of a medical or personal emergency on the part of the person so that the provider may dispatch the appropriate aid; and is not part of a combination of alarm systems that includes a burglar alarm or fire alarm."

SECTION BY SECTION SUMMARY

Section 140.30 introduces the content and purpose of the chapter. Section 140.31 provides definitions of terms used throughout the chapter. Section 140.32 provides a schedule of fees for program. Section 140.33 provides a method for the public to request that rules be adopted or amended. Section 140.34 sets out standard department requirements for the initial license and registration application process. Section 140.35 establishes general liability insurance requirements for licensees. Section 140.36 references the across-the-board application processing timeframes and procedures established for professional licensing staff. Section 140.37 defines who is required to hold a license and a registration. Section 140.38 sets out specific procedures for renewing licenses and registrations; and addresses across-the-board legislative requirements concerning active military duty, student loan default, and child support/custody. Section 140.39 clearly assigns responsibility for address change notifications to the licensee/registrant.

Section 140.40 establishes standards of ethical conduct for PERS licensees and registrants, and addresses the relationship between the department and PERS providers. Section 140.41 addresses department policy to provide information regarding regulatory functions and complaint procedures to the public and other agencies. Section 140.42 details the complaint process and complaint investigation. Section 140.43 defines grounds for disciplinary action to be taken against licensees and registrants. Section 140.44 addresses informal conferences. Section 140.45 addresses formal hearings. Section 140.46 sets out guidelines for the licensing and registration of persons with criminal convictions. Section 140.47 addresses license suspension for failure to maintain insurance coverage.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared responses to the comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The commenters were individuals, associations, and/or groups. The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of comments. Commenters were generally in favor of rules.

Comment: Concerning §140.32, three commenters stated opposition to the amount of the licensing and registration fees. Two of the commenters indicated that the licensing fee amounts will have to be passed on to consumers, and one of the commenters recommended specific fee reductions.

Response: The commission understands concerns relating to the amount of licensing fees, but disagrees with the commenters. Health and Safety Code, §12.0111, requires the Department of State Health Services to "charge a fee for issuing or renewing a license that is in an amount designed to allow the department to recover from its license holders all of the department's direct and indirect costs in administering and enforcing the applicable licensing program." Because of this mandate, the fee amounts are based on the projected direct and indirect costs of administering and enforcing the PERS licensing program, as well as the number of license holders and registrants who will pay the fee. No change was made to the rule as a result of this comment.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Cathy Campbell, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

STATUTORY AUTHORITY

The adopted new sections are authorized by Health and Safety Code, §781.051(b), which requires the Executive Commissioner to adopt rules necessary to administer the chapter and by Health and Safety Code, §781.051(c), which requires the Executive Commissioner to establish fees necessary to administer the chapter, including fees for processing and issuing or renewing a license or registration under the chapter; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

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 January 12, 2007.

TRD-200700115

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: February 1, 2007

Proposal publication date: July 21, 2006

For further information, please call: (512) 458-7111 x6972

Chapter 229. FOOD AND DRUG

The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts new §§229.40, 229.41, 229.241 - 229.252, 229.419 - 229.430, and the repeal of §§229.251 - 229.254, concerning the regulation of cosmetics, the licensing of wholesale distributors of nonprescription drugs--including good manufacturing practices, and the licensing of wholesale distributors of prescription drugs--including good manufacturing practices. New §229.430 is adopted with changes to the proposed text as published in the July 14, 2006, issue of the Texas Register (31 TexReg 5540). The repeal of §§229.251 - 229.254 and new §§229.40, 229.41, 229.241 - 229.252, and 229.419 - 229.429 are adopted without changes and, therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

The new sections are necessary to comply with amendments to Health and Safety Code, Chapter 431, Subchapters I and N, relating to the licensing and regulation of nonprescription and prescription drugs. Subchapter I of the statute sets forth the standards for the licensing and regulation of nonprescription drugs and requires the department to adopt rules to implement and enforce the subchapter. Existing §§229.251 - 229.254 in Subchapter O of Chapter 229 of this title originally set forth the requirements for all drug and cosmetic manufacturers and distributors, but is being repealed in order to separate the licensing and regulation of the various commodities.

SECTION-BY-SECTION SUMMARY

New §229.40 and §229.41 reflect the regulations for cosmetic manufacturing and labeling, setting out the scope and purpose and adopting by reference the federal requirements for cosmetics.

New §§229.241 - 229.252 set forth the licensing and regulation of manufacturers and distributors of nonprescription drugs. Section 229.241 sets forth the purpose of the rules. Section 229.242 adopts by reference the federal requirement for nonprescription drugs. Section 229.243 sets forth the definitions used in the rules. Section 229.244 defines the word "sale" to include entire stream of possession of nonprescription drugs until possession by a consumer. Sections 229.245 - 229.248 set out the exemptions from licensing; licensing requirements; licensing procedures; and the requirements for reporting licensure changes. Section 229.249 sets out the licensing fees for each category of license. Section 229.250 sets forth the reasons for refusing to issue a license and for canceling, suspending, or revoking a license. Section 229.251 sets out the minimum standards for licensure, including good manufacturing practices. Section 229.252 sets out the enforcement and penalties provisions.

New §§229.419 - 229.430 set forth the licensing and regulation of manufacturers and distributors of prescription drugs. Section 229.419 sets forth the purpose of the rules. Section 229.420 adopts by reference the federal requirement for prescription drugs. Section 229.421 sets forth the definitions used in the rules. Section 229.422 defines the word "sale" to include entire stream of possession of prescription drugs until possession by a consumer. Section 229.423 sets out the exemptions from licensing. Section 229.424 outlines licensing requirements. Section 229.425 sets forth the licensing procedures, and §229.426 sets forth the requirements for reporting licensure changes. Section 229.427 sets out the licensing fees for each category of license. Section 229.428 sets forth the reasons for refusing to issue a license and for canceling, suspending, or revoking a license. Section 229.429 sets out the minimum standards for licensure, including good manufacturing practices. Section 229.430 outlines enforcement and penalties provisions.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared a response to the comment received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The commenter was the Healthcare Distribution Management Association. The commenter was not against the rules in their entirety; however, the commenter suggested a recommendation for change as discussed in the summary of comments. The commenter was generally in favor of the rules.

Comment: Concerning the criteria for issuing a cease distribution order in §229.430(f)(1)(A)(ii), the commenter suggested that the reference to the term "falsified pedigree" be removed since the rules do not currently address pedigree requirements.

Response: The commission agrees and has deleted the words "falsified pedigree" so that the rule text in §229.430(f)(1)(A) no longer references the term.

LEGAL CERTIFICATION

The Department of State Health Services, General Counsel, Cathy Campbell, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

Subchapter D. REGULATION OF COSMETICS

25 TAC §229.40, §229.41

STATUTORY AUTHORITY

The new sections are adopted under the Health and Safety Code, §431.241, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary for the implementation and enforcement of Chapter 431 by the department; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

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 January 12, 2007.

TRD-200700110

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: February 1, 2007

Proposal publication date: July 14, 2006

For further information, please call: (512) 458-7111 x6972

Subchapter O. LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES

25 TAC §§229.241 - 229.252

STATUTORY AUTHORITY

The new sections are adopted under the Health and Safety Code, §431.241, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary for the implementation and enforcement of Chapter 431 by the department; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

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 January 12, 2007.

TRD-200700111

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: February 1, 2007

Proposal publication date: July 14, 2006

For further information, please call: (512) 458-7111 x6972

Subchapter O. LICENSING OF WHOLESALE DISTRIBUTORS OF DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES

25 TAC §§229.251 - 229.254

STATUTORY AUTHORITY

The repeals are adopted under the Health and Safety Code, §431.241, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary for the implementation and enforcement of Chapter 431 by the department; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

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 January 12, 2007.

TRD-200700112

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: February 1, 2007

Proposal publication date: July 14, 2006

For further information, please call: (512) 458-7111 x6972

Subchapter W. LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES

25 TAC §§229.419 - 229.430

STATUTORY AUTHORITY

The new sections are adopted under the Health and Safety Code, §431.241, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules necessary for the implementation and enforcement of Chapter 431 by the department; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

§229.430.Enforcement and Penalties.

(a) Inspection.

(1) To enforce these sections or the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act), the commissioner, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:

(A) enter at reasonable times a place of business, including a factory or warehouse, in which a prescription drug is manufactured, packed, or held for introduction into commerce or held after the introduction;

(B) enter a vehicle being used to transport or hold a prescription drug in commerce; or

(C) inspect at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.

(2) The inspection of a place of business, including a factory, warehouse, or consulting laboratory, in which a prescription drug is manufactured, processed, packed, or held for introduction into commerce extends to any place or thing, including a record, file, paper, process, control, or facility, in order to determine whether the drug:

(A) is adulterated or misbranded;

(B) may not be manufactured, introduced into commerce, sold, or offered for sale under the Act; or

(C) is otherwise in violation of these sections or the Act.

(3) An inspection under paragraph (2) of this subsection may not extend to:

(A) financial data;

(B) sales data other than shipment data;

(C) pricing data;

(D) personnel data other than data relating to the qualifications of technical and professional personnel performing functions under the Act;

(E) research data other than data:

(i) relating to new drugs and antibiotic drugs; and

(ii) subject to reporting and inspection under regulations issued under §505(i) or (j) of the Federal Act; or

(F) data relating to other drugs that, in the case of a new drug, would be subject to reporting or inspection under regulations issued under §505(j) of the Federal Act.

(4) An inspection under paragraph (2) of this subsection shall be started and completed with reasonable promptness.

(b) Receipt for samples. An authorized agent or health authority who makes an inspection of a place of business, including a factory or warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, shall give to the owner, operator, or the owner's or operator's agent a receipt describing the sample.

(c) Access to records.

(1) A person who is required to maintain records referenced in these sections or under the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) or Chapter V of the Federal Food, Drug, and Cosmetic Act (Federal Act) or a person who is in charge or custody of those records shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times access to and to copy and verify the records.

(2) A person, including a carrier engaged in commerce, or other person receiving a prescription drug in commerce or holding a prescription drug received in commerce shall, at the request of an authorized agent, permit the authorized agent at all reasonable times to have access to and to copy and verify all records showing:

(A) the movement in commerce of any prescription drug;

(B) the holding of any prescription drug after movement in commerce; and

(C) the quantity, shipper, and consignee of any prescription drug.

(d) Retention of records. Records required by these sections shall be maintained at the place of business or other location that is reasonably accessible for a period of at least three years following disposition of the prescription drug unless a greater period of time is required by laws and regulations adopted in §229.420 of this title (relating to Applicable Laws and Regulations).

(e) Adulterated or misbranded prescription drug. If the department identifies an adulterated or misbranded prescription drug, the department may impose the applicable enforcement provisions of Subchapter C of the Act including, but not limited to: detention, emergency order, recall, condemnation, destruction, injunction, civil penalties, criminal penalties, and/or administrative penalties. Administrative and civil penalties will be assessed using the Severity Levels contained in §229.251 of this title (relating to Minimum Standards for Licensure).

(f) Order to cease distribution.

(1) The commissioner shall issue an order requiring a person, including a manufacturer, distributor, or retailer of a prescription drug, to immediately cease distribution of the drug if the commissioner determines there is a reasonable probability that:

(A) a wholesale distributor has:

(i) violated these sections or the Act; or

(ii) sold, distributed, transferred, manufactured, repackaged, handled, or held a counterfeit prescription drug intended for human use that could cause serious adverse health consequences or death; and

(B) other procedures would result in unreasonable delay.

(2) An order under this subsection must provide the person subject to the order with an opportunity for an informal hearing on the actions required by the order to be held not later than the 10th day after the date of issuance of the order.

(3) If, after providing an opportunity for a hearing, the commissioner determines that inadequate grounds exist to support the actions required by the order, the commissioner shall vacate the order.

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 January 12, 2007.

TRD-200700113

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: February 1, 2007

Proposal publication date: July 14, 2006

For further information, please call: (512) 458-7111 x6972