TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 181. VITAL STATISTICS

The Texas Department of Health (department) adopts amendments to §§181.10, 181.21, and 181.23 concerning confidentiality of birth records; indexes of birth and death indexes; and hearings on denials of requests for certified copies of vital records. Section 181.23 is adopted with changes to the proposed text as published in the December 3, 1999, issue of the Texas Register (24 TexReg 10730). Sections 181.10 and 181.21 are adopted without changes, and therefore will not be republished.

Sections 181.10 and 181.23 clarify that a birth record becomes public information 50 years from the date on the record, and a death record becomes public information 25 years from the date on the record, rather than the date the record was filed by the bureau of vital statistics. The sections require that local registration officials as well as the bureau of vital statistics must make summary birth and death indexes and general birth and death indexes available as public information in conformity with the Texas Open Records Act unless the records would reveal the fact of an adoption or a paternity determination. Section 181.23(c)(1) lists additional data which must be included in birth and death indexes maintained by the bureau of vital statistics or by local registration officials, and amendments to §181.23(c)(2) as proposed make the provisions concerning confidentiality of general death indexes compatible with those for general birth indexes.

Section 181.21 will allow the department to offer applicants a fair hearing by a department hearing examiner rather than a more formal procedure conducted by the State Office of Administrative Hearings, resulting in substantial cost savings by the department and by some applicants.

The department is making the following change due to staff comments to clarify the intent and to increase the consistency and accuracy of the section.

Change: Concerning §181.23(c)(2), the same language which limits the extent to which general birth indexes are public information has been added to this section relating to general death indexes in order to be consistent with Government Code §552.115 as amended by the 76th Legislature.

The following comments were received concerning the proposed sections. Following each comment is the department's response.

Comment: Concerning §181.23(b)(2) and §181.23(c)(2), one commentor agreed that the public should have access to the information in general birth and death indexes, but added that either the public should pay the costs of expunging or deleting state and local file numbers from copies of indexes provided to requestors or the state should provide funding to defray the additional costs incurred by local registration officials.

Response: The department agrees that indexes should be made available to the public. However, Local Government Code §118.011(4)(a) already requires county clerks to collect a fee of $1.00 per page or part of a page for noncertified copies, and municipalities may set fees by ordinance for their municipal clerks who act as local registration officials. Further, since Government Code §552.115 as amended by House Bill 836, 76th Legislature, did not authorize reimbursement for additional costs incurred by local registration officials with state funds, no changes were made as a result of this comment.

Comment: Concerning §181.23(c)(1), a commentor stated that requiring the addition of social security numbers to general death indexes maintained by local registration officials is a bad idea.

Response: Social security numbers are currently included on death certificates, and Government Code, §552.115 provides that death indexes as well as death records are public information and available to the public on and after the 25th anniversary of the date of death. No change was made as a result of this comment.

Comment: Concerning §181.23(c)(1), one commentor asked whether the department would provide funds for purchasing new index books in the middle of a budget year.

Response: Amendments to Texas vital records statutes by the 76th Legislature did not require local registration officials who do not now compile general death indexes to begin doing so, and neither required or authorized the department to provide funds to local registration officials for purchase of index books. No change was made as a result of this comment.

Comment: Concerning §181.23(c)(1), one commentor stated that requiring the inclusion of the social security number and the name of the surviving spouse in general death indexes would allow unscrupulous con artists to prey on loved ones of the deceased.

Response: Social security numbers and the names of surviving spouses are currently included on death certificates which are public information by law 25 years after the date of death. General death indexes are public information only to the extent that they relate to death records that are public information. Requiring inclusion of the registrant's social security number and the name of the surviving spouse in general indexes for deaths which occurred less than 25 years ago will afford con artists no greater opportunity to victimize survivors of the deceased. No change was made as a result of this comment.

The commentors were the County Clerk, Andrews County; the City Secretary, City of Victoria; and the County Clerk, Tom Green County.

Subchapter A. MISCELLANEOUS PROVISIONS

25 TAC §181.10

The amendment is adopted under Health and Safety Code §191.003, which provides the Board of Health (board) with the authority to adopt necessary rules for collecting, recording, transcribing, compiling, and preserving vital statistics; §191.057(c) which provides that if the state registrar refuses to issue a certified copy of a birth, death, or fetal death record, the department shall afford the applicant an opportunity for a hearing; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the Commissioner.

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 February 25, 2000.

TRD-200001447

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 16, 2000

Proposal publication date: December 3, 1999

For further information, please call: (512) 458-7236


Subchapter B. VITAL RECORDS

25 TAC §181.21, §181.23

The amendments are adopted under Health and Safety Code §191.003, which provides the Board of Health (board) with the authority to adopt necessary rules for collecting, recording, transcribing, compiling, and preserving vital statistics; §191.057(c) which provides that if the state registrar refuses to issue a certified copy of a birth, death, or fetal death record, the department shall afford the applicant an opportunity for a hearing; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the Commissioner.

§181.23.Indexes for Vital Records.

(a)

The state registrar shall establish and maintain an index to all vital records filed within the Bureau of Vital Statistics.

(b)

Birth indexes.

(1)

General birth indexes maintained or established by the bureau of vital statistics or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, the state or local file number, the name of the father, the maiden name of the mother, and sex of the registrant.

(2)

A general birth index is public information and available to the public to the extent the index relates to a birth record that is public on or after the 50th anniversary of the date of birth as shown on the record unless the fact of an adoption or paternity determination can be revealed or broken or if the index contains specific identifying information relating to the parents of the child who is the subject of an adoption placement. The bureau of vital statistics and local registration officials shall expunge or delete any state or local file numbers included in any general birth index made available to the public because such file numbers may be used to discover information concerning specific adoptions, paternity determinations, or the identity of the parents of children who are the subjects of adoption placements.

(3)

A summary birth index maintained or established by the bureau of vital statistics or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, and sex of the registrant.

(c)

Death indexes.

(1)

A general death index maintained or established by the bureau of vital statistics or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials; the date of the event; the county of occurrence; the registrant's social security number, sex, and marital status; the name of the registrant's spouse, if applicable; and the state or local file number.

(2)

A general death index is public information and available to the public to the extent the index relates to a death record that is public on or after the 25th anniversary of the date of death as shown on the record unless the fact of an adoption or paternity determination can be revealed or broken or if the index contains specific identifying information relating to the parents of the child who is the subject of an adoption placement. The bureau of vital statistics and local registration officials shall expunge or delete any state or local file numbers included in any general death index made available to the public because such file numbers may be used to discover information concerning specific adoptions, paternity determinations, or the identity of the parents of children who are the subjects of adoption placements.

(3)

A summary death index maintained or established by the bureau of vital statistics or a local registration official shall be prepared by event year, in alphabetical order by surname of the registrant, followed by any given names or initials, the date of the event, the county of occurrence, and sex of the registrant.

(d)

Indexes to marriage and divorce records shall be cross-referenced by the names of the husband and wife and include the event date and county of occurrence.

(e)

Consolidated indexes are indexes of vital records consisting of more than one event year. Consolidated indexes may be prepared for any vital event at the discretion of the state registrar in the form he may prescribe.

(f)

Please refer to §181.10(c) of this title (relating to Confidentiality of Birth Records Covering Adoption Placement) for additional information relating to general indexes including information concerning adoptions, paternity determinations, or the parents of a child who is the subject of an adoption placement and summary indexes of births and deaths.

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 February 25, 2000.

TRD-200001448

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 16, 2000

Proposal publication date: December 3, 1999

For further information, please call: (512) 458-7236


Chapter 229. FOOD AND DRUG

Subchapter A. FEDERAL LAWS AND REGULATIONS ON FOOD AND DRUGS

25 TAC §229.1, §229.2

The Texas Department of Health (department) adopts the repeal of §229.1and §229.2, concerning federal laws and regulations on food and drugs. The repealed sections are adopted without changes to the proposed repeal as published in the October 29, 1999, issue of the Texas Register (24 TexReg 9575), and therefore will not be republished.

The repeal of these rules is necessary because the rules are obsolete. Pursuant to the Government Code, §2001.039, each state agency is required to review and consider for readoption each rule adopted by that agency. The sections have been reviewed and the department has determined that reasons for adopting the sections no longer exist.

No comments were received concerning the proposed repeals during the comment period.

The repeals are adopted under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§229.1. Federal Laws on Food and Drugs.

§229.2. Federal Regulations on Food and Drugs.

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 February 28, 2000.

TRD-200001494

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2000

Proposal publication date: October 29, 1999

For further information, please call: (512) 458-7236


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

25 TAC §§229.251 - 229.254

The Texas Department of Health (department) adopts amendments to §§229.251 - 229.254, concerning the licensing of wholesale distributors of drugs including good manufacturing practices. Specifically, the sections cover definitions; licensing fees and procedures; minimum standards for licensure; and refusal, revocation, or suspension of a license. The department adopts these amendments without changes to the proposed text as published in the October 29, 1999, issue of the Texas Register (24 TexReg 9576), and therefore the sections will not be republished.

In §229.251, all definitions are numbered in accordance with Texas Register format to comply with 1 Texas Administrative Code, §91.1, effective February 17, 1998. Section 229.252 provides for a license, at no cost, for charitable organizations wholesaling over-the-counter (OTC) drugs and conforms §229.252(h) to the requirements of the Health and Safety Code, §431.2021, "Exemption From Licensing," which only allows for exemptions to licensing to those persons engaged in wholesale distribution of prescription drugs for use in humans. Section 229.253(a) clarifies existing requirements for all wholesale drug distributors and provides for guidelines for wholesale drug distributors of OTC drugs and establishes standards for storage practices and procedures for recalls and quarantine. Section 229.253(c) adopts by reference sections of the Health and Safety Code, Chapter 483, Texas Dangerous Drug Act, in order to clarify who can possess, sell, or transfer dangerous or legend drugs by drug wholesalers. Finally, §229.254 replaces "the Administrative Procedure and Texas Register Act, Texas Civil Statutes, Article 6252-13a" with "Government Code, Chapter 2001," pursuant to legislation passed by the 74th Texas Legislature.

Pursuant to Government Code, §2001.039, each state agency is required to review and consider for readoption each rule adopted by that agency. The sections have been reviewed and the department has determined that the reasons for adopting the sections continue to exist; however, the rules required revisions as described in this preamble.

The department published a Notice of Intention to Review these sections as required by Rider 167 in the Texas Register (23 TexReg 9078) on September 4, 1998. No comments were received by the department following the publication of the notice.

The following comment was received from the Consumer Healthcare Products Association concerning the proposed sections. Following the comment is the department's response.

Comment: Concerning the rules in general, the commenter supports these proposed rules and believes the changes will provide the kinds of safeguards for the storage of OTC drugs that are included in the U.S. Food and Drug Administration's regulations regarding the proper storage and handling of OTC products.

Response: The department agrees with the commenter. No changes are necessary.

The final amendments are adopted under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of this chapter; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department and the commissioner of health; Health and Safety Code, Chapter 431, Texas Food, Drug and Cosmetic Act; the Health and Safety Code, Chapter 12; and Government Code, §2001.039, as passed by the 76th Legislature.

§229.251. Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1)

Department -- Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(2)

Manufacturer -- A person who manufactures, prepares, propagates, compounds, processes, packages, repackages, or changes the container, wrapper, or labeling of any drug package.

(3)

Place of business -- Each location at which drugs are distributed at wholesale as defined in the Health and Safety Code, Chapter 431.

(4)

Wholesale distribution -- Distribution to a person other than a consumer or patient, including, but not limited to distribution to any person by a manufacturer, repacker, own label distributor, jobber, or wholesaler.

(5)

Flea market -- A location at which booths or similar spaces are rented or otherwise made available temporarily to two or more persons and at which the persons offer tangible personal property for sale.

§229.252. Licensing Fee and Procedures.

(a)

License fee.

(1)

All wholesale distributors of drugs who are not manufacturers of drugs in Texas shall obtain a license annually with the Texas Department of Health (department). Except as provided for in paragraph (2) of this subsection, wholesale distributors of drugs who are not manufacturers of drugs in Texas shall pay a licensing fee for each place of business operated as follows:

(A)

$250 per distributor engaged in distribution only of compressed medical gases (no transfilling operations) having gross annual drug sales of $0-$20,000;

(B)

$400 per wholesale distributor having gross annual drug sales of $0 - $199,999.99;

(C)

$650 per wholesale distributor having gross annual drug sales of $200,000 - $19,999,999.99;

(D)

$850 per wholesale distributor having gross annual drug sales greater than or equal to $20 million;

(E)

$750 per out-of-state wholesale distributor, unless an audited statement is provided which demonstrates gross annual drug sales of less than $20 million which would require a licensing fee of $500; and

(F)

$0.00 per wholesale distributor engaged in the distribution of an over-the-counter drug by a charitable organization, as described in the Internal Revenue Code of 1986, §501(c)(3), to a nonprofit affiliate of the organization to the extent otherwise permitted by law.

(2)

A wholesale distributor of drugs who is not a manufacturer of drugs, who is required to be licensed under this section and who is also required to be licensed as a device distributor under §229.439(a)(1) of this title (relating to Licensure Fees) or as a wholesale food distributor under §229.182(a)(3) of this title (relating to Licensing Fee and Procedures) shall pay a combined licensure fee for each place of business. The licensure fee shall be based on the combined gross annual sales of these regulated products (foods, drugs, and/or devices) as follows:

(A)

$200 for each place of business having combined gross annual sales of $0 - $199,999.99;

(B)

$300 for each place of business having combined gross annual sales of $200,000 - $499,999.99;

(C)

$400 for each place of business having combined gross annual sales of $500,000 - $999,999.99;

(D)

$500 for each place of business having combined gross annual sales of $1 million - $9,999,999.99; and

(E)

$750 for each place of business having combined gross annual sales greater than or equal to $10 million.

(3)

All wholesale distributors of drugs who are manufacturers of drugs in Texas shall obtain a license annually with the department and shall pay a licensing fee for each place of business operated as follows:

(A)

$400 per wholesale distributor having gross annual drug sales of $0 - $199,999.99 (includes a compressed and/or liquid medical gas transfiller);

(B)

$650 per wholesale distributor having gross annual drug sales of $200,000 - $19,999,999.99; and

(C)

$850 per wholesale distributor having gross annual drug sales greater than or equal to $20 million.

(4)

If the United States Food and Drug Administration (FDA) determines, with respect to a product that is a combination of a drug and a device, that the primary mode of action of the product is as a drug, a person who engages in wholesale distribution of the product is subject to licensure as described in this section.

(b)

License forms. Licensing forms may be obtained from the Texas Department of Health, Drugs and Medical Devices Division, 1100 West 49th Street, Austin, Texas 78756.

(c)

License statement. The wholesale distributors' licensing statement shall be signed and verified by the owner, partner, president, or corporate designee (copy of Resolution must accompany application), shall be made on the department furnished license form, and shall contain the following information:

(1)

the legal name under which the business is conducted;

(2)

the address of each place of business that is licensed;

(3)

if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state; or if any other type of association, then the names of the principals of such association;

(4)

the names and residence addresses and valid driver's license of those individuals in an actual administrative capacity which, in the case of proprietorship, shall be the managing proprietor; partnership, the managing partner; corporation, the officers and directors; or those in a managerial capacity in any other type of association;

(5)

for each place of business, the residence addresses of the individuals in charge thereof; and

(6)

a list of categories which must be marked and adhered to in the determination and paying of the fee.

(d)

Two or more places of business. If the wholesale distributor operates more than one place of business, the wholesale distributor shall license each place of business separately.

(e)

Pre-licensing inspection. The applicant shall cooperate with any pre-licensing inspection by the department of the wholesale distributor's facilities. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with the minimum standards in this chapter for applicants located out-of-state.

(f)

Issuance of license. The department may license a wholesale distributor of drugs who meets the requirements of this section and §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 §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 §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, §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 in wholesale distribution of prescription drugs for use in humans are exempt from the licensing requirements of this subchapter, 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. The exemptions are:

(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, §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.

(i)

Sale of food, drugs, or devices. The provisions of this section regarding the sale of food, drugs, or devices shall be considered to include the manufacture, production, processing, packaging, exposure, offer, possession, and holding of any such article for sale; and the sale, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct of any food, drug or device place of business.

§229.253. Minimum Standards for Licensure.

(a)

Minimum standards. All wholesale distributors of drugs not engaged in manufacturing, processing, packing, or holding of drugs shall comply with the minimum standards specified in subsections (c) and (d) of this section as it applies to the firm's operations, and to the existing statutory standards contained in the Texas Health and Safety Code, Chapter 431. All wholesale distributors of drugs engaged in manufacturing, processing, packing, or holding of drugs shall comply with subsections (b), (c), and (d) of this section as it applies to the firm's operations, and to the existing statutory standards contained in the Texas Health and Safety Code, Chapter 431. For the purpose of this section, the policies described in the United States Food and Drug Administration's Compliance Policy Guides as they apply to drugs shall be the policies of the Texas Department of Health (department).

(b)

Current good manufacturing practices in manufacturing, processing, packing, or holding of drugs by drug manufacturers.

(1)

The department adopts by reference Title 21, Code of Federal Regulations, Part 210, §§210.1 - 210.3, titled "Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs"; and Part 211, §§211.1 - 211.208, titled "Current Good Manufacturing Practice for Finished Pharmaceuticals" as those regulations apply to any building under the control of a drug manufacturer where drugs are manufactured, processed packaged or held.

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(c)

Requirements for wholesale prescription drug distributors.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations, Part 205, §§205.1 - 205.50, 1994, titled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors", for prescription drugs.

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(3)

Prescription drug means any drug, human, or veterinary, required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to the Federal Food, Drug, and Cosmetic Act, §503(b).

(4)

Legend drugs. A wholesale drug distributor may not possess, sell or transfer drugs whose labels bear the legend "Caution: Federal law prohibits dispensing without prescription" or "Rx Only" unless that person is authorized to possess, sell or transfer such drugs in compliance with the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, Subchapter I; and the Texas Dangerous Drug Act, Health and Safety Code, Chapter 483.

(d)

Requirements for wholesale over-the-counter drug distributors.

(1)

Any building used to hold over-the-counter drugs shall be of a suitable size, construction and location to facilitate cleaning, maintenance and proper operations.

(2)

Adequate lighting shall be provided in all areas.

(3)

Adequate ventilation shall be provided.

(4)

All over-the-counter drugs shall be held at appropriate temperatures and under appropriate conditions according to the labeling of such drugs, if applicable.

(5)

Any building used in the holding of over-the-counter drug products shall be maintained in a clean and sanitary condition. Any such building shall be free of infestation by rodents, birds, insects and other vermin.

(6)

Any building used in the holding of an over-the-counter drug product shall be maintained in a good state of repair.

(7)

Written procedures describing the holding of over-the-counter drug products shall be established and followed and shall include:

(A)

a procedure for identifying and retrieving over-the-counter drug products that are subject to a recall; and

(B)

a quarantine procedure for over-the-counter drug products that have expired; are subject to recall; or are otherwise determined to be adulterated or misbranded for the return, destruction, or other disposal of those items.

(e)

Buildings and facilities. No manufacturing, processing, packing or holding of drugs shall be conducted in any personal residence.

(f)

Drug labeling.

(1)

If a person, firm or corporation labels a drug, the label shall meet the requirements of the Texas Health and Safety Code, Chapter 431.

(2)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations, Part 201, §§201.1 - 201.317, titled "Labeling."

(3)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(g)

Drugs general, drug advertising, specific requirements for special drugs, official names and established names, and labeling and packaging requirements for controlled substances.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations:

(A)

Part 200, §§200.5 - 200.200, titled "General";

(B)

Part 202, §202.1, titled "Prescription Drug Advertising";

(C)

Part 250, §§250.10 - 250.250, titled "Special Requirements For Specific Human Drugs";

(D)

Part 299, §§299.3 - 299.5, titled "Drugs; Official Names and Established Names"; and

(E)

Part 1302, §§1302.01 - 1302.08, titled "Labeling and Packaging Requirements For Controlled Substances."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(h)

Current good manufacturing practices in manufacturing, processing, packing, or holding of blood and blood components.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations, Part 606, §§606.3 - 606.170, titled "Current Good Manufacturing Practice For Blood and Blood Components."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(i)

General biological products standards, standards for bacterial products, standards for viral vaccines, standards for human blood and blood products, standards for diagnostic substances for dermal test, standards for diagnostic substances for laboratory test, and standards for miscellaneous biological products.

(1)

The department adopts by reference Title 21, Code of Federal Regulations:

(A)

Part 600, §§600.3 - 600.15, titled "Biological Products: General";

(B)

Part 610, §§610.1 - 610.65, titled "General Biological Products Standards";

(C)

Part 620, §§620.1 - 620.48, titled "Additional Standards For Bacterial Products";

(D)

Part 630, §§630.1 - 630.75, titled "Additional Standards For Viral Vaccines";

(E)

Part 640, §§640.1 - 640.114, titled "Additional Standards for Human Blood and Blood Products";

(F)

Part 650, §§650.1 - 650.15, titled "Additional Standards for Diagnostic Substances for Dermal Test";

(G)

Part 660, §§660.1 - 660.105, titled "Additional Standards for Diagnostic Substances for Laboratory Test"; and

(H)

Part 680, §§680.1 - 680.26, titled "Additional Standards for Miscellaneous Products."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(j)

Labeling and standard requirements for the manufacturing or processing of animal biological products.

(1)

The department adopts by reference and will enforce Title 9, Code of Federal Regulations, Part 113, §§113.1 - 113.455, titled "Standard Requirements."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours.

(k)

Cosmetic labeling for a person, firm, or corporation that labels a cosmetic.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations, Part 701, §§701.1 - 701.30, titled "Cosmetic Labeling."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(l)

Cosmetics general and cosmetic product warning statement.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations, Part 700, §§700.3 - 700.25, titled "General"; and Part 740, §§740.1 - 740.18, titled "Cosmetic Product Warning Statements."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(m)

Current good manufacturing practices in manufacturing, processing, packing, or holding of medicated feeds and Type A medicated articles.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations:

(A)

Part 225, §§225.1 - 225.202, titled "Current Good Manufacturing Practice For Medicated Feeds"; and

(B)

Part 226, §§226.1 - 226.115, titled "Current Good Manufacturing Practices For Type A medicated articles."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(n)

Over-the-Counter (OTC) for human use.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations:

(A)

Part 300, titled "General";

(B)

Part 310, titled "New Drugs";

(C)

Part 312, titled "Investigational New Drug Application";

(D)

Part 314, titled "Applications for FDA Approval to Market a New Drug or an Antibiotic Drug";

(E)

Part 316, titled "Orphan Drugs";

(F)

Part 320, titled "Bioavailability and Bioequivalence Requirements";

(G)

Part 329, titled "Habit-forming Drugs";

(H)

Part 330, titled "Over-the-Counter (OTC) Human Drugs Which are Generally Recognized as Safe and Effective and Not Misbranded";

(I)

Part 331, titled "Antacid Products for Over-the-Counter (OTC) Human Use";

(J)

Part 332, titled "Antiflatulent Products for Over-the-Counter (OTC) Human Use";

(K)

Part 333, titled "Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use";

(L)

Part 336, titled "Antiemetic Drug Products for Over-the-Counter (OTC) Human Use";

(M)

Part 338, titled "Nighttime Sleep-aid Drug Products for Over-the-Counter (OTC) Human Use";

(N)

Part 340, titled "Stimulant Drug Products for Over-the-Counter (OTC) Human Use";

(O)

Part 341, titled "Cold, Cough, Allergy, Bronchodilator, and Anti-asthmatic Drug Products for Over-the-Counter (OTC) Human Use";

(P)

Part 344, titled "Topical OTIC Drug Products for Over-the- Counter (OTC) Human Use";

(Q)

Part 346, titled "Anorectal Drug Products for Over-the-Counter (OTC) Human Use";

(R)

Part 348, titled "External Analgesic Drug Products for Over-the-Counter (OTC) Human Use";

(S)

Part 349, titled "Ophthalmic Drug Products for Over-the-Counter (OTC) Human Use";

(T)

Part 357, titled "Miscellaneous Internal Drug Products for Over-the-Counter (OTC) Human Use";

(U)

Part 358, titled "Miscellaneous External Drug Products for Over-the-Counter (OTC) Human Use";

(V)

Part 361, titled "Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used In Research"; and

(W)

Part 369, titled "Interpretative Statements Re: Warnings on Drugs and Devices for Over-the-Counter Sales."

(2)

A manufacturer, repacker, own label distributor, jobber, or wholesaler or any person distributing over-the-counter drugs shall not market, promote or advertise the drugs in a manner inconsistent with or broader than that permitted by the over-the-counter tentative final monographs or final monographs in Title 21, Code of Federal Regulations, Parts 300 - 369.

(3)

Copies are indexed and filed in the office of the Drugs and Medical Devices. Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(o)

Packaging, labeling, tests, and methods of assays for human antibiotic drugs.

(1)

The department adopts by reference and will enforce Title 21, Code of Federal Regulations:

(A)

Part 429, titled "Drugs Composed Wholly or Partly of Insulin";

(B)

Part 430, titled "Antibiotic Drugs; General";

(C)

Part 431, titled "Certification of Antibiotic Drugs";

(D)

Part 432, titled "Packaging and Labeling of Antibiotic Drugs";

(E)

Part 433, titled "Exemptions from Antibiotic Certification and Labeling Requirements";

(F)

Part 436, titled "Tests and Methods of Assay of Antibiotic and Antibiotic-containing Drugs";

(G)

Part 440, titled "Penicillin Antibiotic Drugs";

(H)

Part 441, titled "Penem Antibiotic Drugs";

(I)

Part 442, titled "Cepha Antibiotic Drugs";

(J)

Part 444, titled "Oligosaccharide Antibiotic Drugs";

(K)

Part 446, titled "Tetracycline Antibiotic Drugs";

(L)

Part 448, titled "Peptide Antibiotic Drugs";

(M)

Part 449, titled "Antifungal Antibiotic Drugs";

(N)

Part 450, titled "Antitumor Antibiotic Drugs";

(O)

Part 452, titled "Macrolide Antibiotic Drugs";

(P)

Part 453, titled "Lincomycin Antibiotic Drugs";

(Q)

Part 455, titled "Certain Other Antibiotic Drugs"; and

(R)

Part 460, titled "Antibiotic Drugs Intended for Use in Laboratory Diagnosis of Disease."

(2)

Copies are indexed and filed in the office of the Drugs and Medical Devices Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.

(p)

Distribution of drugs to flea markets.

(1)

It is a prohibited act for flea markets to sell drugs unless the person selling the drug is authorized in writing to sell the drug at retail by the manufacturer of the drug or the manufacturer's authorized distributor.

(2)

The authorization provided to the person selling drugs at a flea market shall state the person's name.

§229.254. Refusal, Revocation, or Suspension of License.

(a)

Basis. The Texas Department of Health (department) may, after providing opportunity for hearing, refuse to license a wholesale distributor of drugs, or may revoke or suspend the license for violations of the requirements in §§229.251 - 229.253 of this title (relating to Definitions, Licensing Fee and Procedures, and Minimum Standards for Licensure) or for any of the reasons described in the Texas Health and Safety Code, Chapter 431.

(b)

Hearings. Any hearings for the refusal, revocation, or suspension of a license are governed by the department's formal hearing procedures in Chapter 1 of this title (relating to Texas Board of Health) and the Administrative Procedure Act, Government Code, Chapter 2001.

Filed with the Office of the Secretary of State on February 28, 2000.

TRD-200001493

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2000

Proposal publication date: October 29, 1999

For further information, please call: (512) 458-7236


Subchapter U. PERMITTING RETAIL FOOD ESTABLISHMENTS

The Texas Department of Health (department) adopts the repeal of existing §§229.370 - 229.374 and new §§229.370 - 229.374 concerning permitting of food establishments. Section 229.371 is adopted with changes to the proposed text as published in the December 3, 1999 issue of the Texas Register (24 TexReg 10732). The repeal of §§229.370 - 229.374 and new §§229.370 and 229.372 - 229.374 are adopted without changes, and therefore will not be republished.

Specifically, these sections are the basic permitting requirements for all food establishments within the department's permitting authority and concern definitions; permitting fees and procedures; minimum standards for permitting and operation; refusal, revocation or suspension of a permit; and administrative penalties. The new rules will provide a much needed update which reflects consistency with the Texas Food Establishment Rules (TFER), §§229.161 - 229.171 and §§229.173 - 229.175. The TFER were adopted by the Texas Board of Health (board) in September 1998 and became effective October 6, 1998.

The new adopted rules repeal the existing rules for permitting retail food stores, food service establishments, mobile food units, roadside food vendors and temporary food service establishments. The new rules for permitting these facilities make the language consistent with the TFER, which are based on the U.S. Food and Drug Administration 1997 Model Food Code.

The repealed rules were previously adopted under the Health and Safety Code, Chapter 437, Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, and Roadside Food Vendors. The repealed rules had required the department to permit those establishments which are not permitted and inspected by a city or county health department or public health district.

New §229.370 is the purpose and will remain the same stating that the department will establish a permitting system for the regulation of food establishments.

In new §229.371, the definitions are amended to be consistent with the TFER.

New §229.372 contains permitting fees and procedures. This section outlines the fee categories per type of establishment. Some establishments are exempt from the fees as specified in the statute. Those establishments required to permit with the department are described and specific administrative procedures are outlined for permit application, renewal and issuance.

New §229.373 is for minimum standards for permitting and operation. This section is amended making the references consistent with the recently adopted TFER.

New §229.374 is for administrative penalty provisions. This section amends the statutory references for the levying of administrative penalties that were adopted under Health and Safety Code, Chapter 431, Texas Food, Drug and Cosmetic Act, §431.054 and §431.056. The new adopted rules are consistent with the more specific act, Health and Safety Code, Chapter 437, Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, and Roadside Food Vendors, §437.018.

The department received no public comments during the comment period. However, the department is making the following minor changes due to staff comments.

Change: Concerning §229.371(6), the department deleted the semicolon after "catering operation" which is not grammatically correct and the change clarifies the meaning of the sentence.

Change: Concerning §229.371(6)(B), the department changed the semicolon to a colon after the word "include" in order to make the sentence grammatically correct.

Change: Concerning §229.371(6)(C)(xi), the department deleted the word "a" to make the sentence grammatically correct. The last sentence now reads "...regardless of whether or not food preparation occurs on the unit."

25 TAC §§229.370 - 229.374

The repeals are adopted under Health and Safety Code, §437.0056, and §12.001 which provides the Texas Board of Health with authority to adopt rules for its procedure and for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

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 February 28, 2000.

TRD-200001492

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2000

Proposal publication date: December 3, 1999

For further information, please call: (512) 458-7236


The new sections are adopted under Health and Safety Code, §437.0056, and §12.001 which provides the Texas Board of Health with authority to adopt rules for its procedure and for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§229.371.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:

(1)

Bed and breakfast extended means:

(A)

an establishment with more than seven rooms for rent; or

(B)

that provides for food service other than breakfast to overnight guests; and

(C)

for the purposes of these rules, such facilities are classified as food establishments.

(2)

Bed and breakfast food establishment means:

(A)

an establishment that provides food service other than to its overnight guests;

(B)

the establishment must meet the rules and regulations applicable to retail food establishments; and

(C)

for the purposes of these rules, such facilities are classified as food establishments.

(3)

Child care center--Any facility licensed by the regulatory authority to receive 13 or more children for child care which prepares food for on-site consumption. A child care center is classified as a food establishment.

(4)

Department--The Texas Department of Health.

(5)

Food--A raw, cooked, or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum.

(6)

Food establishment--An operation that stores, prepares, packages, serves, or otherwise provides food for human consumption such as: a food service establishment; retail food store; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; remote catered operations; conveyance used to transport people, institution; or food bank; and that relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.

(A)

The term includes an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; a restaurant; a grocery store; an operation that is conducted in a mobile, roadside, stationary, temporary, or permanent facility or location; group residence; outfitter operations; bed and breakfast extended and bed and breakfast food establishments; where consumption is on or off the premises; and regardless of whether there is a charge for the food.

(B)

The term does not include: an establishment that offers only prepackaged foods that are not potentially hazardous; a produce stand that only offers whole, uncut fresh fruits and vegetables; a food processing plant; a kitchen in a private home if only food that is not potentially hazardous is prepared for sale or service at a function, such as a religious or charitable organization's bake sale; a Bed and Breakfast Limited facility as defined in these rules; or a private home.

(C)

All definitions found in §229.162 of this title (relating to Definitions) under the Texas Food Establishment Rules are applicable to these sections except that, for purposes of obtaining a permit and payment of fees only, the term "food establishment" does not include:

(i)

food establishments permitted and inspected under authority granted to Home-Rule or Type A General-Law Municipalities;

(ii)

federally inspected food establishments on federal property;

(iii)

correction facilities under the inspection of the Texas Department of Criminal Justice;

(iv)

nursing homes under the inspection of Long Term Care Regulatory in the Texas Department of Human Services;

(v)

hospitals under the inspection of the Health Facility Licensure Division in the department and which do not serve food to the general public;

(vi)

food establishments on state campuses inspected by state college or university personnel in accordance with the requirements of §229.373 of this title (relating to Minimum Standards for Permitting and Operation);

(vii)

food establishments licensed under the Health and Safety Code, Chapter 431, as manufacturers of food, provided the fee for licensure exceeds the permit fee required under §229.372 of this title (relating to Permitting Fees and Procedures);

(viii)

food establishments under the inspection of the Texas Department of Mental Health and Mental Retardation;

(ix)

nonprofit organizations as defined in these rules. Nonprofit organizations which meet the definition of "manufacturers of food" under Health and Safety Code, Chapter 431, or the definition of "food salvage establishments" under Health and Safety Code, Chapter 432, are not exempt from licensure in those categories;

(x)

food and beverage vending machines; and

(xi)

mobile food units permitted and inspected under the authority granted to Home-Rule or Type A General-Law Municipalities and which operate only within their respective jurisdictions. Except for units which handle only pre-packaged non-potentially hazardous foods, a mobile food unit is classified as a food establishment, regardless of whether or not food preparation occurs on the unit.

(7)

Food Service Establishment--A food establishment as defined in these rules.

(8)

Mobile food unit--A vehicle-mounted mobile food establishment designed to be readily moveable.

(9)

Nonprofit organization--A civic or fraternal organization, charity, lodge, association, proprietorship or corporation possessing a 501(C) exemption under the Internal Revenue Code; or religious organizations meeting the definition of "church" under the Internal Revenue Code, §170(b)(1)(A)(I).

(10)

Outfitter operation--Any operations such as trail rides or river raft trips where food is offered to patrons and which operates out of a central preparation location or food establishment. An outfitter operation is classified as a food establishment.

(11)

Permit holder--The person that is legally responsible for the operation of the food establishment such as the owner, the owner's agent, or other person; and who possesses a valid permit to operate a food establishment.

(12)

Person--An association, corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

(13)

Potentially hazardous food--A food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic microorganisms; the growth and toxin production of Clostridium botulinum ; or in raw shell eggs, the growth of Salmonella enteritidis .

(14)

Pushcart--A non self-propelled mobile food unit limited to serving nonpotentially hazardous food or potentially hazardous foods requiring a limited amount of preparation as authorized by the regulatory authority. A pushcart is classified as a mobile food unit.

(15)

Retail food store--A food establishment or section of an establishment where food and food products are offered to the consumer and intended for off-premise consumption. The term includes delicatessens that offer prepared food in bulk quantities only. The term does not include establishments which handle only prepackaged, nonpotentially hazardous foods; roadside markets that offer only unprocessed fresh fruits and fresh vegetables for sale; or farmers markets; except that, for the purposes of obtaining a permit and payment of fees only, the term "retail food store" does not include establishments permitted and inspected under authority granted to Home-Rule and Type A General-Law Municipalities.

(16)

Roadside food vendor--A person who operates a mobile retail food store from a temporary location adjacent to a public roadway or highway. Potentially hazardous foods shall not be prepared or processed by roadside food vendors. A roadside vendor is classified as a food establishment.

(17)

School food establishment--A food service establishment where food is prepared and intended for service primarily to students in institutions of learning including, but not limited to, public and private schools, including kindergarten, preschool and elementary schools, junior high schools, high schools, colleges, and universities. A school food establishment is classified as a food establishment.

(18)

Temporary food establishment--A food establishment that operates for a period of no more than 14 consecutive days in conjunction with a single event or celebration.

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 February 28, 2000.

TRD-200001491

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: March 19, 2000

Proposal publication date: December 3, 1999

For further information, please call: (512) 458-7236