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