| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER V |
MINIMUM STANDARDS FOR LICENSURE OF
TATTOO AND CERTAIN BODY PIERCING STUDIOS |
| RULE §229.401 |
General Provisions |
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|
(a) These sections provide for the licensing and regulation of
tattoo and certain body piercing studios and temporary locations.
(b) The "Tattoo and Certain Body Piercing Studio Act,"
Texas Health and Safety Code, Chapter 146, requires the Texas
Board of Health to adopt rules regulating tattoo and certain body
piercing studios and temporary locations.
(c) No person may cause, suffer or allow the operation,
management, or maintenance of a tattoo and certain body piercing
studio and temporary location without a license issued in
accordance with these sections.
(d) All tattoo and certain body piercing studios and temporary
locations shall comply with the minimum standards specified in
these sections in addition to the existing standards contained in
the Tattoo and Certain Body Piercing Studio Act and the Health and
Safety Code, Chapter 431, the Texas Food, Drug, and Cosmetic Act,
relating to drugs, devices, and cosmetics, including adulteration
and misbranding.
(e) All tattoo and certain body piercing studios and temporary
locations should comply with applicable provisions of the
Americans With Disabilities Act.
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| Source Note: The provisions of this §229.401 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER V |
MINIMUM STANDARDS FOR LICENSURE OF
TATTOO AND CERTAIN BODY PIERCING STUDIOS |
| RULE §229.402 |
Definitions |
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|
The following words and terms, when used in these sections,
shall have the following meanings, unless the context clearly
indicates otherwise.
(1) Act--The Tattoo and Certain Body Piercing Studio Act, Texas
Health and Safety Code, Chapter 146.
(2) Antiseptic--An agent that kills disease-causing microorganisms
on human skin or mucosa.
(3) Artist--A person who performs tattooing, intradermal
cosmetics, and or certain body piercing, and who is responsible
for complying with the provisions of these sections.
(4) Aseptic technique--A hygienic practice which prevents and
hinders the direct transfer of microorganisms, regardless of
pathogenicity, from one person or place to another person or
place.
(5) Authorized agent--An employee of the department designated by
the commissioner to enforce the Act.
(6) Body piercer--A person who performs body piercing and who is
responsible for adherence to the provisions of these sections;
hereafter referred to as artist.
(7) Body piercing--The creation of an opening in an individual's
body, other than in an individual's earlobe, to insert jewelry or
another decoration.
(8) Body piercing studio--A permanent, nondwelling building or
portion of a building, designated by a license holder and located
in accordance with applicable local zoning codes where body
piercing is performed, completely separated from living quarters;
hereafter referred to as studio.
(9) Client--A person requesting the application of a tattoo or
certain body piercing.
(10) Commissioner--Commissioner of the Texas Department of Health.
(11) Contaminated waste--Any liquid or semi-liquid blood or other
potentially infectious materials; contaminated items that would
release blood or other potentially infectious materials in a
liquid or semi-liquid state if compressed; items that are caked
with dried blood or other potentially infectious materials and are
capable of releasing these materials during handling; contaminated
sharps and pathological and microbiological wastes containing
blood and other potentially infectious material, as defined in 29
Code of Federal Regulations, Part 1910.1030, known as
"Occupational Exposure to Bloodborne Pathogens". Copies
of this provision 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.
(12) Cosmetic--An article or substance intended to be rubbed,
poured, sprinkled, or sprayed on or introduced into or otherwise
applied to the human body for cleansing, beautifying, promoting
attractiveness or altering appearances; or an article or substance
for use as a component of such an article, except that the term
does not include soap.
(13) Department--The Texas Department of Health.
(14) Disinfectant--An agent that kills disease-causing
microorganisms on inanimate objects or surfaces.
(15) Ear piercing--The creation of an opening in an individual's
ear lobe with an ear piercing gun to insert jewelry or other
decoration.
(16) Ear piercing gun--A device that pierces an individual's ear
using a single-use stud and clasp ear piercing system. An ear
piercing gun shall not be used to pierce any other part of the
body besides the ear.
(17) Germicidal solution--An agent that kills disease-causing
microorganisms on hard surfaces; a disinfectant or sanitizer
registered with the Environmental Protection Agency and or an
approximate 1:100 dilution of household chlorine bleach (1/4 cup
bleach and 1 gallon of water).
(18) Germicidal soap--An agent designed for use on the skin that
kills disease-causing microorganisms, including but not limited
to, products containing povidone-iodine, chloroxylenol, triclosan,
and chlorhexidine gluconate.
(19) Hand washing facility--Sink equipped with hot and cold or
tempered running water under pressure, used for washing hands,
arms, or other portions of the body.
(20) Health care practitioner--A person licensed by the state to
practice medicine.
(21) Instruments--Hand pieces, needles, needle bars, hemostats,
forceps, pliers, and other items that may come in contact with a
client's body or possible exposure to bodily fluids during the
tattoo and body piercing procedures.
(22) Jewelry--Any personal ornament inserted into a pierced area,
which must be made of surgical implant grade stainless steel
(minimum of 316L or 316LVM), solid 14k or 18k gold, niobium,
titanium (minimum of 6A14V), or platinum, which is free of nicks,
scratches, or irregular surfaces and has been properly sterilized
prior to use.
(23) License holder--A person who owns, operates, or maintains a
tattoo studio, tattoo and body piercing studio, body piercing
studio or temporary location in compliance with these sections.
(24) Managing conservator--A person, licensed child-placing
agency, or authorized agency designated by a court as having the
right to possession of the child, and the right to consent to
medical, surgical, dental, and psychological treatment of the
child.
(25) Sanitize--To treat a clean surface and kill pathogenic
microorganisms.
(26) Sharps--Any object (sterile or contaminated) that may
purposefully or accidentally cut or penetrate the skin or mucosa
including, but not limited to, needles, scalpel blades, and razor
blades.
(27) Sharps container--A puncture-resistant, leak-proof container
that can be closed for handling, storage, transportation, and
disposal and that is labeled with the International Biohazard
Symbol.
(28) Single-use--Articles intended for one-time, one-person use
and which are to be discarded after such use.
(29) Sterilization area--A separate room or area separate from
workstations with restricted client access in which tattoo and
body piercing instruments are cleaned, disinfected, and
sterilized.
(30) Tattoo/tattooing--The practice of producing an indelible mark
or figure on the human body by scarring or inserting a pigment
under the skin using needles, scalpels, or other related devices
including intradermal cosmetics.
(31) Tattoo and body piercing area--The portion of the tattoo or
body piercing studio used for applying tattoos or performing body
piercing, including all surrounding areas which are likely to come
into contact with contaminated waste.
(32) Tattooist--A person who performs tattooing or applies
intradermal cosmetics and who is responsible for adherence to the
provisions of these sections; hereafter referred to as artist.
(33) Tattoo studio--A permanent, nondwelling building or portion
of a building, designated by a license holder and located in
accordance with applicable local zoning codes where tattooing or
intradermal cosmetic application is performed, completely
separated from living quarters; hereafter referred to as studio.
(34) Temporary location--A fixed location at which tattooing or
body piercing is performed for a specified length of time of not
more than seven days in conjunction with a single event or
celebration, where the primary function of the event or
celebration is tattooing or body piercing.
(35) Universal precautions--A method of infection control in which
employees treat all blood and body fluids as to contain all
bloodborne pathogens and taking proper precautions to prevent the
spread of any bloodborne pathogens. Precautions include hand
washing, gloving, personal protective equipment, injury
prevention, and proper handling and disposal of needles, other
sharp instruments, and blood and body fluid contaminated products.
|
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| Source Note: The provisions of this §229.402 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER V |
MINIMUM STANDARDS FOR LICENSURE OF
TATTOO AND CERTAIN BODY PIERCING STUDIOS |
| RULE §229.403 |
Licensing Fees,
Procedures, and Exemptions |
|
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(a) License fees. All tattoo and body piercing studios shall
obtain a license annually except as indicated below from the Texas
Department of Health (department) and shall pay an annual,
non-refundable license fee for each place of business operated as
follows:
(1) $450 per tattoo only studio or temporary location license for
a specified length of time not to exceed seven days;
(2) $600 for a tattoo and body piercing studio or temporary
location license for a specified length of time not to exceed
seven days--the fee to be paid as follows: $450 for the tattoo
portion; and $150 for the body piercing portion; and
(3) $200 per body piercing only studio or temporary location
license for a specified length of time not to exceed seven days.
(b) License forms. License forms may be obtained from the Drugs
and Medical Devices Division, Texas Department of Health, 1100
West 49th Street, Austin, Texas, 78756-3182.
(c) License application. An application shall be submitted for
each tattoo studio and a separate application shall be submitted
for each body piercing studio. The initial license application for
each studio or temporary location shall be signed and verified,
shall be made on the license application furnished by the
department, and shall contain the following information:
(1) the full or legal name under which the studio or temporary
location is conducted;
(2) the address of the studio or temporary location that is to be
licensed. Sufficient descriptive information must be included if
the studio or temporary location is located in a portion of the
building with other license holders;
(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) for each studio or temporary location, the name(s) and
residence address(es) of the responsible individual(s) thereof;
(5) the name(s) of the studio's or temporary location's artist(s);
(6) the usual days and hours of operation of each studio or
temporary location; and
(7) a description of all services to be provided at the studio or
temporary location.
(d) Issuance of license. The department may issue a license to the
owner of a studio or temporary location after determining that the
studio or temporary location is in compliance with applicable
statutes, rules, and zoning codes.
(1) The initial studio license shall be valid for one year from
the date of issuance which becomes the anniversary date. The
temporary location license is valid for a specified period not to
exceed seven days.
(2) The renewal studio license shall be valid for one year from
the anniversary date.
(3) The license shall be displayed in a prominent place in the
studio or temporary location.
(e) Renewal of license--applicable to studios only.
(1) Each year, the license holder shall renew its license in
accordance with the requirements of this section.
(2) The license holder shall renew the license by filing an
application for renewal on the form prescribed by the department
accompanied by the required 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 application annually shall
subject the studio to the enforcement provisions of the Tattoo and
Certain Body Piercing Studio Act and also to the provision of §229.412
of this title (relating to Refusal, Revocation or Suspension of
License and Enforcement Provisions).
(A) Amendment of license. A license must be amended when the name,
ownership, or location of the licensed studio is changed. Such
changes require submission of the fees as outlined in subsection
(a) of this section.
(B) Notification of change of location of studio.
(i) Not fewer than 30 days in advance of the change, the licensee
shall notify the commissioner or the commissioner's designee in
writing of the licensee's intent to change the location of a
licensed studio. The notice shall include the address of the new
location, and the name and residence address of the individual in
charge of the studio at the new location.
(ii) Notice will be deemed adequate if the licensee provides the
intent and verification notices to the commissioner or the
commissioner's designee within the established time frames of
clause (i) of this subparagraph by certified mail, return receipt
requested, mailed to the Drugs and Medical Devices Division, Texas
Department of Health, 1100 West 49th Street, Austin, Texas, 78756.
(iii) Not later than the tenth day after the change of location is
complete, the license holder shall notify the department in
writing and shall verify the information submitted under clause (i)
of this subparagraph.
(f) Exemption from licensure. Persons who engage only in the
following are exempt from the licensing requirements of this
section:
(1) a studio or temporary location located within a medical
facility which is licensed under other law, or an office or clinic
of a person licensed by the Texas State Board of Medical
Examiners;
(2) a person who performs only ear piercing; or
(3) a facility in which only ear piercing is performed.
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| Source Note: The provisions of this §229.403 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.404 |
Physical Facilities |
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(a) A studio must be in a permanent, nondwelling building or
portion of a building which must be in a location which is
permissible under local zoning codes, if any. The studio shall be
separated from living quarters by complete floor to ceiling
partitioning and shall contain no access to living quarters.
(b) The studio or temporary location shall be maintained in a
sanitary condition.
(1) Work surfaces shall be cleaned and sanitized with a germicide
solution.
(2) Other environmental surfaces shall be cleaned with an
all-purpose detergent disinfectant.
(c) The walls, ceilings, and floors shall be kept in good repair.
The tattoo and body piercing area shall be constructed of smooth,
hard, surfaces that are non-porous, free of open holes or cracks,
light colored, and easily cleaned. New studios shall not include
dark-colored surfaces in the tattoo and body piercing area.
Existing studios with dark-colored surfaces in the tattoo and body
piercing area shall replace the dark-colored surfaces with
light-colored surfaces whenever the facilities are extensively
remodeled.
(d) Studios or temporary locations shall have adequate lighting of
at least 50 foot candles of illumination in the tattooing, body
piercing, and sterilization area.
(e) Adequate mechanical ventilation shall be provided in the
studio.
(f) Each studio or temporary location shall be equipped with
hand-washing facilities for its personnel with unobstructed access
to the tattoo and body piercing area such that artists can return
to the area without having to touch anything with their hands.
Hand-washing facilities shall be equipped with hot and cold or
tempered running water under pressure; liquid germicidal soap;
single-use towels or other approved hand-drying devices; and a
covered refuse container. Such facilities shall be kept clean and
in good repair.
(g) Animals are not permitted in the studios or temporary
locations, except for guide or service animals accompanying
persons with disabilities, or nonmammalian animals in enclosed
glass containers such as fish aquariums, which shall be outside
the tattooing, body piercing, and sterilization area.
(h) Use of tobacco products shall be prohibited in the tattoo,
body piercing, and sterilization area. Consumption of alcoholic
beverages shall be prohibited in the studio or temporary location.
(i) The studio or temporary location shall be kept free of rodents
and vermin and protected from infestation by insects.
(j) If tattooing or body piercing is performed where cosmetology
services are provided, it shall be performed in an area that is
separate and enclosed.
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| Source Note: The provisions of this §229.404 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.405 |
Personnel Responsibilities |
|
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(a) All artists while tattooing or body piercing shall wear clean
outer garments, maintain a high degree of personal cleanliness,
and conform to hygienic practices while on duty.
(b) All artists shall wash their hands thoroughly using hot or
tempered water with a liquid germicidal soap before and after
tattooing or body piercing and as often as necessary to remove
contaminants.
(c) All artists must wear single-use examination gloves while
assembling tattooing and body piercing instruments and while
tattooing and body piercing.
(d) When a session is interrupted or immediately after gloves are
torn or perforated:
(1) gloves shall be removed and discarded; and
(2) hands shall be washed and a fresh pair of gloves used.
(e) Artists shall use universal precautions while tattooing or
body piercing. An artist diagnosed with a communicable disease
shall provide to the department a written statement from a health
care practitioner that the artist's condition no longer poses a
threat to public health.
(f) The area of the client's skin to be tattooed shall be cleaned
with an approved germicidal soap according to label directions.
(g) The external skin of the client to be pierced shall be cleaned
with an approved germicidal soap according to label directions. In
the case of oral piercings, the operator shall provide the
individual with antiseptic mouthwash in a single-use cup and shall
ensure that the individual utilizes the mouthwash provided. In the
case of a lip, labret, or cheek piercing, procedures described in
this paragraph for both skin and oral piercings shall be followed.
(h) If shaving is required, razors shall be single-use.
(i) Each artist performing any tattoo or body piercing procedure
in the studio or temporary location, shall have the education,
training and experience, or any combination thereof, to practice
aseptic technique and prevent the transmission of bloodborne
pathogens. All procedures shall be performed using aseptic
technique.
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| Source Note: The provisions of this §229.405 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.406 |
Client Qualifications,
Disclosure, and Records |
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(a) Except as permitted in subsections (c) and (d) of this
section, a client must be a minimum of 18 years of age and shall
present at the time of tattooing or body piercing a valid,
government issued, positive identification card including, but not
limited to, a driver's license, passport, or military
identification. The identification must contain a photograph of
the individual and a printed date of birth.
(b) The artist shall verify and document in the permanent client
record the client's age, date of birth, and the type of
identification provided.
(c) An artist may not tattoo a person younger than 18 years of age
without consent from the individual's parent or guardian, who
determines it to be in the best interest of the minor child to
cover an existing tattoo.
(1) The existing tattoo must contain:
(A) obscene or offensive language or symbols;
(B) gang-related names, symbols, or markings;
(C) drug-related names, symbols, or pictures; or
(D) some other type of words, symbols or markings that the court
considers would be in the best interest of the minor to cover.
(2) The consent required by subsection (c) can be satisfied by:
(A) a written and notarized consent by the individual's parent or
guardian which shall contain:
(i) the full name, address, and telephone number of the client;
(ii) the full name, address, and telephone number of the parent or
guardian;
(iii) a detailed description or photograph of the tattoo to be
covered;
(iv) the location on the body of the tattoo to be covered; and
(v) the signatures of minor and parent or guardian; or
(B) the individual's parent or guardian:
(i) being physically present at the time the tattooing is being
performed;
(ii) executing an affidavit stating that the person is the parent
or guardian of the individual on whom the tattooing is being
performed;
(iii) presenting evidence of the minor's identity to the artist;
and
(iv) presenting evidence of the status as parent or guardian of
the individual who will receive the tattoo to the artist.
(3) If a parent or guardian of the minor child and the minor child
agree to the covering of the tattoo as described in subsection
(c)(1) of this section, the artist may request the issuance of an
order from a justice court.
(4) If the parent or guardian and the minor child do not agree to
the covering of a tattoo by a artist, then an order must be issued
by a district court or other court with jurisdiction of a suit
affecting the parent-child relationship or a civil proceeding
brought under Title 3 or 4 of the Texas Family Code before an
artist may cover the minor child's tattoo.
(d) An artist may not perform body piercing on a person younger
than 18 years of age without the consent of a parent, managing
conservator, or guardian of the individual. The consent can be
satisfied by:
(1) a written and notarized consent by the individual's parent,
managing conservator, or guardian which shall contain:
(A) the full name, address, and telephone number of the client;
(B) the full name, address, and telephone number of the parent,
managing conservator, or guardian;
(C) the location on the body that may be pierced; and
(D) the signatures of the minor and parent, managing conservator,
or guardian; or
(2) the individual's parent, managing conservator, or guardian:
(A) being physically present at the time the body piercing is
being performed;
(B) executing an affidavit stating that the person is the parent,
managing conservator, or guardian of the individual on whom the
body piercing is being performed;
(C) presenting evidence of the minor's identity to the artist; and
(D) presenting evidence of the status as parent, managing
conservator, or guardian of the individual who will receive the
body piercing to the artist.
(e) No person may be tattooed or body pierced who appears to be
under the influence of alcohol or drugs.
(f) Tattooing and body piercing shall not be performed on any skin
surface which manifests any evidence of unhealthy conditions such
as rashes, boils, infections, or abrasions.
(g) Before receiving a tattoo, each client shall be informed
verbally and in writing about the possible risk and dangers
associated with the application of each tattoo. These shall
include, but are not limited to, at least the following: the
possibility of discomfort or pain; the permanence of the markings;
the risk of infection; and the possibility of allergic reaction to
the pigments or other materials used.
(h) Before receiving a body piercing, each client (and if
applicable, the parent, managing conservator, or guardian) shall
be informed verbally and in writing about the possible risks and
dangers associated with receiving a body piercing. These shall
include, but are not limited to, at least the following: the
possibility of discomfort or pain; the possibility of scarring;
the possibility of bleeding; the possibility of swelling; the risk
of infection; the possibility of nerve damage; and the increased
risk for adolescents during certain stages of development.
(i) The studio or temporary location shall maintain proper records
of each client. The information shall be permanently recorded and
made available for examination by the authorized agent. Records
shall be maintained at the studio for at least two years following
the date of the last entry. The temporary location client records
shall be maintained by the license holder. These permanent records
shall include the following:
(1) the name, address, and telephone number of the client;
(2) the date tattooing or body piercing was performed;
(3) the client's age, date of birth, and type of positive
identification provided to the artist (this information is to be
recorded by the artist as described in subsection (b) of this
section);
(4) the specific color or colors of the tattoo or type of jewelry
used for the piercing and, when available, the manufacturer's
catalogue or identification number of each color or type of
jewelry used;
(5) the location on the body where the tattoo or body piercing was
performed;
(6) the name of the artist;
(7) a statement that the client has received a copy of applicable
written care instructions, and that the client has read and
understands the instructions; and
(8) the signature of the client.
|
|
| Source Note: The provisions of this §229.406 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.407 |
Sterilization |
|
|
(a) A studio or temporary location is required to utilize
instruments that have been prepared as described in §229.409(a)-(c)
of this title (relating to Tattooing and Body Piercing Instruments
and Jewelry). The studio or temporary location shall use
sterilization equipment that is approved by the United States Food
and Drug Administration for the purpose of sterilization, and
adequate in size to accommodate necessary utensils and
instruments. A copy of the manufacturer's recommended procedures
for operation of the sterilization unit(s) must be available for
inspection by an authorized agent.
(b) Each person responsible for the sterilization of instruments
shall be able to demonstrate to the department's authorized agent
the correct sterilization procedures and the proper operation of
autoclave and/or dry heat sterilization equipment.
(c) After each use, the reusable instruments shall be cleansed to
remove blood and tissue residue before sterilization as described
in §229.409(n) of this title.
(d) Instruments requiring sterilization shall be packed in
packages approved for the sterilization unit. Instruments shall be
packed individually, or as a set provided such set is intended to
be used for a single procedure. Each package shall be labeled with
the date of sterilization and the initials of the person
sterilizing the instruments. Packaged sterilized instruments shall
be kept in a sterile condition and stored in a clean dust-tight
container when not in use.
(e) Each package of instruments sterilized shall be monitored for
sterilization by the use of chemical/heat sensitive indicators.
(f) Each studio or temporary location shall maintain sterilization
records. The information shall be permanently recorded and made
available for examination by an authorized agent in the studio for
at least two years from the date of the last entry. These
permanent records shall be maintained at the studio and shall
include the following:
(1) date of sterilization;
(2) quantity and type of instruments to be sterilized; and
(3) name or initials of the individual sterilizing the
instruments.
(g) Sterilized instruments stored in an approved manner and not
used within 30 days after sterilization shall no longer be
considered sterile and shall be resterilized before use, unless
the studio or temporary location utilizes presterilized
instruments sterilized by the manufacturer. If presterilized
instruments are used, the artist shall obtain documentation from
the manufacturer that describes the method of sterilization
utilized by the manufacturer and the manufacturer's
recommendations for storage and maintenance of sterility. This
documentation shall be available for inspection by an authorized
agent. The artist shall follow the manufacturer's instructions for
storage and maintenance of sterility.
(h) One of the following methods of sterilization shall be used.
(1) Autoclave--steam under pressure:
(A) 121 degrees Celsius (250 degrees Fahrenheit) and a pressure of
at least 15 pounds per square inch for not less than 30 minutes
after the chamber of the autoclave has reached the required
temperature and pressure; or
(B) as specified in the manufacturer's operator's manual.
(2) Dry heat sterilization:
(A) 160 degrees Celsius (320 degrees Fahrenheit) for not less than
one hour under atmospheric pressure after the sterilizer has
reached the required temperature; or
(B) as specified in the manufacturer's operator's manual.
|
|
| Source Note: The provisions of this §229.407 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.408 |
Care of the New Tattoo
and/or Body Piercing |
|
|
(a) Each time tattooing or body piercing is performed the client
(and if applicable, the parent, managing conservator, or guardian)
shall receive oral and written instructions on the care of the
area tattooed or pierced. The client shall sign a written
statement in the permanent client record acknowledging that the
client has received a copy of the written care instructions, and
that the client has read and understands the instructions.
(b) The written care instructions for tattooing shall contain at
least the following items:
(1) for at least two weeks, the need to minimize exposure to the
sun, and to discourage swimming in fresh, salt, or chlorinated
water;
(2) the need to properly cleanse the tattooed area;
(3) the need to apply antibiotic ointment or cream;
(4) the need to use sterile bandage(s) or other sterile dressing(s)
when necessary;
(5) the name of the artist, and the name, address, and telephone
number of the studio or temporary location; and
(6) the instructions for the client to consult a health care
practitioner at the first sign of infection or an allergic
reaction, and to report any diagnosed infection, allergic
reaction, or adverse reaction resulting from the application of
the tattoo to the artist and to the Texas Department of Health,
Drugs and Medical Devices Division, at 1-888-839-6676.
(c) The written care instructions for body piercing shall contain
at least the following items:
(1) the need to properly cleanse the pierced area by using
antibacterial or antimicrobial soap for the external skin and or
an antiseptic or carbamide peroxide mouthwash for the oral cavity;
(2) for at least the first two to six weeks, the need to minimize
exposure to the sun, and to discourage swimming in fresh, salt, or
chlorinated water;
(3) the need to use sterile bandage(s) or other sterile dressing(s)
when necessary;
(4) the name of the artist, and the name, address, and telephone
number of the studio or temporary location; and
(5) the instructions for the client to consult a health care
practitioner at the first sign of infection or an allergic
reaction, and to report any diagnosed infection, allergic
reaction, or adverse reaction resulting from the body piercing to
the artist and to the Texas Department of Health, Drugs and
Medical Devices Division, at 1-888-839-6676.
|
|
| Source Note: The provisions of this §229.408 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.409 |
Tattooing and Body
Piercing Instruments and Jewelry |
|
|
(a) Instruments and jewelry used during tattooing and piercing
procedures which may contact blood or other bodily fluids, or
which come in direct contact with skin which is not intact shall
be sterilized after each use or disposed of. These devices
include, but are not limited to, needles, bars, tubes, forceps,
receiving tubes, and tapers. This does not include ear piercing
guns or tattoo machines/devices.
(b) Instruments and jewelry used during tattooing and body
piercing which do not come in contact with broken skin but may
come in contact with mucous membranes and oral tissue should be
sterilized after each use. If, however, sterilization is not
feasible because the instrument or jewelry will be damaged, the
instrument or jewelry shall be treated with a germicidal solution
prior to use. These devices include, but are not limited to,
calipers and gauge wheels.
(c) Instruments that come into contact only with intact skin shall
be treated with a germicidal solution prior to use. These devices
include, but are not limited to, hand mirrors.
(d) Reusable instruments shall be constructed in a manner that
permits easy cleaning and sterilization.
(e) Needles used to perform body piercing shall be single-use and
disposed of in a sharps container.
(f) Single-use disposable instruments shall be maintained in clean
condition and dispensed in a manner to prevent contamination to
the unused instruments. These devices include, but are not limited
to, cups, cotton swabs, corks, rubber bands, and toothpicks.
(g) Use of styptic pens or alum solids to control blood flow is
prohibited.
(h) All dyes or pigments used in tattooing and piercing shall be
non-toxic, free from adulteration, and made from materials
generally regarded as safe. Marking instruments shall be
single-use or sanitized by design, such as alcohol based ink pens,
and shall be used only on intact skin that has been treated with a
germicidal soap. Any marking instrument that comes in contact with
mucous membranes or broken skin shall be single-use.
(i) Only single-use pigment or dye containers shall be used for
each client. Pigments and dyes shall be dispensed from containers
in a manner to prevent contamination to the unused portion.
Individual containers of dye or pigment shall be discarded after
use.
(j) In order to minimize transmission of body fluids and disease,
single-use plastic covers shall be used to cover spray bottles or
other reusable accessories for multiple client use that are
handled by the artist during tattooing and body piercing.
(k) All stencils shall be single-use. Petroleum jellies, soaps,
and other products used in the application of stencils shall be
dispensed and applied using aseptic technique and in a manner to
prevent contamination of the original container and its contents.
The applicator shall be single-use.
(l) Contaminated reusable instruments shall be placed in a labeled
covered container which may contain a disinfectant solution such
as 2.0% alkaline glutaraldehyde (not to be construed as all
inclusive) until it can be cleaned and sterilized.
(m) All containers holding contaminated instruments and container
lids shall be emptied of contaminated solution and cleaned and
sanitized daily or more often if needed.
(n) Reusable instruments shall be cleaned by gloved personnel
prior to sterilization by one of the following methods:
(1) mechanically pre-clean the items by using a clean cotton ball
or swab moistened with a solution of low-residue detergent and
cool water, with care taken to ensure the removal of any pigment
or body substances not visible to the eye, thoroughly rinse with
warm water and then drain, and clean by soaking in a protein
dissolving detergent-enzyme cleaner used according to
manufacturer's instructions; or
(2) clean the items in an ultrasonic cleaning unit used according
to manufacturer's instruction. A copy of the manufacturers
recommended procedures for operation of the ultrasonic cleaning
unit must be available for inspection by an authorized agent; and
(3) rinse and dry the items prior to packaging for sterilization.
|
|
| Source Note: The provisions of this §229.409 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.410 |
Report of Infection or
Allergic Reactions |
|
|
(a) The studio shall provide a written report of any infection or
allergic reaction resulting from a body piercing or the
application of a tattoo to the Texas Department of Health
(department) within five working days of its occurrence or
knowledge thereof. The report shall include:
(1) the name of the affected client;
(2) the name and address of the studio or temporary location where
the tattoo or body piercing was performed;
(3) the name of the artist;
(4) the date the tattoo or piercing was performed;
(5) the specific color or colors of the tattoo or type of jewelry
used for the piercing and, when available, the manufacturer's
catalogue or identification number of each color or type of
jewelry used;
(6) the location of the infection and the location on the body
where the tattoo or piercing was applied;
(7) the name and address of the health care practitioner, if any;
and
(8) any other information considered relevant to the situation.
(b) The department shall use these reports in their efforts to
identify the source of the adverse reaction(s) and to take action
to prevent its recurrence.
|
|
| Source Note: The provisions of this §229.410 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.411 |
Disposal of Infectious
Waste |
|
|
(a) Sharps shall be subjected to the methods of treatment and
disposal as described in Chapter 1, Subchapter K, §1.136 of this
title (relating to Approved Methods of Treatment and Disposition)
and Title 30, Texas Administrative Code, Chapter 330, Subchapter
Y.
(b) Other studio waste generated during the tattooing and body
piercing process, i.e., cotton balls, cotton tip applicators,
corks, toothpicks, tissues, paper towels, gloves, and pigment
containers (not to be construed as all-inclusive) shall be
disposed of in accordance with Chapter 1, Subchapter K, §1.136(a)(2)
of this title or Title 30, Texas Administrative Code, Chapter 330.
Copies of these provisions 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,
1-888-839-6676, and are available weekdays for inspection between
the hours of 8:00 a.m. and 5:00 p.m.
|
|
| Source Note: The provisions of this §229.411 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| RULE §229.412 |
Refusal, Revocation, or
Suspension of License and Enforcement Provisions |
|
|
(a) Basis. The Texas Department of Health (department) may, after
providing notice and opportunity for hearing, refuse to license a
studio or temporary location, or may revoke or suspend the license
for violations of the requirements in these sections or for any
reasons described in the Tattoo and Certain Body Piercing Studio
Act, or in the Texas Food, Drug, and Cosmetic Act, Health and
Safety Code, Chapter 431.
(b) Hearing. All 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 the
Board of Health), the Administrative Procedure Act, Government
Code, Chapter 2001, and the hearing rules adopted by the State
Office of Administrative Hearings.
(c) Enforcement and penalties.
(1) Administrative penalty. The department may, after providing
notice and opportunity for hearing, assess an administrative
penalty as provided in §146.019 of the Tattoo and Certain Body
Piercing Studio Act, the Health and Safety Code, Chapter 431, and
§229.261 of this title (relating to Assessment of Administrative
or Civil Penalties), for violations of these sections. All
hearings for the assessment of an administrative penalty are
governed by the department's formal hearing procedures in Chapter
1 of this title (relating to the Board of Health) and the hearing
rules adopted by the State Office of Administrative Hearings.
(2) Civil penalty; Injunction. If it appears that a person has
violated or is violating Health and Safety Code, Chapter 146, or
an order issued or a rule adopted under Health and Safety Code,
Chapter 146, the commissioner may request the attorney general or
the district attorney, county attorney, or municipal attorney in
the jurisdiction where the violation is alleged to have occurred,
is occurring, or may occur to institute a civil suit for:
(A) an order enjoining the violation;
(B) a permanent or temporary injunction, a temporary restraining
order, or other appropriate remedy, if the department shows that
the person has engaged in or is engaging in a violation;
(C) the assessment and recovery of a civil penalty; or
(D) both injunctive relief and a civil penalty.
(3) Criminal penalty. A person commits an offense if the person
violates the Act or rules adopted under the Act. An offense under
the Act is a Class A misdemeanor.
(d) Re-issuance of a license. If a license issued under these
sections has been revoked or denied for violation of these rules,
the license holder named in the revocation or denial is not
eligible for licensing under these sections for a period of two
years.
|
|
| Source Note: The provisions of this §229.412 adopted to
be effective April 23, 2000, 25 TexReg 3272 |
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER X |
LICENSING OF DEVICE DISTRIBUTORS
AND MANUFACTURERS |
| RULE §229.431 |
Purpose |
|
|
These sections provide for the minimum licensure standards
necessary to ensure the safety and efficacy of devices distributed
by device distributors and manufacturers.
|
|
| Source Note: The provisions of this §229.431 adopted to
be effective October 18, 1994, 19 TexReg 7910; amended to be
effective March 19, 1996, 21 TexReg 1887. |
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER X |
LICENSING OF DEVICE DISTRIBUTORS
AND MANUFACTURERS |
| RULE §229.432 |
Applicable Laws and
Regulations |
|
|
(a) The Texas Department of Health (department) adopts by
reference the following laws and regulations:
(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code,
et seq., as amended;
(2) 21 Code of Federal Regulations (CFR), Part 801, Labeling, as
amended;
(3) 21 CFR, Part 803, Medical Device Reporting, as amended;
(4) 21 CFR, Part 804, Medical Device Distributor Reporting, as
amended;
(5) 21 CFR, Part 807, Establishment Registration and Device
Listing for Manufacturers and Distributors of Devices, as amended;
(6) 21 CFR, Part 814, Premarket Approval of Medical Devices, as
amended;
(7) 21 CFR, Part 820, Quality System Regulation, as amended;
(8) 21 CFR, Part 897, Cigarettes and Smokeless Tobacco, as
amended; and
(9) 21 CFR, Subchapter J--Radiological Health, as amended.
(b) Copies of these laws and regulations 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) Nothing in these sections shall relieve any person of the
responsibility for compliance with other applicable Texas and
federal laws and regulations.
|
|
| Source Note: The provisions of this §229.432 adopted to
be effective October 18, 1994, 19 TexReg 7910; amended to be
effective March 19, 1996, 21 TexReg 1887; amended to be effective
December 13, 1998, 23 TexReg 12353. |
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER X |
LICENSING OF DEVICE DISTRIBUTORS
AND MANUFACTURERS |
| RULE §229.433 |
Definitions |
|
|
The following words and terms, when used in these sections,
shall have the following meanings, unless the context clearly
indicates otherwise.
(1) Act--The Texas Food, Drug, and Cosmetic Act, Health and Safety
Code, Chapter 431.
(2) Adulterated Device--Has the meaning specified in the Texas
Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431,
§431.111.
(3) Advertising--All representations disseminated in any manner or
by any means, other than by labeling, for the purpose of inducing,
or that are likely to induce, directly or indirectly, the purchase
of food, drugs, devices, or cosmetics.
(4) Authorized agent--An employee of the department who is
designated by the commissioner to enforce the provisions of this
chapter.
(5) Board--The Texas Board of Health.
(6) Commissioner--The Commissioner of Health.
(7) Department--The Texas Department of Health.
(8) Device--An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or accessory, that
is:
(A) recognized in the official United States Pharmacopoeia
National Formulary or any supplement to it;
(B) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease in man or other animals; or
(C) intended to affect the structure or any function of the body
of man or other animals and that does not achieve any of its
principal intended purposes through chemical action within or on
the body of man or other animals and is not dependent on
metabolization for the achievement of any of its principal
intended purposes.
(9) Distributor--A person who furthers the marketing of a finished
domestic or imported device from the original place of manufacture
to the person who makes final delivery or sale to the ultimate
user. The term includes an importer or an own-label distributor.
The term does not include a person who repackages a finished
device or who otherwise changes the container, wrapper, or
labeling of the finished device or the finished device package.
(10) Electronic product radiation--Any ionizing or nonionizing
electromagnetic or particulate radiation, or any sonic,
infrasonic, or ultrasonic wave, which is emitted from an
electronic product as the result of the operation of an electronic
circuit in such product.
(11) Finished device--A device, or any accessory to a device,
which is suitable for use, whether or not packaged or labeled for
commercial distribution.
(12) Health authority--A physician designated to administer state
and local laws relating to public health.
(13) Importer--Any person who initially distributes a device
imported into the United States.
(14) Ionizing radiation--Any electromagnetic or particulate
radiation capable of producing ions, directly or indirectly, in
its passage through matter. Ionizing radiation includes gamma rays
and x-rays, alpha and beta particles, high speed electrons,
neutrons, and other nuclear particles.
(15) Labeling--All labels and other written, printed, or graphic
matter:
(A) upon any article or any of its containers or wrappers; or
(B) accompanying such article.
(16) Manufacture--The making by chemical, physical, biological, or
other procedures of any article that meets the definition of
device. The term includes the following activities:
(A) repackaging or otherwise changing the container, wrapper, or
labeling of any device package in furtherance of the distribution
of the device from the original place of manufacture to the person
who makes final delivery or sale to the ultimate consumer; or
(B) initiation of specifications for devices that are manufactured
by a second party for subsequent commercial distribution by the
person initiating specifications.
(17) Manufacturer--A person who manufactures, fabricates,
assembles, or processes a finished device. The term includes a
person who repackages or relabels a finished device. The term does
not include a person who only distributes a finished device.
(18) Misbranded Device--Has the meaning specified in the Texas
Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431,
§431.112.
(19) Person--Includes individual, partnership, corporation, and
association.
(20) Place of business--Each location at which a device is
manufactured or held for distribution.
(21) Radiation machine--Any device capable of producing ionizing
radiation except those devices with radioactive material as the
only source of radiation.
(22) Radioactive material--Any material (solid, liquid, or gas)
that emits radiation spontaneously.
(23) Reconditioning--Any appropriate process or procedure by which
distressed merchandise can be brought into compliance with
departmental standards as specified in the Texas Food, Drug,
Device, and Cosmetic Salvage Act, Health and Safety Code, Chapter
432, §432.003, as interpreted in the rules of the board in §229.192
of this title (relating to Definitions).
(24) Restricted device--A device subject to certain controls
related to sale, distribution, or use as specified in the Federal
Food, Drug, and Cosmetic Act, as amended, §520(e)(1).
|
|
| Source Note: The provisions of this §229.433 adopted to
be effective October 18, 1994, 19 TexReg 7910; amended to be
effective March 19, 1996, 21 TexReg 1887; amended to be effective
December 13, 1998, 23 TexReg 12353. |
|
|
(a) A person is exempt from licensing under these sections if the
person engages only in the following types of device distribution:
(1) intracompany sales;
(2) distribution from a place of business located outside the
State of Texas; or
(3) the sale, purchase, or trade of a distressed or reconditioned
device by a salvage broker or a salvage operator licensed under §229.203
of this title (relating to License).
(b) An exemption from the licensing requirements under these
sections does not constitute an exemption from other applicable
provisions of the Texas Food, Drug, and Cosmetic Act, Health and
Safety Code, Chapter 431 (Act) or the rules adopted by the Texas
Board of Health to administer and enforce the Act.
|
|
| Source Note: The provisions of this §229.434 adopted to
be effective October 18, 1994, 19 TexReg 7910; amended to be
effective March 19, 1996, 21 TexReg 1887. |
| RULE §229.435 |
Licensure Requirements |
|
|
(a) General. Except as provided by §229.434 of this title
(relating to Exemptions), a person may not engage in the
distribution or manufacture of devices in Texas unless the person
has a valid license from the Commissioner of Health (commissioner)
for each place of business.
(b) Display of license. The license shall be displayed in an open
public area at each place of business.
(c) Existing place of business. Each person involved in the
distribution or manufacture of devices in Texas on the effective
date of these sections must apply for a device distributor
manufacturer license no later than 60 days following the effective
date of these sections.
(d) New place of business. Each person acquiring or establishing a
place of business for the purpose of device distribution or
manufacturing after the effective date of these sections shall
apply to the Texas Department of Health (department) for a license
of such business prior to beginning operation.
(e) Two or more places of business. If the device distributor or
manufacturer operates more than one place of business, the device
distributor or manufacturer shall license each place of business
separately.
(f) Issuance of license. The department may license a distributor
or manufacturer of devices who meets the requirements of this
section and §229.441 of this title (relating to Minimum Standards
for Licensure).
(g) Transfer of license. Licenses shall not be transferable from
one person to another or from one place of business to another.
(h) License expiration. Unless the department revokes or suspends
a license as provided in §229.440 of this title (relating to
Refusal, Cancellation, Suspension, or Revocation of a License),
the initial license shall be valid for one year from the date of
issuance which becomes the anniversary date.
(i) Renewal of license.
(1) Each year prior to the anniversary date, the distributor or
manufacturer of devices shall renew its license following the
requirements of this section and §229.436 of this title (relating
to Licensing Procedures).
(2) The renewal license shall be valid for one year from the
anniversary date.
(3) The license renewal application and fee for each place of
business shall be submitted to the department 30 days prior to the
expiration date of the current license in accordance with
department procedures in §229.436 of this title. A person who
files a renewal application after the expiration date must pay an
additional $100 as a delinquency fee.
(4) Failure to submit the renewal application prior to the current
licensure expiration date may subject the device distributor or
manufacturer to the enforcement provisions under the Act and also
to the provisions of §229.440 of this title.
(j) 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 will require submission
of fees as outlined in §229.439 of this title (relating to
Licensure Fees).
(k) 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 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 ten 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 specific date of change, the
new 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, Texas.
|
|
| Source Note: The provisions of this §229.435 adopted to
be effective October 18, 1994, 19 TexReg 7910; amended to be
effective March 19, 1996, 21 TexReg 1887. |
| RULE §229.436 |
Licensing Procedures |
|
|
(a) License application forms. License application forms may be
obtained from the Texas Department of Health, Drugs and Medical
Devices Division, 1100 West 49th Street, Austin, Texas 78756.
(b) License application. The device distributor or manufacturer
license application shall be signed and verified, shall be made on
a license application form furnished by the Texas Department of
Health (department), 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 and a copy of the Articles of Incorporation; or if any other
type of association, then the names of the principals of such
association;
(4) the name, residence address, and valid driver license number
for each individual 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 address of the
individual in charge thereof;
(6) a list of categories which must be marked and adhered to in
the determination and payment of the fee; and
(7) a statement verified by the applicant's signature that
acknowledges the applicant has read, understood, and agrees to
abide by the provisions of these sections and those of the Texas
Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.
|
|
| Source Note: The provisions of this §229.436 adopted to
be effective October 18, 1994, 19 TexReg 7910; amended to be
effective March 19, 1996, 21 TexReg 1887. |
| RULE §229.441 |
Minimum Standards for
Licensure |
|
|
(a) Minimum requirements. All distributors or manufacturers of
devices engaged in the design, manufacture, packaging, labeling,
storage, installation, and servicing of devices must comply with
the minimum standards of this section in addition to the statutory
requirements contained in the Texas Food, Drug, and Cosmetic Act,
Health and Safety Code, Chapter 431 (Act). For the purpose of this
section, the policies described in the United States Food and Drug
Administration's (FDA's) Compliance Policy Guides as they apply to
devices shall be the policies of the Texas Department of Health
(department).
(b) Federal establishment registration and device listing. All
persons who operate as device distributors or manufacturers in
Texas shall meet the applicable requirements in 21 Code of Federal
Regulations (CFR), Part 807, titled "Establishment
Registration and Device Listing for Manufacturers and Distributors
of Devices." Devices distributed by device distributors or
manufacturers shall have met, if applicable, the premarket
notification requirements of 21 CFR, Part 807 or the premarket
approval provisions of 21 CFR, Part 814, titled "Premarket
Approval of Medical Devices."
(c) Good manufacturing practices. Device distributors or
manufacturers engaged in the design, manufacture, packaging,
labeling, storage, installation, and servicing of finished devices
shall be in compliance with the applicable requirements of 21 CFR,
Part 820, titled "Quality System Regulation." The
requirements in this part govern the methods used in, and the
facilities and controls used for, the design, manufacture,
packaging, labeling, storage, installation, and servicing of all
finished devices intended for human use.
(d) Buildings and facilities.
(1) All manufacturing, assembling, packaging, packing, holding,
testing, or labeling of devices by manufacturers shall take place
in buildings and facilities described in 21 CFR, Part 820, Subpart
L, titled "Handling, Storage, Distribution, and
Installation."
(2) No manufacturing, assembling, packaging, packing, holding,
testing, or labeling operations of devices by manufacturers or
distributors shall be conducted in any personal residence.
(3) Any place of business used by a distributor to store,
warehouse, hold, offer, transport, or display devices shall:
(A) be of suitable size and construction to facilitate cleaning,
maintenance, and proper operations;
(B) have storage areas designed to provide adequate lighting,
ventilation, temperature, sanitation, humidity, and space;
(C) have a quarantine area for storage of devices that are
outdated, damaged, deteriorated, misbranded, or adulterated;
(D) be maintained in a clean and orderly condition; and
(E) be free from infestation by insects, rodents, birds, or vermin
of any kind.
(e) Storage of devices. All devices stored by distributors shall
be held at appropriate temperatures and under appropriate
conditions in accordance with requirements, if any, in the
labeling of such devices.
(f) Device labeling. Devices distributed by device distributors or
manufacturers shall meet the labeling requirements of the Act and
21 CFR, Part 801, titled "Labeling."
(g) Device labeling exemptions. Device labeling or packaging
exemptions adopted under the Federal Food, Drug, and Cosmetic Act,
as amended, shall apply to devices in Texas except insofar as
modified or rejected by rules of the Texas Board of Health
(board).
(h) Reconditioned devices. Reconditioned devices must comply with
the provisions of the Act and these sections and are subject to
the provisions of the Texas Food, Drug, Device and Cosmetic
Salvage Act, Health and Safety Code, Chapter 432.
(i) Medical device reporting. Device distributors or manufacturers
shall meet the applicable medical device reporting requirements of
21 CFR, Part 803, titled "Medical Device Reporting" or
21 CFR, Part 804, titled "Medical Device Distributor
Reporting."
(j) Radiation emitting devices. Devices which emit electronic
product radiation and are distributed by device distributors or
manufacturers shall meet the applicable requirements of the Act
and 21 CFR, Subchapter J, titled "Radiological Health."
|
|
| Source Note: The provisions of this §229.441 adopted to
be effective October 18, 1994, 19 TexReg 7910; amended to be
effective March 19, 1996, 21 TexReg 1887; amended to be effective
December 13, 1998, 23 TexReg 12353. |
Tattoo Studio
Program
Julee Magness,
R.S.
Tattoo Program Manager |
The tattoo program is responsible for ensuring that tattoo studios take
precautions to minimize infections due to unsanitary conditions and to
reduce the amount tattooing performed on minors. We require any business
which is in the practice of producing an indelible mark or figure on the
human body by scarring or inserting pigments under the skin using needles,
scalpels, or other related equipment to licence with us. The Texas
Department of Health currently, has about 261 licensed tattoo studios
throughout the state of Texas. This industry consist of two types of
studios--tattoo studios and intradermal cosmetic studios.
Tattoo Studios
Tattoo studios are where most people receive tattoos. The tattoos are
applied using a small electric device which operates similar to a
small sewing machine. One to fourteen needles are grouped together and
attached to the end of a bar called a needlebar. The other end of the
needlebar is attached to the tattoo device. The needlebar moves up and
down through a tube or barrel which serves two purposes--to keep the
needlebar from moving side to side and as a handle for the
tattooist.
The needles stick out only a few millimeters from the end of the tube,
so the needles don't go very deep into the skin. The tattooist dips the
needles into a small amount of pigment or ink. As the tattooist guides the
machine over the skin, the needlebar moves up and down allowing the
needles to puncture the skin, therefore depositing the ink under the skin.
A tattoo machine can puncture the skin 50 to 3,000 times per minute. Once
the tattoo is completed, the tattooist usually applies an antibiotic cream
or ointment and covers the area with a sterile bandage. The tattooist is
required to provide you with oral and written instructions on how to care
for your newly applied tattoo.
Intradermal Cosmetic Studios
Intradermal cosmetic studios (sometimes referred to as permanent makeup
studios) are becoming more and more common in Texas. The permanent makeup
is generally applied to the eyebrows, eyelids, and lips. They use
tattooing devices which work on the same principle as traditional tattoo
studios. In some studios, we have seen smaller, pen-type devices which use
needlebars with one to seven needles. Generally, the components of this
type of machine are disposable (one time use) items.
All tattoo studios must be inspected prior to receiving a license.
During these inspections, we ensure that the studios comply with state and
local laws and regulations. Some cities in Texas have local ordinances
that are more stringent or ban tattooing altogether. We ensure:
- the building is well maintained and clean
- the tattooist takes precautions to prevent the spread of infection,
such as
- washes hands with a germicidal soap
- wear clean clothing and single use gloves
- uses tools which are either disposable or that are routinely
sterilized
- the tattooist has sterilization records showing routine
sterilization practices
- the tattooist prohibits the tattooing of minors and persons under
the influence of drugs or alcohol
- the tattooist maintains records for each person receiving a tattoo
- the tattooist reports any infection or adverse reaction to TDH
Another function of this program is to investigate complaints where
personal injury has occurred or when personal injury could occur. Each
complaint or concern that is forwarded to us is thoroughly investigated to
ensure the tattooist and/or studio are complying with state and local
regulations.
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