HB 1098-1_ Filed 04/26/2005, 18:14
Adopted 4/27/2005
CONFERENCE COMMITTEE REPORT
DIGEST FOR EHB 1098
Citations Affected: IC 10-13-3-38.5; IC 12-9-5-5; IC 16-18-2; IC 16-27; IC 22-1-5;
IC 25-22.5-1-2; IC 25-23-1-27.1; IC 25-26-13-4; IC 25-26-14; IC 25-33-1-9; IC 25-35.6;
IC 34-24-1-1; IC 35-43-10.
Synopsis: Prescription drugs and health professions. Establishes a program for the licensing and
regulation of personal services agencies. Provides that home health agencies and personal
services agencies are approved to provide home health or personal services under certain federal
waivers. Provides that home health services include services that are required to be ordered or
performed by certain health care professionals. Increases the home health agency license fee.
Requires a personal services agency to comply with employee criminal history check
requirements. Provides that a home health agency that operates a personal services agency is not
required to obtain a license to operate the personal services agency. Makes operating or
advertising an unlicensed personal services agency a Class A misdemeanor. Requires a placement
agency to provide the consumer and worker with certain information when a home care services
worker is placed in the consumer's home. Allows the state department of health to impose a civil
penalty against a placement agency for failing to provide the notice. Relocates the definition of
"attendant care services". Requires the board of pharmacy to establish procedures to ensure that
pharmacies may return expired prescription drugs to drug wholesalers and manufacturers.
Specifies information that the board must consider in establishing the procedures. Expands the
requirements that must be met by a wholesale drug distributor for eligibility for licensure.
Specifies prohibited acts. Allows certain state licensure exams to apply to the psychology
reciprocity requirements. Amends several definitions concerning speech-language pathology and
audiology. Requires licensure of speech-language pathology aides, associates, and assistants.
Amends licensure requirements of speech-language pathologists and audiologists. Requires an
audiologist to possess a doctorate degree after January 1, 2007, for an initial license. Allows the
professional standards board to issue credentials to certain speech language professionals. Allows
certified speech-language pathologists and audiologists who meet certain requirements to be
considered to have a National Board of Professional Teaching Standards certification. Requires
a referral to administer a test of vestibular function. Amends reciprocity licensure requirements
for speech language pathologists and audiologists. Requires licenses to be displayed. Specifies
criminal acts related to wholesale drug distribution and legend drugs. Allows the board of
pharmacy to establish an electronic pedigree pilot program. Makes conforming changes. (This
conference committee report: (1) adds provisions from SB 206 concerning personal services
agencies and home health services; (2) adds provisions from SB 590 concerning wholesale
drug distribution; (3) allows certain state licensure exams to apply to the psychology
reciprocity requirements (HB 1599); and (4) adds provisions from HB 1599 concerning
speech and language pathologists.)
Effective: July 1, 2005; January 1, 2006.
Text Box
Adopted Rejected
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CONFERENCE COMMITTEE REPORT
MR. SPEAKER:
Your Conference Committee appointed to confer with a like committee from the Senate
upon Engrossed Senate Amendments to Engrossed House Bill No. 1098 respectfully reports
that said two committees have conferred and agreed as follows to wit:
that the House recede from its dissent from all Senate amendments and that
the House now concur in all Senate amendments to the bill and that the bill
be further amended as follows:
Delete the title and insert the following:
A BILL FOR AN ACT to amend the Indiana Code concerning health.
Delete everything after the enacting clause and insert the following:
SOURCE: IC 10-13-3-38.5; (05)CC109806.1. -->
SECTION 1. IC 10-13-3-38.5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 38.5. (a) Under federal
P.L.92-544 (86 Stat. 1115), the department may use an individual's
fingerprints submitted by the individual for the following purposes:
(1) Determining the individual's suitability for employment with
the state, or as an employee of a contractor of the state, in a
position:
(A) that has a job description that includes contact with, care of,
or supervision over a person less than eighteen (18) years of age;
(B) that has a job description that includes contact with, care of,
or supervision over an endangered adult (as defined in
IC 12-10-3-2), except the individual is not required to meet the
standard for harmed or threatened with harm set forth in
IC 12-10-3-2(a)(3);
(C) at a state institution managed by the office of the secretary of
family and social services or state department of health;
(D) at the Indiana School for the Deaf established by
IC 20-16-2-1;
(E) at the Indiana School for the Blind established by
IC 20-15-2-1;
(F) at a juvenile detention facility;
(G) with the gaming commission under IC 4-33-3-16;
(H) with the department of financial institutions under
IC 28-11-2-3; or
(I) that has a job description that includes access to or
supervision over state financial or personnel data, including state
warrants, banking codes, or payroll information pertaining to
state employees.
(2) Identification in a request related to an application for a
teacher's license submitted to the professional standards board
established under IC 20-1-1.4.
(3) Use by the Indiana board of pharmacy in determining the
individual's suitability for a position or employment with a
wholesale drug distributor, as specified in IC 25-26-14-16(b),
IC 25-26-14-16.5(b), IC 25-26-14-17.8(c), and IC 25-26-14-20.
An applicant shall submit the fingerprints in an appropriate format or
on forms provided for the employment or license application. The
department shall charge each applicant the fee established under section
28 of this chapter and by federal authorities to defray the costs
associated with a search for and classification of the applicant's
fingerprints. The department may forward fingerprints submitted by an
applicant to the Federal Bureau of Investigation or any other agency for
processing. The state personnel department or the agency to which the
applicant is applying for employment or a license may receive the
results of all fingerprint investigations.
(b) An applicant who is an employee of the state may not be charged
under subsection (a).
(c) Subsection (a)(1) does not apply to an employee of a contractor
of the state if the contract involves the construction or repair of a capital
project or other public works project of the state.
SOURCE: IC 12-9-5-5; (05)CC109806.2. -->
SECTION 2. IC 12-9-5-5 IS ADDED TO THE INDIANA CODE AS
A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1,
2005]: Sec. 5. Notwithstanding any other law:
(1) home health agencies licensed under IC 16-27-1 are
approved to provide home health services; and
(2) personal services agencies licensed under IC 16-27-4 are
approved to provide personal services;
under any federal waiver granted to the state under 42 U.S.C. 1315
or 42 U.S.C. 1396n.
SOURCE: IC 16-18-2-28.5; (05)CC109806.3. -->
SECTION 3. IC 16-18-2-28.5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 28.5. (a) "Attendant
care services", for purposes of IC 16-27-1 has the meaning set forth in
IC 16-27-1-0.5. and IC 16-27-4, means services:
(1) that could be performed by an impaired individual for
whom the services are provided if the individual were not
impaired; and
(2) that enable the impaired individual:
(A) to live in the individual's home and community rather
than in an institution; and
(B) to carry out functions of daily living, self-care, and
mobility.
(b) The term includes the following:
(1) Assistance in getting in and out of beds, wheelchairs, and
motor vehicles.
(2) Assistance with routine bodily functions, including:
(A) bathing and personal hygiene;
(B) using the toilet;
(C) dressing and grooming; and
(D) feeding, including preparation and cleanup.
(3) The provision of assistance:
(A) through providing reminders or cues to take medication,
the opening of preset medication containers, and providing
assistance in the handling or ingesting of noncontrolled
substance medications, including eye drops, herbs,
supplements, and over-the-counter medications; and
(B) to an individual who is unable to accomplish the task due
to an impairment and who is:
(i) competent and has directed the services; or
(ii) incompetent and has the services directed by a
competent individual who may consent to health care for
the impaired individual.
SOURCE: IC 16-18-2-56.3; (05)CC109806.4. -->
SECTION 4. IC 16-18-2-56.3 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 56.3. "Client", for purposes of
IC 16-27-4, has the meaning set forth in IC 16-27-4-1.
SOURCE: IC 16-18-2-162; (05)CC109806.5. -->
SECTION 5. IC 16-18-2-162 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 162. (a) "Health care
professional", for purposes of IC 16-27-1 and IC 16-27-4, has the
meaning set forth in IC 16-27-1-1.
(b) "Health care professional", for purposes of IC 16-27-2, has the
meaning set forth in IC 16-27-2-1.
SOURCE: IC 16-18-2-266.5; (05)CC109806.6. -->
SECTION 6. IC 16-18-2-266.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 266.5. "Parent personal services
agency", for purposes of IC 16-27-4, has the meaning set forth in
IC 16-27-4-2.
SOURCE: IC 16-18-2-277.6; (05)CC109806.7. -->
SECTION 7. IC 16-18-2-277.6 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 277.6. "Personal representative",
for purposes of IC 16-27-4, has the meaning set forth in
IC 16-27-4-3.
SOURCE: IC 16-18-2-277.7; (05)CC109806.8. -->
SECTION 8. IC 16-18-2-277.7 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 277.7. "Personal services", for
purposes of IC 16-27-2 and IC 16-27-4, has the meaning set forth
in IC 16-27-4-4.
SOURCE: IC 16-18-2-277.8; (05)CC109806.9. -->
SECTION 9. IC 16-18-2-277.8 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 277.8. "Personal services
agency", for purposes of IC 16-27-4, has the meaning set forth in
IC 16-27-4-5.
SOURCE: IC 16-27-1-5; (05)CC109806.10. -->
SECTION 10. IC 16-27-1-5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 5. (a) As used in this
chapter, "home health services" means services that: are:
(1) are provided to a patient by:
(A) a home health agency; or
(B) another person under an arrangement with a home health
agency;
in the temporary or permanent residence of the patient; and
(2) either, are required by law to be:
(A) ordered by a licensed physician, a licensed dentist, a licensed
chiropractor, a licensed podiatrist, or a licensed optometrist for
the service to be performed; or
(B) performed only by a health care professional.
(b) The term includes the following:
(1) Nursing treatment and procedures.
(2) Physical therapy.
(3) Occupational therapy.
(4) Speech therapy.
(5) Medical social services.
(6) Home health aide services.
(7) Other therapeutic services.
(c) The term does not apply to the following:
(1) Services provided by a physician licensed under IC 25-22.5.
(2) Incidental services provided by a licensed health facility to
patients of the licensed health facility.
(3) Services provided by employers or membership organizations
using health care professionals for their employees, members, and
families of the employees or members if the health or home care
services are not the predominant purpose of the employer or a
membership organization's business.
(4) Nonmedical nursing care given in accordance with the tenets
and practice of a recognized church or religious denomination to a
patient who depends upon healing by prayer and spiritual means
alone in accordance with the tenets and practices of the patient's
church or religious denomination.
(5) Services that are allowed to be performed by an attendant under
IC 16-27-1-10.
(6) Authorized services provided by a personal services attendant
under IC 12-10-17.
SOURCE: IC 16-27-1-7; (05)CC109806.11. -->
SECTION 11. IC 16-27-1-7 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 7. The state department
shall adopt rules under IC 4-22-2 to do the following:
(1) Protect the health, safety, and welfare of patients.
(2) Govern the qualifications of applicants for licenses.
(3) Govern the operating policies, supervision, and maintenance of
service records of home health agencies.
(4) Govern the procedure for issuing, renewing, denying, or
revoking an annual license to a home health agency, including the
following:
(A) The form and content of the license.
(B) The collection of an annual license fee of not more than two
hundred
fifty dollars
($200) ($250) that the state department may
waive.
(5) Exempt persons who do not provide home health services under
this chapter.
SOURCE: IC 16-27-2-2.2; (05)CC109806.12. -->
SECTION 12. IC 16-27-2-2.2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2.2. As used in this
chapter, "services" includes:
(1) home health services (as defined in IC 16-27-1-5); and
(2) any services such as homemaker, companion, sitter, or
handyman services provided by a home health agency in the
temporary or permanent residence of a patient or client of the home
health agency; and
(3) personal services.
SOURCE: IC 16-27-2-3; (05)CC109806.13. -->
SECTION 13. IC 16-27-2-3 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 3. (a) A person may
not operate a home health agency or a personal services agency if the
person has been convicted of any of the following:
(1) Rape (IC 35-42-4-1).
(2) Criminal deviate conduct (IC 35-42-4-2).
(3) Exploitation of an endangered adult (IC 35-46-1-12).
(4) Failure to report battery, neglect, or exploitation of an
endangered adult (IC 35-46-1-13).
(5) Theft (IC 35-43-4), if the person's conviction for theft occurred
less than ten (10) years before the date of submission by the person
of an application for licensure as a home health agency under
IC 16-27-1 or as a personal services agency under IC 16-27-4.
(b) A person who knowingly or intentionally violates this section
commits a Class A misdemeanor.
SOURCE: IC 16-27-2-4; (05)CC109806.14. -->
SECTION 14. IC 16-27-2-4 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. (a) A person who
operates a home health agency under IC 16-27-1 or a personal
services agency under IC 16-27-4 shall apply, not more than three (3)
business days after the date that an employee begins to provide services
in a patient's temporary or permanent residence, for a copy of the
employee's limited criminal history from the Indiana central repository
for criminal history information under IC 10-13-3.
(b) A home health agency or personal services agency may not
employ a person to provide services in a patient's or client's temporary
or permanent residence for more than three (3) business days without
applying for that person's limited criminal history as required by
subsection (a).
SOURCE: IC 16-27-2-5; (05)CC109806.15. -->
SECTION 15. IC 16-27-2-5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 5. (a) Except as
provided in subsection (b), a person who operates a home health agency
under IC 16-27-1 or a personal services agency under IC 16-27-4
may not employ a person to provide services in a patient's or client's
temporary or permanent residence if that person's limited criminal
history indicates that the person has been convicted of any of the
following:
(1) Rape (IC 35-42-4-1).
(2) Criminal deviate conduct (IC 35-42-4-2).
(3) Exploitation of an endangered adult (IC 35-46-1-12).
(4) Failure to report battery, neglect, or exploitation of an
endangered adult (IC 35-46-1-13).
(5) Theft (IC 35-43-4), if the conviction for theft occurred less than
ten (10) years before the person's employment application date.
(b) A home health agency or personal services agency may not
employ a person to provide services in a patient's or client's temporary
or permanent residence for more than twenty-one (21) calendar days
without receipt of that person's limited criminal history required by
section 4 of this chapter, unless the Indiana central repository for
criminal history information under IC 10-13-3 is solely responsible for
failing to provide the person's limited criminal history to the home
health agency or personal services agency within the time required
under this subsection.
SOURCE: IC 16-27-2-6; (05)CC109806.16. -->
SECTION 16. IC 16-27-2-6 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6. (a) A person who
operates a home health agency or a personal services agency under
IC 16-27-4 is responsible for the payment of fees under IC 10-13-3-30
and other fees required under section 4 of this chapter.
(b) A home health agency or personal services agency may require
a person who applies to the home health agency or personal services
agency for employment to provide services in a patient's or client's
temporary or permanent residence:
(1) to pay the cost of fees described in subsection (a) to the home
health agency or personal services agency at the time the person
submits an application for employment; or
(2) to reimburse the home health agency or personal services
agency for the cost of fees described in subsection (a).
SOURCE: IC 16-27-2-7; (05)CC109806.17. -->
SECTION 17. IC 16-27-2-7 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 7. A person who:
(1) operates a home health agency or personal services agency;
and
(2) violates section 4 or 5 of this chapter;
commits a Class A infraction.
SOURCE: IC 16-27-4; (05)CC109806.18. -->
SECTION 18. IC 16-27-4 IS ADDED TO THE INDIANA CODE
AS A
NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2005]:
Chapter 4. Licensure of Personal Services Agencies
Sec. 1. As used in this chapter, "client" means an individual who
has been accepted to receive personal services from a personal
services agency.
Sec. 2. As used in this chapter, "parent personal services agency"
means the personal services agency that develops and maintains
administrative and fiscal control over a branch office.
Sec. 3. As used in this chapter, "personal representative" means
a person who has legal authority to act on behalf of the client with
regard to the action to be taken.
Sec. 4. (a) As used in this chapter, "personal services" means:
(1) attendant care services;
(2) homemaker services that assist with or perform household
tasks, including housekeeping, shopping, laundry, meal
planning and preparation, and cleaning; and
(3) companion services that provide fellowship, care, and
protection for a client, including transportation, letter writing,
mail reading, and escort services;
that are provided to a client at the client's residence.
(b) The term does not apply to the following:
(1) Incidental services provided by a licensed health facility to
patients of the licensed health facility.
(2) Services provided by employers or membership
organizations for their employees, members, and families of the
employees or members if the services are not the predominant
purpose of the employer or the membership organization's
business.
(3) Services that are allowed to be performed by a personal
services attendant under IC 12-10-17.
(4) Services that require the order of a health care professional
for the services to be lawfully performed in Indiana.
(5) Assisted living Medicaid waiver services.
(6) Services that are performed by a facility described in
IC 12-10-15.
Sec. 5. (a) As used in this chapter, "personal services agency"
means a person that provides or offers to provide a personal service
for compensation, whether through the agency's own employees or
by arrangement with another person.
(b) The term does not include the following:
(1) An individual who provides personal services only to the
individual's family or to not more than three (3) individuals per
residence and not more than a total of seven (7) individuals
concurrently. As used in this subdivision, "family" means the
individual's spouse, child, parent, parent-in-law, grandparent,
grandchild, brother, brother-in-law, sister, sister-in-law, aunt,
aunt-in-law, uncle, uncle-in-law, niece, and nephew.
(2) A local health department as described in IC 16-20 or
IC 16-22-8.
(3) A person that:
(A) is approved by the division of disability, aging, and
rehabilitative services to provide supported living services or
supported living support to individuals with developmental
disabilities;
(B) is subject to rules adopted under IC 12-11-2.1; and
(C) serves only individuals with developmental disabilities
who are in a placement authorized under IC 12-11-2.1-4.
Sec. 6. (a) To operate a personal services agency, a person must
obtain a license from the state health commissioner. A personal
services agency may not be opened, operated, managed, or
maintained or conduct business without a license from the state
department. Each parent personal services agency must obtain a
separate license.
(b) A parent personal services agency may maintain branch
offices that operate under the license of the parent personal
services agency. Each branch office must be:
(1) at a location or site from which the personal services agency
provides services;
(2) owned and controlled by the parent personal services
agency; and
(3) located within a radius of one hundred twenty (120) miles
of the parent personal services agency.
(c) A license is required for any personal services agency
providing services in Indiana. An out-of-state personal services
agency must be authorized by the secretary of state to conduct
business in Indiana and have a branch office in Indiana.
(d) Application for a license to operate a personal services agency
must be made on a form provided by the state department and
must be accompanied by the payment of a fee of two hundred fifty
dollars ($250). The application may not require any information
except as required under this chapter.
(e) After receiving a completed application that demonstrates
prima facie compliance with the requirements of this chapter and
the payment of the fee required by subsection (d), the state
department shall issue a license to the applicant to operate a
personal services agency. The state department may conduct an
onsite inspection in conjunction with the issuance of an initial
license or the renewal of a license.
(f) In the state department's consideration of:
(1) an application for licensure;
(2) an application for renewal of licensure;
(3) a complaint alleging noncompliance with the requirements
of this chapter; or
(4) an investigation conducted under section 7(a) of this
chapter;
the state department's onsite inspections in conjunction with those
actions are limited to determining the personal service agency's
compliance with the requirements of this chapter or permitting or
aiding an illegal act in a personal services agency.
(g) Subject to subsection (e), when conducting an onsite
inspection, the state department must receive all documents
necessary to determine the personal service agency's compliance
with the requirements of this chapter. A personal services agency
must produce documents requested by the state department
surveyor not less than twenty-four (24) hours after the documents
have been requested.
(h) A license expires one (1) year after the date of issuance of the
license under subsection (e). However, the state department may
issue an initial license for a period of less than one (1) year to
stagger the expiration dates. The licensee shall notify the state
department in writing at least thirty (30) days before closing or
selling the personal services agency.
(i) A personal services agency license may not be transferred or
assigned. Upon sale, assignment, lease, or other transfer, including
transfers that qualify as a change in ownership, the new owner or
person in interest must obtain a license from the state department
under this chapter before maintaining, operating, or conducting
the personal services agency.
(j) A home health agency licensed under IC 16-27-1 that operates
a personal services agency within the home health agency is subject
to the requirements of this chapter. The requirements under
IC 16-27-1 do not apply to a home health agency's personal services
agency. The requirements under this chapter do not apply to a
home health agency's operations. A home health agency that is
licensed under IC 16-27-1 is not required to obtain a license under
this chapter.
(k) If a person who is licensed to operate a personal services
agency is also licensed to operate a home health agency under
IC 16-27-1, an onsite inspection for renewal of the person's
personal services agency license must, to the extent feasible, be
conducted at the same time as an onsite inspection for the home
health agency license.
Sec. 7. (a) The state department shall investigate a report of an
unlicensed personal services agency operation and report its
findings to the attorney general.
(b) The attorney general may do the following:
(1) Seek an injunction in the circuit or superior court of the
county in which the unlicensed home health agency is located.
(2) Prosecute violations under section 23 of this chapter.
Sec. 8. (a) If a personal services agency is aware that the client's
medical or health condition has become unstable or unpredictable,
the personal services agency shall notify the client, the client's
personal representative, a family member, other relative of the
client, or other person identified by the client of the need for a
referral for medical or health services. The notification may be
given in writing or orally and must be documented in the client's
record with the personal services agency.
(b) The personal services agency may continue to provide
personal services for a client with an unstable or unpredictable
medical or health condition but may not manage or represent itself
as able to manage the client's medical or health condition.
Sec. 9. (a) A personal services agency shall employ an individual
to act as the personal services agency's manager. The manager is
responsible for the organization and daily operation of the personal
services agency.
(b) The manager may designate in writing one (1) or more
individuals to act on behalf of or to perform any or all the
responsibilities of the personal services agency's manager under
this chapter.
Sec. 10. The personal services agency's manager or the manager's
designee shall prepare a service plan for a client before providing
personal services for the client. A permanent change to the service
plan requires a written change to the service plan. The service plan
must:
(1) be in writing, dated, and signed by the individual who
prepared it;
(2) list the types and schedule of services to be provided; and
(3) state that the services to be provided to the client are
subject to the client's right to temporarily suspend,
permanently terminate, temporarily add, or permanently add
the provision of any service.
All permanent changes require a change in the written service
plan. The service plan must be signed and dated by the client not
later than fourteen (14) days after services begin for the client and
not later than fourteen (14) days after any permanent change to the
service plan.
Sec. 11. The personal services agency's manager or the manager's
designee shall conduct a client satisfaction review with the client
every seventy-six (76) to one hundred four (104) days to discuss the
services being provided and to determine if any change in the plan
of services should occur. The review with the client may be in
person or by telephone. This client satisfaction review must:
(1) be put in writing; and
(2) be signed and dated by the individual conducting the
review.
Sec. 12. The personal services agency shall provide the client or
the client's personal representative with the personal services
agency's written statement of client rights not more than seven (7)
days after providing services to the client. The statement of client
rights must include the following information:
(1) The client has the right to have the client's property treated
with respect.
(2) The client has the right to temporarily suspend,
permanently terminate, temporarily add, or permanently add
services in the service plan.
(3) The client has the right to file grievances regarding services
furnished or regarding the lack of respect for property by the
personal services agency and is not subject to discrimination or
reprisal for filing a grievance.
(4) The client has the right to be free from verbal, physical, and
psychological abuse and to be treated with dignity.
(5) A statement that it is not within the scope of the personal
services agency's license to manage the medical and health
conditions of the client if a condition becomes unstable or
unpredictable.
(6) The charges for services provided by the personal services
agency.
(7) The personal services agency's policy for notifying the client
of any increase in the cost of services.
(8) The hours the personal services agency's office is open for
business.
(9) That on request the personal services agency will make
available to the client a written list of the names and addresses
of all persons having at least a five percent (5%) ownership or
controlling interest in the personal services agency.
(10) The procedures for contacting the personal services
agency's manager, or the manager's designee, while the
personal services agency's office is open or closed.
(11) The procedure and telephone number to call to file a
complaint with the personal services agency.
(12) That the state department does not inspect personal
service agencies as part of the licensing process but does
investigate complaints concerning personal service agencies.
(13) The procedure and telephone number to call to file a
complaint with the state department along with the business
hours of the state department.
Sec. 13. A personal services agency shall investigate a complaint
made by a client, the client's family, or the client's personal
representative regarding:
(1) service that is or fails to be furnished; and
(2) lack of respect for the client's property by anyone
furnishing services on behalf of the personal services agency.
The personal services agency shall document the complaint and the
resolution of the complaint.
Sec. 14. The personal services agency's manager or the manager's
designee shall be available to respond to client telephone calls
twenty-four (24) hours a day.
Sec. 15. An employee or agent of a personal services agency who
will have direct client contact must complete a tuberculosis test in
the same manner as required by the state department for licensed
home health agency employees and agents.
Sec. 16. (a) The competency of an employee or agent of a personal
services agency who will perform attendant care services at the
client's residence must be evaluated by the agency or the agency's
designee for each attendant care services task that the personal
services agency chooses to have that employee or agent perform.
The agency has the sole discretion to determine if an employee or
agent is competent to perform an attendant care services task.
(b) After an evaluation, an employee or agent shall be trained in
the attendant care services tasks the personal services agency
believes require improvement. The employee or agent shall be
reevaluated following any training. The evaluation of the employee
or agent and determination by the agency that the employee or
agent is competent to perform the attendant care services task must
occur before the employee or agent performs that task for a client
without direct agency supervision.
(c) The content of the evaluation and training conducted under
this section, including the date and the signature of the person
conducting the evaluation and training, must be documented for
each employee or agent who performs personal services.
Sec. 17. (a) Disclosure of ownership and management
information must be made to the state department:
(1) at the time of the personal services agency's request for
licensure;
(2) during each survey of the personal services agency; and
(3) when there is a change in the management or in an
ownership interest of more than five percent (5%) of the
personal services agency.
(b) The disclosure under subsection (a) must include the
following:
(1) The name and address of all persons having at least five
percent (5%) ownership or controlling interest in the personal
services agency.
(2) The name and address of each person who is an officer, a
director, a managing agent, or a managing employee of the
personal services agency.
(3) The name and address of the person responsible for the
management of the personal services agency.
(4) The name and address of the chief executive officer and the
chairperson (or holder of the equivalent position) of the
governing body that is responsible for the person identified
under subdivision (3).
(c) The determination of an ownership interest and the
percentage of an ownership interest under this chapter must be
determined under 45 CFR 420.201 and 45 CFR 420.202, as in effect
on July 1, 2005.
Sec. 18. A personal services agency shall document evidence of
compliance with the requirements of this chapter and document
services provided to clients. The documentation or copies of the
documentation must be maintained or be electronically accessible
at a personal services agency's office in Indiana for not less than
seven (7) years.
Sec. 19. (a) The state health commissioner may take one (1) or
more of the following actions on any ground listed in subsection
(b):
(1) Issue a probationary license.
(2) Conduct a resurvey.
(3) Deny renewal of a license.
(4) Revoke a license.
(5) Impose a civil penalty in an amount not to exceed one
thousand dollars ($1,000).
(b) The state health commissioner may take action under
subsection (a) on any of the following grounds:
(1) Violation of a provision of this chapter or a rule adopted
under this chapter.
(2) Permitting, aiding, or abetting the commission of an illegal
act in a personal services agency.
(c) IC 4-21.5 applies to an action under this section.
Sec. 20. (a) The state department shall adopt rules under
IC 4-22-2 to govern the procedure for the following:
(1) Issuing, renewing, denying, or revoking a personal services
agency license.
(2) Investigating a complaint against a personal services agency
that alleges a violation of this chapter.
(3) Collecting fees required under this chapter.
(b) The state department may not add to the substantive or
procedural requirements in this chapter.
Sec. 21. A licensee or an applicant for a license aggrieved by an
action under this chapter may request a review under IC 4-21.5.
Sec. 22. (a) In response to a request for review of an order
referred to in subsection (c), the executive board shall appoint an
appeals panel that consists of three (3) members as follows:
(1) One (1) member of the executive board.
(2) One (1) attorney admitted to the practice of law in Indiana.
(3) One (1) individual with qualifications determined by the
executive board.
(b) An employee of the state department may not be a member of
the panel.
(c) The panel shall conduct proceedings for review of an order
issued by an administrative law judge under this chapter. The
panel is the ultimate authority under IC 4-21.5.
Sec. 23. A person who knowingly or intentionally:
(1) operates a personal services agency; or
(2) advertises the operation of a personal services agency;
that is not licensed under this chapter commits a Class A
misdemeanor.
SOURCE: IC 22-1-5; (05)CC109806.19. -->
SECTION 19. IC 22-1-5 IS ADDED TO THE INDIANA CODE AS
A
NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2005]:
Chapter 5. Home Care Consumers and Worker Protection
Sec. 1. As used in this chapter, "attendant care services" has the
meaning set forth in IC 16-18-2-28.5.
Sec. 2. As used in this chapter, "companion type services" refers
to services described in IC 12-10-17-2(2).
Sec. 3. As used in this chapter, "consumer" means an individual
who:
(1) receives home care services given by a home care services
worker in the individual's residence; or
(2) pays for and directs the home care services for another
individual.
Sec. 4. As used in this chapter, "consumer notice" means the
notice described in section 14 of this chapter.
Sec. 5. As used in this chapter, "department" refers to the
department of labor created under IC 22-1-1-1.
Sec. 6. As used in this chapter, "home care services" means
skilled and unskilled services provided to an individual at the
individual's residence to enable the individual to remain in the
residence safely and comfortably. The provision of at least two (2)
of the following is included in home care services:
(1) Nursing.
(2) Therapy.
(3) Attendant care.
(4) Companion type services.
(5) Homemaker services.
Sec. 7. As used in this chapter, "home care services worker"
means an individual performing home care services for
compensation.
Sec. 8. As used in this chapter, "homemaker services" means
assistance with or performing household tasks that include
housekeeping, shopping, laundry, meal planning and preparation,
handyman services, and seasonal chores.
Sec. 9. As used in this chapter, "placement agency" means a
person engaged in the business of securing home care services
employment for an individual or securing a home care services
worker for a consumer. The term:
(1) includes an employment agency, a nurse registry, and an
entity that places a home care services worker for
compensation by a consumer in the consumer's residence to
provide home care services; and
(2) does not include a worker who solely and personally
provides home care services to another individual at the
residence of that individual.
Sec. 10. As used in this chapter, "skilled services" means services
provided by a:
(1) registered nurse (as defined in IC 25-23-1-1.1(a));
(2) licensed practical nurse (as defined in IC 25-23-1-1.2); or
(3) health care professional listed in IC 16-27-1-1.
Sec. 11. As used in this chapter, "worker notice" means the
statement described in section 17 of this chapter.
Sec. 12. This chapter applies to a placement agency, but does not
apply to a:
(1) hospital (as defined in IC 16-18-2-179);
(2) health facility (as defined in IC 16-18-2-167(a)); or
(3) home health agency (as defined in IC 16-18-2-173).
Sec. 13. (a) A placement agency:
(1) must provide a consumer with a consumer notice each time
a home care services worker is placed in the home of the
consumer; and
(2) is not required to provide a consumer notice when a new or
different home care services worker is substituting for the
regular home care services worker placed with the consumer.
(b) Before a placement agency places a home care services
worker with a consumer, the home care services worker must
provide the placement agency with a copy of the individual's
limited criminal history from the central repository for criminal
history information under IC 10-13-3. The home care services
worker is responsible for the fees required under IC 10-13-3-30 and
must annually obtain an updated limited criminal history. A copy
of the home care services worker's limited criminal history must be
made available to the consumer.
Sec. 14. A consumer notice must include the following:
(1) The duties, responsibilities, and obligations of the placement
agency to the:
(A) home care services worker; and
(B) consumer.
(2) A statement identifying the placement agency as:
(A) an employer;
(B) a joint employer;
(C) a leasing employer; or
(D) not an employer.
(3) A statement that notwithstanding the employment status of
the placement agency, the consumer:
(A) may be considered an employer under state and federal
employment laws; and
(B) may be responsible for:
(i) payment of local, state, or federal employment taxes;
(ii) payment for Social Security and Medicare
contributions;
(iii) ensuring payment of at least the minimum wage;
(iv) overtime payment;
(v) unemployment contributions under IC 22-4-11; or
(vi) worker's compensation insurance as required by
IC 22-3-2-5 and IC 22-3-7-34;
of the home care services worker.
(4) The appropriate telephone number, address, and electronic
mail address of the department for inquiries regarding the
contents of the notice.
The department shall determine the content and format of the
consumer notice.
Sec. 15. The failure of a placement agency to provide a consumer
notice to the consumer at the time a home care services worker is
placed in the consumer's home does not relieve a consumer from
the duties or obligations as an employer. If a placement agency fails
to provide a consumer notice and the consumer is liable for
payment of wages, taxes, worker's compensation insurance
premiums, or unemployment compensation employer
contributions, the consumer has a right of indemnification against
the placement agency, which includes the actual amounts paid to
or on behalf of the home care services worker as well as the
consumer's attorney's fees and costs.
Sec. 16. A placement agency that will not be the actual employer
of the home care services worker shall provide a worker notice as
set forth in section 17 of this chapter to a home care services
worker who is placed with a consumer. The worker notice must:
(1) be provided to the home care services worker upon
placement in the consumer's home; and
(2) specify the home care services worker's legal relationship
with the placement agency and the consumer.
Sec. 17. The worker notice referred to in section 16 of this
chapter must contain the following:
(1) The duties, responsibilities, and obligations of the placement
agency, the consumer, and the home care services worker if the
home care services worker is determined to be an independent
contractor, including:
(A) a statement of the party responsible for the payment of
the home care services worker's wages, taxes, Social Security
and Medicare contributions, unemployment contributions,
and worker's compensation insurance premiums; and
(B) a statement identifying the party responsible for the
home care services worker's hiring, firing, discipline, day to
day supervision, assignment of duties, and provision of
equipment or materials for use by the home care services
worker.
(2) The telephone number, address, and electronic mail address
of the department for inquiries regarding the contents of the
notice.
The department shall determine the content and format of the
consumer notice.
Sec. 18. The department may at any time and upon receiving a
complaint from an interested person investigate an alleged
violation of this chapter by a placement agency.
Sec. 19. The department may impose a civil penalty not to exceed
one thousand dollars ($1,000) against a placement agency that fails
to provide a worker notice or a consumer notice at the times
required under section 13 or 16 of this chapter. The civil penalty
may be assessed by the department and, if necessary, shall be
recovered by the prosecuting attorney of the county in which the
violation has occurred or by the attorney general, as provided in
IC 22-1-1-18.
SOURCE: IC 25-22.5-1-2; (05)CC109806.20. -->
SECTION 20. IC 25-22.5-1-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2. (a) This article, as
it relates to the unlawful or unauthorized practice of medicine or
osteopathic medicine, does not apply to any of the following:
(1) A student in training in a medical school approved by the
board, or while performing duties as an intern or a resident in a
hospital under the supervision of the hospital's staff or in a program
approved by the medical school.
(2) A person who renders service in case of emergency where no
fee or other consideration is contemplated, charged, or received.
(3) A paramedic (as defined in IC 16-18-2-266), an emergency
medical technician-basic advanced (as defined in
IC 16-18-2-112.5), an emergency medical technician-intermediate
(as defined in IC 16-18-2-112.7), an emergency medical technician
(as defined in IC 16-18-2-112), or a person with equivalent
certification from another state who renders advanced life support
(as defined in IC 16-18-2-7) or basic life support (as defined in
IC 16-18-2-33.5):
(A) during a disaster emergency declared by the governor under
IC 10-14-3-12 in response to an act that the governor in good
faith believes to be an act of terrorism (as defined in
IC 35-41-1-26.5); and
(B) in accordance with the rules adopted by the Indiana
emergency medical services commission or the disaster
emergency declaration of the governor.
(4) Commissioned medical officers or medical service officers of
the armed forces of the United States, the United States Public
Health Service, and medical officers of the United States
Department of Veterans Affairs in the discharge of their official
duties in Indiana.
(5) An individual who is not a licensee who resides in another state
or country and is authorized to practice medicine or osteopathic
medicine there, who is called in for consultation by an individual
licensed to practice medicine or osteopathic medicine in Indiana.
(6) A person administering a domestic or family remedy to a
member of the person's family.
(7) A member of a church practicing the religious tenets of the
church if the member does not make a medical diagnosis, prescribe
or administer drugs or medicines, perform surgical or physical
operations, or assume the title of or profess to be a physician.
(8) A school corporation and a school employee who acts under
IC 34-30-14 (or IC 34-4-16.5-3.5 before its repeal).
(9) A chiropractor practicing the chiropractor's profession under
IC 25-10 or to an employee of a chiropractor acting under the
direction and supervision of the chiropractor under IC 25-10-1-13.
(10) A dental hygienist practicing the dental hygienist's profession
under IC 25-13.
(11) A dentist practicing the dentist's profession under IC 25-14.
(12) A hearing aid dealer practicing the hearing aid dealer's
profession under IC 25-20.
(13) A nurse practicing the nurse's profession under IC 25-23.
However, a registered nurse may administer anesthesia if the
registered nurse acts under the direction of and in the immediate
presence of a physician and holds a certificate of completion of a
course in anesthesia approved by the American Association of
Nurse Anesthetists or a course approved by the board.
(14) An optometrist practicing the optometrist's profession under
IC 25-24.
(15) A pharmacist practicing the pharmacist's profession under
IC 25-26.
(16) A physical therapist practicing the physical therapist's
profession under IC 25-27.
(17) A podiatrist practicing the podiatrist's profession under
IC 25-29.
(18) A psychologist practicing the psychologist's profession under
IC 25-33.
(19) A speech-language pathologist or audiologist practicing the
pathologist's or audiologist's profession under IC 25-35.6.
(20) An employee of a physician or group of physicians who
performs an act, a duty, or a function that is customarily within the
specific area of practice of the employing physician or group of
physicians, if the act, duty, or function is performed under the
direction and supervision of the employing physician or a
physician of the employing group within whose area of practice the
act, duty, or function falls. An employee may not make a diagnosis
or prescribe a treatment and must report the results of an
examination of a patient conducted by the employee to the
employing physician or the physician of the employing group
under whose supervision the employee is working. An employee
may not administer medication without the specific order of the
employing physician or a physician of the employing group. Unless
an employee is licensed or registered to independently practice in
a profession described in subdivisions (9) through (18), nothing in
this subsection grants the employee independent practitioner status
or the authority to perform patient services in an independent
practice in a profession.
(21) A hospital licensed under IC 16-21 or IC 12-25.
(22) A health care organization whose members, shareholders, or
partners are individuals, partnerships, corporations, facilities, or
institutions licensed or legally authorized by this state to provide
health care or professional services as:
(A) a physician;
(B) a psychiatric hospital;
(C) a hospital;
(D) a health maintenance organization or limited service health
maintenance organization;
(E) a health facility;
(F) a dentist;
(G) a registered or licensed practical nurse;
(H) a midwife;
(I) an optometrist;
(J) a podiatrist;
(K) a chiropractor;
(L) a physical therapist; or
(M) a psychologist.
(23) A physician assistant practicing the physician assistant's
profession under IC 25-27.5.
(24) A physician providing medical treatment under
IC 25-22.5-1-2.1.
(25) An attendant who provides attendant care services (as defined
in IC 16-27-1-0.5. IC 16-18-2-28.5).
(26) A personal services attendant providing authorized attendant
care services under IC 12-10-17.
(b) A person described in subsection (a)(9) through (a)(18) is not
excluded from the application of this article if:
(1) the person performs an act that an Indiana statute does not
authorize the person to perform; and
(2) the act qualifies in whole or in part as the practice of medicine
or osteopathic medicine.
(c) An employment or other contractual relationship between an
entity described in subsection (a)(21) through (a)(22) and a licensed
physician does not constitute the unlawful practice of medicine under
this article if the entity does not direct or control independent medical
acts, decisions, or judgment of the licensed physician. However, if the
direction or control is done by the entity under IC 34-30-15 (or
IC 34-4-12.6 before its repeal), the entity is excluded from the
application of this article as it relates to the unlawful practice of
medicine or osteopathic medicine.
(d) This subsection does not apply to a prescription or drug order for
a legend drug that is filled or refilled in a pharmacy owned or operated
by a hospital licensed under IC 16-21. A physician licensed in Indiana
who permits or authorizes a person to fill or refill a prescription or drug
order for a legend drug except as authorized in IC 16-42-19-11 through
IC 16-42-19-19 is subject to disciplinary action under IC 25-1-9. A
person who violates this subsection commits the unlawful practice of
medicine under this chapter.
(e) A person described in subsection (a)(8) shall not be authorized to
dispense contraceptives or birth control devices.
SOURCE: IC 25-23-1-27.1; (05)CC109806.21. -->
SECTION 21. IC 25-23-1-27.1 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 27.1. (a) As used in
this section, "licensed health professional" means:
(1) a registered nurse;
(2) a licensed practical nurse;
(3) a physician with an unlimited license to practice medicine or
osteopathic medicine;
(4) a licensed dentist;
(5) a licensed chiropractor;
(6) a licensed optometrist;
(7) a licensed pharmacist;
(8) a licensed physical therapist;
(9) a licensed psychologist;
(10) a licensed podiatrist; or
(11) a licensed speech-language pathologist or audiologist.
(b) This chapter does not prohibit:
(1) furnishing nursing assistance in an emergency;
(2) the practice of nursing by any student enrolled in a board
approved nursing education program where such practice is
incidental to the student's program of study;
(3) the practice of any nurse who is employed by the government
of the United States or any of its bureaus, divisions, or agencies
while in the discharge of the nurse's official duties;
(4) the gratuitous care of sick, injured, or infirm individuals by
friends or the family of that individual;
(5) the care of the sick, injured, or infirm in the home for
compensation if the person assists only:
(A) with personal care;
(B) in the administration of a domestic or family remedy; or
(C) in the administration of a remedy that is ordered by a
licensed health professional and that is within the scope of
practice of the licensed health professional under Indiana law;
(6) performance of tasks by persons who provide health care
services which are delegated or ordered by licensed health
professionals, if the delegated or ordered tasks do not exceed the
scope of practice of the licensed health professionals under Indiana
law;
(7) a physician with an unlimited license to practice medicine or
osteopathic medicine in Indiana, a licensed dentist, chiropractor,
dental hygienist, optometrist, pharmacist, physical therapist,
podiatrist, psychologist, speech-language pathologist, or
audiologist from practicing the person's profession;
(8) a school corporation or school employee from acting under
IC 34-30-14;
(9) a personal services attendant from providing authorized
attendant care services under IC 12-10-17; or
(10) an attendant who provides attendant care services (as defined
by IC 16-27-1-0.5. in IC 16-18-2-28.5).
SOURCE: IC 25-26-13-4; (05)CC109806.22. -->
SECTION 22. IC 25-26-13-4 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. (a) The board may:
(1) promulgate rules and regulations under IC 4-22-2 for
implementing and enforcing this chapter;
(2) establish requirements and tests to determine the moral,
physical, intellectual, educational, scientific, technical, and
professional qualifications for applicants for pharmacists' licenses;
(3) refuse to issue, deny, suspend, or revoke a license or permit or
place on probation or fine any licensee or permittee under this
chapter;
(4) regulate the sale of drugs and devices in the state of Indiana;
(5) impound, embargo, confiscate, or otherwise prevent from
disposition any drugs, medicines, chemicals, poisons, or devices
which by inspection are deemed unfit for use or would be
dangerous to the health and welfare of the citizens of the state of
Indiana; the board shall follow those embargo procedures found in
IC 16-42-1-18 through IC 16-42-1-31, and persons may not refuse
to permit or otherwise prevent members of the board or their
representatives from entering such places and making such
inspections;
(6) prescribe minimum standards with respect to physical
characteristics of pharmacies, as may be necessary to the
maintenance of professional surroundings and to the protection of
the safety and welfare of the public;
(7) subject to IC 25-1-7, investigate complaints, subpoena
witnesses, schedule and conduct hearings on behalf of the public
interest on any matter under the jurisdiction of the board;
(8) prescribe the time, place, method, manner, scope, and subjects
of licensing examinations which shall be given at least twice
annually; and
(9) perform such other duties and functions and exercise such other
powers as may be necessary to implement and enforce this chapter.
(b) The board shall adopt rules under IC 4-22-2 for the following:
(1) Establishing standards for the competent practice of pharmacy.
(2) Establishing the standards for a pharmacist to counsel
individuals regarding the proper use of drugs.
(3) Establishing standards and procedures before January 1,
2006, to ensure that a pharmacist:
(A) has entered into a contract that accepts the return of
expired drugs with; or
(B) is subject to a policy that accepts the return of expired
drugs of;
a wholesaler, manufacturer, or agent of a wholesaler or
manufacturer concerning the return by the pharmacist to the
wholesaler, the manufacturer, or the agent of expired legend
drugs or controlled drugs. In determining the standards and
procedures, the board may not interfere with negotiated terms
related to cost, expenses, or reimbursement charges contained
in contracts between parties, but may consider what is a
reasonable quantity of a drug to be purchased by a pharmacy.
The standards and procedures do not apply to vaccines that
prevent influenza, medicine used for the treatment of
malignant hyperthermia, and other drugs determined by the
board to not be subject to a return policy. An agent of a
wholesaler or manufacturer must be appointed in writing and
have policies, personnel, and facilities to handle properly
returns of expired legend drugs and controlled substances.
(c) The board may grant or deny a temporary variance to a rule it has
adopted if:
(1) the board has adopted rules which set forth the procedures and
standards governing the grant or denial of a temporary variance;
and
(2) the board sets forth in writing the reasons for a grant or denial
of a temporary variance.
SOURCE: IC 25-26-14-1; (05)CC109806.23. -->
SECTION 23. IC 25-26-14-1 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 1. (a) This chapter
applies to any individual, partnership, limited liability company,
corporation, or business firm:
(1) located in or outside Indiana; and
(2) engaging in the wholesale distribution of legend drugs within
in Indiana.
(b) Except as required by federal law or regulation, the
requirements of this chapter do not apply to a manufacturer that
is approved by the federal Food and Drug Administration.
However, the board may adopt rules concerning manufacturers
that the board considers appropriate and necessary.
SOURCE: IC 25-26-14-1.5; (05)CC109806.24. -->
SECTION 24. IC 25-26-14-1.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 1.5. As used in this chapter,
"adulterated" refers to a legend drug that:
(1) consists in whole or in part of a filthy, putrid, or
decomposed substance;
(2) has been produced, prepared, packed, or held under
unsanitary conditions and may have been contaminated or
rendered injurious to health;
(3) has been subjected to conditions in the manufacture,
processing, packing, or holding of the legend drug that do not
conform to current standards of manufacturing to ensure that
the legend drug is safe for use and possesses the identity,
strength, quality, and purity characteristics that the legend
drug is represented to possess;
(4) is contained in a container composed of a poisonous or
deleterious substance that may render the legend drug
injurious to health;
(5) bears or contains, for purposes of coloring only, a color
additive that is unsafe;
(6) is of a different strength, quality, or purity from the official
compendium standard for the legend drug; or
(7) does not meet the considerations of the federal Food, Drug,
and Cosmetic Act.
SOURCE: IC 25-26-14-1.7; (05)CC109806.25. -->
SECTION 25. IC 25-26-14-1.7 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 1.7. As used in this chapter,
"authenticate" means to affirmatively verify before distribution
occurs that each transaction that is listed on:
(1) the pedigree of a legend drug; and
(2) other accompanying documentation for a legend drug;
has occurred.
SOURCE: IC 25-26-14-1.8; (05)CC109806.26. -->
SECTION 26. IC 25-26-14-1.8 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 1.8. As used in this chapter,
"authorized distributor" means a wholesale drug distributor with
which a manufacturer has established an ongoing relationship to
distribute the manufacturer's products. For purposes of this
section, an ongoing relationship exists between a wholesale drug
distributor, including any affiliated group (as defined in Section
1504 of the Internal Revenue Code) of which the wholesale
distributor is a member, and a manufacturer if the wholesale drug
distributor:
(1) has a written agreement currently in effect with the
manufacturer evidencing an ongoing relationship;
(2) is listed on the manufacturer's current monthly updated list
of authorized distributors; or
(3) has a verifiable account with the manufacturer and a
minimal transaction or volume requirement limit of:
(A) five thousand (5,000) units per company in the previous
twelve (12) months; or
(B) twelve (12) purchases at the manufacturer's minimum
purchasing requirement per invoice in the previous twelve
(12) months.
SOURCE: IC 25-26-14-4.1; (05)CC109806.27. -->
SECTION 27. IC 25-26-14-4.1 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 4.1. As used in this chapter,
"co-licensed products" means pharmaceutical products:
(1) that have been approved by the federal Food and Drug
Administration; and
(2) concerning which two (2) or more parties have the right to
engage in a business activity or occupation concerning the
pharmaceutical products.
SOURCE: IC 25-26-14-4.2; (05)CC109806.28. -->
SECTION 28. IC 25-26-14-4.2 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 4.2. As used in this chapter,
"compendium" refers to:
(1) the United States Pharmacopoeia;
(2) the Homeopathic Pharmacopoeia of the United States;
(3) the National Formulary;
(4) a drug approved by the federal Food and Drug
Administration; or
(5) a supplement to a document specified in subdivision (1), (2),
or (3).
SOURCE: IC 25-26-14-4.3; (05)CC109806.29. -->
SECTION 29. IC 25-26-14-4.3 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 4.3. As used in this chapter,
"contraband" refers to a legend drug:
(1) that is counterfeit;
(2) that is stolen;
(3) that is misbranded;
(4) that is obtained by fraud;
(5) that is purchased by a nonprofit institution for the
nonprofit institution's own use and placed in commerce in
violation of the own use agreement for the legend drug;
(6) for which a required pedigree does not exist; or
(7) for which a pedigree in existence:
(A) has been forged, counterfeited, or falsely created; or
(B) contains any altered, false, or misrepresented
information.
SOURCE: IC 25-26-14-4.4; (05)CC109806.30. -->
SECTION 30. IC 25-26-14-4.4 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 4.4. As used in this chapter,
"counterfeit" refers to a legend drug, or the container, seal, or
labeling of a legend drug, that, without authorization, bears the
trademark, trade name, or other identifying mark or imprint of a
manufacturer, processor, packer, or distributor other than the
person that manufactured, processed, packed, or distributed the
legend drug.
SOURCE: IC 25-26-14-4.5; (05)CC109806.31. -->
SECTION 31. IC 25-26-14-4.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 4.5. As used in this chapter,
"deliver" means the actual, constructive, or attempted transfer of
a legend drug from one (1) person to another.
SOURCE: IC 25-26-14-4.6; (05)CC109806.32. -->
SECTION 32. IC 25-26-14-4.6 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 4.6. As used in this chapter,
"designated representative" means an individual who:
(1) is designated by a wholesale drug distributor;
(2) serves as the wholesale drug distributor's responsible
individual with the board; and
(3) is actively involved in and aware of the actual daily
operation of the wholesale drug distributor.
SOURCE: IC 25-26-14-4.7; (05)CC109806.33. -->
SECTION 33. IC 25-26-14-4.7 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 4.7. As used in this chapter,
"distribute" means to sell, offer to sell, deliver, offer to deliver,
broker, give away, or transfer a legend drug, whether by passage
of title or physical movement, or both. The term does not include
the following:
(1) Dispensing or administering a legend drug.
(2) Delivering or offering to deliver a legend drug by a common
carrier in the usual course of business as a common carrier.
(3) The provision of a legend drug sample to a patient by a:
(A) practitioner;
(B) health care professional acting at the direction and under
the supervision of a practitioner; or
(C) hospital's or other health care entity's pharmacy that
received the drug sample in accordance with this chapter and
other applicable law to administer or dispense and that is
acting at the direction of a practitioner;
licensed to prescribe the legend drug.
SOURCE: IC 25-26-14-6; (05)CC109806.34. -->
SECTION 34. IC 25-26-14-6 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6. As used in this
chapter, "health care entity" means any organization or business that
provides diagnostic, medical, surgical, dental treatment, or
rehabilitative care. The term does not include a pharmacy or
wholesale drug distributor.
SOURCE: IC 25-26-14-6.5; (05)CC109806.35. -->
SECTION 35. IC 25-26-14-6.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 6.5. As used in this chapter,
"label" means a display of written, printed, or graphic matter on
the immediate container of a legend drug.
SOURCE: IC 25-26-14-6.6; (05)CC109806.36. -->
SECTION 36. IC 25-26-14-6.6 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 6.6. As used in this chapter,
"labeling" means labels and other written, printed, or graphic
matter:
(1) on a legend drug or a legend drug's container or wrapper;
or
(2) accompanying a legend drug.
SOURCE: IC 25-26-14-7; (05)CC109806.37. -->
SECTION 37. IC 25-26-14-7 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 7. As used in this
chapter, "legend drug" has the meaning set forth in IC 16-18-2-199.
The term includes any human drug required by federal law or
regulation to be dispensed only by a prescription, including finished
dosage forms and active ingredients subject to 21 U.S.C. 811 through
812. The term does not include a device or a device component,
part, or accessory.
SOURCE: IC 25-26-14-8.3; (05)CC109806.38. -->
SECTION 38. IC 25-26-14-8.3 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 8.3. As used in this chapter,
"misbranded" means that a legend drug's label:
(1) is false or misleading;
(2) does not bear the name and address of the manufacturer,
packer, or distributor or does not contain an accurate
statement of the quantities of active ingredients of the legend
drug;
(3) does not show an accurate monograph for the legend drug;
or
(4) does not comply with any other requirements of the federal
Food, Drug, and Cosmetic Act.
SOURCE: IC 25-26-14-8.5; (05)CC109806.39. -->
SECTION 39. IC 25-26-14-8.5 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]:
Sec. 8.5. As used in this chapter,
"normal distribution chain of custody" means the route that a
legend drug travels:
(1) from a manufacturer to a wholesale drug distributor, to a
pharmacy, and to a patient or a patient's agent;
(2) from a manufacturer to a wholesale drug distributor, to a
chain drug warehouse, to a pharmacy affiliated with the chain
drug warehouse, and to a patient or a patient's agent;
(3) from a manufacturer to a chain drug warehouse, to a
pharmacy affiliated with the chain drug warehouse, and to a
patient or a patient's agent;
(4) from a manufacturer to a third party logistics provider, to
a wholesale drug distributor, to a pharmacy, and to a patient
or a patient's agent;
(5) from a manufacturer to a third party logistics provider, to
a wholesale drug distributor, to a chain drug warehouse, to a
pharmacy affiliated with the chain drug warehouse, and to a
patient or a patient's agent;
(6) from a manufacturer to a third party logistics provider, to
a chain drug warehouse, to a pharmacy affiliated with the
chain drug warehouse, and to a patient or a patient's agent; or
(7) as prescribed by rules adopted by the board.
SOURCE: IC 25-26-14-8.7; (05)CC109806.40. -->
SECTION 40. IC 25-26-14-8.7 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 8.7. As used in this chapter,
"pedigree" means a statement or record in a written or an
electronic form that is approved by the board, that records each
distribution of a legend drug from the sale by the manufacturer
from the last authorized distributor of record through acquisition
and sale by each wholesale drug distributor, and that includes
information designated by the board through rules for each
transaction.
SOURCE: IC 25-26-14-9; (05)CC109806.41. -->
SECTION 41. IC 25-26-14-9 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. As used in this
chapter, "person" means an individual, a partnership, a business firm,
a limited liability company, or a corporation, or another entity,
including a governmental entity.
SOURCE: IC 25-26-14-9.2; (05)CC109806.42. -->
SECTION 42. IC 25-26-14-9.2 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 9.2. As used in this chapter,
"practitioner" has the meaning set forth in IC 16-42-19-5.
SOURCE: IC 25-26-14-9.3; (05)CC109806.43. -->
SECTION 43. IC 25-26-14-9.3 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 9.3. As used in this chapter,
"repackage" means changing the container, wrapper, quantity, or
labeling of a legend drug to further the distribution of the legend
drug.
SOURCE: IC 25-26-14-10.5; (05)CC109806.44. -->
SECTION 44. IC 25-26-14-10.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 10.5. As used in this chapter,
"third party logistics provider" means an entity that:
(1) provides or coordinates warehousing, distribution, or other
services on behalf of a manufacturer, but does not take title to
the legend drug or have general responsibility to direct the
legend drug's sale or disposition; and
(2) is licensed under this chapter.
SOURCE: IC 25-26-14-11; (05)CC109806.45. -->
SECTION 45. IC 25-26-14-11 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JANUARY 1, 2006]: Sec. 11. As used in
this chapter, "wholesale distribution" means
distribution of to
distribute legend drugs to persons other than a consumer or patient.
The term does not include:
(1) a sale or transfer between a division, a subsidiary, a parent, an
affiliated, or a related company under the common ownership and
control of a corporate entity;
(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 the hospital's or health care entity's own use from the
group purchasing organization or from other hospitals or health
care entities that are members of the organization;
(3) the sale of a drug by a charitable organization described in
Section 501(c)(3) of the Internal Revenue Code, to a nonprofit
affiliate of the organization to the extent otherwise permitted by
law;
(4) the sale of a drug among hospitals or other health care entities
that are under common control;
(5) the sale of a drug for emergency medical reasons, including
transfers of legend drugs by a retail pharmacy to another retail
pharmacy to alleviate a temporary shortage, if the gross dollar
value of the transfers does not exceed five percent (5%) of the total
legend drug sales revenue of either the transferor or transferee
pharmacy during any twelve (12) consecutive month period;
(6) the sale of a drug or the dispensing of a drug pursuant to a
prescription;
(7) the distribution of drug samples by manufacturers'
representatives or distributors' representatives;
(8) the sale of blood and blood components intended for
transfusion;
(9) the sale of a drug by a retail pharmacy to a practitioner (as
defined in IC 25-26-13-2) for office use, if the gross dollar value of
the transfers does not exceed five percent (5%) of the retail
pharmacy's total legend drug sales during any twelve (12)
consecutive months; or
(10) the sale of a drug by a retail pharmacy that is ending its
business and liquidating its inventory to another retail pharmacy;
(11) drug returns by a hospital, health care entity, or charitable
institution conducted under 21 CFR 203.23;
(12) the sale of minimal quantities of drugs by retail
pharmacies to licensed practitioners for office use;
(13) the distribution of prescription drugs by the original
manufacturer of the finished form of the prescription drug or
the distribution of the co-licensed products by a partner of the
original manufacturer of the finished form of the prescription
drug; or
(14) drug returns that meet criteria established by rules
adopted by the board.
SOURCE: IC 25-26-14-14; (05)CC109806.46. -->
SECTION 46. IC 25-26-14-14 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 14. (a)
After September
14, 1992, A person may not engage in wholesale distributions of legend
drugs without:
having
(1) after December 31, 2005, obtaining and maintaining
accreditation or certification from the National Association of
Boards of Pharmacy's Verified Accredited Wholesale
Distributor or an accreditation body approved by the board
under subsection (g);
(2) obtaining and maintaining a license from issued by the board;
and
(3) paying any reasonable fee required by the board.
(b) The board may not issue or renew the license of a wholesale drug
distributor that does not comply with this chapter.
(c) The board may shall require a separate license for
(1) each facility directly or indirectly owned or operated by the
same business in Indiana; or
(2) a parent entity with divisions, subsidiaries, or affiliate
companies in Indiana when operations are conducted at more than
one (1) location and there exists joint ownership and control among
all the entities. or location where wholesale distribution
operations are conducted.
(d) An agent or employee of any licensed wholesale drug distributor
does not need a license and may lawfully possess pharmaceutical drugs
when acting in the usual course of business or employment.
(e) The issuance of a license under this chapter does not affect tax
liability imposed by the department of state revenue or the department
of local government finance on any wholesale drug distributor.
(f) The board may adopt rules that permit out-of-state wholesale drug
distributors to obtain a license on the basis of reciprocity if:
(1) an out-of-state wholesale drug distributor possesses a valid
license granted by another state and the legal standards for
licensure in the other state are comparable to the standards under
this chapter; and
(2) the other state extends reciprocity to wholesale drug distributors
licensed in Indiana.
However, if the requirements for licensure under this chapter are
more restrictive than the standards of the other state, the
out-of-state wholesale drug distributor must comply with the
additional requirements of this chapter to obtain a license under
this chapter.
(g) The board may adopt rules under IC 4-22-2 to approve an
accreditation body to:
(1) evaluate a wholesale drug distributor's operations to
determine compliance with:
(A) professional standards;
(B) this chapter; and
(C) any other applicable law; and
(2) perform inspections of each facility and location where
wholesale distribution operations are conducted by the
wholesale drug distributor.
SOURCE: IC 25-26-14-14.5; (05)CC109806.47. -->
SECTION 47. IC 25-26-14-14.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 14.5. After June 30, 2006, a
wholesale drug distributor may not accept or deliver a legend drug
without a current, accompanying pedigree.
SOURCE: IC 25-26-14-15; (05)CC109806.48. -->
SECTION 48. IC 25-26-14-15 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JANUARY 1, 2006]: Sec. 15. (a) The board
shall require the following minimum information from each wholesale
drug distributor as part of the license described in section 14 of this
chapter and as part of any renewal of such license:
(1) The name, full business address, and telephone number of the
licensee.
(2) All trade or business names used by the licensee.
(3) Addresses, telephone numbers, and the names of contact
persons for all facilities used by the licensee for the storage,
handling, and distribution of legend drugs.
(4) The type of ownership of operation.
(5) The name of each owner and operator of the licensee,
including:
(A) if an individual, the name, address, Social Security
number, and date of birth of the individual;
(B) if a partnership, the name, address, Social Security
number, and date of birth of each partner, and the name of the
partnership and federal employer identification number;
(C) if a corporation:
(i) the name, address, Social Security number, date of birth,
and title of each corporate officer and director;
(ii) the corporate names, and the name of the state of
incorporation, the federal employer identification number,
and the name of the parent company, if any; and
(iii) the name, address, and Social Security number of each
shareholder owning ten percent (10%) or more of the
voting stock of the corporation, unless the stock is traded
on a major stock exchange and not traded over the
counter;
(D) if a limited liability company, the name of each manager and
member, the name and federal employer identification
number of the limited liability company, and the name of the
state where organized; and
(E) if a sole proprietorship, the full name, address, Social
Security number, and date of birth of the sole proprietor and
the name and federal employer identification number of the
business entity.
(6) The name, address, and telephone number of the person
designated by the licensee as responsible for the operation
representative of the facilities. each facility.
(7) Additional information concerning record keeping required
under this chapter.
(b) The board shall require a wholesale drug distributor to post
a surety bond of at least one hundred thousand dollars ($100,000),
or an equivalent means of security acceptable to the board,
including insurance, an irrevocable letter of credit, or funds
deposited in a trust account or financial institution, to secure
payment of any administrative penalties that may be imposed by
the board and any fees and costs that may be incurred by the board
and that:
(1) are related to a license held by the wholesale drug
distributor;
(2) are authorized under Indiana law; and
(3) the wholesale drug distributor fails to pay less than thirty
(30) days after the penalties, fees, or costs become final.
However, a separate surety bond or an equivalent means of
security is not required for a separate location or a company of the
wholesale drug distributor.
(c) The board may make a claim against a bond or security
posted under subsection (b) within one (1) year after the wholesale
drug distributor's license is no longer valid or sixty (60) days after
the conclusion of:
(1) an administrative or legal proceeding before or on behalf of
the board that involves the wholesale drug distributor and
results in penalties, fees, or costs described in subsection (b); or
(2) an appeal of a proceeding described in subdivision (1);
whichever occurs later.
(d) The board shall inspect each facility where wholesale
distribution operations are conducted before initial licensure and
periodically thereafter in accordance with a schedule determined
by the board, but at least one (1) time in each three (3) year period.
(e) A wholesale drug distributor must publicly display or have
readily available all licenses and the most recent inspection report
administered by the board.
(b) (f) A material change in any information in subsection (a) of this
section must be submitted to the board at the time of license renewal or
within thirty (30) days from the date of the change, whichever occurs
first.
SOURCE: IC 25-26-14-15.5; (05)CC109806.49. -->
SECTION 49. IC 25-26-14-15.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 15.5. (a) A wholesale drug
distributor that is an authorized distributor of a manufacturer is
not considered to be an authorized distributor of the manufacturer
under this chapter unless:
(1) the manufacturer files the manufacturer's monthly updated
list of authorized distributors with the board;
(2) the list is available from the manufacturer upon request or
on the Internet; and
(3) the manufacturer notifies the board of any change to the list
within ten (10) days after the change.
(b) The board shall make available on the board's Internet web
site a manufacturer's list of authorized distributors filed as
described in subsection (a).
SOURCE: IC 25-26-14-16; (05)CC109806.50. -->
SECTION 50. IC 25-26-14-16 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 16. (a) In reviewing,
for purposes of licensure or renewal of a license under this chapter,
the qualifications of persons who engage in wholesale distribution of
legend drugs within in Indiana, the board shall consider the following
factors:
(1) A conviction of the applicant relating to drug samples,
wholesale or retail drug distribution, or distribution of controlled
substances. finding by the board that the applicant has:
(A) violated a law; or
(B) been disciplined by a regulatory agency for violating a
law;
related to drug distribution in any state.
(2) A felony criminal conviction of the applicant.
(3) The applicant's past experience in the manufacture or
distribution of legend drugs, including controlled substances.
(4) The furnishing by the applicant of false or fraudulent material
in any application made in connection with drug manufacturing or
distribution.
(5) Suspension or revocation of any license held by the applicant
or the applicant's owner or the imposition of sanctions against
the applicant or the applicant's owner by the federal or a state or
local government of any license held by the applicant for the
manufacture or distribution of any drugs, including controlled
substances.
(6) Compliance with licensing requirements under previously
granted licenses.
(7) Compliance with requirements to maintain and make available
to the board or to federal, state, or local law enforcement officials
those records required under this chapter.
(8) Any other factors or qualifications the board considers relevant
to the public health and safety, including whether the granting of
the license would not be in the public interest.
(b) After December 31, 2005, in reviewing an application for
licensure or renewal of a license under this chapter, the board shall
consider the results of a national criminal history background
check (as defined in IC 10-13-3-12) for:
(1) the applicant;
(2) all personnel involved in the operations of the wholesale
drug distributor;
(3) the most senior individual responsible for facility
operations, purchasing, and inventory control, and the
individual to whom the senior individual reports;
(4) company officers;
(5) key management personnel;
(6) principals; and
(7) owners with at least a ten percent (10%) interest in the
wholesale drug distributor, if the wholesale drug distributor is
a nonpublicly held company.
The national criminal history background check must be
conducted at the applicant's expense and must include all states of
residence since the applicant became eighteen (18) years of age.
(c) After December 31, 2005, an applicant shall provide and attest
to:
(1) an affirmation that the applicant has not been involved in
or convicted of any criminal or prohibited acts; or
(2) a statement providing a complete disclosure of the
applicant's past criminal convictions and violations of state and
federal laws;
regarding drugs.
SOURCE: IC 25-26-14-16.5; (05)CC109806.51. -->
SECTION 51. IC 25-26-14-16.5 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]:
Sec. 16.5. (a) A wholesale drug
distributor shall designate in writing on a form prescribed by the
board a designated representative for each of the wholesale drug
distributor's facilities licensed under this chapter.
(b) A designated representative shall submit to the board an
application prescribed by the board and provide to the board the
following:
(1) A set of the designated representative's fingerprints, under
procedures specified by the board and according to
requirements of the state police department under
IC 10-13-3-38.5, with payment of the amount equal to the costs
of a national criminal history background check (as defined in
IC 10-13-3-12) of the designated representative to be obtained
by the state police department.
(2) The date and place of birth of the designated representative.
(3) A list of the occupations, positions of employment, and
offices held by the designated representative during the
immediately preceding seven (7) years, including the principal
business and address of the organization with which the
occupation, position, or office was associated.
(4) A statement concerning whether the designated
representative, during the immediately preceding seven (7)
years, has been temporarily or permanently enjoined by a
court from violating a state or federal law regulating the
possession, control, or distribution of legend drugs, including
details of related events.
(5) A description of any involvement by the designated
representative with a business that:
(A) manufactured, administered, prescribed, distributed, or
stored legend drugs; and
(B) was named as a party in a lawsuit;
during the immediately preceding seven (7) years, including
investments other than the ownership of stock in a publicly
traded company or mutual fund.
(6) A description of any criminal offense of which the
designated representative has been convicted, regardless of
whether adjudication of guilt was withheld or whether the
designated representative pleaded nolo contendere. If the
designated representative indicates that a criminal conviction
is under appeal, the designated representative shall submit to
the board:
(A) a copy of the notice of appeal; and
(B) a copy of the final written order of disposition.
(7) A photograph of the designated representative taken within
the immediately preceding thirty (30) days under procedures
specified by the board.
(8) A list of the name, address, occupation, and date and place
of birth of each member of the designated representative's
immediate family, including the designated representative's
spouse, children, parents, and siblings, and the spouses of the
designated representative's children and siblings. Information
collected under this subdivision is confidential.
(9) Any other information required by the board.
(c) A designated representative must have at least two (2) years
of verifiable full-time managerial or supervisory experience in a
pharmacy or with a wholesale drug distributor licensed under this
chapter or in another state. The designated representative's
responsibilities must have included record keeping, storage, and
shipment of legend drugs.
(d) A designated representative shall not serve as the designated
representative for more than one (1) wholesale drug distributor
facility at any one (1) time.
(e) A designated representative shall be actively involved and
aware of the actual daily operations of the wholesale drug
distributor as follows:
(1) Be employed full time in a managerial position by the
wholesale drug distributor.
(2) Be physically present at the wholesale drug distributor's
facility during normal business hours, except when absent due
to illness, family illness or death, scheduled vacation, or
another authorized absence.
(3) Be aware of and knowledgeable about all policies and
procedures pertaining to the operations of the wholesale drug
distributor.
(f) A designated representative must complete continuing
education programs specified by the board regarding state and
federal law relevant to the distribution, handling, and storage of
legend drugs.
(g) A third party logistics provider must comply with this
subsection until the third party logistics provider has obtained
accreditation. A third party logistics provider must identify to the
board a designated representative who is responsible for the
facility's compliance with applicable state and federal law. The
designated representative:
(1) may be a corporate employee or officer, outside counsel, or
an outside consulting specialist with authority to help ensure
compliance;
(2) may be responsible for multiple facilities; and
(3) is not required to be physically present at the facility.
SOURCE: IC 25-26-14-16.6; (05)CC109806.52. -->
SECTION 52. IC 25-26-14-16.6 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]:
Sec. 16.6. (a) A wholesale drug
distributor that:
(1) is licensed under this chapter;
(2) is located outside Indiana; and
(3) distributes legend drugs in Indiana;
shall designate an agent in Indiana for service of process.
(b) A wholesale drug distributor that does not designate an agent
under subsection (a) is considered to have designated the secretary
of state to be the wholesale drug distributor's true and lawful
attorney, upon whom legal process may be served in an action or
a proceeding against the wholesale drug distributor arising from
the wholesale drug distributor's wholesale distribution operations.
(c) The board shall mail a copy of any service of process to a
wholesale drug distributor by certified mail, return receipt
requested, postage prepaid, at the address designated by the
wholesale drug distributor on the application for licensure
submitted under this chapter.
(d) Service of process on the secretary of state is sufficient in an
action or a proceeding against a wholesale drug distributor that is
not licensed under this chapter.
SOURCE: IC 25-26-14-17; (05)CC109806.53. -->
SECTION 53. IC 25-26-14-17 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JANUARY 1, 2006]: Sec. 17. As a
condition for receiving and retaining
any a wholesale drug distributor
license issued under
to this chapter,
each an applicant must satisfy the
board that the applicant has and will continuously maintain the
following:
(1) Acceptable storage and handling conditions and facilities
standards
for each facility at which legend drugs are received,
stored, warehoused, handled, held, offered, marketed, or
displayed, or from which legend drugs are transported,
including:
(A) suitable construction of the facility and appropriate
monitoring equipment to ensure that legend drugs in the
facility are maintained in accordance with labeling or in
compliance with official compendium standards;
(B) suitable size and construction to facilitate cleaning,
maintenance, and proper wholesale distribution operations;
(C) adequate storage areas to provide appropriate lighting,
ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
(D) a quarantine area for separate storage of legend drugs
that are outdated, damaged, deteriorated, misbranded,
adulterated, counterfeit, suspected counterfeit, otherwise
unfit for distribution, or contained in immediate or sealed
secondary containers that have been opened;
(E) maintenance of the facility in a clean and orderly
condition;
(F) maintenance of the facility in a commercial,
nonresidential building; and
(G) freedom of the facility from infestation.
(2)
Security of each facility from unauthorized entry as follows:
(A) Entry into areas where legend drugs are held is limited
to authorized personnel.
(B) Each facility is equipped with a security system that
includes:
(A) (i) an after hours central alarm or a comparable entry
detection capability;
(B) (ii) restricted premises access;
(C) (iii) adequate outside perimeter lighting;
and
(D) (iv) safeguards against
theft and diversion, including
employee theft and theft or diversion facilitated or hidden
by tampering with computers or electronic records; and
(v) a means of protecting the integrity and confidentiality
of data and documents and of making the data and
documents readily available to the board and other state
and federal law enforcement officials.
(3) A reasonable system of record keeping that as follows:
(A) The system describes all the wholesale distributor's activities
governed by this chapter for the two (2) three (3) year period
after the disposition of each product, and all records are
maintained for at least three (3) years after disposition of the
legend drug to which the record applies.
(B) The system is reasonably accessible as determined by board
rules in any inspection authorized by the board.
(C) The system provides a means to establish and maintain
inventories and records of transactions regarding the receipt
and distribution or other disposition of all legend drugs,
including the following:
(i) For legend drugs manufactured by a manufacturer for
which the wholesale drug distributor is an authorized
distributor, a pedigree for each distributed legend drug
that leaves the normal distribution chain of custody, as
determined by rules adopted by the board.
(ii) For legend drugs manufactured by a manufacturer for
which the wholesale drug distributor is not an authorized
distributor, a pedigree for each distributed legend drug.
(iii) After January 1, 2007, and after consulting with the
federal Food and Drug Administration, at the board's
discretion, for each legend drug received and distributed
by the wholesale drug distributor, an electronic pedigree
developed in accordance with standards and requirements
of the board to authenticate, track, and trace legend drugs.
The standards and requirements of the board may indicate
the information required to be part of the electronic
pedigree.
(iv) Dates of receipt and distribution or other disposition of
the legend drugs by the wholesale drug distributor.
(v) Availability for inspection and photocopying by any
authorized official of a local, state, or federal governmental
agency for three (3) years after the creation date of the
inventories and records.
(D) Onsite electronic inventories and records are
immediately available for inspection, and records kept at a
central location apart from the inspection site and not
electronically retrievable are available for inspection within
two (2) working days after a request by an authorized official
of a local, state, or federal governmental agency.
(E) The system maintains an ongoing list of persons with
whom the wholesale drug distributor does business.
(F) The system provides for reporting counterfeit or
suspected counterfeit legend drugs or counterfeiting or
suspected counterfeiting activities to the board and the
federal Food and Drug Administration.
(G) The system provides for mandatory reporting of
significant shortages or losses of legend drugs to the board
and the federal Food and Drug Administration if diversion
is known or suspected.
(4) Written policies and procedures to which the wholesale drug
distributor adheres for the receipt, security, storage, inventory,
transport, shipping, and distribution of legend drugs, and that
assure reasonable wholesale distributor preparation for, protection
against, and handling of any facility security or operation problems,
including the following:
(A) those Facility security or operation problems caused by
natural disaster or government emergency.
(B) Correction of inventory inaccuracies. or
(C) Product shipping and receiving problems.
(C) (D) Quarantine and return to the manufacturer or
destruction in accordance with state and federal law of all
outdated product products and outdated or expired legend
drugs, including appropriate documentation and witnessing.
(D) (E) Appropriate disposition of returned goods. and
(E) (F) Product recalls.
(G) Identifying, recording, and reporting losses or thefts.
(H) Implementation and maintenance of a continuous quality
improvement system.
(I) Recalls and withdrawals of legend drugs due to:
(i) an action initiated by the federal Food and Drug
Administration or another federal, state, or local
governmental agency;
(ii) a volunteer action by the manufacturer to remove
defective or potentially defective legend drugs from the
market; or
(iii) an action undertaken to promote public health and
safety by replacing existing merchandise with an improved
product or a new package design.
(J) Disposition and destruction of containers, labels, and
packaging to ensure that the containers, labels, and
packaging are not used in counterfeiting activities, including
necessary documentation and witnessing in accordance with
state and federal law.
(K) Investigation of discrepancies in the inventory involving
counterfeit, suspected counterfeit, contraband, or suspected
contraband legend drugs and reporting of discrepancies
within three (3) business days to the board and any other
appropriate state or federal governmental agency.
(L) Reporting of criminal or suspected criminal activities
involving the inventory of legend drugs to the board within
three (3) business days.
(M) Conducting for cause authentication and random
authentication as required under sections 17.2, 17.3, and 17.8
of this chapter.
(5)
Written policies and procedures and sufficient inspection
procedures for all incoming and outgoing product shipments,
including the following:
(A) Upon receipt, visual examination of each shipping
container in a manner adequate to identify the legend drugs
in the container and to determine whether the legend drugs
may be outdated, adulterated, misbranded, contaminated,
contraband, counterfeit, suspected counterfeit, damaged, or
otherwise unfit for distribution.
(B) Upon receipt, review of records by the wholesale drug
distributor for the acquisition of legend drugs for accuracy
and completeness, considering the:
(i) total facts and circumstances surrounding each
transaction involving the legend drugs; and
(ii) wholesale drug distributors involved.
(C) Quarantine of a legend drug considered to be outdated,
adulterated, misbranded, contaminated, contraband,
counterfeit, suspected counterfeit, damaged, or otherwise
unfit for distribution until:
(i) examination and a determination that the legend drug
is not outdated, adulterated, misbranded, contaminated,
contraband, counterfeit, damaged, or otherwise unfit for
distribution; or
(ii) the legend drug is destroyed or returned to the
manufacturer or wholesale drug distributor from which
the legend drug was acquired.
(D) Written policies and procedures to ensure that a legend
drug that was:
(i) ordered in error or in excess of need by the wholesale
drug distributor;
(ii) identified within three (3) business days after receipt as
ordered in error or in excess of need; and
(iii) maintained such that the legend drug's integrity has
not been compromised;
may be returned to the manufacturer or wholesale drug
distributor from which the legend drug was acquired if the
appropriate documentation is completed and necessary
notations are made to a required pedigree.
(E) Written policies and procedures to ensure that if the
wholesale drug distributor determines that a legend drug is
adulterated, misbranded, counterfeit, or suspected
counterfeit, the wholesale drug distributor provides notice of
the adulteration, misbranding, counterfeiting, or suspected
counterfeiting to the board, the federal Food and Drug
Administration, and the manufacturer or wholesale drug
distributor from which the legend drug was acquired within
three (3) business days.
(F) Written policies and procedures to ensure that if the
immediate or sealed outer or secondary container or labeling
of a legend drug is adulterated, misbranded, counterfeit, or
suspected counterfeit, the wholesale drug distributor:
(i) quarantines the legend drug until the legend drug is
destroyed or returned to the manufacturer or wholesale
drug distributor from which the legend drug was acquired;
and
(ii) provides notice of the adulteration, misbranding,
counterfeiting, or suspected counterfeiting to the board, the
federal Food and Drug Administration, and the
manufacturer or wholesale drug distributor from which
the legend drug was acquired within three (3) business
days.
(G) Written policies and procedures to ensure that a legend
drug that has been opened or used, but is not adulterated,
misbranded, counterfeit, or suspected counterfeit, is
identified as such and quarantined until the legend drug is
destroyed or returned to the manufacturer or wholesale drug
distributor from which the legend drug was acquired.
(H) Written policies and procedures to ensure that:
(i) a legend drug that will be returned to a manufacturer or
wholesale drug distributor is kept under proper conditions
for storage, handling, transport, and shipment before the
return; and
(ii) documentation showing that proper conditions were
maintained is provided to the manufacturer or wholesale
drug distributor to which the legend drug is returned.
(I) Inspection of each outgoing shipment for identity of the
legend drugs and to ensure that the legend drugs have not
been damaged in storage or held under improper conditions.
(J) Written policies and procedures to ensure that if
conditions under which a legend drug has been returned to
the wholesale drug distributor cast doubt on the legend
drug's safety, identity, strength, quality, or purity, the legend
drug is destroyed or returned to the manufacturer or
wholesale drug distributor from which the legend drug was
acquired unless examination, testing, or other investigation
proves that the legend drug meets appropriate standards of
safety, identity, strength, quality, and purity. In determining
whether the conditions under which a legend drug has been
returned cast doubt on the legend drug's safety, identity,
strength, quality, or purity, the wholesale drug distributor
considers the conditions under which the legend drug has
been held, stored, or shipped before or during the legend
drug's return and the condition of the legend drug and the
legend drug's container, carton, or labeling upon receipt of
the returned legend drug.
(K) Written policies and procedures to ensure that
contraband, counterfeit, or suspected counterfeit legend
drugs, other evidence of criminal activity, and accompanying
documentation are retained until a disposition is authorized
by the board and the federal Food and Drug Administration.
(L) Written policies and procedures to ensure that any
shipping, immediate, or sealed outer or secondary container
or labeling, and accompanying documentation, suspected of
or determined to be counterfeit or fraudulent, are retained
until a disposition is authorized by the board and the federal
Food and Drug Administration.
(6) Operations in compliance with all federal legal requirements
applicable to wholesale drug distribution.
(7) Written policies and procedures to provide for the secure
and confidential storage of information with restricted access
and to protect the integrity and confidentiality of the
information.
(8) A pedigree as required under this chapter, including an
electronic pedigree developed in accordance with standards
and requirements of the board under subdivision (3)(C)(iii).
(9) Appropriate inventory management and control systems to:
(A) prevent; and
(B) allow detection and documentation of;
theft, counterfeiting, or diversion of legend drugs.
(10) If the wholesale drug distributor is involved in the
distribution of controlled substances, registration with the
federal Drug Enforcement Administration and the board and
compliance with all laws related to the storage, handling,
transport, shipment, and distribution of controlled substances.
(11) Isolation of controlled substances from noncontrolled
substances and storage of the controlled substances in a secure
area in accordance with federal Drug Enforcement
Administration security requirements and standards.
(12) Technology and equipment that allow the wholesale drug
distributor to authenticate, track, and trace legend drugs. The
technology and equipment meet standards set by the board and
are used as required by the board to conduct for cause and
random tracking, tracing, and authentication of legend drugs.
(13) Employment, training, and documentation of the training
concerning the proper use of the technology and equipment
required under subdivision (12).
(14) Packaging operations in accordance with an official
compendium allowing the identification of a compromise in the
integrity of the legend drugs due to tampering or adverse
storage conditions.
SOURCE: IC 25-26-14-17.2; (05)CC109806.54. -->
SECTION 54. IC 25-26-14-17.2 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]:
Sec. 17.2. (a) A wholesale drug
distributor that purchases legend drugs from another wholesale
drug distributor and has reason to believe that a legend drug
purchased from the other wholesale drug distributor is counterfeit,
suspected counterfeit, misbranded, or adulterated shall conduct a
for cause authentication of each distribution of the legend drug
back to the manufacturer.
(b) A wholesale drug distributor that has engaged in the
distribution of a legend drug for which a purchasing wholesale
drug distributor conducts a for cause authentication under
subsection (a) shall provide, upon request, detailed information
regarding the distribution of the legend drug, including the:
(1) date of purchase of the legend drug;
(2) lot number of the legend drug;
(3) sales invoice number of the legend drug; and
(4) contact information, including name, address, telephone
number, and electronic mail address of the wholesale drug
distributor that sold the legend drug.
(c) If a wholesale drug distributor conducts a for cause
authentication under subsection (a) and is unable to authenticate
each distribution of the legend drug, the wholesale drug distributor
shall quarantine the legend drug and report the circumstances to
the board and the federal Food and Drug Administration not more
than ten (10) business days after completing the attempted
authentication.
(d) If a wholesale drug distributor authenticates the distribution
of a legend drug back to the manufacturer under subsection (a), the
wholesale drug distributor shall maintain records of the
authentication for three (3) years and shall produce the records for
the board and the federal Food and Drug Administration upon
request.
SOURCE: IC 25-26-14-17.3; (05)CC109806.55. -->
SECTION 55. IC 25-26-14-17.3 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 17.3. (a) A wholesale drug
distributor that purchases legend drugs from another wholesale
drug distributor shall, at least annually, conduct a random
authentication of a required pedigree on at least ten percent (10%)
of sales units of wholesale distributions of legend drugs purchased
from other wholesale drug distributors.
(b) A wholesale drug distributor from whom another wholesale
drug distributor purchases legend drugs shall cooperate with
random authentications of pedigrees described in this section and
provide requested information in a timely manner.
(c) If a wholesale drug distributor conducts a random
authentication under this section and is unable to authenticate each
distribution of the legend drug, the wholesale drug distributor shall
quarantine the legend drug and report the circumstances to the
board and the federal Food and Drug Administration not more
than ten (10) business days after completing the attempted
authentication.
SOURCE: IC 25-26-14-17.8; (05)CC109806.56. -->
SECTION 56. IC 25-26-14-17.8 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]:
Sec. 17.8. (a) A wholesale drug
distributor licensed under this chapter that purchases legend drugs
from a wholesale drug distributor that is not licensed under this
chapter shall act with due diligence as required under this section
and rules adopted by the board.
(b) Before the initial purchase of legend drugs from the
unlicensed wholesale drug distributor, the licensed wholesale drug
distributor shall obtain the following information from the
unlicensed wholesale drug distributor:
(1) A list of states in which the unlicensed wholesale drug
distributor is licensed.
(2) A list of states into which the unlicensed wholesale drug
distributor ships legend drugs.
(3) Copies of all state and federal regulatory licenses and
registrations held by the unlicensed wholesale drug distributor.
(4) The unlicensed wholesale drug distributor's most recent
facility inspection reports.
(5) Information regarding general and product liability
insurance maintained by the unlicensed wholesale drug
distributor, including copies of relevant policies.
(6) A list of other names under which the unlicensed wholesale
drug distributor does business or has been previously known.
(7) A list of corporate officers and managerial employees of the
unlicensed wholesale drug distributor.
(8) A list of all owners of the unlicensed wholesale drug
distributor that own more than ten percent (10%) of the
unlicensed wholesale drug distributor, unless the unlicensed
wholesale drug distributor is publicly traded.
(9) A list of all disciplinary actions taken against the unlicensed
wholesale drug distributor by state and federal agencies.
(10) A description, including the address, dimensions, and
other relevant information, of each facility used by the
unlicensed wholesale drug distributor for legend drug storage
and distribution.
(11) A description of legend drug import and export activities
of the unlicensed wholesale drug distributor.
(12) A description of the unlicensed wholesale drug
distributor's procedures to ensure compliance with this
chapter.
(13) A statement:
(A) as to whether; and
(B) of the identity of each manufacturer for which;
the unlicensed wholesale drug distributor is an authorized
distributor.
(c) Before the initial purchase of legend drugs from an unlicensed
wholesale drug distributor, the licensed wholesale drug distributor
shall:
(1) request that the board obtain and consider the results of a
national criminal history background check (as defined in
IC 10-13-3-12) through the state police department of all
individuals associated with the unlicensed wholesale drug
distributor as specified for licensure of a wholesale drug
distributor under section 16(b) of this chapter; and
(2) verify the unlicensed wholesale drug distributor's status as
an authorized distributor, if applicable.
(d) If an unlicensed wholesale drug distributor's facility has not
been inspected by the board or the board's agent within three (3)
years after a contemplated purchase described in subsection (a),
the licensed wholesale drug distributor shall conduct an inspection
of the unlicensed wholesale drug distributor's facility:
(1) before the initial purchase of legend drugs from the
unlicensed wholesale drug distributor; and
(2) at least once every three (3) years unless the unlicensed
wholesale drug distributor's facility has been inspected by the
board, or the board's agent, during the same period;
to ensure compliance with applicable laws and regulations relating
to the storage and handling of legend drugs. A third party may be
engaged to conduct the site inspection on behalf of the licensed
wholesale drug distributor.
(e) At least annually, a licensed wholesale drug distributor that
purchases legend drugs from an unlicensed wholesale drug
distributor shall ensure that the unlicensed wholesale drug
distributor maintains a record keeping system that meets the
requirements of section 17(3) of this chapter.
(f) If a licensed wholesale drug distributor that purchases legend
drugs from an unlicensed wholesale drug distributor has reason to
believe that a legend drug purchased from the unlicensed wholesale
drug distributor is misbranded, adulterated, counterfeit, or
suspected counterfeit, the licensed wholesale drug distributor shall
conduct a for cause authentication of each distribution of the
legend drug back to the manufacturer.
(g) An unlicensed wholesale drug distributor that has engaged in
the distribution of a legend drug for which a licensed wholesale
drug distributor conducts a for cause authentication under
subsection (f) shall provide, upon request, detailed information
regarding the distribution of the legend drug, including the:
(1) date of purchase of the legend drug;
(2) lot number of the legend drug;
(3) sales invoice number of the legend drug; and
(4) contact information, including name, address, telephone
number, and any electronic mail address of the unlicensed
wholesale drug distributor that sold the legend drug.
(h) If a licensed wholesale drug distributor conducts a for cause
authentication under subsection (f) and is unable to authenticate
each distribution of the legend drug, the licensed wholesale drug
distributor shall quarantine the legend drug and report the
circumstances to the board and the federal Food and Drug
Administration within ten (10) business days after completing the
attempted authentication.
(i) If a licensed wholesale drug distributor authenticates the
distribution of a legend drug back to the manufacturer under
subsection (f), the licensed wholesale drug distributor shall
maintain records of the authentication for three (3) years and shall
provide the records to the board upon request.
(j) A licensed wholesale drug distributor that purchases legend
drugs from an unlicensed wholesale drug distributor shall, at least
annually, conduct random authentications of required pedigrees on
at least ten percent (10%) of sales units of distributions of legend
drugs that were purchased from unlicensed wholesale drug
distributors.
(k) An unlicensed wholesale drug distributor from which a
licensed wholesale drug distributor has purchased legend drugs
shall cooperate with the random authentications of pedigrees under
this section and provide requested information in a timely manner.
(l) If a wholesale drug distributor conducts a random
authentication under subsection (j) and is unable to authenticate
each distribution of the legend drug, the wholesale drug distributor
shall quarantine the legend drug and report the circumstances to
the board and the federal Food and Drug Administration not more
than ten (10) business days after completing the attempted
authentication.
SOURCE: IC 25-26-14-17.9; (05)CC109806.57. -->
SECTION 57. IC 25-26-14-17.9 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]: Sec. 17.9. A wholesale drug
distributor licensed under this chapter may not use a trade name
or business name identical to a trade name or business name used
by another wholesale drug distributor licensed under this chapter.
SOURCE: IC 25-26-14-20; (05)CC109806.58. -->
SECTION 58. IC 25-26-14-20 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 20. (a) A person
employed in wholesale distribution must have appropriate education or
experience to assume responsibility for positions related to compliance
with licensing requirements.
(b) After December 31, 2005, before employing a person to be
engaged in the operation and handling of legend drugs, a wholesale
drug distributor shall request that the board obtain and consider
the results of a national criminal history background check (as
defined in IC 10-13-3-12) through the state police department for
the person.
SOURCE: IC 25-26-14-21.5; (05)CC109806.59. -->
SECTION 59. IC 25-26-14-21.5 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JANUARY 1, 2006]:
Sec. 21.5. (a) A person may not
perform, cause the performance of, or aid the performance of the
following:
(1) The manufacture, repackaging, sale, delivery, holding, or
offering for sale of a legend drug that is adulterated,
misbranded, counterfeit, suspected counterfeit, or is otherwise
unfit for distribution.
(2) The adulteration, misbranding, or counterfeiting of a legend
drug.
(3) The receipt of a legend drug that is adulterated,
misbranded, stolen, obtained by fraud or deceit, counterfeit, or
suspected counterfeit, and the delivery or proffered delivery of
the legend drug for pay or otherwise.
(4) The alteration, mutilation, destruction, obliteration, or
removal of the whole or a part of the labeling of a legend drug
or the commission of another act with respect to a legend drug
that results in the legend drug being misbranded.
(5) Forging, counterfeiting, simulating, or falsely representing
a legend drug using a mark, stamp, tag, label, or other
identification device without the authorization of the
manufacturer.
(6) The purchase or receipt of a legend drug from a person that
is not licensed to distribute legend drugs to the purchaser or
recipient.
(7) The sale or transfer of a legend drug to a person that is not
authorized under the law of the jurisdiction in which the
person receives the legend drug to purchase or receive legend
drugs from the person selling or transferring the legend drug.
(8) Failure to maintain or provide records as required under
this chapter.
(9) Providing the board, a representative of the board, or a
state or federal official with false or fraudulent records or
making false or fraudulent statements regarding a matter
related to this chapter.
(10) The wholesale distribution of a legend drug that was:
(A) purchased by a public or private hospital or other health
care entity;
(B) donated or supplied at a reduced price to a charitable
organization; or
(C) stolen or obtained by fraud or deceit.
(11) Obtaining or attempting to obtain a legend drug by fraud,
deceit, misrepresentation, or engaging in fraud, deceit, or
misrepresentation in the distribution of a legend drug.
(12) Failure to obtain, authenticate, or provide a required
pedigree.
(13) The receipt of a legend drug through wholesale
distribution without first receiving a required pedigree attested
to as accurate and complete by the wholesale drug distributor.
(14) Distributing a legend drug that was previously dispensed
by a retail pharmacy or distributed by a practitioner.
(15) Failure to report an act prohibited by this section.
(b) The board may impose the following sanctions if, after a
hearing under IC 4-21.5-3, the board finds that a person has
violated subsection (a):
(1) Revoke the wholesale drug distributor's license issued
under this chapter if the person is a wholesale drug distributor.
(2) Assess a civil penalty against the person. A civil penalty
assessed under this subdivision may not be more than ten
thousand dollars ($10,000) per violation.
SOURCE: IC 25-26-14-26; (05)CC109806.60. -->
SECTION 60. IC 25-26-14-26 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 26.
(a) A person
that
who knowingly or intentionally engages in the wholesale distribution
of a legend drug without a license issued under this chapter commits a
Class D felony.
(b) A person who engages in the wholesale distribution of a
legend drug and:
(1) who, with intent to defraud or deceive:
(A) fails to obtain or deliver to another person a complete
and accurate required pedigree concerning a legend drug
before:
(i) obtaining the legend drug from another person; or
(ii) transferring the legend drug to another person; or
(B) falsely swears or certifies that the person has
authenticated any documents related to the wholesale
distribution of legend drugs;
(2) who knowingly or intentionally:
(A) destroys, alters, conceals, or fails to maintain a complete
and accurate required pedigree concerning a legend drug in
the person's possession;
(B) purchases or receives legend drugs from a person not
authorized to distribute legend drugs in wholesale
distribution;
(C) sells, barters, brokers, or transfers a legend drug to a
person not authorized to purchase the legend drug in the
jurisdiction in which the person receives the legend drug in
a wholesale distribution;
(D) forges, counterfeits, or falsely creates a pedigree;
(E) falsely represents a factual matter contained in a
pedigree; or
(F) fails to record material information required to be
recorded in a pedigree; or
(3) who:
(A) possesses a required pedigree concerning a legend drug;
(B) knowingly or intentionally fails to authenticate the
matters contained in the pedigree as required; and
(C) distributes or attempts to further distribute the legend
drug;
commits a Class D felony.
SOURCE: IC 25-26-14-27; (05)CC109806.61. -->
SECTION 61. IC 25-26-14-27 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 27. A wholesale drug
distributor that fails to comply with the conditions and requirements
described in:
(1) section 17; or
(2) after December 31, 2005, section 17.2, 17.3, 17.8, 17.9, or 20;
of this chapter commits a Class D felony.
SOURCE: IC 25-33-1-9; (05)CC109806.62. -->
SECTION 62. IC 25-33-1-9 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. (a) The board shall
issue a license to practice psychology to an individual who:
(1) applies in the manner required by the board;
(2) pays a fee;
(3) is at least eighteen (18) years of age;
(4) has not been convicted of a crime that has a direct bearing on
the individual's ability to practice competently;
(5) holds, at the time of application, a valid license or certificate as
a psychologist from another state;
(6) possesses a doctoral degree from a recognized institution of
higher learning;
(7) has successfully completed:
(A) a degree program that would have been approved by the
board at the time the individual was licensed or certified in the
other state; or
(B) if the individual was licensed or certified in the other state
before July 1, 1969, a degree program that satisfied the
educational requirements of the board in effect January 4, 1971;
(8) has practiced psychology continuously since being licensed or
certified;
(9) if the individual was licensed or certified by the other state:
(A) after September 30, 1972, has taken the Examination for the
Professional Practice of Psychology and achieved the passing
score required by the board at the time the examination was
administered; or
(B) before January 1, 1990, and the other state required an
examination other than the Examination for the Professional
Practice of Psychology, and the individual achieved a passing
score in the other state at the time of licensure or
certification;
(10) has passed an examination administered by the board that
covers Indiana law related to the practice of psychology; and
(11) is not in violation of this chapter or rules adopted under this
chapter.
(b) The board may adopt rules under IC 4-22-2 concerning the
issuance of a license under this section.
SOURCE: IC 25-35.6-1-2; (05)CC109806.63. -->
SECTION 63. IC 25-35.6-1-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2. (a) As used in this
article, "board" means the speech-language pathology and audiology
board established by this article.
(b) As used in this article, "person" means any individual,
organization, or corporate body, except that only an individual may be
licensed under this article.
(c) As used in this article, "speech-language pathologist" means an
individual who practices speech-language pathology and who presents
himself to the public by any title or description of services
incorporating the words speech pathologist, speech-language
pathologist, speech therapist,
speech-language specialist, teacher of
communication disorders, speech correctionist, speech clinician,
language pathologist, language therapist, logopedist, communicologist,
voice therapist, voice pathologist, or any similar title or description of
service.
(d) As used in this article, "speech-language pathology" means the
application of nonmedical and nonsurgical principles, methods, and
procedures for the
measurement, testing, evaluation, prediction,
counseling, instruction, habilitation, or rehabilitation related to the
development and disorders of speech, voice, or language for the
purpose of evaluating, preventing, ameliorating, or modifying such
disorders and conditions in individuals or groups of individuals.
following:
(1) The prevention, evaluation, habilitation, rehabilitation,
instruction, and research of communication and swallowing
disorders.
(2) The elective modification of communication behaviors.
(3) The enhancement of communication, including the use of
augmentative or alternate communication strategies.
(e) As used in this article, "audiologist" means an individual who
practices audiology and who presents himself to the public by any title
or description of services incorporating the words audiologist, hearing
clinician, hearing therapist,
hearing specialist, audiometrist,
vestibular specialist, or any similar title or description of service.
(f) As used in this article, "audiology" means the application of
nonmedical and nonsurgical principles, methods, and procedures of
measurement, testing, evaluation, prediction, consultation, counseling,
instruction, habilitation, or rehabilitation related to hearing and
disorders of hearing for the purpose of evaluating, identifying,
preventing, ameliorating, or modifying such disorders and conditions
in individuals or groups of individuals. prevention, evaluation,
habilitation, rehabilitation, instruction, and research of disorders
of hearing, auditory function, and vestibular function.
(g) As used in this article, "speech-language pathology aide"
"support personnel" means an individual individuals who meets
minimum meet the qualifications which the board may shall establish
for the following:
(1) Speech-language pathology aides. aide.
(2) Speech-language pathology associate.
(3) Speech-language pathology assistant.
which qualifications shall be less than those established by this article
as necessary for licensure as a speech-language pathologist, and who
works under the direct supervision of a licensed speech pathologist.
(h) As used in this article, "audiology aide" assistant" means an
individual who:
(1) is not licensed as an audiologist under this article;
(2) meets minimum qualifications which the board may establish;
for audiology aides, which qualifications shall be less than those
established by this article as necessary for licensure as an
audiologist, and who works and
(3) provides specific services under the direct direction and
supervision of a licensed audiologist.
(i) As used in this article, "clinical fellowship" means a
supervised professional experience.
(j) As used in this article, "direct supervision" means onsite
observation and guidance while an assigned evaluation or
therapeutic activity is being performed.
SOURCE: IC 25-35.6-1-4; (05)CC109806.64. -->
SECTION 64. IC 25-35.6-1-4 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. Nothing in this
article shall be construed as preventing or restricting the following:
(1) A physician or surgeon from engaging in the practice of
medicine in this state, or a person under the supervision and control
of a physician or surgeon from conducting hearing testing,
provided such a person is not called an audiologist.
(2) Any hearing aid dealer from:
(A) engaging in the testing of hearing and other practices and
procedures necessary for the business for which the dealer is
registered in this state under IC 25-20-1;
and
(B) using the title hearing aid specialist or any similar title or
description of service.
(3) Any person licensed or registered in this state by any other law
from engaging in the profession or occupation for which the person
is licensed or registered.
(4) A person
who holds a valid and current credential as a
speech-language or hearing specialist issued by the department of
education, or a person employed as a speech-language pathologist
or audiologist by the government of the United States, if such
person performs speech-language pathology or audiology services
solely within the confines or under the jurisdiction of the
governmental or state educational organization by which the person
is employed. However, such person may, without obtaining a
license under this article, consult with or disseminate the person's
research findings and other scientific information to
speech-language pathologists and audiologists outside the
jurisdiction of the organization by which the person is employed.
Such person may also offer instruction and lectures to the public
for a fee, monetary or other, without being licensed under this
article. Such person may additionally elect to be subject to this
article.
(5) The activities and services of persons pursuing a course of
study leading to a degree in speech-language pathology or
audiology at a college or university, if:
(A) such activities and services constitute a part of a supervised
course of study; and that
(B) such person is designated speech-language pathology or
audiology intern, speech-language pathology or audiology
trainee, or by other such titles clearly indicating the training
status appropriate to the person's level of training; and
(C) the person works only under the supervision of a
speech-language pathologist or audiologist licensed under
this article.
(6) The activities and services of a person pursuing a course of
study leading to a degree in audiology at a college or university, if
such activities and services constitute a part of a supervised course
of study and such person is designated audiology intern, audiology
trainee, or by any other such titles clearly indicating the training
status appropriate to the person's level of training.
(7) (6) The activities and services of persons fulfilling the clinical
experience requirement of section 5(a)(5) 5(2)(B)(ii) or 6(3)(B) of
this chapter, if such activities and services constitute a part of the
experience required for that section's fulfillment.
(8) (7) The performance of pure tone air conduction testing by an
industrial audiometric technician, as defined by federal law, who
is working in an industrial hearing conservation program directed
by a physician or an audiologist.
(9) (8) The performance of speech-language pathology or
audiology services in this state by any person not a resident of this
state who is not licensed under this article, if such services are
performed for no more than five (5) days in any calendar year and
in cooperation with a speech-language pathologist or audiologist
licensed under this article, and if such person meets the
qualifications and requirements for application for licensure
described in sections 5(a)(1) and 5(a)(2) sections 5(1) and 5(2) or
6(1) and 6(2) of this chapter. However, a person not a resident of
this state who is not licensed under this article, but who is licensed
under the law of another state which has established licensure
requirements at least equivalent to those established by section 5 or
6 of this chapter or who is the holder of a certificate of clinical
competence in speech-language pathology or audiology or its
equivalent issued by a nationally recognized association for
speech-language and or hearing, may offer speech-language
pathology or audiology services in this state for no more than thirty
(30) days in any calendar year, if such services are performed in
cooperation with a speech-language pathologist or audiologist
licensed under this article.
SOURCE: IC 25-35.6-1-5; (05)CC109806.65. -->
SECTION 65. IC 25-35.6-1-5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 5. To be eligible for
licensure by the board as a speech-language pathologist or audiologist,
registration as a speech-language pathology aide, a
speech-language pathology associate, or a speech-language
pathology assistant, a person must satisfy the following:
(1) Not have been convicted of a crime that has a direct bearing on
the person's ability to practice competently.
(2) For licensure as a speech-language pathologist:
(A) possess at least a master's degree or its equivalent in the area
of speech-language pathology or audiology, as the case may be,
from an educational institution recognized by the board; and
(B) submit evidence of:
(i) a national certification in speech-language pathology
that is approved by the board; or
(ii) satisfaction of the academic and clinical experience
requirements necessary for licensure as defined in the rules
of the board.
(3) For registration as a speech-language pathology aide,
possess at least a high school degree or its equivalent.
(4) For registration as a speech-language pathology associate,
possess at least an associate degree in speech-language
pathology.
(5) For registration as a speech-language pathology assistant,
possess at least a bachelor's degree in speech-language
pathology.
(3) Submit to the board transcripts from one (1) or more of the
educational institutions described in subdivision (2) evidencing
completion of at least eighteen (18) semester hours in courses
providing fundamental information applicable to the normal
development of speech, hearing, and language and at least
forty-two (42) semester hours in courses providing information
about and practical experience in the management of speech,
hearing, and language disorders, and of these forty-two (42)
semester hours:
(A) no fewer than six (6) shall be in audiology for a person
applying for licensure in speech-language pathology;
(B) no fewer than six (6) shall be in speech-language pathology
for a person applying for licensure in audiology;
(C) no more than six (6) shall be in courses providing academic
credit for clinical practice;
(D) at least twenty-four (24), not including credits for thesis or
dissertation requirements, shall be in the field for which the
license is sought; and
(E) at least thirty (30) shall be in courses considered by the
educational institution in which they are conducted as acceptable
for application toward a graduate degree.
(4) Submit to the board evidence of the completion of at least three
hundred (300) hours of supervised, direct clinical experience with
a variety of communication disorders, which experience is received
within the educational institution itself or a clinical program with
which it cooperates.
(5) Submit to the board evidence of the completion of at least nine
(9) consecutive months, at no less than thirty (30) hours per week,
of clinical experience in the professional area (speech-language
pathology and audiology) for which a license is sought. This
requirement may also be fulfilled by part-time clinical experience
as follows: fifteen (15) to nineteen (19) hours per week for eighteen
(18) consecutive months, twenty (20) to twenty-four (24) hours per
week for fifteen (15) consecutive months, or twenty-five (25) to
twenty-nine (29) hours per week for twelve (12) consecutive
months. The clinical experience must be under the direct
supervision of and attested to in a notarized statement by a person
licensed in the area (speech-language pathology or audiology) for
which a license is being sought. Such clinical experience must
additionally follow the completion of the requirements described
in subdivisions (2), (3), and (4).
(6) Pass a written examination approved by the board.
SOURCE: IC 25-35.6-1-6; (05)CC109806.66. -->
SECTION 66. IC 25-35.6-1-6 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 6. To be eligible for an initial
license by the board as an audiologist, an individual must satisfy
the following:
(1) Not have been convicted of a crime that has a direct bearing
on the individual's ability to practice competently.
(2) Possess a doctoral degree from an accredited educational
program recognized by the board.
(3) Submit evidence of:
(A) a national certification in audiology that is approved by
the board; or
(B) satisfaction of the academic and clinical experience
requirements necessary for licensure as defined in the rules
of the board.
SOURCE: IC 25-35.6-1-7; (05)CC109806.67. -->
SECTION 67. IC 25-35.6-1-7 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]:
Sec. 7. (a) The professional standards
board may issue an initial license as a speech-language pathologist
only to an individual who is licensed as a speech-language
pathologist under this article. The professional standards board
shall issue a license as a speech-language pathologist to an
individual who:
(1) is licensed as a speech-language pathologist under this
article; and
(2) requests licensure.
(b) A speech-language pathologist licensed by the professional
standards board shall register with the health professions bureau
all speech-language pathology support personnel that the
speech-language pathologist supervises.
(c) The professional standards board may not impose different or
additional supervision requirements upon speech-language
pathology support personnel than the supervision requirements
that are imposed under this article.
(d) The professional standards board may not impose continuing
education requirements upon an individual who receives a license
under this section that are different from or in addition to the
continuing education requirements imposed under this article.
(e) An individual who:
(1) if:
(A) the individual is a speech-language pathologist, receives
a license under this section or received a license as a
speech-language pathologist issued by the professional
standards board before July 1, 2005; or
(B) the individual is an audiologist, works in an educational
setting;
(2) has been the holder of a certificate of clinical competence in
speech-language pathology or audiology or its equivalent issued
by a nationally recognized association for speech-language
pathology and audiology for at least three (3) consecutive
years; and
(3) has professional experience as a licensed speech-language
pathologist or audiologist in a school setting that is equivalent
to the experience required for a teacher seeking national
certification by the National Board of Professional Teaching
Standards;
is considered to have the equivalent of and is entitled to the same
benefits that accrue to a holder of a national certification issued by
the National Board for Professional Teaching Standards.
SOURCE: IC 25-35.6-1-8; (05)CC109806.68. -->
SECTION 68. IC 25-35.6-1-8 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]:
Sec. 8. (a) The board shall adopt rules
under IC 4-22-2 to define the role of support personnel, including
the following:
(1) Supervisory responsibilities of the speech-language
pathologist.
(2) Ratio of support personnel to speech-language pathologists.
(3) Scope of duties and restrictions of responsibilities for each
type of support personnel.
(4) Frequency, duration, and documentation of supervision.
(5) Education and training required to perform services.
(6) Procedures for renewing registration and terminating
duties.
(b) A speech-language pathologist must meet the following
qualifications to supervise speech-language pathology support
personnel:
(1) Hold a current license as a speech-language pathologist.
(2) Have at least three (3) years of clinical experience.
(3) Hold a certificate of clinical competence in speech-language
pathology or its equivalent issued by a nationally recognized
association for speech-language and hearing.
(c) Speech-language pathology support personnel may provide
support services only under the supervision of a speech-language
pathologist.
SOURCE: IC 25-35.6-1-9; (05)CC109806.69. -->
SECTION 69. IC 25-35.6-1-9 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 9. (a) If a speech-language
pathologist performs an evaluation and the evaluation suggests the
possibility of a condition that requires medical attention, the
speech-language pathologist shall promptly refer the patient to an
individual licensed under IC 25-22.5.
(b) A speech-language pathologist shall perform instrumental
procedures using rigid or flexible endoscopes only under the
authorization and general supervision of an individual licensed
under IC 25-22.5.
SOURCE: IC 25-35.6-1-10; (05)CC109806.70. -->
SECTION 70. IC 25-35.6-1-10 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 10. (a) If an audiologist performs
an evaluation and the evaluation suggests the possibility of a
condition that requires medical attention, the audiologist shall
promptly refer the patient to an individual licensed under
IC 25-22.5.
(b) An audiologist shall administer tests of vestibular function
only to patients who have been referred by an individual licensed
under IC 25-22.5.
SOURCE: IC 25-35.6-2-2; (05)CC109806.71. -->
SECTION 71. IC 25-35.6-2-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2. (a) The board:
(1) shall administer, coordinate, and enforce this article;
(2) shall evaluate the qualifications and supervise the examinations
of applicants for licensure under this article;
(3) may issue subpoenas, examine witnesses, and administer oaths;
and
(4) shall, at its discretion, investigate allegations of practices
violating this article, subject to IC 25-1-7.
(b) The board shall adopt rules under IC 4-22-2 relating to
professional conduct commensurate with the policy of this article,
including rules that establish standards for the competent practice of
speech-language pathology and audiology. Following their adoption,
the rules govern and control the professional conduct of every person
who holds a license to practice speech-language pathology or audiology
in this state.
(c) The board shall conduct the hearings and keep the records and
minutes necessary for the orderly dispatch of its functions. The board
shall have notice provided to the appropriate persons in a manner it
considers appropriate of the times and places of all hearings authorized
by this subsection. Approval by a majority of a quorum of the board is
required for any action to be taken in actions for revocation or
suspension of a license issued under this article.
(d) The board may adopt rules under IC 4-22-2 to:
(1) administer or enforce this article;
(2) register persons in the process of fulfilling the clinical
experience required for a license under this article;
(3) establish fees in accordance with IC 25-1-8-2; and
(4) register speech-language pathology assistants, associates, and
audiology aides and establish rules governing the duties of
assistants, associates, and aides.
(e) The conferral or enumeration of specific powers elsewhere in this
article shall not be construed as a limitation of the general functions
conferred by this section.
SOURCE: IC 25-35.6-3-3; (05)CC109806.72. -->
SECTION 72. IC 25-35.6-3-3 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 3. (a) The board may
waive the examination and grant licensure shall issue a license in
speech-language pathology or audiology to any applicant who:
(1) presents proof of:
(A) current licensure in speech-language pathology or
audiology in another state, including the District of Columbia or
a territory of the United States, which maintains under
professional standards considered by that the board considers to
be at least equivalent to those set forth in this article at the time
that the license was issued in the other state or territory; or
(B) practice as a speech-language pathologist or an
audiologist under the authority and supervision of an agency
of the federal government; and
(2) meets any other requirements that the board establishes by
rule.
(b) The board may waive the examination and grant licensure to any
person certified as clinically competent by a nationally recognized
association for speech-language and hearing in the area for which such
person is applying for licensure.
SOURCE: IC 25-35.6-3-3.5; (05)CC109806.73. -->
SECTION 73. IC 25-35.6-3-3.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 3.5. The board may issue a
provisional license in audiology to an individual who meets the
requirements that the board establishes by rule.
SOURCE: IC 25-35.6-3-8.1; (05)CC109806.74. -->
SECTION 74. IC 25-35.6-3-8.1 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]:
Sec. 8.1. (a) Each individual licensed
under this article and each individual registered as a
speech-language pathology aide, a speech-language pathology
associate, or a speech-language pathology assistant shall make the
license or registration, or an official duplicate of the license or
registration, available when the individual practices
speech-language pathology or audiology or provides support
services.
(b) Before support personnel may provide services, the
speech-language pathologist shall ensure that prior written
notification is provided to the recipient of the services that services
are to be provided in whole or in part by support personnel.
SOURCE: IC 34-24-1-1; (05)CC109806.75. -->
SECTION 75. IC 34-24-1-1, AS AMENDED BY SEA 47-2005,
SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2005]: Sec. 1. (a) The following may be seized:
(1) All vehicles (as defined by IC 35-41-1), if they are used or are
intended for use by the person or persons in possession of them to
transport or in any manner to facilitate the transportation of the
following:
(A) A controlled substance for the purpose of committing,
attempting to commit, or conspiring to commit any of the
following:
(i) Dealing in or manufacturing cocaine, a narcotic drug, or
methamphetamine (IC 35-48-4-1).
(ii) Dealing in a schedule I, II, or III controlled substance (IC
35-48-4-2).
(iii) Dealing in a schedule IV controlled substance (IC
35-48-4-3).
(iv) Dealing in a schedule V controlled substance (IC
35-48-4-4).
(v) Dealing in a counterfeit substance (IC 35-48-4-5).
(vi) Possession of cocaine, a narcotic drug, or
methamphetamine (IC 35-48-4-6).
(vii) Dealing in paraphernalia (IC 35-48-4-8.5).
(viii) Dealing in marijuana, hash oil, or hashish (IC
35-48-4-10).
(B) Any stolen (IC 35-43-4-2) or converted property (IC
35-43-4-3) if the retail or repurchase value of that property is one
hundred dollars ($100) or more.
(C) Any hazardous waste in violation of IC 13-30-6-6.
(D) A bomb (as defined in IC 35-41-1-4.3) or weapon of mass
destruction (as defined in IC 35-41-1-29.4) used to commit, used
in an attempt to commit, or used in a conspiracy to commit an
offense under IC 35-47 as part of or in furtherance of an act of
terrorism (as defined by IC 35-41-1-26.5).
(2) All money, negotiable instruments, securities, weapons,
communications devices, or any property used to commit, used in
an attempt to commit, or used in a conspiracy to commit an offense
under IC 35-47 as part of or in furtherance of an act of terrorism or
commonly used as consideration for a violation of IC 35-48-4
(other than items subject to forfeiture under IC 16-42-20-5 or
IC 16-6-8.5-5.1 before its repeal):
(A) furnished or intended to be furnished by any person in
exchange for an act that is in violation of a criminal statute;
(B) used to facilitate any violation of a criminal statute; or
(C) traceable as proceeds of the violation of a criminal statute.
(3) Any portion of real or personal property purchased with money
that is traceable as a proceed of a violation of a criminal statute.
(4) A vehicle that is used by a person to:
(A) commit, attempt to commit, or conspire to commit;
(B) facilitate the commission of; or
(C) escape from the commission of;
murder (IC 35-42-1-1), kidnapping (IC 35-42-3-2), criminal
confinement (IC 35-42-3-3), rape (IC 35-42-4-1), child molesting
(IC 35-42-4-3), or child exploitation (IC 35-42-4-4), or an offense
under IC 35-47 as part of or in furtherance of an act of terrorism.
(5) Real property owned by a person who uses it to commit any of
the following as a Class A felony, a Class B felony, or a Class C
felony:
(A) Dealing in or manufacturing cocaine, a narcotic drug, or
methamphetamine (IC 35-48-4-1).
(B) Dealing in a schedule I, II, or III controlled substance (IC
35-48-4-2).
(C) Dealing in a schedule IV controlled substance (IC
35-48-4-3).
(D) Dealing in marijuana, hash oil, or hashish (IC 35-48-4-10).
(6) Equipment and recordings used by a person to commit fraud
under IC 35-43-5-4(11).
(7) Recordings sold, rented, transported, or possessed by a person
in violation of IC 24-4-10.
(8) Property (as defined by IC 35-41-1-23) or an enterprise (as
defined by IC 35-45-6-1) that is the object of a corrupt business
influence violation (IC 35-45-6-2).
(9) Unlawful telecommunications devices (as defined in
IC 35-45-13-6) and plans, instructions, or publications used to
commit an offense under IC 35-45-13.
(10) Any equipment used or intended for use in preparing,
photographing, recording, videotaping, digitizing, printing,
copying, or disseminating matter in violation of IC 35-42-4-4.
(11) Destructive devices used, possessed, transported, or sold in
violation of IC 35-47.5.
(12) Cigarettes that are sold in violation of IC 24-3-5.2, cigarettes
that a person attempts to sell in violation of IC 24-3-5.2, and other
personal property owned and used by a person to facilitate a
violation of IC 24-3-5.2.
(13) Tobacco products that are sold in violation of IC 24-3-5,
tobacco products that a person attempts to sell in violation of
IC 24-3-5, and other personal property owned and used by a person
to facilitate a violation of IC 24-3-5.
(14) Property used by a person to commit counterfeiting or forgery
in violation of IC 35-43-5-2.
(15) After December 31, 2005, if a person is convicted of an
offense specified in IC 25-26-14-26(b) or IC 35-43-10, the
following real or personal property:
(A) Property used or intended to be used to commit,
facilitate, or promote the commission of the offense.
(B) Property constituting, derived from, or traceable to the
gross proceeds that the person obtained directly or indirectly
as a result of the offense.
(b) A vehicle used by any person as a common or contract carrier in
the transaction of business as a common or contract carrier is not
subject to seizure under this section, unless it can be proven by a
preponderance of the evidence that the owner of the vehicle knowingly
permitted the vehicle to be used to engage in conduct that subjects it to
seizure under subsection (a).
(c) Equipment under subsection (a)(10) may not be seized unless it
can be proven by a preponderance of the evidence that the owner of the
equipment knowingly permitted the equipment to be used to engage in
conduct that subjects it to seizure under subsection (a)(10).
(d) Money, negotiable instruments, securities, weapons,
communications devices, or any property commonly used as
consideration for a violation of IC 35-48-4 found near or on a person
who is committing, attempting to commit, or conspiring to commit any
of the following offenses shall be admitted into evidence in an action
under this chapter as prima facie evidence that the money, negotiable
instrument, security, or other thing of value is property that has been
used or was to have been used to facilitate the violation of a criminal
statute or is the proceeds of the violation of a criminal statute:
(1) IC 35-48-4-1 (dealing in or manufacturing cocaine, a narcotic
drug, or methamphetamine).
(2) IC 35-48-4-2 (dealing in a schedule I, II, or III controlled
substance).
(3) IC 35-48-4-3 (dealing in a schedule IV controlled substance).
(4) IC 35-48-4-4 (dealing in a schedule V controlled substance) as
a Class B felony.
(5) IC 35-48-4-6 (possession of cocaine, a narcotic drug, or
methamphetamine) as a Class A felony, Class B felony, or Class C
felony.
(6) IC 35-48-4-10 (dealing in marijuana, hash oil, or hashish) as a
Class C felony.
SOURCE: IC 35-43-10; (05)CC109806.76. -->
SECTION 76. IC 35-43-10 IS ADDED TO THE INDIANA CODE
AS A
NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
JANUARY 1, 2006]:
Chapter 10. Legend Drug Deception
Sec. 1. The definitions in IC 25-26-14 apply throughout this
chapter.
Sec. 2. Except as provided by federal law or regulation, this
chapter does not apply to a pharmaceutical manufacturer that is
approved by the federal Food and Drug Administration.
Sec. 3. A person who knowingly or intentionally:
(1) possesses a contraband legend drug;
(2) sells, delivers, or possesses with intent to sell or deliver a
contraband legend drug;
(3) forges, counterfeits, or falsely creates a label for a legend
drug or falsely represents a factual matter contained on a label
of a legend drug; or
(4) manufactures, purchases, sells, delivers, brings into
Indiana, or possesses a contraband legend drug;
commits legend drug deception, a Class D felony.
Sec. 4. A person:
(1) who knowingly or intentionally manufactures, purchases,
sells, delivers, brings into Indiana, or possesses a contraband
legend drug; and
(2) whose act under subdivision (1) results in the death of an
individual;
commits legend drug deception resulting in death, a Class A felony.
SOURCE: IC 16-27-1-0.5; (05)CC109806.77. -->
SECTION 77. IC 16-27-1-0.5 IS REPEALED [EFFECTIVE JULY
1, 2005].
SOURCE: ; (05)CC109806.78. -->
SECTION 78. [EFFECTIVE JULY 1, 2005] (a) The definitions in
IC 16-27-4, as added by this act, apply to this SECTION.
(b) Notwithstanding IC 16-27-4, as added by this act, a person is
not required to be licensed by the state department of health to
operate a personal services agency before January 1, 2006.
(c) This SECTION expires January 1, 2006.
SOURCE: ; (05)CC109806.79. -->
SECTION 79. [EFFECTIVE JULY 1, 2005] (a) IC 25-26-14, as
amended by this act, applies:
(1) after December 31, 2005, for an initial license issued under
IC 25-26-14, as amended by this act; and
(2) on the first expiration date occurring after December 31,
2005, for renewal of a license issued under IC 25-26-14, before
amendment by this act.
(b) The Indiana board of pharmacy established by IC 25-26-13-3
may establish an electronic pedigree pilot program to authenticate,
track, and trace legend drugs. The pilot program must include
participation of drug manufacturers, wholesale drug distributors,
and pharmacies that are licensed in Indiana. The board may
establish the requirements and guidelines for the pilot program.
(c) Before June 30, 2007, the Indiana board of pharmacy
established by IC 25-26-13-3 shall conduct a study of the electronic
pedigree pilot program. The study must include consultation with
manufacturers, distributors, and pharmacies that participate in the
electronic pedigree pilot program. The study may include
consultation with manufacturers, distributors, and pharmacies that
do not participate in the electronic pedigree pilot program. Based
on the results of the study, the board shall determine a date to
implement a mandatory electronic pedigree program. However, the
board may not implement a mandatory electronic pedigree
program until after:
(1) the board has completed the study under this subsection;
and
(2) the board has consulted with the federal Food and Drug
Administration concerning the implementation of a mandatory
electronic pedigree program.
(d) The Indiana board of pharmacy established by IC 25-26-13-3
shall adopt rules under IC 25-26-14-8.5(7), as added by this act,
prescribing the route that a legend drug travels that is in the
normal distribution chain of custody.
(e) IC 25-26-14-26(b), as added by this act, applies only to
offenses committed after December 31, 2005.
(f) This SECTION expires December 31, 2007.
SOURCE: ; (05)CC109806.80. -->
SECTION 80. [EFFECTIVE JULY 1, 2005]
(a) Notwithstanding
IC 25-35.6, as amended by this act, concerning issuance of a license,
the health professions bureau shall issue a license in
speech-language pathology as follows:
(1) To each individual who applies for licensure and meets all
the following qualifications:
(A) Holds a license in speech and hearing therapy issued by
the professional standards board.
(B) Has a master's degree in speech-language pathology or a
related discipline.
(C) Has been employed as a speech-language pathologist for
at least nine (9) months in the last five (5) years.
(2) To each individual who applies for licensure and meets all
the following qualifications:
(A) Holds a life license in speech-language pathology issued
by the professional standards board.
(B) Has:
(i) been employed as a speech-language pathologist for at
least nine (9) months in the last five (5) years; or
(ii) taken at least thirty-six (36) hours of continuing
education approved by the professional standards board or
health professions bureau after December 31, 2001, and
before January 1, 2007.
(b) This SECTION expires July 1, 2007.
SOURCE: ; (05)CC109806.81. -->
SECTION 81. [EFFECTIVE JULY 1, 2005] (a) Notwithstanding
IC 25-35.6-1-8(b)(3), as added by this act, a speech-language
pathologist is not required to hold a certificate of clinical
competence in speech-language pathology or its equivalent issued
by a nationally recognized association for speech-language and
hearing to supervise speech-language pathology support personnel.
(b) This SECTION expires July 1, 2010.
SOURCE: ; (05)CC109806.82. -->
SECTION 82. [EFFECTIVE JULY 1, 2005]
(a) Notwithstanding
IC 25-35.6-1-6(2), as added by this act, an applicant for an initial
license as an audiologist is required to possess only a master's
degree in audiology from an accredited educational program
recognized by the speech-language pathology and audiology board.
(b) This SECTION expires January 1, 2007.
(Reference is to EHB 1098 as reprinted April 6, 2005.)
Conference Committee Report
on
Engrossed House
Bill 1098
Text Box
S
igned by:
____________________________ ____________________________
Representative Messer Senator Dillon
Chairperson
____________________________ ____________________________
Representative Brown C Senator Simpson
House Conferees Senate Conferees