Reprinted
March 1, 2006
ENGROSSED
SENATE BILL No. 202
_____
DIGEST OF SB 202
(Updated February 28, 2006 9:58 pm - DI 110)
Citations Affected: IC 16-42; IC 25-26.
Synopsis: Pharmacy, cigarette displays, and wholesale distributor
matters. Allows a mechanical device that dispenses drugs to be used at
certain remote locations and health care facilities. Removes authority
for pharmacist extern programs. Adds persons who are allowed to be
pharmacist interns. Changes references from the Foreign Pharmacy
Graduate Equivalency Examination to the Foreign Pharmacy Graduate
Examination Committee Certificate. Removes the practical
examination requirement for certain pharmacists who are licensed in
another jurisdiction. Provides that a person who has not renewed a
pharmacist license within seven years must apply for a new license.
Allows certain hospitals to operate Type II pharmacies in approved
locations near the licensed area. Prohibits licensing a pharmacy in a
residence. Authorizes the board of pharmacy (board) to temporarily
(Continued next page)
Effective: Upon passage; July 1, 2006.
Riegsecker
(HOUSE SPONSORS _ BROWN T, BUDAK, BROWN C)
January 9, 2006, read first time and referred to Committee on Health and Provider
Services.
January 26, 2006, amended, reported favorably _ Do Pass.
January 30, 2006, read second time, ordered engrossed. Engrossed.
February 1, 2006, read third time, passed. Yeas 49, nays 1.
HOUSE ACTION
February 7, 2006, read first time and referred to Committee on Public Health.
February 23, 2006, amended, reported _ Do Pass.
February 28, 2006, read second time, amended, ordered engrossed.
Digest Continued
suspend certain statutes or administrative rules that would prevent,
hinder, or delay the appropriate delivery of pharmaceutical care during
a state of emergency declared by the governor or the President of the
United States. Prohibits pharmacies and certain retail establishments
from selling cigarettes through a self service display. Provides that
companies that only manufacture or distribute medical gases are not
wholesale drug distributors or manufacturers. Adds and amends
definitions concerning wholesale drug distributors. Allows the board
to appoint a designee to inspect wholesale distribution operations.
Requires a person seeking a wholesale drug distributor license to
provide the board with a criminal history and financial background
checks. Requires a record keeping pedigree for certain legend drugs
that leave the normal chain of custody. Removes the requirement that
drug distributors have: (1) a continuous quality improvement system;
and (2) policies concerning certain drugs that may be returned.
Requires that certain wholesale drug accreditation bodies that have an
agreement with the board review accreditation denials. Allows the
board to grant reciprocity to out of state home medical equipment
service providers. Makes certain other changes, including conforming
and technical changes. Repeals provisions concerning: (1) temporary
pharmacist licenses; (2) qualifications to be an authorized wholesale
drug distributor; and (3) certain random authentications of pedigrees
by wholesale drug distributors.
Reprinted
March 1, 2006
Second Regular Session 114th General Assembly (2006)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in
this style type, and deletions will appear in
this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional
provision adopted), the text of the new provision will appear in
this style type. Also, the
word
NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in
this style type or
this style type reconciles conflicts
between statutes enacted by the 2005 Regular Session of the General Assembly.
ENGROSSED
SENATE BILL No. 202
A BILL FOR AN ACT to amend the Indiana Code concerning
professions and occupations.
Be it enacted by the General Assembly of the State of Indiana:
SOURCE: IC 16-42-19-23; (06)ES0202.2.1. -->
SECTION 1. IC 16-42-19-23 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 23. (a) As used in
this section, "mechanical device" means a machine for storage and
dispensing of drugs. The term does not include devices or instruments
used by practitioners in the diagnosis, cure, mitigation, treatment, or
prevention of disease in human beings or other animals.
(b) A person may not maintain, operate, or use any type of
mechanical device in which any legend drug or narcotic drug is stored
or held for the purpose of dispensing the drug from the mechanical
device. However, the mechanical device may be used for the storage
and dispensing of legend drugs if:
(1) the mechanical device is located on the premises of a business
or establishment holding a valid used in a:
(A) pharmacy that holds a permit issued by the Indiana board
of pharmacy; and
(B) remote location under the jurisdiction of the board of
pharmacy; or
(C) health care facility that is licensed under IC 16-28 or
IC 16-21-2; and
(2) the mechanical device is operated under the direct supervision
and control of a:
(A) registered pharmacist; or
(B) practitioner;
who is directly responsible for dispensing the drug from the
mechanical device.
(c) Inspectors of the Indiana board of pharmacy may inspect the
premises of any person suspected of violating this section.
SOURCE: IC 25-26-13-2; (06)ES0202.2.2. -->
SECTION 2. IC 25-26-13-2, AS AMENDED BY P.L.204-2005,
SECTION 14, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: Sec. 2. As used in this chapter:
"Board" means the Indiana board of pharmacy.
"Controlled drugs" are those drugs on schedules I through V of the
Federal Controlled Substances Act or on schedules I through V of
IC 35-48-2.
"Counseling" means effective communication between a pharmacist
and a patient concerning the contents, drug to drug interactions, route,
dosage, form, directions for use, precautions, and effective use of a
drug or device to improve the therapeutic outcome of the patient
through the effective use of the drug or device.
"Dispensing" means issuing one (1) or more doses of a drug in a
suitable container with appropriate labeling for subsequent
administration to or use by a patient.
"Drug" means:
(1) articles or substances recognized in the official United States
Pharmacopoeia, official National Formulary, official
Homeopathic Pharmacopoeia of the United States, or any
supplement to any of them;
(2) articles or substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or animals;
(3) articles other than food intended to affect the structure or any
function of the body of man or animals; or
(4) articles intended for use as a component of any article
specified in subdivisions (1) through (3) and devices.
"Drug order" means a written order in a hospital or other health care
institution for an ultimate user for any drug or device, issued and
signed by a practitioner, or an order transmitted by other means of
communication from a practitioner, which is immediately reduced to
writing by the pharmacist, registered nurse, or other licensed health
care practitioner authorized by the hospital or institution. The order
shall contain the name and bed number of the patient; the name and
strength or size of the drug or device; unless specified by individual
institution policy or guideline, the amount to be dispensed either in
quantity or days; adequate directions for the proper use of the drug or
device when it is administered to the patient; and the name of the
prescriber.
"Drug regimen review" means the retrospective, concurrent, and
prospective review by a pharmacist of a patient's drug related history
that includes the following areas:
(1) Evaluation of prescriptions or drug orders and patient records
for drug allergies, rational therapy contradictions, appropriate
dose and route of administration, appropriate directions for use,
or duplicative therapies.
(2) Evaluation of prescriptions or drug orders and patient records
for drug-drug, drug-food, drug-disease, and drug-clinical
laboratory interactions.
(3) Evaluation of prescriptions or drug orders and patient records
for adverse drug reactions.
(4) Evaluation of prescriptions or drug orders and patient records
for proper utilization and optimal therapeutic outcomes.
"Drug utilization review" means a program designed to measure and
assess on a retrospective and prospective basis the proper use of drugs.
"Device" means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article
including any component part or accessory, which is:
(1) recognized in the official United States Pharmacopoeia,
official National Formulary, or any supplement to them;
(2) intended for use in the diagnosis of disease or other conditions
or the cure, mitigation, treatment, or prevention of disease in man
or other animals; or
(3) intended to affect the structure or any function of the body of
man or other animals and which does not achieve any of its
principal intended purposes through chemical action within or on
the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its
principal intended purposes.
"Electronic data intermediary" means an entity that provides the
infrastructure that connects a computer system or another electronic
device used by a prescribing practitioner with a computer system or
another electronic device used by a pharmacy to facilitate the secure
transmission of:
(1) an electronic prescription order;
(2) a refill authorization request;
(3) a communication; and
(4) other patient care information;
between a practitioner and a pharmacy.
"Electronic signature" means an electronic sound, symbol, or
process:
(1) attached to or logically associated with a record; and
(2) executed or adopted by a person;
with the intent to sign the record.
"Electronically transmitted" or "electronic transmission" means the
transmission of a prescription in electronic form. The term does not
include the transmission of a prescription by facsimile.
"Investigational or new drug" means any drug which is limited by
state or federal law to use under professional supervision of a
practitioner authorized by law to prescribe or administer such drug.
"Legend drug" has the meaning set forth in IC 16-18-2-199.
"License" and "permit" are interchangeable and mean a written
certificate from the Indiana board of pharmacy for the practice of
pharmacy or the operation of a pharmacy.
"Nonprescription drug" means a drug that may be sold without a
prescription and that is labeled for use by a patient in accordance with
state and federal laws.
"Person" means any individual, partnership, copartnership, firm,
company, corporation, association, joint stock company, trust, estate,
or municipality, or a legal representative or agent, unless this chapter
expressly provides otherwise.
"Practitioner" has the meaning set forth in IC 16-42-19-5.
"Pharmacist" means a person licensed under this chapter.
"Pharmacist extern" means a pharmacy student enrolled full time in
an approved school of pharmacy and who is working in a school
sponsored, board approved program related to the practice of
pharmacy.
"Pharmacist intern" means a person who is:
working to secure
additional hours of practice and experience prior to making application
for a license to practice as a pharmacist.
(1) permitted by the board to engage in the practice of
pharmacy while under the personal supervision of a
pharmacist and who is satisfactorily progressing toward
meeting the requirements for licensure as a pharmacist;
(2) a graduate of an approved college of pharmacy or a
graduate who has established educational equivalency by
obtaining a Foreign Pharmacy Graduate Examination
Committee Certificate and who is permitted by the board to
obtain practical experience as a requirement for licensure as
a pharmacist;
(3) a qualified applicant awaiting examination for licensure;
or
(4) an individual participating in a residency or fellowship
program.
"Pharmacy" means any facility, department, or other place where
prescriptions are filled or compounded and are sold, dispensed, offered,
or displayed for sale and which has as its principal purpose the
dispensing of drug and health supplies intended for the general health,
welfare, and safety of the public, without placing any other activity on
a more important level than the practice of pharmacy.
"The practice of pharmacy" or "the practice of the profession of
pharmacy" means a patient oriented health care profession in which
pharmacists interact with and counsel patients and with other health
care professionals concerning drugs and devices used to enhance
patients' wellness, prevent illness, and optimize the outcome of a drug
or device, by accepting responsibility for performing or supervising a
pharmacist intern a pharmacist extern, or an unlicensed person under
section 18(a)(4) of this chapter to do the following acts, services, and
operations:
(1) The offering of or performing of those acts, service operations,
or transactions incidental to the interpretation, evaluation, and
implementation of prescriptions or drug orders.
(2) The compounding, labeling, administering, dispensing, or
selling of drugs and devices, including radioactive substances,
whether dispensed under a practitioner's prescription or drug
order or sold or given directly to the ultimate consumer.
(3) The proper and safe storage and distribution of drugs and
devices.
(4) The maintenance of proper records of the receipt, storage,
sale, and dispensing of drugs and devices.
(5) Counseling, advising, and educating patients, patients'
caregivers, and health care providers and professionals, as
necessary, as to the contents, therapeutic values, uses, significant
problems, risks, and appropriate manner of use of drugs and
devices.
(6) Assessing, recording, and reporting events related to the use
of drugs or devices.
(7) Provision of the professional acts, professional decisions, and
professional services necessary to maintain all areas of a patient's
pharmacy related care as specifically authorized to a pharmacist
under this article.
"Prescription" means a written order or an order transmitted by other
means of communication from a practitioner to or for an ultimate user
for any drug or device containing:
(1) the name and address of the patient;
(2) the date of issue;
(3) the name and strength or size (if applicable) of the drug or
device;
(4) the amount to be dispensed (unless indicated by directions and
duration of therapy);
(5) adequate directions for the proper use of the drug or device by
the patient;
(6) the name of the practitioner; and
(7) if the prescription:
(A) is in written form, the signature of the practitioner; or
(B) is in electronic form, the electronic signature of the
practitioner.
"Qualifying pharmacist" means the pharmacist who will qualify the
pharmacy by being responsible to the board for the legal operations of
the pharmacy under the permit.
"Record" means all papers, letters, memoranda, notes, prescriptions,
drug orders, invoices, statements, patient medication charts or files,
computerized records, or other written indicia, documents, or objects
which are used in any way in connection with the purchase, sale, or
handling of any drug or device.
"Sale" means every sale and includes:
(1) manufacturing, processing, transporting, handling, packaging,
or any other production, preparation, or repackaging;
(2) exposure, offer, or any other proffer;
(3) holding, storing, or any other possession;
(4) dispensing, giving, delivering, or any other supplying; and
(5) applying, administering, or any other using.
SOURCE: IC 25-26-13-9; (06)ES0202.2.3. -->
SECTION 3. IC 25-26-13-9 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 9. (a) The board
shall establish standards for pharmacist intern
and pharmacist extern
programs. Such standards shall include, but not be limited to, the
number of hours students must spend in a program, the number of
hours a student must spend in a pharmacy each week, and the types of
duties the student may perform.
(b) The board shall, by regulation, establish standards and
requirements for continuing education and shall endorse those
continuing education programs which meet the standards and
requirements.
SOURCE: IC 25-26-13-10; (06)ES0202.2.4. -->
SECTION 4. IC 25-26-13-10 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 10. (a) An
applicant for registration as a pharmacist intern or pharmacist extern
must furnish proof satisfactory to the board that the applicant: is a high
school graduate or its equivalent, has obtained a general educational
development (GED) diploma, or is enrolled in a pre-pharmacy or
pharmacy curriculum at an accredited school of pharmacy. The board
may require the applicant to successfully complete an examination
prior to registering the applicant as a pharmacist intern or pharmacist
extern.
(1) is actively enrolled in a school of pharmacy accredited by
the American Council of Pharmaceutical Education;
(2) has obtained the Foreign Pharmacy Graduate
Examination Committee Certificate; or
(3) is a qualified applicant awaiting the examination for
licensure as a pharmacist.
(b) A registration issued under subsection (a) of this section is valid
for one (1) year and may be renewed by the board for an additional year
until the expiration date established by the health professions bureau
Indiana professional licensing agency under IC 25-1-5-4.
(c) An application for registration or renewal must be accompanied
by the appropriate fee and one (1) of the following:
(1) Proof of having obtained the Foreign Pharmacy Graduate
Examination Committee Certificate.
(2) Proof of active enrollment in a school of pharmacy
accredited by the American Council of Pharmaceutical
Education.
SOURCE: IC 25-26-13-10.5; (06)ES0202.2.5. -->
SECTION 5. IC 25-26-13-10.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE UPON PASSAGE]: Sec. 10.5. (a) A pharmacy intern
may engage in the practice of pharmacy if the activities are under
the direct supervision of a pharmacist. The pharmacist in charge
is responsible for the activities relating to the practice of pharmacy
performed by the pharmacy intern.
(b) A pharmacist shall review in person the prescription drug
order and the dispensed product prepared by a pharmacy intern
before the product is dispensed to the patient or the patient's agent.
SOURCE: IC 25-26-13-11; (06)ES0202.2.6. -->
SECTION 6. IC 25-26-13-11 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 11. (a) To be
eligible for licensure as a pharmacist, an individual must file such
evidence as is required by the board that:
(1) the individual is at least eighteen (18) years of age;
(2) the individual does not have a conviction for a crime that has
a direct bearing on the individual's ability to practice competently;
(3) the individual:
(A) has graduated with a professional degree from a school of
pharmacy accredited by the American Council of
Pharmaceutical Education or the Canadian Council on
Pharmacy Accreditation and approved by the board; or
(B) has:
(i) graduated with a professional degree from a school of
pharmacy located outside the United States and Canada; and
(ii) met the requirements under subsection (c); and
(4) the individual has satisfactorily completed either a pharmacist
intern or pharmacist extern program approved by the board.
(b) An applicant who has graduated with a professional degree from
a school of pharmacy accredited by the Canadian Council on Pharmacy
Accreditation and approved by the board must pass obtain the Foreign
Pharmacy Graduate Equivalency Examination (FPGEE) Committee
Certificate administered by the National Association of Boards of
Pharmacy before taking the examination required under subsection (d).
(c) An applicant who has graduated with a professional degree from
a school of pharmacy located outside the United States and Canada
must do the following:
(1) Provide the board with verification of the applicant's academic
record and graduation.
(2) Pass Obtain the Foreign Pharmacy Graduate Equivalency
Examination (FPGEE) Committee Certificate administered by
the National Association of Boards of Pharmacy.
(3) Pass an examination approved by the board to establish
proficiency in English.
(d) After filing an application on a form provided by the board,
submitting the information required in subsection (a), and successfully
completing the examination administered by the board, the applicant
may be licensed as a pharmacist.
SOURCE: IC 25-26-13-12; (06)ES0202.2.7. -->
SECTION 7. IC 25-26-13-12 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 12. (a) An
individual who is licensed as a pharmacist in another state where the
requirements for licensure were not less than those required in this
state at the time of original licensure may be issued a license in this
state if:
(1) the individual has registered with and been approved by the
National Association of Boards of Pharmacy;
(2) the individual has graduated with a professional degree in
pharmacy from a school of pharmacy accredited by the American
Council of Pharmaceutical Education or the Canadian Council on
Pharmacy Accreditation and approved by the board; and
(3) the individual has successfully completed an examination
administered by the board concerning the federal statutes and
regulations and the Indiana statutes and rules governing the
practice of pharmacy. and
(4) in the case of an individual who has not been actively engaged
in the practice of pharmacy for the twelve (12) months
immediately preceding the individual's application, the individual
has successfully completed a practical examination administered
by the board.
(b) An individual who has a professional pharmacy degree from a
school of pharmacy located outside the United States and Canada and
who is licensed in another state where the requirements for licensure
are substantially the same as those in this state may be issued a license
under this chapter if:
(1) the individual has registered with and been approved by the
National Association of Boards of Pharmacy;
(2) the individual has provided the board with proof of the
applicant's:
(A) academic record and graduation with a professional degree
from a school of pharmacy; and
(B) successful completion of the requirements for obtaining
a Foreign Pharmacy Graduate Equivalency Examination
(FPGEE) approved Committee Certificate administered by
the National Association of Boards of Pharmacy; and
(C) successful completion of an English proficiency
examination approved by the board;
(3) the individual has successfully completed an examination
administered by the board concerning the federal statutes and
regulations and the Indiana statutes and rules governing the
practice of pharmacy. and
(4) in the event that the individual has not been actively engaged
in the practice of pharmacy in the twelve (12) months preceding
the application, the individual has successfully completed a
practical examination administered by the board.
SOURCE: IC 25-26-13-14; (06)ES0202.2.8. -->
SECTION 8. IC 25-26-13-14 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 14. (a) A
pharmacist's license expires July 1 of each even-numbered year, unless
renewed before that date.
(b) If an application for renewal is not filed and the required fee
paid before July 1 of each even-numbered year, the license expires and
becomes invalid, and may be reinstated only by meeting the
requirements under IC 25-1-8-6.
(c) Subject to IC 25-1-4-3, a statement attesting that the pharmacist
has met the continuing education requirements shall be submitted with
the application for license renewal.
(d) If a pharmacist surrenders the pharmacist's license to practice
pharmacy in Indiana, the board may subsequently consider
reinstatement of the pharmacist's license upon written request of the
pharmacist. The board may impose any conditions it considers
appropriate to the surrender or to the reinstatement of a surrendered
license. The practitioner may not voluntarily surrender the
practitioner's license to the board without the written consent of the
board if any disciplinary proceedings are pending against the
practitioner under this chapter or IC 25-1-9.
(e) If a person fails to renew a license that expires under subsection
(a) within three (3) years after the date the license expires, the board
may reinstate the license only if the person:
(1) meets the requirements under IC 25-1-8-6; and
(2) passes an examination concerning state and federal laws that
the board considers relevant to the practice of pharmacy.
(f) The board may require a person who applies for a license under
subsection (e) to appear before the board and explain the reason the
person failed to renew the person's license.
(g) If a person fails to renew a license that expires under
subsection (a) within seven (7) years after the date the license
expires, the person must apply for a new license.
SOURCE: IC 25-26-13-17; (06)ES0202.2.9. -->
SECTION 9. IC 25-26-13-17 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 17. (a) The board
shall establish classes of pharmacy permits as follows:
Type I. A retail permit for a pharmacy that provides
pharmaceutical care to the general public by the dispensing of a
drug or device.
Type II. An institutional permit for hospitals, clinics, health care
facilities, sanitariums, nursing homes, or dispensaries that offer
pharmaceutical care by dispensing a drug product to an inpatient
under a drug order or to an outpatient of the institution under a
prescription.
Type III. A permit for a pharmacy that is not:
(A) open to the general public; or
(B) located in an institution listed under a Type II permit;
and provides pharmaceutical care to a patient who is located in an
institution or in the patient's home.
Type IV. A permit for a pharmacy not open to the general public
that provides pharmaceutical care by dispensing drugs and
devices to patients exclusively through the United States Postal
Services or other parcel delivery service.
Type V. A permit for a pharmacy that engages exclusively in the
preparation and dispensing of diagnostic or therapeutic
radioactive drugs.
Type VI. A permit for a pharmacy open to the general public that
provides pharmaceutical care by engaging in an activity under a
Type I or Type III permit. A pharmacy that obtains a Type VI
permit may provide services to:
(A) a home health care patient;
(B) a long term care facility; or
(C) a member of the general public.
(b) Hospitals holding a Type II permit may offer drugs or devices to
an employee, student, or medical staff member or their dependents for
their own use.
(c) Nothing in this section prohibits a pharmacy holding a permit
other than a Type IV permit from delivering drugs or devices through
mail, parcel delivery, or hand delivery.
(d) Hospitals holding a Type II permit may operate remote
locations within a reasonable distance of the licensed area, as
determined by the board, after:
(1) filing an application on a form prepared by the board;
(2) having each location inspected by the board; and
(3) obtaining approval from the board.
(d) (e) Any applicable rule governing the practice of pharmacy in
Indiana shall apply to all permits under this section.
SOURCE: IC 25-26-13-20; (06)ES0202.2.10. -->
SECTION 10. IC 25-26-13-20 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 20. (a) A person
desiring to open, establish, operate, or maintain a pharmacy shall apply
to the board for a pharmacy permit on a form provided by the board.
The applicant shall set forth:
(1) the name and occupation of the persons desiring the permit;
(2) the location, including street address and city, of the
pharmacy;
(3) the name of the pharmacist who will qualify the pharmacy by
being responsible to the board for the legal operation of the
pharmacy under the permit; and
(4) such other information as the board may require.
(b) If the applicant desires to open, establish, operate, or maintain
more than one (1) pharmacy, he must file a separate application for
each. Each pharmacy must be qualified by a different pharmacist.
(c) The board shall permit a pharmacist to serve as a qualifying
pharmacist for more than one (1) pharmacy holding a Type II pharmacy
permit upon the holder of the Type II permit showing circumstances
establishing that:
(1) the permit holder has made a reasonable effort, without
success, to obtain a qualifying pharmacist who is not serving as
a qualifying pharmacist at another Type II pharmacy; and
(2) the single pharmacist could effectively fulfill all duties and
responsibilities of the qualifying pharmacist at both locations.
(d) The board shall grant or deny an application for a permit not
later than one hundred twenty (120) days after the application and any
additional information required by the board are submitted.
(e) The board may not issue a pharmacy permit to a person who
desires to operate the pharmacy out of a residence.
SOURCE: IC 25-26-13-32; (06)ES0202.2.11. -->
SECTION 11. IC 25-26-13-32 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE UPON PASSAGE]: Sec. 32. If a state of emergency is
declared by:
(1) the governor under IC 10-14-3-12; or
(2) the President of the United States;
the board may, for the duration of the state of emergency, suspend
the provisions of a statute or rule under this article that would
prevent, hinder, or delay the appropriate delivery of
pharmaceutical care.
SOURCE: IC 25-26-13-33; (06)ES0202.2.12. -->
SECTION 12. IC 25-26-13-33 IS ADDED TO THE INDIANA
CODE AS A
NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2006]:
Sec. 33. (a) As used in this section,
"self-service display" means a display that contains cigarettes in an
area where a customer:
(1) is permitted; and
(2) has access to the cigarettes without assistance from a sales
person.
(b) This section does not apply to a self-service display located
in a pharmacy or other retail establishment that:
(1) has a primary purpose to sell cigarettes; and
(2) prohibits entry by persons who are less than eighteen (18)
years of age.
(c) The owner of a pharmacy or other retail establishment that
sells or distributes cigarettes through a self-service display, other
than a coin operated machine operated under IC 35-46-1-11 or
IC 35-46-1-11.5, commits a Class C infraction.
(d) Notwithstanding IC 34-28-5-4(c), civil penalties collected
under this section must be deposited in the Richard D. Doyle youth
tobacco education and enforcement fund (IC 7.1-6-2-6).
SOURCE: IC 25-26-14-1; (06)ES0202.2.13. -->
SECTION 13. IC 25-26-14-1, AS AMENDED BY P.L.212-2005,
SECTION 23, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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 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.
(c) The requirements of this chapter do not apply to a medical
gas manufacturer or distributor that only manufactures or
distributes medical gases.
SOURCE: IC 25-26-14-3.7; (06)ES0202.2.14. -->
SECTION 14. IC 25-26-14-3.7 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE UPON PASSAGE]: Sec. 3.7. As used in this chapter,
"chain drug warehouse" means a permanent physical location for
drugs or devices, or both, that:
(1) is licensed as a wholesale distributor;
(2) acts as a central warehouse; and
(3) primarily performs intracompany sales and transfers of
legend drugs or devices to members of the same affiliated
group that is under common ownership and control.
SOURCE: IC 25-26-14-8.7; (06)ES0202.2.15. -->
SECTION 15. IC 25-26-14-8.7, AS ADDED BY P.L.212-2005,
SECTION 40, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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:
(1) records each wholesale 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, that leaves the normal distribution chain of
custody and that includes information designated by the board
through rules for each transaction; or
(2) complies with a legend drug pedigree law or regulation in
another state or United States territory that meets the
pedigree requirements under this chapter.
SOURCE: IC 25-26-14-12; (06)ES0202.2.16. -->
SECTION 16. IC 25-26-14-12 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 12. As used in this
chapter, "wholesale drug distributor" means a person engaged in
wholesale distribution of legend drugs, including:
(1) manufacturers;
(2) repackers;
(3) own-label distributors;
(4) private-label distributors;
(5) jobbers;
(6) brokers;
(7) warehouses, including manufacturers' and distributors'
warehouses, chain drug warehouses, and wholesale drug
warehouses;
(8) independent wholesale drug traders; and
(9) retail and hospital pharmacies that conduct wholesale
distributions; and
(10) reverse distributors.
The term does not include a common carrier or person hired solely to
transport prescription drugs.
SOURCE: IC 25-26-14-14.5; (06)ES0202.2.17. -->
SECTION 17. IC 25-26-14-14.5, AS ADDED BY P.L.212-2005,
SECTION 47, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: Sec. 14.5. After June 30, 2006, a wholesale drug
distributor may not accept or deliver a legend drug without a current,
accompanying pedigree as required under section 17 of this chapter.
SOURCE: IC 25-26-14-15; (06)ES0202.2.18. -->
SECTION 18. IC 25-26-14-15, AS AMENDED BY P.L.212-2005,
SECTION 48, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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, 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 designated
representative of 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 or the board's designee 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 or the board's designee.
(f) A material change in any information in 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 25-26-14-16; (06)ES0202.2.19. -->
SECTION 19. IC 25-26-14-16, AS AMENDED BY P.L.212-2005,
SECTION 50, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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 in Indiana, the
board shall consider the following factors:
(1) A 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 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 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 and financial
background check (as defined in IC 10-13-3-12) checks for:
(1) the applicant;
(2) all personnel involved in the operations of the wholesale drug
distributor;
(3) (1) the designated representative or 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) (2) the supervisor or the designated representative or the
most senior individual under subsection (b)(1); and
(3) principals and owners with at least more than a ten percent
(10%) interest in the wholesale drug distributor, if the wholesale
drug distributor is a nonpublicly held company.
(c) The national criminal history and financial background check
checks conducted under subsection (b) must:
(1) be conducted at the applicant's expense; and must
(2) include a criminal history for all current and previous
states of residence since of the applicant; became eighteen (18)
years of age.
(3) include the criminal history in the federal district where
the applicant currently resides;
(4) include information from the previous seven (7) years; and
(5) be approved by the board.
(c) After December 31, 2005, (d) 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; (06)ES0202.2.20. -->
SECTION 20. IC 25-26-14-16.5, AS ADDED BY P.L.212-2005,
SECTION 51, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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) (1)The date and place of birth of the designated representative.
(3) (2) 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) (3) 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) (4) 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) (5) 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) (6) A photograph of the designated representative taken within
the immediately preceding thirty (30) days under procedures
specified by the board.
(8) (7) 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) (8) 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 25-26-14-17; (06)ES0202.2.21. -->
SECTION 21. IC 25-26-14-17, AS AMENDED BY P.L.212-2005,
SECTION 53, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: Sec. 17. As a condition for receiving and retaining
a wholesale drug distributor license issued under this chapter, 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:
(i) an after hours central alarm or a comparable entry
detection capability;
(ii) restricted premises access;
(iii) adequate outside perimeter lighting;
(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 as follows:
(A) The system describes all the wholesale distributor's
activities governed by this chapter for the 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
that
leaves the normal chain of custody.
(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 applicable, 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) Facility security or operation problems caused by natural
disaster or government emergency.
(B) Correction of inventory inaccuracies.
(C) Product shipping and receiving problems.
(D) Quarantine and return to the manufacturer or destruction
in accordance with state and federal law of all outdated
products and outdated or expired legend drugs, including
appropriate documentation and witnessing.
(E) Appropriate disposition of returned goods.
(F) Product recalls.
(G) Identifying, recording, and reporting losses or thefts.
(H) Implementation and maintenance of a continuous quality
improvement system.
(I) (H) 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) (I) 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) (J) 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) (K) Reporting of criminal or suspected criminal activities
involving the inventory of legend drugs to the board within
three (3) business days.
(M) (L) 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) (D) 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) (E) 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) (F) 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) (G) 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) (H) 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) (I) 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) (J) 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) (K) 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; (06)ES0202.2.22. -->
SECTION 22. IC 25-26-14-17.2, AS ADDED BY P.L.212-2005,
SECTION 54, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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, if applicable, 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 25-26-14-17.8; (06)ES0202.2.23. -->
SECTION 23. IC 25-26-14-17.8, AS ADDED BY P.L.212-2005,
SECTION 56, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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.
However, the due diligence requirements of this
section do not apply to purchases from an unlicensed wholesale
drug distributor that has obtained accreditation through the
National Association of Boards of Pharmacy's Verified-Accredited
Wholesale Distributors program.
(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; (06)ES0202.2.24. -->
SECTION 24. IC 25-26-14-17.9, AS ADDED BY P.L.212-2005,
SECTION 57, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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 an unrelated
wholesale drug distributor licensed under this chapter.
SOURCE: IC 25-26-14-18; (06)ES0202.2.25. -->
SECTION 25. IC 25-26-14-18 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 18. (a) Any
applicant denied a license or renewal under this chapter has the right
of review of the board's action under IC 4-21.5.
(b) An applicant that is denied the accreditation under section
14 of this chapter from an accreditation body that has entered into
an agreement with the board has the right of review of the
accreditation body's decision by the board.
SOURCE: IC 25-26-14-20; (06)ES0202.2.26. -->
SECTION 26. IC 25-26-14-20, AS AMENDED BY P.L.212-2005,
SECTION 58, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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 25-26-14-27; (06)ES0202.2.27. -->
SECTION 27. IC 25-26-14-27, AS AMENDED BY P.L.212-2005,
SECTION 61, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: 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 25-26-16-3; (06)ES0202.2.28. -->
SECTION 28. IC 25-26-16-3 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE UPON PASSAGE]: Sec. 3. (a) At the time
of admission to a hospital that has adopted a protocol under this
chapter, the following apply:
(1) The admitting practitioner shall signify in writing in the form
and manner prescribed by the hospital whether the protocol
applies in the care and treatment of the patient.
(2) A pharmacist may adjust the drug therapy regimen of the
patient pursuant to the:
(A) written authorization of the admitting practitioner under
subdivision (1); and
(B) protocols of the hospital.
The pharmacist shall review the appropriate medical records of
the patient to determine whether the admitting practitioner has
authorized the use of a specific protocol before adjusting the
patient's drug therapy regimen. The admitting practitioner may at
any time modify or cancel a protocol by entering the modification
or cancellation in the patient's medical record.
(b) Notwithstanding subsection (a)(2), if a protocol involves
parenteral nutrition of the patient, the pharmacist shall communicate
with the admitting practitioner to receive approval to begin the
protocol. The authorization of the admitting practitioner to use the
protocol shall be entered immediately in the patient's medical record,
if required by the protocol.
SOURCE: IC 25-26-21-8; (06)ES0202.2.29. -->
SECTION 29. IC 25-26-21-8, AS ADDED BY P.L.122-2005,
SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
UPON PASSAGE]: Sec. 8. (a) After June 30, 2006, a provider must be
licensed by the board before the provider may provide home medical
equipment services. If a provider provides home medical equipment
services from more than one (1) location in Indiana, the provider must
obtain a license under this chapter for each location.
(b) An applicant shall submit the application to the board on a form
adopted by the board. The nonrefundable application fee set by the
board must be submitted with the application. The fee must be
deposited in the state general fund.
(c) If the board determines that the applicant:
(1) meets the standards set forth by the board; and
(2) has satisfied the requirements under this chapter and the
requirements established by the board by rule;
the board shall notify the applicant in writing that the license is being
issued to the applicant. The license is effective on the applicant's
receipt of the written notification.
(d) A license issued under this chapter is effective for not more than
two (2) years, beginning on a date determined by the board. An entity
that is licensed under this chapter shall display the license or a copy of
the license on the licensed premises.
(e) The board may renew a license every two (2) years.
(f) The board may adopt rules that permit an out-of-state
provider to obtain a license on the basis of reciprocity if:
(1) the out-of-state provider possesses a valid license granted
by another state;
(2) the legal standards for licensure in the other state are
comparable to the standards under this chapter; and
(3) the other state extends reciprocity to providers 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 provider must comply with the additional
requirements of this chapter to obtain a reciprocal license under
this chapter.
SOURCE: IC 25-26-13-12.5; IC 25-26-14-15.5; IC 25-26-14-17.3.
; (06)ES0202.2.30. -->
SECTION 30. THE FOLLOWING ARE REPEALED [EFFECTIVE
UPON PASSAGE]: IC 25-26-13-12.5; IC 25-26-14-15.5;
IC 25-26-14-17.3.
SOURCE: ; (06)ES0202.2.31. -->
SECTION 31.
An emergency is declared for this act.