SB 590-1_ Filed 04/27/2005, 13:16
Adopted 4/27/2005
CONFERENCE COMMITTEE REPORT
DIGEST FOR ESB 590
Citations Affected: IC 16-18-2; IC 16-28-11-4; IC 16-42; IC 25-26; IC 27-13-38-2;
IC 35-48-3-9; IC 35-48-7-5; IC 35-48-7-8.
Synopsis: Electronic prescriptions. Conference committee report for ESB 590. Allows: (1) the
electronic transmission of prescriptions and instructions related to the prescriptions; and (2) the
transmission of prescriptions for schedule III, IV, and V controlled substances by facsimile.
Provides that a prescription may be transmitted electronically only through the use of an
electronic data intermediary. Requires the board of pharmacy to: (1) adopt rules concerning
security of electronically transmitted prescription information; and (2) establish a process for
approving electronic data intermediaries. (This conference committee report removes
provisions concerning wholesale drug distribution.)
Effective: July 1, 2005.
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 House Amendments to Engrossed Senate Bill No. 590 respectfully reports
that said two committees have conferred and agreed as follows to wit:
that the Senate recede from its dissent from all House amendments and that
the Senate now concur in all House amendments to the bill and that the bill
be further amended as follows:
Delete everything after the enacting clause and insert the following:
SOURCE: IC 16-18-2-106.3; (05)CC059001.1. -->
SECTION 1. IC 16-18-2-106.3 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 106.3. For purposes of IC 16-42-3
and IC 16-42-22, "electronic signature" means an electronic sound,
symbol, or process:
(1) attached to or logically associated with an electronically
transmitted prescription or order; and
(2) executed or adopted by a person;
with the intent to sign the electronically transmitted prescription
or order.
SOURCE: IC 16-18-2-106.4; (05)CC059001.2. -->
SECTION 2. IC 16-18-2-106.4 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 106.4. For purposes of
IC 16-42-3, IC 16-42-19, and IC 16-42-22, "electronically
transmitted" or "electronic transmission" means the transmission
of a prescription in electronic form. The term does not include
transmission of a prescription by facsimile.
SOURCE: IC 16-28-11-4; (05)CC059001.3. -->
SECTION 3. IC 16-28-11-4 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. A health facility that
possesses unused medication that meets the requirements of
IC 25-26-13-25(i)(1) IC 25-26-13-25(j)(1) through
IC 25-26-13-25(i)(6): IC 25-26-13-25(j)(6):
(1) shall return medication that belonged to a Medicaid recipient;
and
(2) may return other unused medication;
to the pharmacy that dispensed the medication.
SOURCE: IC 16-42-3-6; (05)CC059001.4. -->
SECTION 4. IC 16-42-3-6 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6. (a) This section
applies to a drug intended for use by humans that:
(1) is a habit forming drug to which section 4(4) of this chapter
applies;
(2) because of:
(A) the drug's toxicity or other potential for harmful effect;
(B) the method of the drug's use; or
(C) the collateral measures necessary to the drug's use;
is not safe for use except under the supervision of a practitioner
licensed by law to administer the drug; or
(3) is limited by an approved application under Section 505 of the
Federal Act or section 7 or 8 of this chapter to use under the
professional supervision of a practitioner licensed by law to
administer the drug.
(b) A drug described in subsection (a) may be dispensed only:
(1) upon a written or an electronically transmitted prescription
of a practitioner licensed by law to administer the drug;
(2) upon an oral prescription of the practitioner that is reduced
promptly to writing and filed by the pharmacist; pharmacist or
pharmacist intern (as defined in IC 25-26-13-2); or
(3) by refilling a written or oral prescription if the refilling is
authorized by the prescriber either in the original prescription, by
an electronically transmitted order that is recorded in an
electronic format, or by oral order that is reduced promptly to
writing or is entered into an electronic format and filed by the
pharmacist or pharmacist intern (as defined in IC 25-26-13-2).
(c) If a prescription for a drug described in subsection (a) does not
indicate how many times the prescription may be refilled, if any, the
prescription may not be refilled unless the pharmacist is subsequently
authorized to do so by the practitioner.
(d) The act of dispensing a drug contrary to subsection (a), (b), or (c)
is considered to be an act that results in a drug being misbranded while
held for sale.
(e) A drug dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer the drug is
exempt from the requirements of section 4(2), 4(3), 4(4), 4(5), 4(6),
4(7), 4(8), and 4(9) of this chapter if the drug bears a label containing
the following:
(1) The name and address of the dispenser.
(2) The serial number and date of the prescription or of the
prescription's filling.
(3) The name of the drug's prescriber and, if stated in the
prescription, the name of the patient.
(4) The directions for use and cautionary statements, if any,
contained in the prescription.
This exemption does not apply to any drugs dispensed in the course of
the conduct of a business of dispensing drugs pursuant to diagnosis by
mail or to a drug dispensed in violation of subsection (a), (b), (c), or (d).
(f) The state department may adopt rules to remove drugs subject to
section 4(4) of this chapter, section 7 of this chapter, or section 8 of this
chapter from the requirements of subsections (a) through (d) when the
requirements are not necessary for the protection of public health.
Drugs removed from the prescription requirements of the Federal Act
by regulations issued under the Federal Act may also, by rules adopted
by the state department, be removed from the requirement of
subsections (a) through (d).
(g) A drug that is subject to subsections (a) through (d) is considered
to be misbranded if at any time before dispensing the drug's label fails
to bear the statement "Caution: Federal Law Prohibits Dispensing
Without Prescription" or "Caution: State Law Prohibits Dispensing
Without Prescription". A drug to which subsections (a) through (d) does
do not apply is considered to be misbranded if, at any time before
dispensing, the drug's label bears the caution statement described in this
subsection.
(h) This section does not relieve a person from a requirement
prescribed by or under authority of law with respect to drugs included
within the classifications of narcotic drugs or marijuana as defined in
the applicable federal and state laws relating to narcotic drugs and
marijuana.
(i) A drug may be dispensed under subsection (b) upon an
electronically transmitted prescription only to the extent permitted
by federal law.
SOURCE: IC 16-42-3-9; (05)CC059001.5. -->
SECTION 5. IC 16-42-3-9 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. (a) Sections 7 and
8 of this chapter do not apply to the following:
(1) To a drug dispensed on a written or an electronically
transmitted prescription signed by or with an electronic
signature of a physician, dentist, or veterinarian (except a drug
dispensed in the course of the conduct of a business of dispensing
drugs pursuant to diagnosis by mail) if the physician, dentist, or
veterinarian is licensed by law to administer the drug, and the drug
bears a label containing the name and place of business of the
dispenser, the serial number and date of the prescription, and the
name of the physician, dentist, or veterinarian.
(2) To a drug exempted by rule of the state department and that is
intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of drugs.
(3) To a drug sold in Indiana or introduced into intrastate
commerce at any time before the enactment of the Federal Act, if
the drug's labeling contained the same representations concerning
the conditions of the drug's use.
(4) To any drug that is licensed under the Public Health Service
Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et
seq.) or under the Animal Virus-Serum Toxin Act of March 4,
1913 (13 Stat. 832; 21 U.S.C. 151 et seq.).
(5) To a drug subject to section 4(10) of this chapter.
(b) Rules exempting drugs intended for investigational use under
subsection (a)(2) may, within the discretion of the state department
among other conditions relating to the protection of the public health,
provide for conditioning the exemption upon the following:
(1) The submission to the state department, before any clinical
testing of a new drug is undertaken, of reports by the manufacturer
or the sponsor of the investigation of the drug or preclinical tests,
including tests on animals, of the drug adequate to justify the
proposed clinical testing.
(2) The manufacturer or the sponsor of the investigation of a new
drug proposed to be distributed to investigators for clinical testing
obtaining a signed agreement from each of the investigators that
patients to whom the drug is administered will be under the
manufacturer's or sponsor's personal supervision or under the
supervision of investigators responsible to the manufacturer or
sponsor and that the manufacturer or sponsor will not supply the
drug to any other investigator or to clinics for administration to
human beings.
(3) The establishment and maintenance of the records and the
making of the reports to the state department by the manufacturer
or the sponsor of the investigation of the drug of data (including
analytical reports by investigators) obtained as the result of the
investigational use of the drug that the state department finds will
enable the state department to evaluate the safety and effectiveness
of the drug if an application is filed under section 8 of this chapter.
(c) Rules exempting drugs intended for investigational use under
subsection (a)(2) must provide that the exemption is conditioned upon
the manufacturer or the sponsor of the investigation requiring that
experts using the drugs for investigational purposes certify to the
manufacturer or sponsor that the experts will inform any human beings
to whom the drugs or any controls used in connection with the drugs
are being administered that the drugs are being used for investigational
purposes and will obtain the consent of the human beings or their
representatives, except where they consider it not feasible or, in their
professional judgment, contrary to the best interests of the human
beings.
(d) This section does not require a clinical investigator to submit
directly to the state department reports on the investigational use of
drugs. The regulations adopted under Section 505(i) of the Federal Act
are the rules in Indiana. The state may adopt rules, whether or not in
accordance with regulations promulgated under the Federal Act.
SOURCE: IC 16-42-19-7; (05)CC059001.6. -->
SECTION 6. IC 16-42-19-7 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 7. As used in this
chapter, "prescription" means:
(1) a written order to or for an ultimate user for a drug or device
containing the name and address of the patient, the name and
strength or size of the drug or device, the amount to be dispensed,
adequate directions for the proper use of the drug or device by the
patient, and the name of the practitioner, issued and signed by a
practitioner; or
(2) an order transmitted by other means of communication from a
practitioner that is:
(A) immediately reduced to writing by the pharmacist;
pharmacist or pharmacist intern (as defined in
IC 25-26-13-2); or
(B) for an electronically transmitted prescription:
(i) has the electronic signature of the practitioner; and
(ii) is recorded by the pharmacist in an electronic format.
SOURCE: IC 16-42-19-12; (05)CC059001.7. -->
SECTION 7. IC 16-42-19-12 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 12. Except as
authorized under IC 25-26-13-25(c), IC 25-26-13-25(d), a person may
not refill a prescription or drug order for a legend drug except in the
manner designated on the prescription or drug order or by the
authorization of the practitioner.
SOURCE: IC 16-42-22-3; (05)CC059001.8. -->
SECTION 8. IC 16-42-22-3 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 3. As used in this
chapter, "customer" means the individual for whom a prescription is
written or electronically transmitted or the individual's representative.
SOURCE: IC 16-42-22-6; (05)CC059001.9. -->
SECTION 9. IC 16-42-22-6 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6. (a) Each written
prescription issued by a practitioner must have two (2) signature lines
printed at the bottom of the prescription form, one (1) of which must be
signed by the practitioner for the prescription to be valid. Under the
blank line on the left side of the form must be printed the words
"Dispense as written.". Under the blank line on the right side of the
form must be printed the words "May substitute.".
(b) Each electronically transmitted prescription issued by a
practitioner must:
(1) have an electronic signature; and
(2) include the electronically transmitted instructions
"Dispense as written." or "May substitute.".
SOURCE: IC 16-42-22-8; (05)CC059001.10. -->
SECTION 10. IC 16-42-22-8 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 8. (a) For substitution
to occur for a prescription other than a prescription filled under the
Medicaid program (42 U.S.C. 1396 et seq.), the children's health
insurance program established under IC 12-17.6-2, or the Medicare
program (42 U.S.C. 1395 et seq.):
(1) the practitioner must:
(A) sign on the line under which the words "May substitute"
appear; or
(B) for an electronically transmitted prescription,
electronically transmit the instruction "May substitute."; and
(2) the pharmacist must inform the customer of the substitution.
(b) This section does not authorize any substitution other than
substitution of a generically equivalent drug product.
SOURCE: IC 16-42-22-9; (05)CC059001.11. -->
SECTION 11. IC 16-42-22-9 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. If the practitioner
communicates instructions to the pharmacist orally or electronically,
the pharmacist shall:
(1) indicate the instructions in the pharmacist's own handwriting on
the written copy of the prescription order; or
(2) record the electronically transmitted instructions in an
electronic format.
SOURCE: IC 16-42-22-10; (05)CC059001.12. -->
SECTION 12. IC 16-42-22-10 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 10. (a) If a prescription
is filled under the Medicaid program (42 U.S.C. 1396 et seq.), the
children's health insurance program established under IC 12-17.6-2, or
the Medicare program (42 U.S.C. 1395 et seq.), the pharmacist shall
substitute a generically equivalent drug product and inform the
customer of the substitution if the substitution would result in a lower
price unless:
(1) the words "Brand Medically Necessary" are:
(A) written in the practitioner's own writing on the form; or
(B) electronically transmitted with an electronically
transmitted prescription; or
(2) the practitioner has indicated that the pharmacist may not
substitute a generically equivalent drug product by:
(A) orally stating that a substitution is not permitted; or
(B) for an electronically transmitted prescription, indicating
with the electronic prescription that a substitution is not
permitted.
(b) If a practitioner orally states that a generically equivalent drug
product may not be substituted, the practitioner must subsequently
forward to the pharmacist a written or electronically transmitted
prescription with the "Brand Medically Necessary" instruction
appropriately indicated in the physician's own handwriting.
(c) This section does not authorize any substitution other than
substitution of a generically equivalent drug product.
SOURCE: IC 16-42-22-12; (05)CC059001.13. -->
SECTION 13. IC 16-42-22-12 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 12. The pharmacist
shall record on the prescription in writing or in an electronic format
for an electronically transmitted prescription the name of the
manufacturer or distributor, or both, of the actual drug product
dispensed under this chapter.
SOURCE: IC 25-26-13-2; (05)CC059001.14. -->
SECTION 14. IC 25-26-13-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: 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.
"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 the name and address of the patient,
the name and strength or size of the drug or device, the amount to be
dispensed, adequate directions for the proper use of the drug or device
by the patient, and the name of the practitioner issued and, if the
prescription is in written form, signed by a practitioner.
"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) the signature of the practitioner 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 25-26-13-4; (05)CC059001.15. -->
SECTION 15. 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.
(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.
(d) The board shall adopt rules and procedures, in consultation
with the medical licensing board, concerning the electronic
transmission of prescriptions. The rules adopted under this
subsection must address the following:
(1) Privacy protection for the practitioner and the
practitioner's patient.
(2) Security of the electronic transmission.
(3) A process for approving electronic data intermediaries for
the electronic transmission of prescriptions.
(4) Use of a practitioner's United States Drug Enforcement
Agency registration number.
(5) Protection of the practitioner from identity theft or
fraudulent use of the practitioner's prescribing authority.
SOURCE: IC 25-26-13-25; (05)CC059001.16. -->
SECTION 16. IC 25-26-13-25 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 25. (a) All original
prescriptions, whether in written or electronic format, shall be
numbered and maintained in numerical and chronological order, or in
a manner approved by the board and accessible for at least two (2)
years in the pharmacy. A prescription transmitted from a practitioner by
means of communication other than writing must immediately be
reduced to writing or recorded in an electronic format by the
pharmacist. The files shall be open for inspection to any member of the
board or its duly authorized agent or representative.
(b) A prescription may be electronically transmitted from the
practitioner by computer or another electronic device to a
pharmacy that is licensed under this article or any other state or
territory. An electronic data intermediary that is approved by the
board:
(1) may transmit the prescription information between the
prescribing practitioner and the pharmacy;
(2) may archive copies of the electronic information related to
the transmissions as necessary for auditing and security
purposes; and
(3) must maintain patient privacy and confidentiality of all
archived information as required by applicable state and
federal laws.
(b) (c) Except as provided in subsection
(c), (d), a prescription for
any drug, the label of which bears either the legend, "Caution: Federal
law prohibits dispensing without prescription" or "Rx Only", may not
be refilled without written,
electronically transmitted, or oral
authorization of a licensed practitioner.
(c) (d) A prescription for any drug, the label of which bears either the
legend, "Caution: Federal law prohibits dispensing without
prescription" or "Rx Only", may be refilled by a pharmacist one (1)
time without the written,
electronically transmitted, or oral
authorization of a licensed practitioner if all of the following conditions
are met:
(1) The pharmacist has made every reasonable effort to contact the
original prescribing practitioner or the practitioner's designee for
consultation and authorization of the prescription refill.
(2) The pharmacist believes that, under the circumstances, failure
to provide a refill would be seriously detrimental to the patient's
health.
(3) The original prescription authorized a refill but a refill would
otherwise be invalid for either of the following reasons:
(A) All of the authorized refills have been dispensed.
(B) The prescription has expired under subsection (f). (g).
(4) The prescription for which the patient requests the refill was:
(A) originally filled at the pharmacy where the request for a refill
is received and the prescription has not been transferred for
refills to another pharmacy at any time; or
(B) filled at or transferred to another location of the same
pharmacy or its affiliate owned by the same parent corporation
if the pharmacy filling the prescription has full access to
prescription and patient profile information that is simultaneously
and continuously updated on the parent corporation's information
system.
(5) The drug is prescribed for continuous and uninterrupted use and
the pharmacist determines that the drug is being taken properly in
accordance with IC 25-26-16.
(6) The pharmacist shall document the following information
regarding the refill:
(A) The information required for any refill dispensed under
subsection (d). (e).
(B) The dates and times that the pharmacist attempted to contact
the prescribing practitioner or the practitioner's designee for
consultation and authorization of the prescription refill.
(C) The fact that the pharmacist dispensed the refill without the
authorization of a licensed practitioner.
(7) The pharmacist notifies the original prescribing practitioner of
the refill and the reason for the refill by the practitioner's next
business day after the refill has been made by the pharmacist.
(8) Any pharmacist initiated refill under this subsection may not be
for more than the minimum amount necessary to supply the patient
through the prescribing practitioner's next business day. However,
a pharmacist may dispense a drug in an amount greater than the
minimum amount necessary to supply the patient through the
prescribing practitioner's next business day if:
(A) the drug is packaged in a form that requires the pharmacist
to dispense the drug in a quantity greater than the minimum
amount necessary to supply the patient through the prescribing
practitioner's next business day; or
(B) the pharmacist documents in the patient's record the amount
of the drug dispensed and a compelling reason for dispensing the
drug in a quantity greater than the minimum amount necessary
to supply the patient through the prescribing practitioner's next
business day.
(9) Not more than one (1) pharmacist initiated refill is dispensed
under this subsection for a single prescription.
(10) The drug prescribed is not a controlled substance.
A pharmacist may not refill a prescription under this subsection if the
practitioner has designated on the prescription form the words "No
Emergency Refill".
(d) (e) When refilling a prescription, the refill record shall include:
(1) the date of the refill;
(2) the quantity dispensed if other than the original quantity; and
(3) the dispenser's identity on:
(A) the original prescription form; or
(B) another board approved, uniformly maintained, readily
retrievable record.
(e) (f) The original prescription form or the other board approved
record described in subsection
(d) (e) must indicate by the number of
the original prescription the following information:
(1) The name and dosage form of the drug.
(2) The date of each refill.
(3) The quantity dispensed.
(4) The identity of the pharmacist who dispensed the refill.
(5) The total number of refills for that prescription.
(f) (g) A prescription is valid for not more than one (1) year after the
original date of issue.
(g) (h) A pharmacist may not knowingly dispense a prescription after
the demise of the practitioner, unless in the pharmacist's professional
judgment it is in the best interest of the patient's health.
(h) (i) A pharmacist may not knowingly dispense a prescription after
the demise of the patient.
(i) (j) A pharmacist or a pharmacy shall not resell, reuse, or
redistribute a medication that is returned to the pharmacy after being
dispensed unless the medication:
(1) was dispensed to a patient:
(A) residing in an institutional facility (as defined in 856
IAC 1-28.1-1(6)); or
(B) in a hospice program under IC 16-25;
(2) was properly stored and securely maintained according to
sound pharmacy practices;
(3) is returned unopened and:
(A) was dispensed in the manufacturer's original:
(i) bulk, multiple dose container with an unbroken tamper
resistant seal; or
(ii) unit dose package; or
(B) was packaged by the dispensing pharmacy in a:
(i) multiple dose blister container; or
(ii) unit dose package;
(4) was dispensed by the same pharmacy as the pharmacy
accepting the return;
(5) is not expired; and
(6) is not a controlled substance (as defined in IC 35-48-1-9),
unless the pharmacy holds a Type II permit (as described in section
17 of this chapter).
(j) (k) A pharmacist may use the pharmacist's professional judgment
as to whether to accept medication for return under this section.
(k) (l) A pharmacist who violates subsection
(c) (d) commits a Class
A infraction.
SOURCE: IC 25-26-13-25.5; (05)CC059001.17. -->
SECTION 17. IC 25-26-13-25.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2005]: Sec. 25.5. A prescription may be
transmitted electronically from a practitioner to a pharmacy only
through the use of an electronic data intermediary approved by the
board.
SOURCE: IC 25-26-15-10; (05)CC059001.18. -->
SECTION 18. IC 25-26-15-10 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 10. As used in this
chapter, "prescription" means a written order or an order transmitted by
other means of communication that is immediately reduced to writing
by the pharmacist or, for electronically transmitted orders, recorded
in an electronic format from an optometrist to or for an ultimate user
for a 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 and certification number of the prescribing
optometrist; and
(7) the signature of the optometrist if the prescription:
(A) is in written form, the signature of the optometrist; or
(B) is in electronic form, the electronic signature of the
optometrist.
SOURCE: IC 25-26-20-4; (05)CC059001.19. -->
SECTION 19. IC 25-26-20-4 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. (a) Except as
provided in subsections (b) and (c), unadulterated drugs that meet the
requirements set forth in IC 25-26-13-25(i) IC 25-26-13-25(j) may be
donated without a prescription or drug order to the regional drug
repository program by the following:
(1) A pharmacist or pharmacy.
(2) A wholesale drug distributor.
(3) A hospital licensed under IC 16-21.
(4) A health care facility (as defined in IC 16-18-2-161).
(5) A hospice.
(6) A practitioner.
(b) An unadulterated drug that:
(1) was returned under IC 25-26-13-25; and
(2) was prescribed for a Medicaid recipient;
may not be donated under this section unless the Medicaid program has
been credited for the product cost of the drug as provided in policies
under the Medicaid program.
(c) A controlled drug may not be donated under this section.
SOURCE: IC 27-13-38-2; (05)CC059001.20. -->
SECTION 20. IC 27-13-38-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2. Subject to
IC 16-42-22:
(1) a pharmacist shall not substitute; and
(2) a health maintenance organization shall not require the
substitution of;
a different single source brand name drug for a single source brand
name drug written on a prescription form or electronically transmitted
to a pharmacy unless the substitution is approved by the prescribing
provider.
SOURCE: IC 35-48-3-9; (05)CC059001.21. -->
SECTION 21. IC 35-48-3-9 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. (a) Except for
dosages medically required for a period of not more than forty-eight
(48) hours that are dispensed by or on the direction of a practitioner or
medication dispensed directly by a practitioner, other than a pharmacy,
to an ultimate user, no controlled substance in schedule II may be
dispensed without the written prescription of a practitioner.
(b) In emergency situations, as defined by rule of the board, schedule
II drugs may be dispensed upon oral prescription of a practitioner,
reduced promptly to writing and filed by the pharmacy. Prescriptions
shall be retained in conformity with the requirements of section 7 of
this chapter. No prescription for a schedule II substance may be refilled.
(c) Except for dosages medically required for a period of not more
than forty-eight (48) hours that are dispensed by or on the direction of
a practitioner, or medication dispensed directly by a practitioner, other
than a pharmacy, to an ultimate user, a controlled substance included
in schedule III or IV, which is a prescription drug as determined under
IC 16-42-19, shall not be dispensed without a written or oral
prescription of a practitioner. The prescription shall not be filled or
refilled more than six (6) months after the date thereof or be refilled
more than five (5) times, unless renewed by the practitioner.
Prescriptions for schedule III, IV, and V controlled substances may
be transmitted by facsimile from the practitioner or the agent of
the practitioner to a pharmacy. The facsimile prescription is
equivalent to an original prescription to the extent permitted under
federal law.
(d) A controlled substance included in schedule V shall not be
distributed or dispensed other than for a medical purpose.
SOURCE: IC 35-48-7-5; (05)CC059001.22. -->
SECTION 22. IC 35-48-7-5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 5. As used in this
chapter, "identification number" refers to the following:
(1) The unique number contained on any of the following:
(1) (A) A valid driver's license of a recipient or a recipient's
representative issued under Indiana law or the law of any other
state.
(2) (B) A recipient's or a recipient representative's valid military
identification card.
(3) (C) A valid identification card of a recipient or a recipient's
representative issued by:
(A) (i) the bureau of motor vehicles and as described in
IC 9-24-16-3; or
(B) (ii) any other state and that is similar to the identification
card issued by the bureau of motor vehicles.
(4) (D) If the recipient is an animal:
(A) (i) the valid driver's license issued under Indiana law or the
law of any other state;
(B) (ii) the valid military identification card; or
(C) (iii) the valid identification card issued by the bureau of
motor vehicles and described in IC 9-24-16-3 or a valid
identification card of similar description that is issued by any
other state;
of the animal's owner.
(2) The identification number or phrase designated by the
central repository.
SOURCE: IC 35-48-7-8; (05)CC059001.23. -->
SECTION 23. IC 35-48-7-8 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 8. The advisory
committee shall provide for a controlled substance prescription
monitoring program that includes the following components:
(1) Each time a controlled substance designated by the advisory
committee under IC 35-48-2-5 through IC 35-48-2-10 is dispensed,
the dispenser shall transmit to the central repository the following
information:
(A) The recipient's name.
(B) The recipient's or the recipient representative's identification
number
or the identification number or phrase designated by
the central repository.
(C) The recipient's date of birth.
(D) The national drug code number of the controlled substance
dispensed.
(E) The date the controlled substance is dispensed.
(F) The quantity of the controlled substance dispensed.
(G) The number of days of supply dispensed.
(H) The dispenser's United States Drug Enforcement Agency
registration number.
(I) The prescriber's United States Drug Enforcement Agency
registration number.
(J) An indication as to whether the prescription was transmitted
to the pharmacist orally or in writing.
(2) The information required to be transmitted under this section
must be transmitted not more than fifteen (15) days after the date
on which a controlled substance is dispensed.
(3) A dispenser shall transmit the information required under this
section by:
(A) an electronic device compatible with the receiving device of
the central repository;
(B) a computer diskette;
(C) a magnetic tape; or
(D) a pharmacy universal claim form;
that meets specifications prescribed by the advisory committee.
(4) The advisory committee may require that prescriptions for
controlled substances be written on a one (1) part form that cannot
be duplicated. However, the advisory committee may not apply
such a requirement to prescriptions filled at a pharmacy with a
Type II permit (as described in IC 25-26-13-17) and operated by a
hospital licensed under IC 16-21, or prescriptions ordered for and
dispensed to bona fide enrolled patients in facilities licensed under
IC 16-28. The committee may not require multiple copy
prescription forms and serially numbered prescription forms for
any prescriptions written. The committee may not require different
prescription forms for any individual drug or group of drugs.
Prescription forms required under this subdivision must be jointly
approved by the committee and by the Indiana board of pharmacy
established by IC 25-26-13-3.
(5) The costs of the program.
(Reference is to ESB 590 as printed March 18, 2005.)
Conference Committee Report
on
Engrossed Senate Bill 590
Text Box
S
igned by:
____________________________ ____________________________
Senator RiegseckerRepresentative Budak
Chairperson
____________________________ ____________________________
Senator SimpsonRepresentative Brown C
Senate Conferees House Conferees