Be it enacted by the General Assembly of the State of Indiana:
SECTION 1. IC 25-26-13-2, AS AMENDED BY P.L.187-1999,
SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2001]: 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;
principal intended purpose 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.
"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" means a physician licensed under IC 25-22.5, a has
the meaning set forth in IC 16-42-19-5. veterinarian licensed under
IC 15-5-1.1, a dentist licensed under IC 25-14, a podiatrist licensed
under IC 25-29, or any other person licensed by law to prescribe and
administer legend drugs in this state.
"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:
(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; and
(6) the name of the practitioner; issued and
(7) the signature of the practitioner if the prescription is in
written form. signed by a practitioner.
"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.
SECTION 2. IC 25-26-13-12 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: 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;
(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;
(B) successful completion of the Foreign Pharmacy Graduate
Equivalency Examination (FPGEE) approved 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.
SECTION 3. IC 25-26-13-19 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: Sec. 19. (a) A pharmacy
holding a Type I or Type VI permit may be open to the general public
without a pharmacist on duty if the following conditions are met:
(1) Approval is obtained from the board.
(2) All legend drugs and other merchandise that can only be
dispensed by a pharmacist are securely locked or secured by an
alternative system approved by the board when the pharmacist is
absent.
(3) During the pharmacist's absence, a sign at least twenty (20)
inches by thirty (30) inches is prominently displayed in the
prescription department stating: "Prescription Department Closed,
No Pharmacist on Duty".
(4) Only a pharmacist has access to the secured area. when the
pharmacist is absent.
(b) The board may revoke or limit a pharmacy's privilege under this
section after a hearing under IC 4-21.5-3.
SECTION 4. IC 25-26-13-25, AS AMENDED BY P.L.187-1999,
SECTION 5, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2001]: 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 for any drug, the label of which bears the legend,
"Caution: Federal law prohibits dispensing without prescription" or
"Rx Only", may not be refilled without written or oral authorization
of a licensed practitioner.
(c) 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.
(d) The original prescription form or the other board approved
record described in subsection (c) 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.
(e) A prescription is valid for not more than one (1) year after the
original date of filling. issue.
(f) 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.
(g) A pharmacist may not knowingly dispense a prescription after
the demise of the patient.
(h) A pharmacist or a pharmacy shall not accept medication that is
returned for resale or redistribution unless the medication:
(1) was dispensed to a patient residing in an institutional facility
(as defined in 856 IAC 1-28-1(a));
(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 defined in
IC 25-26-13-17).
(i) A pharmacist may use the pharmacist's professional judgment as
to whether to accept medication for return under subsection (h).
SECTION 5. IC 25-26-15-10 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: Sec. 10. As used in this
chapter, "prescription" means
(1) a written order, or an order transmitted by other means of
communication that is immediately reduced to writing by the
pharmacist, from an optometrist to or for an ultimate user for
a drug or device, containing:
(A) (1) the name and address of the patient;
(2) the date of issue;
(B) (3) the name and strength or size (if applicable) of the drug
or device;
(C) (4) the amount to be dispensed (unless indicated by
directions and duration of therapy);
(D) (5) adequate directions for the proper use of the drug or
device by the patient; and
(E) (6) the name and certification number of the prescribing
optometrist; issued and signed by
(7) the signature of the optometrist if the prescription is in
written form. or
(2) an order transmitted by other means of communication from
an optometrist that is immediately reduced to writing by the
pharmacist.
SECTION 6. IC 25-27.5-1-1 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: Sec. 1. This article does not
apply to the following:
(1) A physician assistant trainee or a student enrolled in a
physician assistant or a surgeon assistant educational program
accredited by the CAHEA, an accrediting agency.
(2) A physician assistant employed in the service of the federal
government while performing duties incident to that employment.
(3) A health care professional, technician, and or other assistant
or employee of a physician who performs delegated tasks in the
office of a physician but who does not render services as a
physician assistant or profess to be a physician assistant.
SECTION 7. IC 25-27.5-2-2 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: Sec. 2. "Approved program"
means a physician assistant or a surgeon assistant program accredited
by CAHEA, an accrediting agency.
certification agency of another state or jurisdiction on the
grounds that the individual was not able to practice as a
physician assistant without endangering the public.
SECTION 11. IC 25-27.5-6-5 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: Sec. 5. (a) Before initiating
practice the supervising physician and the physician assistant must
submit, on forms approved by the board, the following information:
(1) The name, the business address, and the telephone number of
the supervising physician.
(2) The name, the business address, and the telephone number of
the physician assistant.
(3) A brief description of the setting in which the physician
assistant will practice.
(4) Any other information required by the board.
(b) A physician assistant must notify the board committee of any
changes or additions in practice sites or supervising physicians not
more than thirty (30) days after the change or addition.
SECTION 12. IC 25-34.5-1-4.7, AS ADDED BY P.L.60-2000,
SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2001]: Sec. 4.7. "Other authorized health care professional"
means a licensed health care professional whose scope of practice:
(1) includes the respiratory care practice task being supervised;
and
(2) authorizes the professional to supervise an individual who is
not licensed, certified, or registered as a health care professional.
SECTION 13. IC 25-34.5-2-6.4, AS ADDED BY P.L.60-2000,
SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2001]: Sec. 6.4. (a) Notwithstanding any other law and
except as otherwise provided in this article, to perform the practice
of respiratory care other than a task, an individual must be:
(1) a practitioner; or
(2) a licensed, registered, or certified health care professional
whose scope of practice includes the respiratory care practice.
(b) An individual who is not a licensed, registered, or certified
health care professional may perform a task only:
(1) under the proximate supervision of a practitioner or other
authorized health care professional; and
(2) if the individual has demonstrated to the facility that employs
or contracts with the individual competency to perform the task.
The facility shall document competency in accordance with licensure,
certification, and accreditation standards applicable to the facility.
(b) (c) A practitioner may do the following:
resinous extractives of Cannabis, sp. and synthetic substances,
derivatives, and their isomers with similar chemical structure and
pharmacological activity such as:
(A) .1 cis or trans tetrahydrocannabinol, and their optical
isomers;
(B) .6 cis or trans tetrahydrocannabinol, and their optical
isomers; and
(C) .3,4 cis or trans tetrahydrocannabinol, and their optical
isomers.
Since nomenclature of these substances is not internationally
standardized, compounds of these structures, regardless of
numerical designation of atomic positions are covered. Other
name: THC.
(23) Ethylamine analog of phencyclidine (7455). Some trade or
other names: N-Ethyl-1-phenylcyclohexylamine;
(1-phenylcyclohexyl) ethylamine; N-(1-phenylcyclohexyl)
ethylamine; cyclohexamine; PCE.
(24) Pyrrolidine analog of phencyclidine (7458). Some trade or
other names: 1-(1-phenylcyclohexyl)-pyrrolidine; PCPy; PHP.
(25) Thiophene analog of phencyclidine (7470). Some trade or
other names: 1-(1-(2-thienyl) cyclohexyl) piperidine; 2-Thienyl
Analog of Phencyclidine; TPCP.
(e) Depressants. Unless specifically excepted in a rule adopted by
the board or unless listed in another schedule, any material, compound,
mixture, or preparation which contains any quantity of the following
substances having a depressant effect on the central nervous system,
including its salts, isomers, and salts of isomers whenever the existence
of such salts, isomers, and salts of isomers is possible within the
specific chemical designation:
Gamma-hydroxybutyric acid (other names include GHB;
gamma-hydroxybutyrate; 4-hydroxybutanoic acid; sodium
oxybate; sodium oxybutyrate) (2010)
Mecloqualone (2572)
Methaqualone (2565)
(f) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation that
contains any quantity of the following substances having a stimulant
effect on the central nervous system, including its salts, isomers, and
salts of isomers:
Fenethylline (1503)
N-ethylamphetamine (1475)
Methcathinone (1237) (Some other trade names:
2-Methylamino-1-Phenylpropan-I-one; Ephedrone;
Monomethylpropion; UR 1431.
SECTION 16. IC 35-48-2-8 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: Sec. 8. (a) The controlled
substances listed in this section are included in schedule III.
(b) Stimulants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
which contains any quantity of the following substances having a
stimulant effect on the central nervous system, including its salts,
isomers (whether optical, position, or geometric), and salts of such
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation:
(1) Those compounds, mixtures, or preparations in dosage unit
form containing any stimulant substances listed in schedule II
which compounds, mixtures, or preparations were listed on April
1, 1986, as excepted compounds under 21 CFR 1308.32, and any
other drug of the quantitative composition shown in that list for
those drugs or that is the same except that it contains a lesser
quantity of controlled substances (1405).
(2) Benzphetamine (1228).
(3) Chlorphentermine (1645).
(4) Clortermine (1647).
(5) Phendimetrazine (1615).
(c) Depressants. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
which contains any quantity of the following substances having a
depressant effect on the central nervous system:
(1) Any compound, mixture, or preparation containing:
(A) amobarbital (2125);
(B) secobarbital (2315);
(C) pentobarbital (2270); or
(D) any of their salts;
and one (1) or more other active medicinal ingredients which are
not listed in any schedule.
(2) Any suppository dosage form containing:
(A) amobarbital (2125);
(B) secobarbital (2315);
(C) pentobarbital (2270); or
(D) any of their salts;
and approved by the Food and Drug Administration for marketing
only as a suppository.
(3) Any substance which contains any quantity of a derivative of
barbituric acid, or any salt thereof (2100).
(4) Chlorhexadol (2510).
(5) Glutethimide (2550).
(6) Lysergic acid (7300).
(7) Lysergic acid amide (7310).
(8) Methyprylon (2575).
(9) Sulfondiethylmethane (2600).
(10) Sulfonethylmethane (2605).
(11) Sulfonmethane (2610).
(12) A combination product containing tiletimine and zolazepam
(Telazol) (7295).
(13) Any drug product containing gamma-hydroxybutyric
acid, including its salts, isomers, and salts of isomers, for
which an application is approved under section 505 of the
federal Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq.
(2012).
(d) Nalorphine (a narcotic drug) (9400).
(e) Narcotic Drugs. Unless specifically excepted or unless listed in
another schedule, any material, compound, mixture, or preparation
containing any of the following narcotic drugs, or their salts calculated
as the free anhydrous base or alkaloid, in the following limited
quantities:
(1) Not more than 1.8 grams of codeine, per 100 milliliters or not
more than 90 milligrams per dosage unit, with an equal or greater
quantity of an isoquinoline alkaloid of opium (9803).
(2) Not more than 1.8 grams of codeine, per 100 milliliters or not
more than 90 milligrams per dosage unit, with one (1) or more
active, nonnarcotic ingredients in recognized therapeutic amounts
(9804).
(3) Not more than 300 milligrams of dihydrocodeinone, per 100
milliliters or not more than 15 milligrams per dosage unit, with a
fourfold or greater quantity of an isoquinoline alkaloid of opium
(9805).
(4) Not more than 300 milligrams of dihydrocodeinone, per 100
milliliters or not more than 15 milligrams per dosage unit, with
one (1) or more active nonnarcotic ingredients in recognized
therapeutic amounts (9806).
(5) Not more than 1.8 grams of dihydrocodeine, per 100 milliliters
or not more than 90 milligrams per dosage unit, with one (1) or
more active, nonnarcotic ingredients in recognized therapeutic
amounts (9807).
(6) Not more than 300 milligrams of ethylmorphine, per 100
milliliters or not more than 15 milligrams per dosage unit, with
one (1) or more active, nonnarcotic ingredients in recognized
therapeutic amounts (9808).
(7) Not more than 500 milligrams of opium per 100 milliliters or
per 100 grams or not more than 25 milligrams per dosage unit,
with one (1) or more active, nonnarcotic ingredients in recognized
therapeutic amounts (9809).
(8) Not more than 50 milligrams of morphine, per 100 milliliters
or per 100 grams with one (1) or more active nonnarcotic
ingredients in recognized therapeutic amounts (9810).
(f) Anabolic steroid (as defined in 21 U.S.C. 802(41)(A) and 21
U.S.C. 802(41)(B)).
(g) The board shall except by rule any compound, mixture, or
preparation containing any stimulant or depressant substance listed in
subsections (b) through (e) from the application of any part of this
article if the compound, mixture, or preparation contains one (1) or
more active medicinal ingredients not having a stimulant or depressant
effect on the central nervous system, and if the admixtures are included
therein in combinations, quantity, proportion, or concentration that
vitiate the potential for abuse of the substances which have a stimulant
or depressant effect on the central nervous system.
(h) Any material, compound, mixture, or preparation which contains
any quantity of Ketamine.
SECTION 17. IC 35-48-2-10 IS AMENDED TO READ AS
FOLLOWS [EFFECTIVE JULY 1, 2001]: Sec. 10. (a) The controlled
substances listed in this section are included in schedule IV.
(b) Narcotic drugs. Unless specifically excepted in a rule adopted
by the board or unless listed in another schedule, any material,
compound, mixture, or preparation containing any of the following
narcotic drugs, or their salts calculated as the free anhydrous base or
alkaloid, in the following limited quantities:
(1) Not more than 1 milligram of difenoxin (9618) and not less
than 25 micrograms of atropine sulfate per dosage unit.
(2) Dextropropoxyphene (alpha-
(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane
(9273).
(c) Depressants. Unless specifically excepted in a rule adopted by
the board or unless listed in another schedule, any material, compound,
mixture, or preparation which contains any quantity of the following
substances, including its salts, isomers, and salts of isomers whenever
the existence of such salts, isomers, and salts of isomers is possible
within the specific chemical designation:
1, 2001].
SECTION 19. [EFFECTIVE UPON PASSAGE] (a) Not later than
July 2, 2001, the respiratory care committee established by
IC 25-34.5-2-1 shall have an appropriate application for a student
permit available for use by applicants under IC 25-34.5-2-14, as
amended by this act.
(b) This SECTION expires July 31, 2001.
SECTION 20. [EFFECTIVE UPON PASSAGE] (a) If the medical
licensing board established by IC 25-22.5-2-1 does not establish the
fee for a student permit under IC 25-34.5-2-14, as amended by this
act, the fee is twenty-five dollars ($25).
(b) The fee established by the medical licensing board for a
student permit under IC 25-34.5-2-14, as amended by this act, may
not be greater than the fee for a license as a respiratory care
practitioner.
(c) This SECTION expires July 1, 2002.
SECTION 21. [EFFECTIVE UPON PASSAGE] (a) This
SECTION applies to an individual who:
(1) before July 1, 2001, submits a request for an application
for a student permit under IC 25-34.5-2-14, as amended by
this act; and
(2) at the time of submitting a request for an application for
a student permit:
(A) has been employed in or was otherwise under contract
or other arrangement with the same respiratory care
setting since June 30, 2001, and continues to be employed;
and
(B) is a student in good standing in a school or program
identified in IC 25-34.5-2-14, as amended by this act, since
June 30, 2001, and continues to be a student in good
standing.
(b) An individual described in subsection (a) may continue to
work in a respiratory care setting as if the individual held a student
permit until:
(1) the respiratory care committee established by
IC 25-34.5-2-1 issues a student permit to the individual, at
which time the individual will be a student permit holder
under IC 25-34.5-2-14, as amended by this act; or
(2) the individual receives notification from the respiratory
care committee that the individual's application for a student
permit is denied.
(c) An individual who is permitted to work under subsection (b)
may only perform those respiratory care procedures that qualify
under IC 25-34.5-2-14(c) and IC 25-34.5-2-14(d), as amended by
this act.
(d) This SECTION expires October 1, 2001.
SECTION 22. An emergency is declared for this act.