IC 35-48-3-1 Rules
Sec. 1. Rules. The board may promulgate rules and charge
reasonable fees relating to the registration and control of the
manufacture, distribution, and dispensing of controlled substances
within this state. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-2 Limited permits for entities operating animal shelters
Sec. 2. (a) Any humane society, animal control agency, or
governmental entity operating an animal shelter or other animal
impounding facility is entitled to receive a limited permit only for the
purpose of buying, possessing, and using:
(1) sodium pentobarbital to euthanize injured, sick, homeless,
or unwanted domestic pets and animals;
(2) ketamine and ketamine products to anesthetize or
immobilize fractious domestic pets and animals; and
(3) a combination product containing tiletimine and zolazepam
as an agent for the remote chemical capture of domestic pets or
animals that otherwise cannot be restrained or captured.
(b) A humane society, animal control agency, or governmental
entity entitled to receive a permit under this chapter must:
(1) apply to the board according to the rules established by the
board;
(2) pay annually to the board a fee set by the board for the
limited permit; and
(3) submit proof, as determined by the board, that the
employees of an applicant who will handle a controlled
substance are sufficiently trained to use and administer the
controlled substance.
(c) All fees collected by the board under this section shall be
credited to the state board of pharmacy account.
(d) Storage, handling, and use of controlled substances obtained
according to this section are subject to the rules adopted by the
board.
(e) Before issuing a permit under this section, the board may
consult with the board of veterinary medical examiners. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.193-1987,
SEC.16; P.L.136-2001, SEC.1; P.L.84-2010, SEC.93.
IC 35-48-3-3 Registration requirements
Sec. 3. (a) Every person who manufactures or distributes any
controlled substance within this state or who proposes to engage in
the manufacture or distribution of any controlled substance within
this state, must obtain biennially a registration issued by the board in
accordance with its rules.
(b) Every person who dispenses or proposes to dispense any
controlled substance within Indiana must have a registration issued
by the board in accordance with its rules. A registration issued to a
dispenser under this subsection expires whenever the dispenser's
license as a practitioner expires. The board shall renew a dispenser's
registration under this subsection concurrently with any state license
authorizing the dispenser to act as a practitioner.
(c) Persons registered by the board under this article to
manufacture, distribute, dispense, or conduct research with
controlled substances may possess, manufacture, distribute, dispense,
or conduct research with those substances to the extent authorized by
their registration and in conformity with the other provisions of this
chapter.
(d) The following persons need not register and may lawfully
possess controlled substances under this article:
(1) An agent or employee of any registered manufacturer,
distributor, or dispenser of any controlled substance if he is
acting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or an
employee thereof, whose possession of any controlled substance
is in the usual course of business or employment.
(3) An ultimate user or a person in possession of any controlled
substance under a lawful order of a practitioner or in lawful
possession of a schedule V substance.
(e) The board may waive by rule the requirement for registration
of certain manufacturers, distributors, or dispensers if it finds it
consistent with the public health and safety.
(f) A separate registration is required at each principal place of
business or professional practice where the applicant manufactures,
distributes, dispenses, or possesses controlled substances.
(g) The board may inspect the establishment of a registrant or
applicant for registration in accordance with the board's rules. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.156-1986,
SEC.6.
IC 35-48-3-4 Registration
Sec. 4. (a) The board shall register an applicant to manufacture or
distribute controlled substances unless it determines that the issuance
of that registration would be inconsistent with the public interest. In
determining the public interest, the board shall consider:
(1) maintenance of effective controls against diversion of
controlled substances into other than legitimate medical,
scientific, or industrial channels;
(2) compliance with applicable state and local law;
(3) any convictions of the applicant under any federal and state
laws relating to any controlled substance;
(4) past experience in the manufacture or distribution of
controlled substances, and the existence in the applicant's
establishment of effective controls against diversion;
(5) furnishing by the applicant of false or fraudulent material in
any application filed under this article;
(6) suspension or revocation of the applicant's federal
registration to manufacture, distribute, or dispense controlled
substances as authorized by federal law; and
(7) any other factors relevant to and consistent with the public
health and safety.
(b) Registration under subsection (a) of this section does not
entitle a registrant to manufacture and distribute controlled
substances in schedules I or II other than those specified in the
registration.
(c) Practitioners must be registered to dispense any controlled
substances or to conduct research with controlled substances in
schedules II through V if they are authorized to dispense or conduct
research under the law of this state. The board need not require
separate registration under this chapter for practitioners engaging in
research with nonnarcotic controlled substances in schedules II
through V where the registrant is already registered under this
chapter in another capacity, to the extent authorized by his
registration in that other capacity.
(d) Registration to conduct research or instructional activities with
controlled substances in schedules I through V does not entitle a
registrant to conduct research or instructional activities with
controlled substances other than those approved by the board in
accordance with the registration.
(e) The board may consult with the board of veterinary medical
examiners before issuing a registration to a person:
(1) who seeks to conduct research or instructional activities
with controlled substances in schedules I through IV; and
(2) whose activities constitute the practice of veterinary
medicine (as defined by IC 25-38.1-1-12).
(f) Compliance by manufacturers and distributors with the
provisions of the federal law respecting registration (excluding fees)
entitles them to be registered under this article. As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1981,
P.L.170, SEC.7; P.L.84-2010, SEC.94.
IC 35-48-3-5 Denial, revocation, and suspension of registration; reinstatement
Sec. 5. (a) An application for registration or reregistration
submitted pursuant to and a registration issued under section 3 of this
chapter to manufacture, distribute, or dispense a controlled substance
may be denied, suspended, or revoked by the board upon a finding
that the applicant or registrant:
(1) has furnished false or fraudulent material information in any
application filed under this article;
(2) has violated any state or federal law relating to any
controlled substance;
(3) has had the applicant's or registrant's federal registration
suspended or revoked to manufacture, distribute, or dispense
controlled substances; or
(4) has failed to maintain reasonable controls against diversion
of controlled substances into other than legitimate medical,
scientific, or industrial channels.
(b) The board may limit revocation or suspension of a registration
or the denial of an application for registration or reregistration to the
particular controlled substance with respect to which grounds for
revocation, suspension, or denial exist.
(c) If the board suspends or revokes a registration or denies an
application for reregistration, all controlled substances owned or
possessed by the registrant at the time of suspension or the effective
date of the revocation or denial order may be placed under seal. The
board may require the removal of such substances from the premises.
No disposition may be made of substances under seal until the time
for taking an appeal has elapsed or until all appeals have been
concluded unless a court, upon application therefor, orders the sale
of perishable substances and the deposit of the proceeds of the sale
with the court. Upon a revocation or denial order becoming final, all
controlled substances may be forfeited to the state.
(d) The board shall promptly notify the drug enforcement
administration of all orders suspending or revoking registration, all
orders denying any application for registration or reregistration, and
all forfeitures of controlled substances.
(e) If the Drug Enforcement Administration terminates, denies,
suspends, or revokes a federal registration for the manufacture,
distribution, or dispensing of controlled substances, a registration
issued by the board under this chapter is automatically suspended.
(f) The board may reinstate a registration that has been suspended
under subsection (e), after a hearing, if the board is satisfied that the
applicant is able to manufacture, distribute, or dispense controlled
substances with reasonable skill and safety to the public. As a
condition of reinstatement, the board may impose disciplinary or
corrective measures authorized under IC 25-1-9-9 or this article.
(g) A registration issued under this chapter is automatically
revoked if any state license authorizing a dispenser to act as a
practitioner is revoked. As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1981,
P.L.170, SEC.8; P.L.197-2007, SEC.93; P.L.84-2010, SEC.95.
IC 35-48-3-6 Order to show cause
Sec. 6. (a) Before recommending a denial, suspension, or
revocation of a registration, or before refusing a renewal of
registration, the board shall serve upon the applicant or registrant an
order to show cause why registration should not be denied, revoked,
or suspended, or why the renewal should not be denied. The order to
show cause shall contain a statement of the basis therefor and shall
call upon the applicant or registrant to appear before the board at a
time and place not less than thirty (30) days after the date of service
of the order, but in the case of a denial or renewal of registration the
show cause order shall be served not later than thirty (30) days
before the expiration of the registration. These proceedings shall be
conducted in accordance with IC 4-21.5 without regard to any
criminal prosecution or other proceeding. Proceedings to refuse
renewal of registration shall not abate the existing registration, which
shall remain in effect pending the outcome of the administrative
hearing.
(b) The board may suspend, without an order to show cause, any
registration simultaneously with the institution of proceedings under
section 4 of this chapter, or where renewal of registration is refused,
if it finds that there is an imminent danger to the public health or
safety which warrants this action. The suspension shall continue in
effect until the conclusion of the proceedings, including judicial
review thereof, unless sooner withdrawn by the board or dissolved
by a court of competent jurisdiction.
(c) If an applicant for reregistration (who is doing business under
a registration previously granted and not revoked nor suspended) has
applied for reregistration at least forty-five (45) days before the date
on which the existing registration is due to expire, the existing
registration of the applicant shall automatically be extended and
continue in effect until the date on which the board so issues its
order. The board may extend any other existing registration under the
circumstances contemplated in this section even though the registrant
failed to apply for reregistration at least forty-five (45) days before
expiration of the existing registration, with or without request by the
registrant, if the board finds that such extension is not inconsistent
with the public health and safety. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.7-1987,
SEC.166; P.L.84-2010, SEC.96.
IC 35-48-3-7 Records of registrants
Sec. 7. Records of Registrants. Persons registered to manufacture,
distribute, or dispense controlled substances under this article shall
keep records and maintain inventories in conformance with the
record-keeping and inventory requirements of federal law and with
any additional rules the board issues. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-8 Order forms
Sec. 8. Order Forms. Controlled substances in schedules I and II
shall be distributed by a registrant to another registrant only pursuant
to an order form. Compliance with the provisions of federal law
respecting order forms is deemed compliance with this section. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-9 Prescriptions
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. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.2-1993,
SEC.192; P.L.163-1994, SEC.4; P.L.204-2005, SEC.21.
IC 35-48-3-10
Repealed
(Repealed by P.L.157-1999, SEC.2.)
IC 35-48-3-11 Treatment for weight reduction or to control obesity
Sec. 11. (a) Only a physician licensed under IC 25-22.5 may treat
a patient with a Schedule III or Schedule IV controlled substance for
the purpose of weight reduction or to control obesity.
(b) A physician licensed under IC 25-22.5 may not prescribe,
dispense, administer, supply, sell, or give any amphetamine,
sympathomimetic amine drug, or compound designated as a
Schedule III or Schedule IV controlled substance under IC 35-48-2-8
and IC 35-48-2-10 for a patient for purposes of weight reduction or
to control obesity, unless the physician does the following:
(1) Determines:
(A) through review of:
(i) the physician's records of prior treatment of the patient;
or
(ii) the records of prior treatment of the patient provided
by a previous treating physician or weight loss program;
that the physician's patient has made a reasonable effort to
lose weight in a treatment program using a regimen of
weight reduction based on caloric restriction, nutritional
counseling, behavior modification, and exercise without
using controlled substances; and
(B) that the treatment described in clause (A) has been
ineffective for the physician's patient.
(2) Obtains a thorough history and performs a thorough
physical examination of the physician's patient before initiating
a treatment plan using a Schedule III or Schedule IV controlled
substance for purposes of weight reduction or to control
obesity.
(c) A physician licensed under IC 25-22.5 may not begin and shall
discontinue using a Schedule III or Schedule IV controlled substance
for purposes of weight reduction or to control obesity after the
physician determines in the physician's professional judgment that:
(1) the physician's patient has failed to lose weight using a
treatment plan involving the controlled substance;
(2) the controlled substance has provided a decreasing
contribution toward further weight loss for the patient unless
continuing to take the controlled substance is medically
necessary or appropriate for maintenance therapy;
(3) the physician's patient:
(A) has a history of; or
(B) shows a propensity for;
alcohol or drug abuse; or
(4) the physician's patient has consumed or disposed of a
controlled substance in a manner that does not strictly comply
with a treating physician's direction. As added by P.L.157-1999, SEC.1. Amended by P.L.37-2001, SEC.1.
IC 35-48-3-1 Rules
Sec. 1. Rules. The board may promulgate rules and charge
reasonable fees relating to the registration and control of the
manufacture, distribution, and dispensing of controlled substances
within this state. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-2 Limited permits for entities operating animal shelters
Sec. 2. (a) Any humane society, animal control agency, or
governmental entity operating an animal shelter or other animal
impounding facility is entitled to receive a limited permit only for the
purpose of buying, possessing, and using:
(1) sodium pentobarbital to euthanize injured, sick, homeless,
or unwanted domestic pets and animals;
(2) ketamine and ketamine products to anesthetize or
immobilize fractious domestic pets and animals; and
(3) a combination product containing tiletimine and zolazepam
as an agent for the remote chemical capture of domestic pets or
animals that otherwise cannot be restrained or captured.
(b) A humane society, animal control agency, or governmental
entity entitled to receive a permit under this chapter must:
(1) apply to the board according to the rules established by the
board;
(2) pay annually to the board a fee set by the board for the
limited permit; and
(3) submit proof, as determined by the board, that the
employees of an applicant who will handle a controlled
substance are sufficiently trained to use and administer the
controlled substance.
(c) All fees collected by the board under this section shall be
credited to the state board of pharmacy account.
(d) Storage, handling, and use of controlled substances obtained
according to this section are subject to the rules adopted by the
board.
(e) Before issuing a permit under this section, the board may
consult with the board of veterinary medical examiners. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.193-1987,
SEC.16; P.L.136-2001, SEC.1; P.L.84-2010, SEC.93.
IC 35-48-3-3 Registration requirements
Sec. 3. (a) Every person who manufactures or distributes any
controlled substance within this state or who proposes to engage in
the manufacture or distribution of any controlled substance within
this state, must obtain biennially a registration issued by the board in
accordance with its rules.
(b) Every person who dispenses or proposes to dispense any
controlled substance within Indiana must have a registration issued
by the board in accordance with its rules. A registration issued to a
dispenser under this subsection expires whenever the dispenser's
license as a practitioner expires. The board shall renew a dispenser's
registration under this subsection concurrently with any state license
authorizing the dispenser to act as a practitioner.
(c) Persons registered by the board under this article to
manufacture, distribute, dispense, or conduct research with
controlled substances may possess, manufacture, distribute, dispense,
or conduct research with those substances to the extent authorized by
their registration and in conformity with the other provisions of this
chapter.
(d) The following persons need not register and may lawfully
possess controlled substances under this article:
(1) An agent or employee of any registered manufacturer,
distributor, or dispenser of any controlled substance if he is
acting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or an
employee thereof, whose possession of any controlled substance
is in the usual course of business or employment.
(3) An ultimate user or a person in possession of any controlled
substance under a lawful order of a practitioner or in lawful
possession of a schedule V substance.
(e) The board may waive by rule the requirement for registration
of certain manufacturers, distributors, or dispensers if it finds it
consistent with the public health and safety.
(f) A separate registration is required at each principal place of
business or professional practice where the applicant manufactures,
distributes, dispenses, or possesses controlled substances.
(g) The board may inspect the establishment of a registrant or
applicant for registration in accordance with the board's rules. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.156-1986,
SEC.6.
IC 35-48-3-4 Registration
Sec. 4. (a) The board shall register an applicant to manufacture or
distribute controlled substances unless it determines that the issuance
of that registration would be inconsistent with the public interest. In
determining the public interest, the board shall consider:
(1) maintenance of effective controls against diversion of
controlled substances into other than legitimate medical,
scientific, or industrial channels;
(2) compliance with applicable state and local law;
(3) any convictions of the applicant under any federal and state
laws relating to any controlled substance;
(4) past experience in the manufacture or distribution of
controlled substances, and the existence in the applicant's
establishment of effective controls against diversion;
(5) furnishing by the applicant of false or fraudulent material in
any application filed under this article;
(6) suspension or revocation of the applicant's federal
registration to manufacture, distribute, or dispense controlled
substances as authorized by federal law; and
(7) any other factors relevant to and consistent with the public
health and safety.
(b) Registration under subsection (a) of this section does not
entitle a registrant to manufacture and distribute controlled
substances in schedules I or II other than those specified in the
registration.
(c) Practitioners must be registered to dispense any controlled
substances or to conduct research with controlled substances in
schedules II through V if they are authorized to dispense or conduct
research under the law of this state. The board need not require
separate registration under this chapter for practitioners engaging in
research with nonnarcotic controlled substances in schedules II
through V where the registrant is already registered under this
chapter in another capacity, to the extent authorized by his
registration in that other capacity.
(d) Registration to conduct research or instructional activities with
controlled substances in schedules I through V does not entitle a
registrant to conduct research or instructional activities with
controlled substances other than those approved by the board in
accordance with the registration.
(e) The board may consult with the board of veterinary medical
examiners before issuing a registration to a person:
(1) who seeks to conduct research or instructional activities
with controlled substances in schedules I through IV; and
(2) whose activities constitute the practice of veterinary
medicine (as defined by IC 25-38.1-1-12).
(f) Compliance by manufacturers and distributors with the
provisions of the federal law respecting registration (excluding fees)
entitles them to be registered under this article. As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1981,
P.L.170, SEC.7; P.L.84-2010, SEC.94.
IC 35-48-3-5 Denial, revocation, and suspension of registration; reinstatement
Sec. 5. (a) An application for registration or reregistration
submitted pursuant to and a registration issued under section 3 of this
chapter to manufacture, distribute, or dispense a controlled substance
may be denied, suspended, or revoked by the board upon a finding
that the applicant or registrant:
(1) has furnished false or fraudulent material information in any
application filed under this article;
(2) has violated any state or federal law relating to any
controlled substance;
(3) has had the applicant's or registrant's federal registration
suspended or revoked to manufacture, distribute, or dispense
controlled substances; or
(4) has failed to maintain reasonable controls against diversion
of controlled substances into other than legitimate medical,
scientific, or industrial channels.
(b) The board may limit revocation or suspension of a registration
or the denial of an application for registration or reregistration to the
particular controlled substance with respect to which grounds for
revocation, suspension, or denial exist.
(c) If the board suspends or revokes a registration or denies an
application for reregistration, all controlled substances owned or
possessed by the registrant at the time of suspension or the effective
date of the revocation or denial order may be placed under seal. The
board may require the removal of such substances from the premises.
No disposition may be made of substances under seal until the time
for taking an appeal has elapsed or until all appeals have been
concluded unless a court, upon application therefor, orders the sale
of perishable substances and the deposit of the proceeds of the sale
with the court. Upon a revocation or denial order becoming final, all
controlled substances may be forfeited to the state.
(d) The board shall promptly notify the drug enforcement
administration of all orders suspending or revoking registration, all
orders denying any application for registration or reregistration, and
all forfeitures of controlled substances.
(e) If the Drug Enforcement Administration terminates, denies,
suspends, or revokes a federal registration for the manufacture,
distribution, or dispensing of controlled substances, a registration
issued by the board under this chapter is automatically suspended.
(f) The board may reinstate a registration that has been suspended
under subsection (e), after a hearing, if the board is satisfied that the
applicant is able to manufacture, distribute, or dispense controlled
substances with reasonable skill and safety to the public. As a
condition of reinstatement, the board may impose disciplinary or
corrective measures authorized under IC 25-1-9-9 or this article.
(g) A registration issued under this chapter is automatically
revoked if any state license authorizing a dispenser to act as a
practitioner is revoked. As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1981,
P.L.170, SEC.8; P.L.197-2007, SEC.93; P.L.84-2010, SEC.95.
IC 35-48-3-6 Order to show cause
Sec. 6. (a) Before recommending a denial, suspension, or
revocation of a registration, or before refusing a renewal of
registration, the board shall serve upon the applicant or registrant an
order to show cause why registration should not be denied, revoked,
or suspended, or why the renewal should not be denied. The order to
show cause shall contain a statement of the basis therefor and shall
call upon the applicant or registrant to appear before the board at a
time and place not less than thirty (30) days after the date of service
of the order, but in the case of a denial or renewal of registration the
show cause order shall be served not later than thirty (30) days
before the expiration of the registration. These proceedings shall be
conducted in accordance with IC 4-21.5 without regard to any
criminal prosecution or other proceeding. Proceedings to refuse
renewal of registration shall not abate the existing registration, which
shall remain in effect pending the outcome of the administrative
hearing.
(b) The board may suspend, without an order to show cause, any
registration simultaneously with the institution of proceedings under
section 4 of this chapter, or where renewal of registration is refused,
if it finds that there is an imminent danger to the public health or
safety which warrants this action. The suspension shall continue in
effect until the conclusion of the proceedings, including judicial
review thereof, unless sooner withdrawn by the board or dissolved
by a court of competent jurisdiction.
(c) If an applicant for reregistration (who is doing business under
a registration previously granted and not revoked nor suspended) has
applied for reregistration at least forty-five (45) days before the date
on which the existing registration is due to expire, the existing
registration of the applicant shall automatically be extended and
continue in effect until the date on which the board so issues its
order. The board may extend any other existing registration under the
circumstances contemplated in this section even though the registrant
failed to apply for reregistration at least forty-five (45) days before
expiration of the existing registration, with or without request by the
registrant, if the board finds that such extension is not inconsistent
with the public health and safety. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.7-1987,
SEC.166; P.L.84-2010, SEC.96.
IC 35-48-3-7 Records of registrants
Sec. 7. Records of Registrants. Persons registered to manufacture,
distribute, or dispense controlled substances under this article shall
keep records and maintain inventories in conformance with the
record-keeping and inventory requirements of federal law and with
any additional rules the board issues. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-8 Order forms
Sec. 8. Order Forms. Controlled substances in schedules I and II
shall be distributed by a registrant to another registrant only pursuant
to an order form. Compliance with the provisions of federal law
respecting order forms is deemed compliance with this section. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-9 Prescriptions
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. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.2-1993,
SEC.192; P.L.163-1994, SEC.4; P.L.204-2005, SEC.21.
IC 35-48-3-10
Repealed
(Repealed by P.L.157-1999, SEC.2.)
IC 35-48-3-11 Treatment for weight reduction or to control obesity
Sec. 11. (a) Only a physician licensed under IC 25-22.5 may treat
a patient with a Schedule III or Schedule IV controlled substance for
the purpose of weight reduction or to control obesity.
(b) A physician licensed under IC 25-22.5 may not prescribe,
dispense, administer, supply, sell, or give any amphetamine,
sympathomimetic amine drug, or compound designated as a
Schedule III or Schedule IV controlled substance under IC 35-48-2-8
and IC 35-48-2-10 for a patient for purposes of weight reduction or
to control obesity, unless the physician does the following:
(1) Determines:
(A) through review of:
(i) the physician's records of prior treatment of the patient;
or
(ii) the records of prior treatment of the patient provided
by a previous treating physician or weight loss program;
that the physician's patient has made a reasonable effort to
lose weight in a treatment program using a regimen of
weight reduction based on caloric restriction, nutritional
counseling, behavior modification, and exercise without
using controlled substances; and
(B) that the treatment described in clause (A) has been
ineffective for the physician's patient.
(2) Obtains a thorough history and performs a thorough
physical examination of the physician's patient before initiating
a treatment plan using a Schedule III or Schedule IV controlled
substance for purposes of weight reduction or to control
obesity.
(c) A physician licensed under IC 25-22.5 may not begin and shall
discontinue using a Schedule III or Schedule IV controlled substance
for purposes of weight reduction or to control obesity after the
physician determines in the physician's professional judgment that:
(1) the physician's patient has failed to lose weight using a
treatment plan involving the controlled substance;
(2) the controlled substance has provided a decreasing
contribution toward further weight loss for the patient unless
continuing to take the controlled substance is medically
necessary or appropriate for maintenance therapy;
(3) the physician's patient:
(A) has a history of; or
(B) shows a propensity for;
alcohol or drug abuse; or
(4) the physician's patient has consumed or disposed of a
controlled substance in a manner that does not strictly comply
with a treating physician's direction. As added by P.L.157-1999, SEC.1. Amended by P.L.37-2001, SEC.1.
IC 35-48-3-1 Rules
Sec. 1. Rules. The board may promulgate rules and charge
reasonable fees relating to the registration and control of the
manufacture, distribution, and dispensing of controlled substances
within this state. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-2 Limited permits for entities operating animal shelters
Sec. 2. (a) Any humane society, animal control agency, or
governmental entity operating an animal shelter or other animal
impounding facility is entitled to receive a limited permit only for the
purpose of buying, possessing, and using:
(1) sodium pentobarbital to euthanize injured, sick, homeless,
or unwanted domestic pets and animals;
(2) ketamine and ketamine products to anesthetize or
immobilize fractious domestic pets and animals; and
(3) a combination product containing tiletimine and zolazepam
as an agent for the remote chemical capture of domestic pets or
animals that otherwise cannot be restrained or captured.
(b) A humane society, animal control agency, or governmental
entity entitled to receive a permit under this chapter must:
(1) apply to the board according to the rules established by the
board;
(2) pay annually to the board a fee set by the board for the
limited permit; and
(3) submit proof, as determined by the board, that the
employees of an applicant who will handle a controlled
substance are sufficiently trained to use and administer the
controlled substance.
(c) All fees collected by the board under this section shall be
credited to the state board of pharmacy account.
(d) Storage, handling, and use of controlled substances obtained
according to this section are subject to the rules adopted by the
board.
(e) Before issuing a permit under this section, the board may
consult with the board of veterinary medical examiners. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.193-1987,
SEC.16; P.L.136-2001, SEC.1; P.L.84-2010, SEC.93.
IC 35-48-3-3 Registration requirements
Sec. 3. (a) Every person who manufactures or distributes any
controlled substance within this state or who proposes to engage in
the manufacture or distribution of any controlled substance within
this state, must obtain biennially a registration issued by the board in
accordance with its rules.
(b) Every person who dispenses or proposes to dispense any
controlled substance within Indiana must have a registration issued
by the board in accordance with its rules. A registration issued to a
dispenser under this subsection expires whenever the dispenser's
license as a practitioner expires. The board shall renew a dispenser's
registration under this subsection concurrently with any state license
authorizing the dispenser to act as a practitioner.
(c) Persons registered by the board under this article to
manufacture, distribute, dispense, or conduct research with
controlled substances may possess, manufacture, distribute, dispense,
or conduct research with those substances to the extent authorized by
their registration and in conformity with the other provisions of this
chapter.
(d) The following persons need not register and may lawfully
possess controlled substances under this article:
(1) An agent or employee of any registered manufacturer,
distributor, or dispenser of any controlled substance if he is
acting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or an
employee thereof, whose possession of any controlled substance
is in the usual course of business or employment.
(3) An ultimate user or a person in possession of any controlled
substance under a lawful order of a practitioner or in lawful
possession of a schedule V substance.
(e) The board may waive by rule the requirement for registration
of certain manufacturers, distributors, or dispensers if it finds it
consistent with the public health and safety.
(f) A separate registration is required at each principal place of
business or professional practice where the applicant manufactures,
distributes, dispenses, or possesses controlled substances.
(g) The board may inspect the establishment of a registrant or
applicant for registration in accordance with the board's rules. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.156-1986,
SEC.6.
IC 35-48-3-4 Registration
Sec. 4. (a) The board shall register an applicant to manufacture or
distribute controlled substances unless it determines that the issuance
of that registration would be inconsistent with the public interest. In
determining the public interest, the board shall consider:
(1) maintenance of effective controls against diversion of
controlled substances into other than legitimate medical,
scientific, or industrial channels;
(2) compliance with applicable state and local law;
(3) any convictions of the applicant under any federal and state
laws relating to any controlled substance;
(4) past experience in the manufacture or distribution of
controlled substances, and the existence in the applicant's
establishment of effective controls against diversion;
(5) furnishing by the applicant of false or fraudulent material in
any application filed under this article;
(6) suspension or revocation of the applicant's federal
registration to manufacture, distribute, or dispense controlled
substances as authorized by federal law; and
(7) any other factors relevant to and consistent with the public
health and safety.
(b) Registration under subsection (a) of this section does not
entitle a registrant to manufacture and distribute controlled
substances in schedules I or II other than those specified in the
registration.
(c) Practitioners must be registered to dispense any controlled
substances or to conduct research with controlled substances in
schedules II through V if they are authorized to dispense or conduct
research under the law of this state. The board need not require
separate registration under this chapter for practitioners engaging in
research with nonnarcotic controlled substances in schedules II
through V where the registrant is already registered under this
chapter in another capacity, to the extent authorized by his
registration in that other capacity.
(d) Registration to conduct research or instructional activities with
controlled substances in schedules I through V does not entitle a
registrant to conduct research or instructional activities with
controlled substances other than those approved by the board in
accordance with the registration.
(e) The board may consult with the board of veterinary medical
examiners before issuing a registration to a person:
(1) who seeks to conduct research or instructional activities
with controlled substances in schedules I through IV; and
(2) whose activities constitute the practice of veterinary
medicine (as defined by IC 25-38.1-1-12).
(f) Compliance by manufacturers and distributors with the
provisions of the federal law respecting registration (excluding fees)
entitles them to be registered under this article. As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1981,
P.L.170, SEC.7; P.L.84-2010, SEC.94.
IC 35-48-3-5 Denial, revocation, and suspension of registration; reinstatement
Sec. 5. (a) An application for registration or reregistration
submitted pursuant to and a registration issued under section 3 of this
chapter to manufacture, distribute, or dispense a controlled substance
may be denied, suspended, or revoked by the board upon a finding
that the applicant or registrant:
(1) has furnished false or fraudulent material information in any
application filed under this article;
(2) has violated any state or federal law relating to any
controlled substance;
(3) has had the applicant's or registrant's federal registration
suspended or revoked to manufacture, distribute, or dispense
controlled substances; or
(4) has failed to maintain reasonable controls against diversion
of controlled substances into other than legitimate medical,
scientific, or industrial channels.
(b) The board may limit revocation or suspension of a registration
or the denial of an application for registration or reregistration to the
particular controlled substance with respect to which grounds for
revocation, suspension, or denial exist.
(c) If the board suspends or revokes a registration or denies an
application for reregistration, all controlled substances owned or
possessed by the registrant at the time of suspension or the effective
date of the revocation or denial order may be placed under seal. The
board may require the removal of such substances from the premises.
No disposition may be made of substances under seal until the time
for taking an appeal has elapsed or until all appeals have been
concluded unless a court, upon application therefor, orders the sale
of perishable substances and the deposit of the proceeds of the sale
with the court. Upon a revocation or denial order becoming final, all
controlled substances may be forfeited to the state.
(d) The board shall promptly notify the drug enforcement
administration of all orders suspending or revoking registration, all
orders denying any application for registration or reregistration, and
all forfeitures of controlled substances.
(e) If the Drug Enforcement Administration terminates, denies,
suspends, or revokes a federal registration for the manufacture,
distribution, or dispensing of controlled substances, a registration
issued by the board under this chapter is automatically suspended.
(f) The board may reinstate a registration that has been suspended
under subsection (e), after a hearing, if the board is satisfied that the
applicant is able to manufacture, distribute, or dispense controlled
substances with reasonable skill and safety to the public. As a
condition of reinstatement, the board may impose disciplinary or
corrective measures authorized under IC 25-1-9-9 or this article.
(g) A registration issued under this chapter is automatically
revoked if any state license authorizing a dispenser to act as a
practitioner is revoked. As added by Acts 1976, P.L.148, SEC.7. Amended by Acts 1981,
P.L.170, SEC.8; P.L.197-2007, SEC.93; P.L.84-2010, SEC.95.
IC 35-48-3-6 Order to show cause
Sec. 6. (a) Before recommending a denial, suspension, or
revocation of a registration, or before refusing a renewal of
registration, the board shall serve upon the applicant or registrant an
order to show cause why registration should not be denied, revoked,
or suspended, or why the renewal should not be denied. The order to
show cause shall contain a statement of the basis therefor and shall
call upon the applicant or registrant to appear before the board at a
time and place not less than thirty (30) days after the date of service
of the order, but in the case of a denial or renewal of registration the
show cause order shall be served not later than thirty (30) days
before the expiration of the registration. These proceedings shall be
conducted in accordance with IC 4-21.5 without regard to any
criminal prosecution or other proceeding. Proceedings to refuse
renewal of registration shall not abate the existing registration, which
shall remain in effect pending the outcome of the administrative
hearing.
(b) The board may suspend, without an order to show cause, any
registration simultaneously with the institution of proceedings under
section 4 of this chapter, or where renewal of registration is refused,
if it finds that there is an imminent danger to the public health or
safety which warrants this action. The suspension shall continue in
effect until the conclusion of the proceedings, including judicial
review thereof, unless sooner withdrawn by the board or dissolved
by a court of competent jurisdiction.
(c) If an applicant for reregistration (who is doing business under
a registration previously granted and not revoked nor suspended) has
applied for reregistration at least forty-five (45) days before the date
on which the existing registration is due to expire, the existing
registration of the applicant shall automatically be extended and
continue in effect until the date on which the board so issues its
order. The board may extend any other existing registration under the
circumstances contemplated in this section even though the registrant
failed to apply for reregistration at least forty-five (45) days before
expiration of the existing registration, with or without request by the
registrant, if the board finds that such extension is not inconsistent
with the public health and safety. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.7-1987,
SEC.166; P.L.84-2010, SEC.96.
IC 35-48-3-7 Records of registrants
Sec. 7. Records of Registrants. Persons registered to manufacture,
distribute, or dispense controlled substances under this article shall
keep records and maintain inventories in conformance with the
record-keeping and inventory requirements of federal law and with
any additional rules the board issues. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-8 Order forms
Sec. 8. Order Forms. Controlled substances in schedules I and II
shall be distributed by a registrant to another registrant only pursuant
to an order form. Compliance with the provisions of federal law
respecting order forms is deemed compliance with this section. As added by Acts 1976, P.L.148, SEC.7.
IC 35-48-3-9 Prescriptions
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. As added by Acts 1976, P.L.148, SEC.7. Amended by P.L.2-1993,
SEC.192; P.L.163-1994, SEC.4; P.L.204-2005, SEC.21.
IC 35-48-3-10
Repealed
(Repealed by P.L.157-1999, SEC.2.)
IC 35-48-3-11 Treatment for weight reduction or to control obesity
Sec. 11. (a) Only a physician licensed under IC 25-22.5 may treat
a patient with a Schedule III or Schedule IV controlled substance for
the purpose of weight reduction or to control obesity.
(b) A physician licensed under IC 25-22.5 may not prescribe,
dispense, administer, supply, sell, or give any amphetamine,
sympathomimetic amine drug, or compound designated as a
Schedule III or Schedule IV controlled substance under IC 35-48-2-8
and IC 35-48-2-10 for a patient for purposes of weight reduction or
to control obesity, unless the physician does the following:
(1) Determines:
(A) through review of:
(i) the physician's records of prior treatment of the patient;
or
(ii) the records of prior treatment of the patient provided
by a previous treating physician or weight loss program;
that the physician's patient has made a reasonable effort to
lose weight in a treatment program using a regimen of
weight reduction based on caloric restriction, nutritional
counseling, behavior modification, and exercise without
using controlled substances; and
(B) that the treatment described in clause (A) has been
ineffective for the physician's patient.
(2) Obtains a thorough history and performs a thorough
physical examination of the physician's patient before initiating
a treatment plan using a Schedule III or Schedule IV controlled
substance for purposes of weight reduction or to control
obesity.
(c) A physician licensed under IC 25-22.5 may not begin and shall
discontinue using a Schedule III or Schedule IV controlled substance
for purposes of weight reduction or to control obesity after the
physician determines in the physician's professional judgment that:
(1) the physician's patient has failed to lose weight using a
treatment plan involving the controlled substance;
(2) the controlled substance has provided a decreasing
contribution toward further weight loss for the patient unless
continuing to take the controlled substance is medically
necessary or appropriate for maintenance therapy;
(3) the physician's patient:
(A) has a history of; or
(B) shows a propensity for;
alcohol or drug abuse; or
(4) the physician's patient has consumed or disposed of a
controlled substance in a manner that does not strictly comply
with a treating physician's direction. As added by P.L.157-1999, SEC.1. Amended by P.L.37-2001, SEC.1.
