CHAPTER 3. REGISTRATION AND CONTROL
IC 35-48-3
Chapter 3. Registration and Control
IC 35-48-3-1
Rules
Sec. 1. Rules. The board may promulgate rules and chargereasonable fees relating to the registration and control of themanufacture, distribution, and dispensing of controlled substanceswithin 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, orgovernmental entity operating an animal shelter or other animalimpounding facility is entitled to receive a limited permit only for thepurpose 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 orimmobilize fractious domestic pets and animals; and
(3) a combination product containing tiletimine and zolazepamas an agent for the remote chemical capture of domestic pets oranimals that otherwise cannot be restrained or captured.
(b) A humane society, animal control agency, or governmentalentity entitled to receive a permit under this chapter must:
(1) apply to the board according to the rules established by theboard;
(2) pay annually to the board a fee set by the board for thelimited permit; and
(3) submit proof, as determined by the board, that theemployees of an applicant who will handle a controlledsubstance are sufficiently trained to use and administer thecontrolled substance.
(c) All fees collected by the board under this section shall becredited to the state board of pharmacy account.
(d) Storage, handling, and use of controlled substances obtainedaccording to this section are subject to the rules adopted by theboard.
(e) Before issuing a permit under this section, the board mayconsult 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 anycontrolled substance within this state or who proposes to engage inthe manufacture or distribution of any controlled substance withinthis state, must obtain biennially a registration issued by the board in
accordance with its rules.
(b) Every person who dispenses or proposes to dispense anycontrolled substance within Indiana must have a registration issuedby the board in accordance with its rules. A registration issued to adispenser under this subsection expires whenever the dispenser'slicense as a practitioner expires. The board shall renew a dispenser'sregistration under this subsection concurrently with any state licenseauthorizing the dispenser to act as a practitioner.
(c) Persons registered by the board under this article tomanufacture, distribute, dispense, or conduct research withcontrolled substances may possess, manufacture, distribute, dispense,or conduct research with those substances to the extent authorized bytheir registration and in conformity with the other provisions of thischapter.
(d) The following persons need not register and may lawfullypossess controlled substances under this article:
(1) An agent or employee of any registered manufacturer,distributor, or dispenser of any controlled substance if he isacting in the usual course of his business or employment.
(2) A common or contract carrier or warehouseman, or anemployee thereof, whose possession of any controlled substanceis in the usual course of business or employment.
(3) An ultimate user or a person in possession of any controlledsubstance under a lawful order of a practitioner or in lawfulpossession of a schedule V substance.
(e) The board may waive by rule the requirement for registrationof certain manufacturers, distributors, or dispensers if it finds itconsistent with the public health and safety.
(f) A separate registration is required at each principal place ofbusiness or professional practice where the applicant manufactures,distributes, dispenses, or possesses controlled substances.
(g) The board may inspect the establishment of a registrant orapplicant 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 ordistribute controlled substances unless it determines that the issuanceof that registration would be inconsistent with the public interest. Indetermining the public interest, the board shall consider:
(1) maintenance of effective controls against diversion ofcontrolled 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 statelaws relating to any controlled substance;
(4) past experience in the manufacture or distribution ofcontrolled substances, and the existence in the applicant's
establishment of effective controls against diversion;
(5) furnishing by the applicant of false or fraudulent material inany application filed under this article;
(6) suspension or revocation of the applicant's federalregistration to manufacture, distribute, or dispense controlledsubstances as authorized by federal law; and
(7) any other factors relevant to and consistent with the publichealth and safety.
(b) Registration under subsection (a) of this section does notentitle a registrant to manufacture and distribute controlledsubstances in schedules I or II other than those specified in theregistration.
(c) Practitioners must be registered to dispense any controlledsubstances or to conduct research with controlled substances inschedules II through V if they are authorized to dispense or conductresearch under the law of this state. The board need not requireseparate registration under this chapter for practitioners engaging inresearch with nonnarcotic controlled substances in schedules IIthrough V where the registrant is already registered under thischapter in another capacity, to the extent authorized by hisregistration in that other capacity.
(d) Registration to conduct research or instructional activities withcontrolled substances in schedules I through V does not entitle aregistrant to conduct research or instructional activities withcontrolled substances other than those approved by the board inaccordance with the registration.
(e) The board may consult with the board of veterinary medicalexaminers before issuing a registration to a person:
(1) who seeks to conduct research or instructional activitieswith controlled substances in schedules I through IV; and
(2) whose activities constitute the practice of veterinarymedicine (as defined by IC 25-38.1-1-12).
(f) Compliance by manufacturers and distributors with theprovisions 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 reregistrationsubmitted pursuant to and a registration issued under section 3 of thischapter to manufacture, distribute, or dispense a controlled substancemay be denied, suspended, or revoked by the board upon a findingthat the applicant or registrant:
(1) has furnished false or fraudulent material information in anyapplication filed under this article;
(2) has violated any state or federal law relating to anycontrolled substance;
(3) has had the applicant's or registrant's federal registration
suspended or revoked to manufacture, distribute, or dispensecontrolled substances; or
(4) has failed to maintain reasonable controls against diversionof controlled substances into other than legitimate medical,scientific, or industrial channels.
(b) The board may limit revocation or suspension of a registrationor the denial of an application for registration or reregistration to theparticular controlled substance with respect to which grounds forrevocation, suspension, or denial exist.
(c) If the board suspends or revokes a registration or denies anapplication for reregistration, all controlled substances owned orpossessed by the registrant at the time of suspension or the effectivedate of the revocation or denial order may be placed under seal. Theboard may require the removal of such substances from the premises.No disposition may be made of substances under seal until the timefor taking an appeal has elapsed or until all appeals have beenconcluded unless a court, upon application therefor, orders the saleof perishable substances and the deposit of the proceeds of the salewith the court. Upon a revocation or denial order becoming final, allcontrolled substances may be forfeited to the state.
(d) The board shall promptly notify the drug enforcementadministration of all orders suspending or revoking registration, allorders denying any application for registration or reregistration, andall 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 registrationissued by the board under this chapter is automatically suspended.
(f) The board may reinstate a registration that has been suspendedunder subsection (e), after a hearing, if the board is satisfied that theapplicant is able to manufacture, distribute, or dispense controlledsubstances with reasonable skill and safety to the public. As acondition of reinstatement, the board may impose disciplinary orcorrective measures authorized under IC 25-1-9-9 or this article.
(g) A registration issued under this chapter is automaticallyrevoked if any state license authorizing a dispenser to act as apractitioner 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, orrevocation of a registration, or before refusing a renewal ofregistration, the board shall serve upon the applicant or registrant anorder to show cause why registration should not be denied, revoked,or suspended, or why the renewal should not be denied. The order toshow cause shall contain a statement of the basis therefor and shallcall upon the applicant or registrant to appear before the board at atime 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 theshow cause order shall be served not later than thirty (30) daysbefore the expiration of the registration. These proceedings shall beconducted in accordance with IC 4-21.5 without regard to anycriminal prosecution or other proceeding. Proceedings to refuserenewal of registration shall not abate the existing registration, whichshall remain in effect pending the outcome of the administrativehearing.
(b) The board may suspend, without an order to show cause, anyregistration simultaneously with the institution of proceedings undersection 4 of this chapter, or where renewal of registration is refused,if it finds that there is an imminent danger to the public health orsafety which warrants this action. The suspension shall continue ineffect until the conclusion of the proceedings, including judicialreview thereof, unless sooner withdrawn by the board or dissolvedby a court of competent jurisdiction.
(c) If an applicant for reregistration (who is doing business undera registration previously granted and not revoked nor suspended) hasapplied for reregistration at least forty-five (45) days before the dateon which the existing registration is due to expire, the existingregistration of the applicant shall automatically be extended andcontinue in effect until the date on which the board so issues itsorder. The board may extend any other existing registration under thecircumstances contemplated in this section even though the registrantfailed to apply for reregistration at least forty-five (45) days beforeexpiration of the existing registration, with or without request by theregistrant, if the board finds that such extension is not inconsistentwith 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 shallkeep records and maintain inventories in conformance with therecord-keeping and inventory requirements of federal law and withany 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 IIshall be distributed by a registrant to another registrant only pursuantto an order form. Compliance with the provisions of federal lawrespecting 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 ofnot more than forty-eight (48) hours that are dispensed by or on thedirection of a practitioner or medication dispensed directly by apractitioner, other than a pharmacy, to an ultimate user, no controlledsubstance in schedule II may be dispensed without the writtenprescription of a practitioner.
(b) In emergency situations, as defined by rule of the board,schedule II drugs may be dispensed upon oral prescription of apractitioner, reduced promptly to writing and filed by the pharmacy.Prescriptions shall be retained in conformity with the requirementsof section 7 of this chapter. No prescription for a schedule IIsubstance may be refilled.
(c) Except for dosages medically required for a period of not morethan forty-eight (48) hours that are dispensed by or on the directionof a practitioner, or medication dispensed directly by a practitioner,other than a pharmacy, to an ultimate user, a controlled substanceincluded in schedule III or IV, which is a prescription drug asdetermined under IC 16-42-19, shall not be dispensed without awritten or oral prescription of a practitioner. The prescription shallnot be filled or refilled more than six (6) months after the datethereof or be refilled more than five (5) times, unless renewed by thepractitioner. Prescriptions for schedule III, IV, and V controlledsubstances may be transmitted by facsimile from the practitioner orthe agent of the practitioner to a pharmacy. The facsimileprescription is equivalent to an original prescription to the extentpermitted under federal law.
(d) A controlled substance included in schedule V shall not bedistributed 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 treata patient with a Schedule III or Schedule IV controlled substance forthe 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 aSchedule III or Schedule IV controlled substance under IC 35-48-2-8and IC 35-48-2-10 for a patient for purposes of weight reduction orto 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 providedby a previous treating physician or weight loss program;
that the physician's patient has made a reasonable effort tolose weight in a treatment program using a regimen ofweight reduction based on caloric restriction, nutritionalcounseling, behavior modification, and exercise withoutusing controlled substances; and
(B) that the treatment described in clause (A) has beenineffective for the physician's patient.
(2) Obtains a thorough history and performs a thoroughphysical examination of the physician's patient before initiatinga treatment plan using a Schedule III or Schedule IV controlledsubstance for purposes of weight reduction or to controlobesity.
(c) A physician licensed under IC 25-22.5 may not begin and shalldiscontinue using a Schedule III or Schedule IV controlled substancefor purposes of weight reduction or to control obesity after thephysician determines in the physician's professional judgment that:
(1) the physician's patient has failed to lose weight using atreatment plan involving the controlled substance;
(2) the controlled substance has provided a decreasingcontribution toward further weight loss for the patient unlesscontinuing to take the controlled substance is medicallynecessary 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 acontrolled substance in a manner that does not strictly complywith a treating physician's direction.
As added by P.L.157-1999, SEC.1. Amended by P.L.37-2001, SEC.1.