CHAPTER 7. CENTRAL REPOSITORY FOR CONTROLLED SUBSTANCES DATA
IC 35-48-7
Chapter 7. Central Repository for Controlled Substances Data
IC 35-48-7-1
Repealed
(Repealed by P.L.84-2010, SEC.102.)
IC 35-48-7-2
Repealed
(Repealed by P.L.65-2006, SEC.18.)
IC 35-48-7-2.9
"Dispense" defined
Sec. 2.9. (a) As used in this chapter, "dispense" has the meaningset forth in IC 35-48-1-12.
(b) The term does not apply to the following:
(1) A drug administered directly to a patient.
(2) A drug dispensed by a practitioner, if the quantity dispensedis not more than a seventy-two (72) hour supply of a controlledsubstance listed in schedule II, III, IV, or V as set forth inIC 35-48-3-9.
As added by P.L.105-2008, SEC.65.
IC 35-48-7-3
Repealed
(Repealed by P.L.105-2008, SEC.66.)
IC 35-48-7-4
"Exception report" defined
Sec. 4. As used in this chapter, "exception report" means a recordof data concerning:
(1) a practitioner practicing a particular specialty or field ofhealth care;
(2) a dispenser doing business in a particular location; or
(3) a recipient;
that indicates dispensing or receiving of controlled substancesoutside norms for dispensing or receiving controlled substancesestablished by the advisory committee under this chapter.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-5
"Identification number" defined
Sec. 5. As used in this chapter, "identification number" refers tothe following:
(1) The unique number contained on any of the following:
(A) A valid driver's license of a recipient or a recipient'srepresentative issued under Indiana law or the law of anyother state.
(B) A recipient's or a recipient representative's valid militaryidentification card. (C) A valid identification card of a recipient or a recipient'srepresentative issued by:
(i) the bureau of motor vehicles as described inIC 9-24-16-3; or
(ii) any other state and that is similar to the identificationcard issued by the bureau of motor vehicles.
(D) If the recipient is an animal:
(i) the valid driver's license issued under Indiana law orthe law of any other state;
(ii) the valid military identification card; or
(iii) the valid identification card issued by the bureau ofmotor vehicles and described in IC 9-24-16-3 or a valididentification card of similar description that is issued byany other state;
of the animal's owner.
(2) The identification number or phrase designated by thecentral repository.
As added by P.L.163-1994, SEC.5. Amended by P.L.204-2005,SEC.22.
IC 35-48-7-5.2
"INSPECT" defined
Sec. 5.2. As used in this chapter, "INSPECT" means the Indianascheduled prescription electronic collection and tracking programestablished by IC 25-1-13-4.
As added by P.L.65-2006, SEC.3.
IC 35-48-7-5.4
"Interoperability" defined
Sec. 5.4. As used in this chapter, "interoperability" refers to theINSPECT program electronically sharing reported information withanother state concerning the dispensing of a controlled substance:
(1) to a recipient who resides in the other state; or
(2) prescribed by a practitioner whose principal place ofbusiness is located in another state.
As added by P.L.65-2006, SEC.4.
IC 35-48-7-5.6
"Patient" defined
Sec. 5.6. As used in this chapter, "patient" means an individualwho has requested or received health care services from a providerfor the examination, treatment, diagnosis, or prevention of a physicalor mental condition.
As added by P.L.65-2006, SEC.5.
IC 35-48-7-5.8
"Practitioner" defined
Sec. 5.8. As used in this chapter, "practitioner" means a physician,dentist, veterinarian, podiatrist, nurse practitioner, scientificinvestigator, pharmacist, hospital, or other institution or individual
licensed, registered, or otherwise permitted to distribute, dispense,conduct research with respect to, or administer a controlledsubstance in the course of professional practice or research in theUnited States.
As added by P.L.65-2006, SEC.6.
IC 35-48-7-6
"Recipient" defined
Sec. 6. As used in this chapter, "recipient" means an individual forwhom a controlled substance is dispensed.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-7
"Recipient representative" defined
Sec. 7. As used in this chapter, "recipient representative" meansthe individual to whom a controlled substance is dispensed if therecipient is either less than eighteen (18) years of age or unavailableto receive the controlled substance.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-7.5
"State" defined
Sec. 7.5. As used in this chapter, "state" means any state of theUnited States or the District of Columbia.
As added by P.L.65-2006, SEC.7.
IC 35-48-7-8
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-8.1 Version a
Controlled substance prescription monitoring program;information; prescription forms
Note: This version of section amended by P.L.84-2010, SEC.97.See also following version of this section amended by P.L.94-2010,SEC.13.
Sec. 8.1. (a) The board shall provide for a controlled substanceprescription monitoring program that includes the followingcomponents:
(1) Each time a controlled substance designated by the boardunder IC 35-48-2-5 through IC 35-48-2-10 is dispensed, thedispenser shall transmit to the INSPECT program the followinginformation:
(A) The controlled substance recipient's name.
(B) The controlled substance recipient's or the recipientrepresentative's identification number or the identificationnumber or phrase designated by the INSPECT program.
(C) The controlled substance recipient's date of birth.
(D) The national drug code number of the controlledsubstance dispensed. (E) The date the controlled substance is dispensed.
(F) The quantity of the controlled substance dispensed.
(G) The number of days of supply dispensed.
(H) The dispenser's United States Drug Enforcement Agencyregistration number.
(I) The prescriber's United States Drug Enforcement Agencyregistration number.
(J) An indication as to whether the prescription wastransmitted to the pharmacist orally or in writing.
(K) Other data required by the board.
(2) The information required to be transmitted under thissection must be transmitted not more than seven (7) days afterthe date on which a controlled substance is dispensed.
(3) A dispenser shall transmit the information required underthis section by:
(A) uploading to the INSPECT web site;
(B) a computer diskette; or
(C) a CD-ROM disk;
that meets specifications prescribed by the board.
(4) The board may require that prescriptions for controlledsubstances be written on a one (1) part form that cannot beduplicated. However, the board may not apply such arequirement to prescriptions filled at a pharmacy with a Type IIpermit (as described in IC 25-26-13-17) and operated by ahospital licensed under IC 16-21, or prescriptions ordered forand dispensed to bona fide enrolled patients in facilitieslicensed under IC 16-28. The board may not require multiplecopy prescription forms for any prescriptions written. The boardmay not require different prescription forms for any individualdrug or group of drugs. Prescription forms required under thissubdivision must be approved by the Indiana board of pharmacyestablished by IC 25-26-13-3.
(5) The costs of the program.
(b) This subsection applies only to a retail pharmacy. Apharmacist, pharmacy technician, or person authorized by apharmacist to dispense a controlled substance may not dispense acontrolled substance to a person who is not personally known to thepharmacist, pharmacy technician, or person authorized by apharmacist to dispense a controlled substance unless the persontaking possession of the controlled substance provides documentedproof of the person's identification to the pharmacist, pharmacytechnician, or person authorized by a pharmacist to dispense acontrolled substance.
As added by P.L.65-2006, SEC.9. Amended by P.L.182-2009(ss),SEC.399; P.L.84-2010, SEC.97.
IC 35-48-7-8.1 Version b
Controlled substance prescription monitoring program;information; prescription forms; identification
Note: This version of section amended by P.L.94-2010, SEC.13.
See also preceding version of this section amended by P.L.84-2010,SEC.97.
Sec. 8.1. (a) The advisory committee shall provide for a controlledsubstance prescription monitoring program that includes thefollowing components:
(1) Each time a controlled substance designated by the advisorycommittee under IC 35-48-2-5 through IC 35-48-2-10 isdispensed, the dispenser shall transmit to the INSPECTprogram the following information:
(A) The controlled substance recipient's name.
(B) The controlled substance recipient's or the recipientrepresentative's identification number or the identificationnumber or phrase designated by the INSPECT program.
(C) The controlled substance recipient's date of birth.
(D) The national drug code number of the controlledsubstance dispensed.
(E) The date the controlled substance is dispensed.
(F) The quantity of the controlled substance dispensed.
(G) The number of days of supply dispensed.
(H) The dispenser's United States Drug Enforcement Agencyregistration number.
(I) The prescriber's United States Drug Enforcement Agencyregistration number.
(J) An indication as to whether the prescription wastransmitted to the pharmacist orally or in writing.
(K) Other data required by the advisory committee.
(2) The information required to be transmitted under thissection must be transmitted not more than seven (7) days afterthe date on which a controlled substance is dispensed.
(3) A dispenser shall transmit the information required underthis section by:
(A) uploading to the INSPECT web site;
(B) a computer diskette; or
(C) a CD-ROM disk;
that meets specifications prescribed by the advisory committee.
(4) The advisory committee may require that prescriptions forcontrolled substances be written on a one (1) part form thatcannot be duplicated. However, the advisory committee may notapply such a requirement to prescriptions filled at a pharmacywith a Type II permit (as described in IC 25-26-13-17) andoperated by a hospital licensed under IC 16-21, or prescriptionsordered for and dispensed to bona fide enrolled patients infacilities licensed under IC 16-28. The committee may notrequire multiple copy prescription forms for any prescriptionswritten. The advisory committee may not require differentprescription forms for any individual drug or group of drugs.Prescription forms required under this subdivision must bejointly approved by the committee and by the Indiana board ofpharmacy established by IC 25-26-13-3.
(5) The costs of the program. (b) This subsection applies only to a retail pharmacy. Apharmacist, pharmacy technician, or person authorized by apharmacist to dispense a controlled substance may not dispense acontrolled substance to a person who is not personally known to thepharmacist, pharmacy technician, or person authorized by apharmacist to dispense a controlled substance unless the persontaking possession of the controlled substance provides documentedproof of the person's identification to the pharmacist, pharmacytechnician, or person authorized by a pharmacist to dispense acontrolled substance.
As added by P.L.65-2006, SEC.9. Amended by P.L.182-2009(ss),SEC.399; P.L.94-2010, SEC.13.
IC 35-48-7-9
Repealed
(Repealed by P.L.65-2006, SEC.18.)
IC 35-48-7-10
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-10.1
INSPECT program; designation; powers and duties; funding
Sec. 10.1. (a) The INSPECT program must do the following:
(1) Create a data base for information required to be transmittedunder section 8.1 of this chapter in the form required underrules adopted by the board, including search capability for thefollowing:
(A) A controlled substance recipient's name.
(B) A controlled substance recipient's or recipientrepresentative's identification number.
(C) A controlled substance recipient's date of birth.
(D) The national drug code number of a controlled substancedispensed.
(E) The dates a controlled substance is dispensed.
(F) The quantities of a controlled substance dispensed.
(G) The number of days of supply dispensed.
(H) A dispenser's United States Drug Enforcement Agencyregistration number.
(I) A prescriber's United States Drug Enforcement Agencyregistration number.
(J) Whether a prescription was transmitted to the pharmacistorally or in writing.
(K) A controlled substance recipient's method of paymentfor the controlled substance dispensed.
(2) Provide the board with continuing twenty-four (24) hour aday online access to the data base.
(3) Secure the information collected and the data basemaintained against access by unauthorized persons.
(b) The board may execute a contract with a vendor designated by
the board to perform any function associated with the administrationof the INSPECT program.
(c) The INSPECT program may gather prescription data from theMedicaid retrospective drug utilization review (DUR) programestablished under IC 12-15-35.
(d) The board may accept and designate grants, public and privatefinancial assistance, and licensure fees to provide funding for theINSPECT program.
As added by P.L.65-2006, SEC.11. Amended by P.L.84-2010,SEC.98.
IC 35-48-7-11
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-11.1
Confidentiality
Sec. 11.1. (a) Information received by the INSPECT programunder section 8.1 of this chapter is confidential.
(b) The board shall carry out a program to protect theconfidentiality of the information described in subsection (a). Theboard may disclose the information to another person only undersubsection (c), (d), or (g).
(c) The board may disclose confidential information described insubsection (a) to any person who is authorized to engage inreceiving, processing, or storing the information.
(d) Except as provided in subsections (e) and (f), the board mayrelease confidential information described in subsection (a) to thefollowing persons:
(1) A member of the board or another governing body thatlicenses practitioners and is engaged in an investigation, anadjudication, or a prosecution of a violation under any state orfederal law that involves a controlled substance.
(2) An investigator for the consumer protection division of theoffice of the attorney general, a prosecuting attorney, theattorney general, a deputy attorney general, or an investigatorfrom the office of the attorney general, who is engaged in:
(A) an investigation;
(B) an adjudication; or
(C) a prosecution;
of a violation under any state or federal law that involves acontrolled substance.
(3) A law enforcement officer who is an employee of:
(A) a local, state, or federal law enforcement agency; or
(B) an entity that regulates controlled substances or enforcescontrolled substances rules or laws in another state;
that is certified to receive information from the INSPECTprogram.
(4) A practitioner or practitioner's agent certified to receiveinformation from the INSPECT program. (5) A controlled substance monitoring program in another statewith which Indiana has established an interoperabilityagreement.
(6) The state toxicologist.
(7) A certified representative of the Medicaid retrospective andprospective drug utilization review program.
(8) A substance abuse assistance program for a licensed healthcare provider who:
(A) has prescriptive authority under IC 25; and
(B) is participating in the assistance program.
(e) Information provided to an individual under:
(1) subsection (d)(3) is limited to information:
(A) concerning an individual or proceeding involving theunlawful diversion or misuse of a schedule II, III, IV, or Vcontrolled substance; and
(B) that will assist in an investigation or proceeding; and
(2) subsection (d)(4) may be released only for the purpose of:
(A) providing medical or pharmaceutical treatment; or
(B) evaluating the need for providing medical orpharmaceutical treatment to a patient.
(f) Before the board releases confidential information undersubsection (d), the applicant must be approved by the INSPECTprogram in a manner prescribed by the board.
(g) The board may release to:
(1) a member of the board or another governing body thatlicenses practitioners;
(2) an investigator for the consumer protection division of theoffice of the attorney general, a prosecuting attorney, theattorney general, a deputy attorney general, or an investigatorfrom the office of the attorney general; or
(3) a law enforcement officer who is:
(A) authorized by the state police department to receive thetype of information released; and
(B) approved by the board to receive the type of informationreleased;
confidential information generated from computer records thatidentifies practitioners who are prescribing or dispensing largequantities of a controlled substance.
(h) The information described in subsection (g) may not bereleased until it has been reviewed by:
(1) a member of the board who is licensed in the sameprofession as the prescribing or dispensing practitioneridentified by the data; or
(2) the board's designee;
and until that member or the designee has certified that furtherinvestigation is warranted. However, failure to comply with thissubsection does not invalidate the use of any evidence that isotherwise admissible in a proceeding described in subsection (i).
(i) An investigator or a law enforcement officer receivingconfidential information under subsection (c), (d), or (g) may
disclose the information to a law enforcement officer or an attorneyfor the office of the attorney general for use as evidence in thefollowing:
(1) A proceeding under IC 16-42-20.
(2) A proceeding under any state or federal law that involves acontrolled substance.
(3) A criminal proceeding or a proceeding in juvenile court thatinvolves a controlled substance.
(j) The board may compile statistical reports from the informationdescribed in subsection (a). The reports must not include informationthat identifies any practitioner, ultimate user, or other personadministering a controlled substance. Statistical reports compiledunder this subsection are public records.
(k) This section may not be construed to require a practitioner toobtain information about a patient from the data base.
(l) A practitioner is immune from civil liability for an injury,death, or loss to a person solely due to a practitioner seeking or notseeking information from the INSPECT program. The civil immunitydescribed in this subsection does not extend to a practitioner if thepractitioner receives information directly from the INSPECTprogram and then negligently misuses this information. Thissubsection does not apply to an act or omission that is a result ofgross negligence or intentional misconduct.
(m) The board may review the records of the INSPECT program.If the board determines that a violation of the law may haveoccurred, the board shall notify the appropriate law enforcementagency or the relevant government body responsible for thelicensure, regulation, or discipline of practitioners authorized by lawto prescribe controlled substances.
(n) A practitioner who in good faith discloses information basedon a report from the INSPECT program to a law enforcement agencyis immune from criminal or civil liability. A practitioner thatdiscloses information to a law enforcement agency under thissubsection is presumed to have acted in good faith.
As added by P.L.65-2006, SEC.13. Amended by P.L.84-2010,SEC.99.
IC 35-48-7-11.5
Dissemination of exception reports
Sec. 11.5. (a) Each board of a health care provider that prescribesor dispenses prescription drugs shall do the following:
(1) Establish prescribing norms and dispensing guidelines forthe unsolicited dissemination of exception reports under section11.1(d) of this chapter.
(2) Provide the information determined in subdivision (1) to theboard.
(b) The exception reports that are disseminated based on theprescribing norms and dispensing guidelines established undersubsection (a) must comply with the following requirements:
(1) A report of prescriptive activity of a practitioner to the
practitioner's professional licensing board designee when thepractitioner deviates from the dispensing guidelines or theprescribing norms for the prescribing of a controlled substancewithin a particular drug class.
(2) A reporting of recipient activity to the practitioners whoprescribed or dispensed the controlled substance when therecipient deviates from the dispensing guidelines of a controlledsubstance within a particular drug class.
(c) The board designee may, at the designee's discretion, forwardthe exception report under subsection (b)(2) to only the following forpurposes of an investigation:
(1) A law enforcement agency.
(2) The attorney general.
As added by P.L.84-2010, SEC.100.
IC 35-48-7-12
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-12.1
Rules to implement chapter
Sec. 12.1. (a) The board shall adopt rules under IC 4-22-2 toimplement this chapter, including the following:
(1) Information collection and retrieval procedures for theINSPECT program, including the controlled substances to beincluded in the program required under section 8.1 of thischapter.
(2) Design for the creation of the data base required undersection 10.1 of this chapter.
(3) Requirements for the development and installation of onlineelectronic access by the board to information collected by theINSPECT program.
(4) Identification of emergency situations or othercircumstances in which a practitioner may prescribe, dispense,and administer a prescription drug specified in section 8.1 ofthis chapter without a written prescription or on a form otherthan a form specified in section 8.1(4) of this chapter.
(b) The board may:
(1) set standards for education courses for individualsauthorized to use the INSPECT program;
(2) identify treatment programs for individuals addicted tocontrolled substances monitored by the INSPECT program; and
(3) work with impaired practitioner associations to provideintervention and treatment.
As added by P.L.65-2006, SEC.15. Amended by P.L.84-2010,SEC.101.
IC 35-48-7-13
Repealed
(Repealed by P.L.3-2008, SEC.269.)
IC 35-48-7-13.1
Controlled substances data fund; establishment
Sec. 13.1. (a) This section applies after June 30, 2007.
(b) The controlled substances data fund is established to fund theoperation of the INSPECT program. The fund shall be administeredby the Indiana professional licensing agency.
(c) Expenses of administering the fund shall be paid from moneyin the fund. The fund consists of grants, public and private financialassistance, and sixteen percent (16%) of the controlled substancesregistration fees imposed under rules adopted under IC 35-48-3-1.
(d) The treasurer of state shall invest the money in the fund notcurrently needed to meet the obligations of the fund in the samemanner as other public money may be invested.
(e) Money in the fund at the end of a state fiscal year does notrevert to the state general fund.
As added by P.L.65-2006, SEC.17.
IC 35-48-7-14
Violations of chapter; misdemeanor offense
Sec. 14. A person who knowingly or intentionally violates thischapter commits a Class A misdemeanor.
As added by P.L.163-1994, SEC.5.
IC 35-48-7-15
Repealed
(Repealed by P.L.214-2001, SEC.1.)