March 18, 2005





ENGROSSED

SENATE BILL No. 590

_____


DIGEST OF SB 590 (Updated March 15, 2005 5:21 pm - DI 77)



Citations Affected: IC 10-13; IC 16-18; IC 16-28; IC 16-42; IC 25-26; IC 27-13; IC 34-24; IC 35-43; IC 35-48; noncode.

Synopsis: Prescription drugs. Allows the: (1) electronic transmission of prescriptions and instructions related to the prescriptions; and (2) transmission of prescriptions by facsimiles for schedule III, IV, and V controlled substances. Requires that a prescription may be transmitted electronically only through the use of an electronic data intermediary. Requires the board of pharmacy to: (1) adopt rules concerning security of electronically transmitted prescription information; and (2) establish an process for approving electronic data intermediaries. Expands the requirements that must be met by a wholesale drug distributor for eligibility for licensure. Specifies prohibited acts. Specifies criminal acts related to wholesale drug distribution and legend drugs. Allows the board of pharmacy to establish an electronic pedigree pilot program.

Effective: July 1, 2005.





Riegsecker, Simpson
(HOUSE SPONSORS _ BUDAK, BROWN C)




    January 20, 2005, read first time and referred to Committee on Economic Development and Technology.
    January 31, 2005, reported favorably _ Do Pass.
    February 10, 2005, read second time, amended, ordered engrossed.
    February 11, 2005, engrossed.
    February 28, 2005, read third time, passed. Yeas 48, nays 0.

HOUSE ACTION

    March 8, 2005, read first time and referred to Committee on Public Health.
    March 17, 2005, amended, reported _ Do Pass.






March 18, 2005

First Regular Session 114th General Assembly (2005)


PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts between statutes enacted by the 2004 Regular Session of the General Assembly.


ENGROSSED

SENATE BILL No. 590



    A BILL FOR AN ACT to amend the Indiana Code concerning health.

Be it enacted by the General Assembly of the State of Indiana:

SOURCE: IC 10-13-3-38.5; (05)ES0590.1.1. -->     SECTION 1. IC 10-13-3-38.5 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 38.5. (a) Under federal P.L.92-544 (86 Stat. 1115), the department may use an individual's fingerprints submitted by the individual for the following purposes:
        (1) Determining the individual's suitability for employment with the state, or as an employee of a contractor of the state, in a position:
            (A) that has a job description that includes contact with, care of, or supervision over a person less than eighteen (18) years of age;
            (B) that has a job description that includes contact with, care of, or supervision over an endangered adult (as defined in IC 12-10-3-2), except the individual is not required to meet the standard for harmed or threatened with harm set forth in IC 12-10-3-2(a)(3);
            (C) at a state institution managed by the office of the secretary of family and social services or state department of health;
            (D) at the Indiana School for the Deaf established by IC 20-16-2-1;
            (E) at the Indiana School for the Blind established by IC 20-15-2-1;
            (F) at a juvenile detention facility;
            (G) with the gaming commission under IC 4-33-3-16;
            (H) with the department of financial institutions under IC 28-11-2-3; or
            (I) that has a job description that includes access to or supervision over state financial or personnel data, including state warrants, banking codes, or payroll information pertaining to state employees.
        (2) Identification in a request related to an application for a teacher's license submitted to the professional standards board established under IC 20-1-1.4.
         (3) Use by the Indiana board of pharmacy in determining the individual's suitability for a position or employment with a wholesale drug distributor, as specified in IC 25-26-14-16(b), IC 25-26-14-16.5(b), IC 25-26-14-17.8(c), and IC 25-26-14-20.
An applicant shall submit the fingerprints in an appropriate format or on forms provided for the employment or license application. The department shall charge each applicant the fee established under section 28 of this chapter and by federal authorities to defray the costs associated with a search for and classification of the applicant's fingerprints. The department may forward fingerprints submitted by an applicant to the Federal Bureau of Investigation or any other agency for processing. The state personnel department or the agency to which the applicant is applying for employment or a license may receive the results of all fingerprint investigations.
    (b) An applicant who is an employee of the state may not be charged under subsection (a).
    (c) Subsection (a)(1) does not apply to an employee of a contractor of the state if the contract involves the construction or repair of a capital project or other public works project of the state.
SOURCE: IC 16-18-2-106.3; (05)ES0590.1.2. -->     SECTION 2. IC 16-18-2-106.3 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 106.3. For purposes of IC 16-42-3 and IC 16-42-22, "electronic signature" means an electronic sound, symbol, or process:
        (1) attached to or logically associated with an electronically transmitted prescription or order; and
        (2) executed or adopted by a person;
with the intent to sign the electronically transmitted prescription or order.

SOURCE: IC 16-18-2-106.4; (05)ES0590.1.3. -->     SECTION 3. IC 16-18-2-106.4 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 106.4. For purposes of IC 16-42-3, IC 16-42-19, and IC 16-42-22, "electronically transmitted" or "electronic transmission" means the transmission of a prescription in electronic form. The term does not include transmission of a prescription by facsimile.
SOURCE: IC 16-28-11-4; (05)ES0590.1.4. -->     SECTION 4. IC 16-28-11-4 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. A health facility that possesses unused medication that meets the requirements of IC 25-26-13-25(i)(1) IC 25-26-13-25(j)(1) through IC 25-26-13-25(i)(6): IC 25-26-13-25(j)(6):
        (1) shall return medication that belonged to a Medicaid recipient; and
        (2) may return other unused medication;
to the pharmacy that dispensed the medication.
SOURCE: IC 16-42-3-6; (05)ES0590.1.5. -->     SECTION 5. IC 16-42-3-6 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6. (a) This section applies to a drug intended for use by humans that:
        (1) is a habit forming drug to which section 4(4) of this chapter applies;
        (2) because of:
            (A) the drug's toxicity or other potential for harmful effect;
            (B) the method of the drug's use; or
            (C) the collateral measures necessary to the drug's use;
        is not safe for use except under the supervision of a practitioner licensed by law to administer the drug; or
        (3) is limited by an approved application under Section 505 of the Federal Act or section 7 or 8 of this chapter to use under the professional supervision of a practitioner licensed by law to administer the drug.
    (b) A drug described in subsection (a) may be dispensed only:
        (1) upon a written or an electronically transmitted prescription of a practitioner licensed by law to administer the drug;
        (2) upon an oral prescription of the practitioner that is reduced promptly to writing and filed by the pharmacist; pharmacist or pharmacist intern (as defined in IC 25-26-13-2); or
        (3) by refilling a written or oral prescription if the refilling is authorized by the prescriber either in the original prescription, by an electronically transmitted order that is recorded in an

electronic format, or by oral order that is reduced promptly to writing or is entered into an electronic format and filed by the pharmacist or pharmacist intern (as defined by IC 25-26-13-2).
    (c) If a prescription for a drug described in subsection (a) does not indicate how many times the prescription may be refilled, if any, the prescription may not be refilled unless the pharmacist is subsequently authorized to do so by the practitioner.
    (d) The act of dispensing a drug contrary to subsection (a), (b), or (c) is considered to be an act that results in a drug being misbranded while held for sale.
    (e) A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer the drug is exempt from the requirements of section 4(2), 4(3), 4(4), 4(5), 4(6), 4(7), 4(8), and 4(9) of this chapter if the drug bears a label containing the following:
        (1) The name and address of the dispenser.
        (2) The serial number and date of the prescription or of the prescription's filling.
        (3) The name of the drug's prescriber and, if stated in the prescription, the name of the patient.
        (4) The directions for use and cautionary statements, if any, contained in the prescription.
This exemption does not apply to any drugs dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to a drug dispensed in violation of subsection (a), (b), (c), or (d).
    (f) The state department may adopt rules to remove drugs subject to section 4(4) of this chapter, section 7 of this chapter, or section 8 of this chapter from the requirements of subsections (a) through (d) when the requirements are not necessary for the protection of public health. Drugs removed from the prescription requirements of the Federal Act by regulations issued under the Federal Act may also, by rules adopted by the state department, be removed from the requirement of subsections (a) through (d).
    (g) A drug that is subject to subsections (a) through (d) is considered to be misbranded if at any time before dispensing the drug's label fails to bear the statement "Caution: Federal Law Prohibits Dispensing Without Prescription" or "Caution: State Law Prohibits Dispensing Without Prescription". A drug to which subsections (a) through (d) does do not apply is considered to be misbranded if, at any time before dispensing, the drug's label bears the caution statement described in this subsection.


    (h) This section does not relieve a person from a requirement prescribed by or under authority of law with respect to drugs included within the classifications of narcotic drugs or marijuana as defined in the applicable federal and state laws relating to narcotic drugs and marijuana.
     (i) A drug may be dispensed under subsection (b) upon an electronically transmitted prescription only to the extent permitted by federal law.
SOURCE: IC 16-42-3-9; (05)ES0590.1.6. -->     SECTION 6. IC 16-42-3-9 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. (a) Sections 7 and 8 of this chapter do not apply to the following:
        (1) To a drug dispensed on a written or an electronically transmitted prescription signed by or with an electronic signature of a physician, dentist, or veterinarian (except a drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail) if the physician, dentist, or veterinarian is licensed by law to administer the drug, and the drug bears a label containing the name and place of business of the dispenser, the serial number and date of the prescription, and the name of the physician, dentist, or veterinarian.
        (2) To a drug exempted by rule of the state department and that is intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
        (3) To a drug sold in Indiana or introduced into intrastate commerce at any time before the enactment of the Federal Act, if the drug's labeling contained the same representations concerning the conditions of the drug's use.
        (4) To any drug that is licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et seq.) or under the Animal Virus-Serum Toxin Act of March 4, 1913 (13 Stat. 832; 21 U.S.C. 151 et seq.).
        (5) To a drug subject to section 4(10) of this chapter.
    (b) Rules exempting drugs intended for investigational use under subsection (a)(2) may, within the discretion of the state department among other conditions relating to the protection of the public health, provide for conditioning the exemption upon the following:
        (1) The submission to the state department, before any clinical testing of a new drug is undertaken, of reports by the manufacturer or the sponsor of the investigation of the drug or preclinical tests, including tests on animals, of the drug adequate to justify the proposed clinical testing.
        (2) The manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of the investigators that patients to whom the drug is administered will be under the manufacturer's or sponsor's personal supervision or under the supervision of investigators responsible to the manufacturer or sponsor and that the manufacturer or sponsor will not supply the drug to any other investigator or to clinics for administration to human beings.
        (3) The establishment and maintenance of the records and the making of the reports to the state department by the manufacturer or the sponsor of the investigation of the drug of data (including analytical reports by investigators) obtained as the result of the investigational use of the drug that the state department finds will enable the state department to evaluate the safety and effectiveness of the drug if an application is filed under section 8 of this chapter.
    (c) Rules exempting drugs intended for investigational use under subsection (a)(2) must provide that the exemption is conditioned upon the manufacturer or the sponsor of the investigation requiring that experts using the drugs for investigational purposes certify to the manufacturer or sponsor that the experts will inform any human beings to whom the drugs or any controls used in connection with the drugs are being administered that the drugs are being used for investigational purposes and will obtain the consent of the human beings or their representatives, except where they consider it not feasible or, in their professional judgment, contrary to the best interests of the human beings.
    (d) This section does not require a clinical investigator to submit directly to the state department reports on the investigational use of drugs. The regulations adopted under Section 505(i) of the Federal Act are the rules in Indiana. The state may adopt rules, whether or not in accordance with regulations promulgated under the Federal Act.
SOURCE: IC 16-42-19-7; (05)ES0590.1.7. -->     SECTION 7. IC 16-42-19-7 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 7. As used in this chapter, "prescription" means:
        (1) a written order to or for an ultimate user for a drug or device containing the name and address of the patient, the name and strength or size of the drug or device, the amount to be dispensed, adequate directions for the proper use of the drug or device by the patient, and the name of the practitioner, issued and signed by a practitioner; or
        (2) an order transmitted by other means of communication from a practitioner that is:
             (A) immediately reduced to writing by the pharmacist; pharmacist or pharmacist intern (as defined in IC 25-26-13-2); or
            (B) for an electronically transmitted prescription:
                (i) has the electronic signature of the practitioner; and
                (ii) is recorded by the pharmacist in an electronic format.

SOURCE: IC 16-42-19-12; (05)ES0590.1.8. -->     SECTION 8. IC 16-42-19-12 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 12. Except as authorized under IC 25-26-13-25(c), IC 25-26-13-25(d), a person may not refill a prescription or drug order for a legend drug except in the manner designated on the prescription or drug order or by the authorization of the practitioner.
SOURCE: IC 16-42-22-3; (05)ES0590.1.9. -->     SECTION 9. IC 16-42-22-3 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 3. As used in this chapter, "customer" means the individual for whom a prescription is written or electronically transmitted or the individual's representative.
SOURCE: IC 16-42-22-6; (05)ES0590.1.10. -->     SECTION 10. IC 16-42-22-6 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6. (a) Each written prescription issued by a practitioner must have two (2) signature lines printed at the bottom of the prescription form, one (1) of which must be signed by the practitioner for the prescription to be valid. Under the blank line on the left side of the form must be printed the words "Dispense as written.". Under the blank line on the right side of the form must be printed the words "May substitute.".
     (b) Each electronically transmitted prescription issued by a practitioner must:
        (1) have an electronic signature; and
        (2) include the electronically transmitted instructions "Dispense as written." or "May substitute.".

SOURCE: IC 16-42-22-8; (05)ES0590.1.11. -->     SECTION 11. IC 16-42-22-8 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 8. (a) For substitution to occur for a prescription other than a prescription filled under the Medicaid program (42 U.S.C. 1396 et seq.), the children's health insurance program established under IC 12-17.6-2, or the Medicare program (42 U.S.C. 1395 et seq.):
        (1) the practitioner must:
             (A) sign on the line under which the words "May substitute" appear; or
            (B) for an electronically transmitted prescription, electronically transmit the instruction "May substitute.";
and
        (2) the pharmacist must inform the customer of the substitution.
    (b) This section does not authorize any substitution other than substitution of a generically equivalent drug product.
SOURCE: IC 16-42-22-9; (05)ES0590.1.12. -->     SECTION 12. IC 16-42-22-9 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. If the practitioner communicates instructions to the pharmacist orally or electronically, the pharmacist shall:
         (1) indicate the instructions in the pharmacist's own handwriting on the written copy of the prescription order; or
        (2) record the electronically transmitted instructions in an electronic format.

SOURCE: IC 16-42-22-10; (05)ES0590.1.13. -->     SECTION 13. IC 16-42-22-10 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 10. (a) If a prescription is filled under the Medicaid program (42 U.S.C. 1396 et seq.), the children's health insurance program established under IC 12-17.6-2, or the Medicare program (42 U.S.C. 1395 et seq.), the pharmacist shall substitute a generically equivalent drug product and inform the customer of the substitution if the substitution would result in a lower price unless:
        (1) the words "Brand Medically Necessary" are:
             (A) written in the practitioner's own writing on the form; or
             (B) electronically transmitted with an electronically transmitted prescription; or
        (2) the practitioner has indicated that the pharmacist may not substitute a generically equivalent drug product by:
             (A) orally stating that a substitution is not permitted; or
            (B) for an electronically transmitted prescription, indicating with the electronic prescription that a substitution is not permitted.

    (b) If a practitioner orally states that a generically equivalent drug product may not be substituted, the practitioner must subsequently forward to the pharmacist a written or electronically transmitted prescription with the "Brand Medically Necessary" instruction appropriately indicated in the physician's own handwriting.
    (c) This section does not authorize any substitution other than substitution of a generically equivalent drug product.
SOURCE: IC 16-42-22-12; (05)ES0590.1.14. -->     SECTION 14. IC 16-42-22-12 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 12. The pharmacist shall record on the prescription in writing or in an electronic format

for an electronically transmitted prescription the name of the manufacturer or distributor, or both, of the actual drug product dispensed under this chapter.

SOURCE: IC 25-26-13-2; (05)ES0590.1.15. -->     SECTION 15. IC 25-26-13-2 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2. As used in this chapter:
    "Board" means the Indiana board of pharmacy.
    "Controlled drugs" are those drugs on schedules I through V of the Federal Controlled Substances Act or on schedules I through V of IC 35-48-2.
    "Counseling" means effective communication between a pharmacist and a patient concerning the contents, drug to drug interactions, route, dosage, form, directions for use, precautions, and effective use of a drug or device to improve the therapeutic outcome of the patient through the effective use of the drug or device.
    "Dispensing" means issuing one (1) or more doses of a drug in a suitable container with appropriate labeling for subsequent administration to or use by a patient.
    "Drug" means:
        (1) articles or substances recognized in the official United States Pharmacopoeia, official National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them;
        (2) articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;
        (3) articles other than food intended to affect the structure or any function of the body of man or animals; or
        (4) articles intended for use as a component of any article specified in subdivisions (1) through (3) and devices.
    "Drug order" means a written order in a hospital or other health care institution for an ultimate user for any drug or device, issued and signed by a practitioner, or an order transmitted by other means of communication from a practitioner, which is immediately reduced to writing by the pharmacist, registered nurse, or other licensed health care practitioner authorized by the hospital or institution. The order shall contain the name and bed number of the patient; the name and strength or size of the drug or device; unless specified by individual institution policy or guideline, the amount to be dispensed either in quantity or days; adequate directions for the proper use of the drug or device when it is administered to the patient; and the name of the prescriber.
    "Drug regimen review" means the retrospective, concurrent, and

prospective review by a pharmacist of a patient's drug related history that includes the following areas:
        (1) Evaluation of prescriptions or drug orders and patient records for drug allergies, rational therapy contradictions, appropriate dose and route of administration, appropriate directions for use, or duplicative therapies.
        (2) Evaluation of prescriptions or drug orders and patient records for drug-drug, drug-food, drug-disease, and drug-clinical laboratory interactions.
        (3) Evaluation of prescriptions or drug orders and patient records for adverse drug reactions.
        (4) Evaluation of prescriptions or drug orders and patient records for proper utilization and optimal therapeutic outcomes.
    "Drug utilization review" means a program designed to measure and assess on a retrospective and prospective basis the proper use of drugs.
    "Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article including any component part or accessory, which is:
        (1) recognized in the official United States Pharmacopoeia, official National Formulary, or any supplement to them;
        (2) intended for use in the diagnosis of disease or other conditions or the cure, mitigation, treatment, or prevention of disease in man or other animals; or
        (3) intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
     "Electronic data intermediary" means an entity that provides the infrastructure that connects a computer system or another electronic device used by a prescribing practitioner with a computer system or another electronic device used by a pharmacy to facilitate the secure transmission of:
        (1) an electronic prescription order;
        (2) a refill authorization request;
        (3) a communication; and
        (4) other patient care information;
between a practitioner and a pharmacy.

     "Electronic signature" means an electronic sound, symbol, or process:
        (1) attached to or logically associated with a record; and


        (2) executed or adopted by a person;
with the intent to sign the record.

     "Electronically transmitted" or "electronic transmission" means the transmission of a prescription in electronic form. The term does not include the transmission of a prescription by facsimile.
    "Investigational or new drug" means any drug which is limited by state or federal law to use under professional supervision of a practitioner authorized by law to prescribe or administer such drug.
    "Legend drug" has the meaning set forth in IC 16-18-2-199.
    "License" and "permit" are interchangeable and mean a written certificate from the Indiana board of pharmacy for the practice of pharmacy or the operation of a pharmacy.
    "Nonprescription drug" means a drug that may be sold without a prescription and that is labeled for use by a patient in accordance with state and federal laws.
    "Person" means any individual, partnership, copartnership, firm, company, corporation, association, joint stock company, trust, estate, or municipality, or a legal representative or agent, unless this chapter expressly provides otherwise.
    "Practitioner" has the meaning set forth in IC 16-42-19-5.
    "Pharmacist" means a person licensed under this chapter.
    "Pharmacist extern" means a pharmacy student enrolled full time in an approved school of pharmacy and who is working in a school sponsored, board approved program related to the practice of pharmacy.
    "Pharmacist intern" means a person who is working to secure additional hours of practice and experience prior to making application for a license to practice as a pharmacist.
    "Pharmacy" means any facility, department, or other place where prescriptions are filled or compounded and are sold, dispensed, offered, or displayed for sale and which has as its principal purpose the dispensing of drug and health supplies intended for the general health, welfare, and safety of the public, without placing any other activity on a more important level than the practice of pharmacy.
    "The practice of pharmacy" or "the practice of the profession of pharmacy" means a patient oriented health care profession in which pharmacists interact with and counsel patients and with other health care professionals concerning drugs and devices used to enhance patients' wellness, prevent illness, and optimize the outcome of a drug or device, by accepting responsibility for performing or supervising a pharmacist intern, a pharmacist extern, or an unlicensed person under

section 18(a)(4) of this chapter to do the following acts, services, and operations:
        (1) The offering of or performing of those acts, service operations, or transactions incidental to the interpretation, evaluation, and implementation of prescriptions or drug orders.
        (2) The compounding, labeling, administering, dispensing, or selling of drugs and devices, including radioactive substances, whether dispensed under a practitioner's prescription or drug order or sold or given directly to the ultimate consumer.
        (3) The proper and safe storage and distribution of drugs and devices.
        (4) The maintenance of proper records of the receipt, storage, sale, and dispensing of drugs and devices.
        (5) Counseling, advising, and educating patients, patients' caregivers, and health care providers and professionals, as necessary, as to the contents, therapeutic values, uses, significant problems, risks, and appropriate manner of use of drugs and devices.
        (6) Assessing, recording, and reporting events related to the use of drugs or devices.
        (7) Provision of the professional acts, professional decisions, and professional services necessary to maintain all areas of a patient's pharmacy related care as specifically authorized to a pharmacist under this article.
    "Prescription" means a written order or an order transmitted by other means of communication from a practitioner to or for an ultimate user for any drug or device containing the name and address of the patient, the name and strength or size of the drug or device, the amount to be dispensed, adequate directions for the proper use of the drug or device by the patient, and the name of the practitioner issued and, if the prescription is in written form, signed by a practitioner.
    "Prescription" means a written order or an order transmitted by other means of communication from a practitioner to or for an ultimate user for any drug or device containing:
        (1) the name and address of the patient;
        (2) the date of issue;
        (3) the name and strength or size (if applicable) of the drug or device;
        (4) the amount to be dispensed (unless indicated by directions and duration of therapy);
        (5) adequate directions for the proper use of the drug or device by the patient;


        (6) the name of the practitioner; and
        (7) the signature of the practitioner if the prescription:
             (A) is in written form, the signature of the practitioner; or
            (B) is in electronic form, the electronic signature of the practitioner.

    "Qualifying pharmacist" means the pharmacist who will qualify the pharmacy by being responsible to the board for the legal operations of the pharmacy under the permit.
    "Record" means all papers, letters, memoranda, notes, prescriptions, drug orders, invoices, statements, patient medication charts or files, computerized records, or other written indicia, documents, or objects which are used in any way in connection with the purchase, sale, or handling of any drug or device.
    "Sale" means every sale and includes:
        (1) manufacturing, processing, transporting, handling, packaging, or any other production, preparation, or repackaging;
        (2) exposure, offer, or any other proffer;
        (3) holding, storing, or any other possession;
        (4) dispensing, giving, delivering, or any other supplying; and
        (5) applying, administering, or any other using.
SOURCE: IC 25-26-13-4; (05)ES0590.1.16. -->     SECTION 16. IC 25-26-13-4 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. (a) The board may:
        (1) promulgate rules and regulations under IC 4-22-2 for implementing and enforcing this chapter;
        (2) establish requirements and tests to determine the moral, physical, intellectual, educational, scientific, technical, and professional qualifications for applicants for pharmacists' licenses;
        (3) refuse to issue, deny, suspend, or revoke a license or permit or place on probation or fine any licensee or permittee under this chapter;
        (4) regulate the sale of drugs and devices in the state of Indiana;
        (5) impound, embargo, confiscate, or otherwise prevent from disposition any drugs, medicines, chemicals, poisons, or devices which by inspection are deemed unfit for use or would be dangerous to the health and welfare of the citizens of the state of Indiana; the board shall follow those embargo procedures found in IC 16-42-1-18 through IC 16-42-1-31, and persons may not refuse to permit or otherwise prevent members of the board or their representatives from entering such places and making such inspections;
        (6) prescribe minimum standards with respect to physical

characteristics of pharmacies, as may be necessary to the maintenance of professional surroundings and to the protection of the safety and welfare of the public;
        (7) subject to IC 25-1-7, investigate complaints, subpoena witnesses, schedule and conduct hearings on behalf of the public interest on any matter under the jurisdiction of the board;
        (8) prescribe the time, place, method, manner, scope, and subjects of licensing examinations which shall be given at least twice annually; and
        (9) perform such other duties and functions and exercise such other powers as may be necessary to implement and enforce this chapter.
    (b) The board shall adopt rules under IC 4-22-2 for the following:
        (1) Establishing standards for the competent practice of pharmacy.
        (2) Establishing the standards for a pharmacist to counsel individuals regarding the proper use of drugs.
    (c) The board may grant or deny a temporary variance to a rule it has adopted if:
        (1) the board has adopted rules which set forth the procedures and standards governing the grant or denial of a temporary variance; and
        (2) the board sets forth in writing the reasons for a grant or denial of a temporary variance.
     (d) The board shall adopt rules and procedures, in consultation with the medical licensing board, concerning the electronic transmission of prescriptions. The rules adopted under this subsection must address the following:
        (1) Privacy protection for the practitioner and the practitioner's patient.
        (2) Security of the electronic transmission.
        (3) A process for approving electronic data intermediaries for the electronic transmission of prescriptions.
        (4) Use of a practitioner's United States Drug Enforcement Agency registration number.
        (5) Protection of the practitioner from identity theft or fraudulent use of the practitioner's prescribing authority.

SOURCE: IC 25-26-13-25; (05)ES0590.1.17. -->     SECTION 17. IC 25-26-13-25 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 25. (a) All original prescriptions, whether in written or electronic format, shall be numbered and maintained in numerical and chronological order, or in a manner approved by the board and accessible for at least two (2)

years in the pharmacy. A prescription transmitted from a practitioner by means of communication other than writing must immediately be reduced to writing or recorded in an electronic format by the pharmacist. The files shall be open for inspection to any member of the board or its duly authorized agent or representative.
     (b) A prescription may be electronically transmitted from the practitioner by computer or another electronic device to a pharmacy that is licensed under this article or any other state or territory. An electronic data intermediary that is approved by the board:
        (1) may transmit the prescription information between the prescribing practitioner and the pharmacy;
        (2) may archive copies of the electronic information related to the transmissions as necessary for auditing and security purposes; and
        (3) must maintain patient privacy and confidentiality of all archived information as required by applicable state and federal laws.

    (b) (c) Except as provided in subsection (c), (d), a prescription for any drug, the label of which bears either the legend, "Caution: Federal law prohibits dispensing without prescription" or "Rx Only", may not be refilled without written, electronically transmitted, or oral authorization of a licensed practitioner.
    (c) (d) A prescription for any drug, the label of which bears either the legend, "Caution: Federal law prohibits dispensing without prescription" or "Rx Only", may be refilled by a pharmacist one (1) time without the written, electronically transmitted, or oral authorization of a licensed practitioner if all of the following conditions are met:
        (1) The pharmacist has made every reasonable effort to contact the original prescribing practitioner or the practitioner's designee for consultation and authorization of the prescription refill.
        (2) The pharmacist believes that, under the circumstances, failure to provide a refill would be seriously detrimental to the patient's health.
        (3) The original prescription authorized a refill but a refill would otherwise be invalid for either of the following reasons:
            (A) All of the authorized refills have been dispensed.
            (B) The prescription has expired under subsection (f). (g).
        (4) The prescription for which the patient requests the refill was:
            (A) originally filled at the pharmacy where the request for a refill is received and the prescription has not been transferred

for refills to another pharmacy at any time; or
            (B) filled at or transferred to another location of the same pharmacy or its affiliate owned by the same parent corporation if the pharmacy filling the prescription has full access to prescription and patient profile information that is simultaneously and continuously updated on the parent corporation's information system.
        (5) The drug is prescribed for continuous and uninterrupted use and the pharmacist determines that the drug is being taken properly in accordance with IC 25-26-16.
        (6) The pharmacist shall document the following information regarding the refill:
            (A) The information required for any refill dispensed under subsection (d). (e).
            (B) The dates and times that the pharmacist attempted to contact the prescribing practitioner or the practitioner's designee for consultation and authorization of the prescription refill.
            (C) The fact that the pharmacist dispensed the refill without the authorization of a licensed practitioner.
        (7) The pharmacist notifies the original prescribing practitioner of the refill and the reason for the refill by the practitioner's next business day after the refill has been made by the pharmacist.
        (8) Any pharmacist initiated refill under this subsection may not be for more than the minimum amount necessary to supply the patient through the prescribing practitioner's next business day. However, a pharmacist may dispense a drug in an amount greater than the minimum amount necessary to supply the patient through the prescribing practitioner's next business day if:
            (A) the drug is packaged in a form that requires the pharmacist to dispense the drug in a quantity greater than the minimum amount necessary to supply the patient through the prescribing practitioner's next business day; or
            (B) the pharmacist documents in the patient's record the amount of the drug dispensed and a compelling reason for dispensing the drug in a quantity greater than the minimum amount necessary to supply the patient through the prescribing practitioner's next business day.
        (9) Not more than one (1) pharmacist initiated refill is dispensed under this subsection for a single prescription.
        (10) The drug prescribed is not a controlled substance.
A pharmacist may not refill a prescription under this subsection if the

practitioner has designated on the prescription form the words "No Emergency Refill".
    (d) (e) When refilling a prescription, the refill record shall include:
        (1) the date of the refill;
        (2) the quantity dispensed if other than the original quantity; and
        (3) the dispenser's identity on:
            (A) the original prescription form; or
            (B) another board approved, uniformly maintained, readily retrievable record.
    (e) (f) The original prescription form or the other board approved record described in subsection (d) (e) must indicate by the number of the original prescription the following information:
        (1) The name and dosage form of the drug.
        (2) The date of each refill.
        (3) The quantity dispensed.
        (4) The identity of the pharmacist who dispensed the refill.
        (5) The total number of refills for that prescription.
    (f) (g) A prescription is valid for not more than one (1) year after the original date of issue.
    (g) (h) A pharmacist may not knowingly dispense a prescription after the demise of the practitioner, unless in the pharmacist's professional judgment it is in the best interest of the patient's health.
    (h) (i) A pharmacist may not knowingly dispense a prescription after the demise of the patient.
    (i) (j) A pharmacist or a pharmacy shall not resell, reuse, or redistribute a medication that is returned to the pharmacy after being dispensed unless the medication:
        (1) was dispensed to a patient:
            (A) residing in an institutional facility (as defined in 856 IAC 1-28.1-1(6)); or
            (B) in a hospice program under IC 16-25;
        (2) was properly stored and securely maintained according to sound pharmacy practices;
        (3) is returned unopened and:
            (A) was dispensed in the manufacturer's original:
                (i) bulk, multiple dose container with an unbroken tamper resistant seal; or
                (ii) unit dose package; or
            (B) was packaged by the dispensing pharmacy in a:
                (i) multiple dose blister container; or
                (ii) unit dose package;
        (4) was dispensed by the same pharmacy as the pharmacy

accepting the return;
        (5) is not expired; and
        (6) is not a controlled substance (as defined in IC 35-48-1-9), unless the pharmacy holds a Type II permit (as described in section 17 of this chapter).
    (j) (k) A pharmacist may use the pharmacist's professional judgment as to whether to accept medication for return under this section.
    (k) (l) A pharmacist who violates subsection (c) (d) commits a Class A infraction.

SOURCE: IC 25-26-13-25.5; (05)ES0590.1.18. -->     SECTION 18. IC 25-26-13-25.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 25.5. A prescription may be transmitted electronically from a practitioner to a pharmacy only through the use of an electronic data intermediary approved by the board.
SOURCE: IC 25-26-14-1; (05)ES0590.1.19. -->     SECTION 19. IC 25-26-14-1 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 1. (a) This chapter applies to any individual, partnership, limited liability company, corporation, or business firm:
         (1) located within or outside Indiana; and
        (2)
engaging in the wholesale distribution of legend drugs within in Indiana.
     (b) Except as required by federal law or regulation, the requirements of this chapter do not apply to a manufacturer that is approved by the federal Food and Drug Administration. However, the board may adopt rules concerning manufacturers that the board considers appropriate and necessary.
SOURCE: IC 25-26-14-1.5; (05)ES0590.1.20. -->     SECTION 20. IC 25-26-14-1.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 1.5. As used in this chapter, "adulterated" refers to a drug that:
        (1) consists in whole or in part of a filthy, putrid, or decomposed substance;
        (2) has been produced, prepared, packed, or held under unsanitary conditions and may have been contaminated or rendered injurious to health;
        (3) has been subjected to conditions in the manufacture, processing, packing, or holding of the drug that do not conform to current standards of manufacturing to ensure that the drug is safe for use and possesses the identity, strength, quality, and purity characteristics that the drug is represented to possess;
        (4) is contained in a container composed of a poisonous or deleterious substance that may render the drug injurious to health;
        (5) bears or contains, for purposes of coloring only, a color additive that is unsafe;
        (6) is of a different strength, quality, or purity from the official compendium standard for the drug; or
        (7) does not meet the considerations of the federal Food, Drug, and Cosmetic Act.

SOURCE: IC 25-26-14-1.7; (05)ES0590.1.21. -->     SECTION 21. IC 25-26-14-1.7 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 1.7. As used in this chapter, "authenticate" means to affirmatively verify before distribution occurs that each transaction that is listed on:
        (1) the pedigree of a drug; and
        (2) other accompanying documentation for a drug;
has occurred.

SOURCE: IC 25-26-14-1.8; (05)ES0590.1.22. -->     SECTION 22. IC 25-26-14-1.8 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 1.8. As used in this chapter, "authorized distributor" means a wholesale drug distributor with which a manufacturer has established an ongoing relationship to distribute the manufacturer's products. For purposes of this section, an ongoing relationship exists between a wholesale drug distributor, including any affiliated group (as defined in Section 1504 of the Internal Revenue Code) of which the wholesale distributor is a member, and a manufacturer if the wholesale drug distributor:
        (1) has a written agreement currently in effect with the manufacturer evidencing an ongoing relationship;
        (2) is listed on the manufacturer's current monthly updated list of authorized distributors; or

         (3) has a verifiable account with the manufacturer and a minimal transaction or volume requirement limit of:
            (A) five thousand (5,000) units per company in the previous twelve (12) months; or
            (B) twelve (12) purchases at the manufacturer's minimum purchasing requirement per invoice in the previous twelve (12) months.

SOURCE: IC 25-26-14-4.1; (05)ES0590.1.23. -->     SECTION 23. IC 25-26-14-4.1 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4.1. As used in this chapter,

"compendium" refers to:
        (1) the United States Pharmacopoeia;
        (2) the Homeopathic Pharmacopoeia of the United States;
        (3) the National Formulary;
        (4) a drug approved by the federal Food and Drug Administration; or
        (5) a supplement to a document specified in subdivision (1), (2), or (3).

SOURCE: IC 25-26-14-4.2; (05)ES0590.1.24. -->     SECTION 24. IC 25-26-14-4.2 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4.2. As used in this chapter, "contraband" refers to a drug:
        (1) that is counterfeit;
        (2) that is stolen;
        (3) that is misbranded;
        (4) that is obtained by fraud;
        (5) that is purchased by a nonprofit institution for the nonprofit institution's own use and placed in commerce in violation of the own use agreement for the drug;
        (6) for which a required pedigree does not exist; or
        (7) for which a pedigree in existence:
            (A) has been forged, counterfeited, or falsely created; or
            (B) contains any altered, false, or misrepresented information.

SOURCE: IC 25-26-14-4.3; (05)ES0590.1.25. -->     SECTION 25. IC 25-26-14-4.3 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4.3. As used in this chapter, "counterfeit" refers to a drug, or the container, seal, or labeling of a drug, that, without authorization, bears the trademark, trade name, or other identifying mark or imprint of a manufacturer, processor, packer, or distributor other than the person that manufactured, processed, packed, or distributed the drug.
SOURCE: IC 25-26-14-4.4; (05)ES0590.1.26. -->     SECTION 26. IC 25-26-14-4.4 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4.4. As used in this chapter, "deliver" means the actual, constructive, or attempted transfer of a drug from one (1) person to another.
SOURCE: IC 25-26-14-4.5; (05)ES0590.1.27. -->     SECTION 27. IC 25-26-14-4.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4.5. As used in this chapter, "designated representative" means an individual who:
        (1) is designated by a wholesale drug distributor;
        (2) serves as the wholesale drug distributor's responsible individual with the board; and
        (3) is actively involved in and aware of the actual daily operation of the wholesale drug distributor.

SOURCE: IC 25-26-14-4.7; (05)ES0590.1.28. -->     SECTION 28. IC 25-26-14-4.7 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4.7. As used in this chapter, "distribute" means to sell, offer to sell, deliver, offer to deliver, broker, give away, or transfer a legend drug, whether by passage of title or physical movement, or both. The term does not include the following:
        (1) Dispensing or administering a legend drug.
        (2) Delivering or offering to deliver a legend drug by a common carrier in the usual course of business as a common carrier.
        (3) The provision of a drug sample to a patient by a:
            (A) practitioner;
            (B) health care professional acting at the direction and under the supervision of a practitioner; or
            (C) hospital's or other health care entity's pharmacy that received the drug sample in accordance with this chapter and other applicable law to administer or dispense and that is acting at the direction of a practitioner;
        licensed to prescribe the legend drug.

SOURCE: IC 25-26-14-4.9; (05)ES0590.1.29. -->     SECTION 29. IC 25-26-14-4.9 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4.9. As used in this chapter, "drug" means any of the following:
        (1) Articles recognized in an official compendium and designated by the board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.
        (2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.
        (3) Articles other than food intended to affect the structure or function of the body of humans or animals.
        (4) Articles intended for use as a component of an article specified in subdivision (1), (2), or (3).
The term does not include a device or a device component, part, or accessory.

SOURCE: IC 25-26-14-6; (05)ES0590.1.30. -->     SECTION 30. IC 25-26-14-6 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6. As used in this

chapter, "health care entity" means any organization or business that provides diagnostic, medical, surgical, dental treatment, or rehabilitative care. The term does not include a pharmacy or wholesale drug distributor.

SOURCE: IC 25-26-14-6.5; (05)ES0590.1.31. -->     SECTION 31. IC 25-26-14-6.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6.5. As used in this chapter, "label" means a display of written, printed, or graphic matter on the immediate container of a legend drug.
SOURCE: IC 25-26-14-6.6; (05)ES0590.1.32. -->     SECTION 32. IC 25-26-14-6.6 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 6.6. As used in this chapter, "labeling" means labels and other written, printed, or graphic matter:
        (1) on a legend drug or a legend drug's container or wrapper; or
        (2) accompanying a legend drug.

SOURCE: IC 25-26-14-8.3; (05)ES0590.1.33. -->     SECTION 33. IC 25-26-14-8.3 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 8.3. As used in this chapter, "misbranded" means that a legend drug's label:
        (1) is false or misleading;
        (2) does not bear the name and address of the manufacturer, packer, or distributor or does not contain an accurate statement of the quantities of active ingredients of the legend drug;
        (3) does not show an accurate monograph for the legend drug; or
        (4) does not comply with any other requirements of the federal Food, Drug and Cosmetic Act.

SOURCE: IC 25-26-14-8.7; (05)ES0590.1.34. -->     SECTION 34. IC 25-26-14-8.7 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 8.7. As used in this chapter, "pedigree" means a statement or record in a written or an electronic form that is approved by the board, that records each distribution of a legend drug from the sale by the manufacturer or, except for drugs on the specified list of susceptible products, from the last authorized distributor of record through acquisition and sale by each wholesale drug distributor, and that includes the following information for each transaction:
        (1) The source of the legend drug, including the name and principal address of the seller.
        (2) The:
            (A) amount and dosage form and strength;
            (B) date of purchase;
            (C) sales invoice number;
            (D) container size;
            (E) number of containers;
            (F) lot number; and
            (G) proprietary and established name;
        of the legend drug.
        (3) The:
            (A) business name and address of each owner of the legend drug; and
            (B) legend drug's shipping information, including the name and address of the facility of each person certifying delivery or receipt of the legend drug.
        (4) Information that states that the wholesale drug distributor has acted with due diligence as required under this chapter with respect to another wholesale drug distributor from which the wholesale drug distributor purchased or may have purchased the legend drug.
        (5) A certification from the designated representative of the wholesale drug distributor that the information contained in the document is true and accurate under penalty of perjury.

SOURCE: IC 25-26-14-9; (05)ES0590.1.35. -->     SECTION 35. IC 25-26-14-9 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. As used in this chapter, "person" means an individual, a partnership, a business firm, a limited liability company, or a corporation, or another entity, including a governmental entity.
SOURCE: IC 25-26-14-9.2; (05)ES0590.1.36. -->     SECTION 36. IC 25-26-14-9.2 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9.2. As used in this chapter, "practitioner" has the meaning set forth in IC 16-42-19-5.
SOURCE: IC 25-26-14-9.3; (05)ES0590.1.37. -->     SECTION 37. IC 25-26-14-9.3 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9.3. As used in this chapter, "repackage" means changing the container, wrapper, quantity, or labeling of a legend drug to further the distribution of the legend drug.
SOURCE: IC 25-26-14-10.5; (05)ES0590.1.38. -->     SECTION 38. IC 25-26-14-10.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 10.5. As used in this chapter, "specified list of susceptible products" means a specific list of

legend drugs established by the board, the board's agent, or a third party approved by the board, as:
        (1) susceptible to adulteration, counterfeiting, or diversion; and
        (2) posing the potential for a particular public health risk.

SOURCE: IC 25-26-14-11; (05)ES0590.1.39. -->     SECTION 39. IC 25-26-14-11 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 11. As used in this chapter, "wholesale distribution" means distribution of to distribute legend drugs to persons other than a consumer or patient. The term does not include:
        (1) a sale or transfer between a division, a subsidiary, a parent, an affiliated, or a related company under the common ownership and control of a corporate entity;
        (2) the purchase or acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for the hospital's or health care entity's own use from the group purchasing organization or from other hospitals or health care entities that are members of the organization;
        (3) the sale of a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
        (4) the sale of a drug among hospitals or other health care entities that are under common control;
        (5) the sale of a drug for emergency medical reasons, including transfers of legend drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, if the gross dollar value of the transfers does not exceed five percent (5%) of the total legend drug sales revenue of either the transferor or transferee pharmacy during any twelve (12) consecutive month period;
        (6) the sale of a drug or the dispensing of a drug pursuant to a prescription;
        (7) the distribution of drug samples by manufacturers' representatives or distributors' representatives;
        (8) the sale of blood and blood components intended for transfusion;
        (9) the sale of a drug by a retail pharmacy to a practitioner (as defined in IC 25-26-13-2) for office use, if the gross dollar value of the transfers does not exceed five percent (5%) of the retail pharmacy's total legend drug sales during any twelve (12) consecutive months; or
        (10) the sale of a drug by a retail pharmacy that is ending its business and liquidating its inventory to another retail pharmacy;
         (11) drug returns by a hospital, health care entity, or charitable institution conducted under 21 CFR 203.23;
        (12) the sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use; or
        (13) the distribution of prescription drugs by the original manufacturer of the finished form of the prescription drug or the distribution of the prescription drugs by a co-promoting partner of the original manufacturer of the finished form of the prescription drug.

SOURCE: IC 25-26-14-12; (05)ES0590.1.40. -->     SECTION 40. IC 25-26-14-12 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 12. As used in this chapter, "wholesale drug distributor" means a person engaged in wholesale distribution of legend drugs, including:
        (1) manufacturers;
        (2) repackers;
        (3) own-label distributors;
        (4) private-label distributors;
        (5) jobbers;
        (6) brokers;
        (7) warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses;
        (8) independent wholesale drug traders; and
        (9) retail and hospital pharmacies that conduct wholesale distributions.
The term does not include a common carrier or person hired solely to transport prescription drugs.
SOURCE: IC 25-26-14-14; (05)ES0590.1.41. -->     SECTION 41. IC 25-26-14-14 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 14. (a) After September 14, 1992, A person may not engage in wholesale distributions of legend drugs without: having
         (1) obtaining and maintaining accreditation or certification from an accreditation body approved by the board under subsection (g);
        (2) obtaining and maintaining
a license from issued by the board; and
         (3) paying any reasonable fee required by the board.
    (b) The board may not issue or renew the license of a wholesale drug distributor that does not comply with this chapter.
    (c) The board may shall require a separate license for
        (1) each facility directly or indirectly owned or operated by the same business in Indiana; or
        (2) a parent entity with divisions, subsidiaries, or affiliate companies in Indiana when operations are conducted at more than one (1) location and there exists joint ownership and control among all the entities. or location where wholesale distribution operations are conducted.
    (d) An agent or employee of any licensed wholesale drug distributor does not need a license and may lawfully possess pharmaceutical drugs when acting in the usual course of business or employment.
    (e) The issuance of a license under this chapter does not affect tax liability imposed by the department of state revenue or the department of local government finance on any wholesale drug distributor.
    (f) The board may adopt rules that permit out-of-state wholesale drug distributors to obtain a license on the basis of reciprocity if:
        (1) an out-of-state wholesale drug distributor possesses a valid license granted by another state and the legal standards for licensure in the other state are comparable to the standards under this chapter; and
        (2) the other state extends reciprocity to wholesale drug distributors licensed in Indiana.
However, if the requirements for licensure under this chapter are more restrictive than the standards of the other state, the out-of-state wholesale drug distributor must comply with the additional requirements of this chapter to obtain a license under this chapter.
    (g) The board shall adopt rules under IC 4-22-2 to approve an accreditation body to:
        (1) evaluate a wholesale drug distributor's operations to determine compliance with:
            (A) professional standards;
            (B) this chapter; and
            (C) any other applicable law; and
        (2) perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesale drug distributor.

SOURCE: IC 25-26-14-14.5; (05)ES0590.1.42. -->     SECTION 42. IC 25-26-14-14.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 14.5. After June 30, 2006, a wholesale drug distributor may not accept or deliver a legend drug without a current, accompanying pedigree.
SOURCE: IC 25-26-14-15; (05)ES0590.1.43. -->     SECTION 43. IC 25-26-14-15 IS AMENDED TO READ AS

FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 15. (a) The board shall require the following minimum information from each wholesale drug distributor as part of the license described in section 14 of this chapter and as part of any renewal of such license:
        (1) The name, full business address, and telephone number of the licensee.
        (2) All trade or business names used by the licensee.
        (3) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of legend drugs.
        (4) The type of ownership of operation.
        (5) The name of each owner and operator of the licensee, including:
            (A) if an individual, the name, address, Social Security number, and date of birth of the individual;
            (B) if a partnership, the name, address, Social Security number, and date of birth of each partner, and the name of the partnership and federal employer identification number;
            (C) if a corporation:
                 (i) the name, address, Social Security number, date of birth, and title of each corporate officer and director;
                 (ii) the corporate names, and the name of the state of incorporation, the federal employer identification number, and the name of the parent company, if any; and
                (iii) the name, address, and Social Security number of each shareholder owning ten percent (10%) or more of the voting stock of the corporation, unless the stock is traded on a major stock exchange and not traded over the counter;

            (D) if a limited liability company, the name of each manager and member, the name and federal identification number of the limited liability company, and the name of the state where organized; and
            (E) if a sole proprietorship, the full name, address, Social Security number, and date of birth of the sole proprietor and the name and federal employer identification number of the business entity.
        (6) The name, address, and telephone number of the person designated by the licensee as responsible for the operation representative of the facilities. each facility.
        (7) Additional information concerning record keeping

required under this chapter.
    (b) The board shall require a wholesale drug distributor to post a surety bond of at least one hundred thousand dollars ($100,000), or an equivalent means of security acceptable to the board, including insurance, an irrevocable letter of credit, or funds deposited in a trust account or financial institution, to secure payment of any administrative penalties that may be imposed by the board and any fees and costs that may be incurred by the board and that:
        (1) are related to a license held by the wholesale drug distributor;
        (2) are authorized under Indiana law; and
        (3) the wholesale drug distributor fails to pay less than thirty (30) days after the penalties, fees, or costs become final.
However, a separate surety bond or an equivalent means of security is not required for a separate location or a company of the wholesale drug distributor.
    (c) The board may make a claim against a bond or security posted under subsection (b) within one (1) year after the wholesale drug distributor's license is no longer valid or sixty (60) days after the conclusion of:
        (1) an administrative or legal proceeding before or on behalf of the board that involves the wholesale drug distributor and results in penalties, fees, or costs described in subsection (b); or
        (2) an appeal of a proceeding described in subdivision (1);
whichever occurs later.
    (d) The board shall inspect each facility where wholesale distribution operations are conducted before initial licensure and periodically thereafter in accordance with a schedule determined by the board, but at least one (1) time in each three (3) year period.
    (e) A wholesale drug distributor must publicly display or have readily available all licenses and the most recent inspection report administered by the board.

    (b) (f) A material change in any information in subsection (a) of this section must be submitted to the board at the time of license renewal or within thirty (30) days from the date of the change, whichever occurs first.

SOURCE: IC 25-26-14-15.5; (05)ES0590.1.44. -->     SECTION 44. IC 25-26-14-15.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 15.5. (a) A wholesale drug distributor that is an authorized distributor of a manufacturer is

not considered to be an authorized distributor of the manufacturer under this chapter unless:
        (1) the manufacturer files the manufacturer's monthly updated list of authorized distributors with the board;
        (2) the list is available from the manufacturer upon request or on the Internet; and
        (3) the manufacturer notifies the board of any change to the list within ten (10) days after the change.
    (b) The board shall make available on the board's Internet web site a manufacturer's list of authorized distributors filed as described in subsection (a).

SOURCE: IC 25-26-14-16; (05)ES0590.1.45. -->     SECTION 45. IC 25-26-14-16 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 16. (a) In reviewing, for purposes of licensure or renewal of a license under this chapter, the qualifications of persons who engage in wholesale distribution of legend drugs within in Indiana, the board shall consider the following factors:
        (1) A conviction of the applicant relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances. finding by the board that the applicant has:
            (A) violated a law; or
            (B) been disciplined by a regulatory agency for violating a law;
        related to drug distribution in any state.

        (2) A felony criminal conviction of the applicant.
        (3) The applicant's past experience in the manufacture or distribution of legend drugs, including controlled substances.
        (4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution.
        (5) Suspension or revocation of any license held by the applicant or the applicant's owner or the imposition of sanctions against the applicant or the applicant's owner by the federal or a state or local government of any license held by the applicant for the manufacture or distribution of any drugs, including controlled substances.
        (6) Compliance with licensing requirements under previously granted licenses.
        (7) Compliance with requirements to maintain and make available to the board or to federal, state, or local law enforcement officials those records required under this chapter.
        (8) Any other factors or qualifications the board considers

relevant to the public health and safety, including whether the granting of the license would not be in the public interest.
     (b) In reviewing an application for licensure or renewal of a license under this chapter, the board shall consider the results of a national criminal history background check (as defined in IC 10-13-3-12) for:
        (1) the applicant;
        (2) all personnel involved in the operations of the wholesale drug distributor;
        (3) the most senior individual responsible for facility operations, purchasing, and inventory control, and the individual to whom the senior individual reports;
        (4) company officers;
        (5) key management personnel;
        (6) principals; and
        (7) owners with at least a ten percent (10%) interest in the wholesale drug distributor, if the wholesale drug distributor is a nonpublicly held company.
The national criminal history background check must be conducted at the applicant's expense and must include all states of residence since the applicant became eighteen (18) years of age.
    (c) An applicant shall provide and attest to:
        (1) an affirmation that the applicant has not been involved in or convicted of any criminal or prohibited acts; or

        (2) a statement providing a complete disclosure of the applicant's past criminal convictions and violations of state and federal laws;
regarding drugs.

SOURCE: IC 25-26-14-16.5; (05)ES0590.1.46. -->     SECTION 46. IC 25-26-14-16.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 16.5. (a) A wholesale drug distributor shall designate in writing on a form prescribed by the board a designated representative for each of the wholesale drug distributor's facilities licensed under this chapter.
    (b) A designated representative shall submit to the board an application prescribed by the board and provide to the board the following:
        (1) A set of the designated representative's fingerprints, under procedures specified by the board and according to requirements of the state police department under IC 10-13-3-38.5, with the payment of the amount equal to the costs of a national criminal history background check (as

defined in IC 10-13-3-12) of the designated representative to be obtained by the state police department.
        (2) The date and place of birth of the designated representative.
        (3) A list of the occupations, positions of employment, and offices held by the designated representative during the immediately preceding seven (7) years, including the principal business and address of the organization with which the occupation, position, or office was associated.
        (4) A statement concerning whether the designated representative, during the immediately preceding seven (7) years, has been temporarily or permanently enjoined by a court from violating a state or federal law regulating the possession, control, or distribution of drugs, including details of related events.
        (5) A description of any involvement by the designated representative with a business that:
            (A) manufactured, administered, prescribed, distributed, or stored drugs; and
            (B) was named as a party in a lawsuit;
        during the immediately preceding seven (7) years, including investments other than the ownership of stock in a publicly traded company or mutual fund.
        (6) A description of any criminal offense of which the designated representative has been convicted, regardless of whether adjudication of guilt was withheld or whether the designated representative pleaded nolo contendere. If the designated representative indicates that a criminal conviction is under appeal, the designated representative shall submit to the board:
            (A) a copy of the notice of appeal; and
            (B) a copy of the final written order of disposition.
        (7) A photograph of the designated representative taken within the immediately preceding thirty (30) days under procedures specified by the board.
        (8) A list of the name, address, occupation, and date and place of birth of each member of the designated representative's immediate family, including the designated representative's spouse, children, parents, and siblings, and the spouses of the designated representative's children and siblings. Information collected under this subdivision is confidential.
        (9) Any other information required by the board.


    (c) A designated representative must have at least two (2) years of verifiable full-time managerial or supervisory experience in a pharmacy or with a wholesale drug distributor licensed under this chapter or in another state. The designated representative's responsibilities must have included record keeping, storage, and shipment of legend drugs.
    (d) A designated representative shall not serve as the designated representative for more than one (1) wholesale drug distributor facility at any one (1) time.
    (e) A designated representative shall be actively involved and aware of the actual daily operations of the wholesale drug distributor as follows:
        (1) Be employed full time in a managerial position by the wholesale drug distributor.
        (2) Be physically present at the wholesale drug distributor's facility during normal business hours, except when absent due to illness, family illness or death, scheduled vacation, or another authorized absence.
        (3) Be aware of and knowledgeable about all policies and procedures pertaining to the operations of the wholesale drug distributor.
    (f) A designated representative must complete continuing education programs specified by the board regarding state and federal law relevant to the distribution, handling, and storage of legend drugs.

SOURCE: IC 25-26-14-16.6; (05)ES0590.1.47. -->     SECTION 47. IC 25-26-14-16.6 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 16.6. (a) A wholesale drug distributor that:
        (1) is licensed under this chapter;
        (2) is located outside Indiana; and
        (3) distributes legend drugs in Indiana;
shall designate an agent in Indiana for service of process.
    (b) A wholesale drug distributor that does not designate an agent under subsection (a) is considered to have designated the secretary of state to be the wholesale drug distributor's true and lawful attorney, upon whom legal process may be served in an action or a proceeding against the wholesale drug distributor arising from the wholesale drug distributor's wholesale distribution operations.
    (c) The board shall mail a copy of any service of process to a wholesale drug distributor by certified mail, return receipt

requested, postage prepaid, at the address designated by the wholesale drug distributor on the application for licensure submitted under this chapter.
    (d) Service of process on the secretary of state is sufficient in an action or a proceeding against a wholesale drug distributor that is not licensed under this chapter.

SOURCE: IC 25-26-14-17; (05)ES0590.1.48. -->     SECTION 48. IC 25-26-14-17 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 17. As a condition for receiving and retaining any a wholesale drug distributor license issued under to this chapter, each an applicant must satisfy the board that the applicant has and will continuously maintain the following:
        (1) Acceptable storage and handling conditions and facilities standards for each facility at which legend drugs are received, stored, warehoused, handled, held, offered, marketed, or displayed, or from which legend drugs are transported, including:
            (A) suitable construction of the facility and appropriate monitoring equipment to ensure that legend drugs in the facility are maintained in accordance with labeling or in compliance with official compendium standards;
            (B) suitable size and construction to facilitate cleaning, maintenance, and proper wholesale distribution operations;
            (C) adequate storage areas to provide appropriate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
            (D) a quarantine area for separate storage of legend drugs that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, suspected counterfeit, otherwise unfit for distribution, or contained in immediate or sealed secondary containers that have been opened;
            (E) maintenance of the facility in a clean and orderly condition;
            (F) maintenance of the facility in a commercial, nonresidential building; and
            (G) freedom of the facility from infestation.

        (2) Security of each facility from unauthorized entry as follows:
            (A) Entry into areas where legend drugs are held is limited to authorized personnel.
            (B) Each facility is equipped with
a security system that includes:
                (A) (i) an after hours central alarm or a comparable entry detection capability;
                (B) (ii) restricted premises access;
                (C) (iii) adequate outside perimeter lighting; and
                (D) (iv) safeguards against theft and diversion, including employee theft and theft or diversion facilitated or hidden by tampering with computers or electronic records; and
                (v) a means of protecting the integrity and confidentiality of data and documents and of making the data and documents readily available to the board and other state and federal law enforcement officials.

        (3) A reasonable system of record keeping that as follows:
            (A) The system describes all the wholesale distributor's activities governed by this chapter for the two (2) three (3) year period after the disposition of each product and all records are maintained for at least three (3) years after disposition of the legend drug to which the record applies.
            (B) The system is reasonably accessible as determined by board rules in any inspection authorized by the board.
             (C) The system provides a means to establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of all legend drugs, including the following:
                (i) For legend drugs manufactured by a manufacturer for which the wholesale drug distributor is an authorized distributor, a pedigree for each distributed legend drug that is on the specified list of susceptible products or that leaves the normal distribution chain of custody from the manufacturer to a wholesale drug distributor, to a pharmacy, and to the patient or the patient's agent.
                (ii) For legend drugs manufactured by a manufacturer for which the wholesale drug distributor is not an authorized distributor, a pedigree for each distributed legend drug.
                (iii) After January 1, 2007, at the board's discretion, for each legend drug received and distributed by the wholesale drug distributor, an electronic pedigree developed in accordance with standards and requirements of the board to authenticate, track, and trace legend drugs. The standards and requirements of the board may indicate the information required to be part of the electronic pedigree.
                (iv) Dates of receipt and distribution or other disposition of the legend drugs by the wholesale drug distributor.
                (v) Availability for inspection and photocopying by any authorized official of a local, state, or federal governmental agency for three (3) years after the creation date of the inventories and records.
            (D) Onsite electronic inventories and records are immediately available for inspection. Records kept at a central location apart from the inspection site and not electronically retrievable are available for inspection within two (2) working days after a request by an authorized official of a local, state, or federal governmental agency.
            (E) The system maintains an ongoing list of persons with whom the wholesale drug distributor does business.
            (F) The system provides for reporting counterfeit or suspected counterfeit legend drugs or counterfeiting or suspected counterfeiting activities to the board and federal Food and Drug Administration.
            (G) The system provides for mandatory reporting of significant shortages or losses of legend drugs to the board and federal Food and Drug Administration if diversion is known or suspected.

        (4) Written policies and procedures to which the wholesale drug distributor adheres for the receipt, security, storage, inventory, transport, shipping, and distribution of legend drugs, and that assure reasonable wholesale distributor preparation for, protection against, and handling of any facility security or operation problems, including the following:
            (A) those Facility security or operation problems caused by natural disaster or government emergency.
            (B) Correction of inventory inaccuracies. or
             (C) Product shipping and receiving problems.
            (C) (D) Quarantine and return to the manufacturer or destruction in accordance with state and federal law of all outdated product products and outdated or expired legend drugs, including appropriate documentation and witnessing.
            (D) (E) Appropriate disposition of returned goods. and
            (E) (F) Product recalls.
             (G) Identifying, recording, and reporting losses or thefts.
            (H) Implementation and maintenance of a continuous

quality improvement system.
            (I) Recalls and withdrawals of legend drugs due to:
                (i) an action initiated by the federal Food and Drug Administration or another federal, state, or local governmental agency;
                (ii) a volunteer action by the manufacturer to remove defective or potentially defective legend drugs from the market; or
                (iii) an action undertaken to promote public health and safety by replacing existing merchandise with an improved product or a new package design.
            (J) Disposition and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging are not used in counterfeiting activities, including necessary documentation and witnessing in accordance with state and federal law.
            (K) Investigation of discrepancies in the inventory involving counterfeit, suspected counterfeit, contraband, or suspected contraband legend drugs and reporting of discrepancies within three (3) business days to the board and any other appropriate state or federal governmental agency.
            (L) Reporting of criminal or suspected criminal activities involving the inventory of legend drugs to the board within three (3) business days.
            (M) Conducting for cause authentication and random authentication as required under sections 17.2, 17.3, and 17.8 of this chapter.

        (5) Written policies and procedures and sufficient inspection procedures for all incoming and outgoing product shipments, including the following:
            (A) Upon receipt, visual examination of each shipping container in a manner adequate to identify the
legend drugs in the container and to determine whether the legend drugs may be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, suspected counterfeit, damaged, or otherwise unfit for distribution.
            (B) Upon receipt, review of records by the wholesale drug distributor for the acquisition of legend drugs for accuracy and completeness, considering the:
                (i) total facts and circumstances surrounding each transaction involving the legend drugs; and


                (ii) wholesale drug distributors involved.
            (C) Quarantine of a legend drug considered to be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, suspected counterfeit, damaged, or otherwise unfit for distribution until:
                (i) examination and a determination that the
legend drug is not outdated, adulterated, misbranded, contaminated, contraband, counterfeit, damaged, or otherwise unfit for distribution; or
                (ii) the legend drug is destroyed or returned to the manufacturer or wholesale drug distributor from which the legend drug was acquired.
            (D) Written policies and procedures to ensure that a legend drug that was:
                (i) ordered in error or in excess of need by the wholesale drug distributor;
                (ii) identified within three (3) business days after receipt as ordered in error or in excess of need; and
                (iii) maintained such that the legend drug's integrity has not been compromised;
            may be returned to the manufacturer or wholesale drug distributor from which the
legend drug was acquired if the appropriate documentation is completed and necessary notations are made to a required pedigree.
            (E) Written policies and procedures to ensure that if the wholesale drug distributor determines that a legend drug is adulterated, misbranded, counterfeit, or suspected counterfeit, the wholesale drug distributor provides notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting to the board, the federal Food and Drug Administration, and the manufacturer or wholesale drug distributor from which the legend drug was acquired within three (3) business days.
            (F) Written policies and procedures to ensure that if the immediate or sealed outer or secondary container or labeling of a legend drug is adulterated, misbranded, counterfeit, or suspected counterfeit, the wholesale drug distributor:
                (i) quarantines the legend drug until the legend drug is destroyed or returned to the manufacturer or wholesale drug distributor from which the legend drug was acquired; and
                (ii) provides notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting to the board, the federal Food and Drug Administration, and the manufacturer or wholesale drug distributor from which the legend drug was acquired within three (3) business days.
            (G) Written policies and procedures to ensure that a legend drug that has been opened or used, but is not adulterated, misbranded, counterfeit, or suspected counterfeit, is identified as such and quarantined until the legend drug is destroyed or returned to the manufacturer or wholesale drug distributor from which the legend drug was acquired.
            (H) Written policies and procedures to ensure that:
                (i) a legend drug that will be returned to a manufacturer or wholesale drug distributor is kept under proper conditions for storage, handling, transport, and shipment before the return; and
                (ii) documentation showing that proper conditions were maintained is provided to the manufacturer or wholesale drug distributor to which the legend drug is returned.
            (I) Inspection of each outgoing shipment for identity of the legend drugs and to ensure that the legend drugs have not been damaged in storage or held under improper conditions.
            (J) Written policies and procedures to ensure that if conditions under which a legend drug has been returned to the wholesale drug distributor cast doubt on the legend drug's safety, identity, strength, quality, or purity, the legend drug is destroyed or returned to the manufacturer or wholesale drug distributor from which the legend drug was acquired unless examination, testing, or other investigation proves that the legend drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a legend drug has been returned cast doubt on the legend drug's safety, identity, strength, quality, or purity, the wholesale drug distributor considers the conditions under which the legend drug has been held, stored, or shipped before or during the legend drug's return and the condition of the legend drug and the legend drug's container, carton, or labeling upon receipt of the returned

legend drug.
            (K) Written policies and procedures to ensure that contraband, counterfeit, or suspected counterfeit legend drugs, other evidence of criminal activity, and accompanying documentation are retained until a disposition is authorized by the board and the federal Food and Drug Administration.
            (L) Written policies and procedures to ensure that any shipping, immediate, or sealed outer or secondary container or labeling, and accompanying documentation, suspected of or determined to be counterfeit or fraudulent, are retained until a disposition is authorized by the board and federal Food and Drug Administration.

        (6) Operations in compliance with all federal legal requirements applicable to wholesale drug distribution.
         (7) Written policies and procedures to provide for the secure and confidential storage of information with restricted access and to protect the integrity and confidentiality of the information.
        (8) A pedigree as required under this chapter, including an electronic pedigree developed in accordance with standards and requirements of the board under subdivision (3)(C)(iii).
        (9) Appropriate inventory management and control systems to:
            (A) prevent; and
            (B) allow detection and documentation of;
        theft, counterfeiting, or diversion of legend drugs.
        (10) If the wholesale drug distributor is involved in the distribution of controlled substances, registration with the federal Drug Enforcement Administration and board and compliance with all laws related to the storage, handling, transport, shipment, and distribution of controlled substances.
        (11) Isolation of controlled substances from noncontrolled substances and storage of the controlled substances in a secure area in accordance with federal Drug Enforcement Administration security requirements and standards.
        (12) Technology and equipment that allow the wholesale drug distributor to authenticate, track, and trace legend drugs. The technology and equipment meets standards set by the board and is used as required by the board to conduct for cause and random tracking, tracing, and authentication of legend drugs.


        (13) Employment, training, and documentation of the training concerning the proper use of the technology and equipment required under subdivision (12).
        (14) Packaging operations in accordance with an official compendium allowing the identification of a compromise in the integrity of the legend drugs due to tampering or adverse storage conditions.

SOURCE: IC 25-26-14-17.2; (05)ES0590.1.49. -->     SECTION 49. IC 25-26-14-17.2 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 17.2. (a) A wholesale drug distributor that purchases legend drugs from another wholesale drug distributor and has reason to believe that a legend drug purchased from the other wholesale drug distributor is counterfeit, suspected counterfeit, misbranded, or adulterated shall conduct a for cause authentication of each distribution of the legend drug back to the manufacturer.
    (b) A wholesale drug distributor that has engaged in the distribution of a legend drug for which a purchasing wholesale drug distributor conducts a for cause authentication under subsection (a) shall provide, upon request, detailed information regarding the distribution of the legend drug, including the:
        (1) date of purchase of the legend drug;
        (2) lot number of the legend drug;
        (3) sales invoice number of the
legend drug; and
        (4) contact information, including name, address, telephone number, and electronic mail address of the wholesale drug distributor that sold the legend drug.
    (c) If a wholesale drug distributor conducts a for cause authentication under subsection (a) and is unable to authenticate each distribution of the legend drug, the wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration not more than ten (10) business days after completing the attempted authentication.
    (d) If a wholesale drug distributor authenticates the distribution of a legend drug back to the manufacturer under subsection (a), the wholesale drug distributor shall maintain records of the authentication for three (3) years and shall produce the records for the board and the federal Food and Drug Administration upon request.

SOURCE: IC 25-26-14-17.3; (05)ES0590.1.50. -->     SECTION 50. IC 25-26-14-17.3 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS

[EFFECTIVE JULY 1, 2005]: Sec. 17.3. (a) A wholesale drug distributor that purchases legend drugs from another wholesale drug distributor shall, at least annually, conduct a random authentication of a required pedigree on at least ten percent (10%) of sales units of wholesale distributions of legend drugs purchased from other wholesale drug distributors.
    (b) If a wholesale drug distributor purchases from another wholesale drug distributor a legend drug that is on the specified list of susceptible products, the wholesale drug distributor shall, at least quarterly, conduct a random authentication of a required pedigree on at least ninety percent (90%) of sales units of distributions of legend drugs that are on the specified list of susceptible products and that were purchased from other wholesale drug distributors.
    (c) A wholesale drug distributor from whom another wholesale drug distributor purchases legend drugs shall cooperate with random authentications of pedigrees described in this section and provide requested information in a timely manner.

     (d) If a wholesale drug distributor conducts a random authentication under this section and is unable to authenticate each distribution of the legend drug, the wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration not more than ten (10) business days after completing the attempted authentication.

SOURCE: IC 25-26-14-17.8; (05)ES0590.1.51. -->     SECTION 51. IC 25-26-14-17.8 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 17.8. (a) A wholesale drug distributor licensed under this chapter that purchases legend drugs from a wholesale drug distributor that is not licensed under this chapter shall act with due diligence as required under this section.
    (b) Before the initial purchase of legend drugs from the unlicensed wholesale drug distributor, the licensed wholesale drug distributor shall obtain the following information from the unlicensed wholesale drug distributor:
        (1) A list of states in which the unlicensed wholesale drug distributor is licensed.
        (2) A list of states into which the unlicensed wholesale drug distributor ships legend drugs.
        (3) Copies of all state and federal regulatory licenses and registrations held by the unlicensed wholesale drug distributor.
        (4) The unlicensed wholesale drug distributor's most recent facility inspection reports.
        (5) Information regarding general and product liability insurance maintained by the unlicensed wholesale drug distributor, including copies of relevant policies.
        (6) A list of other names under which the unlicensed wholesale drug distributor does business or has been previously known.
        (7) A list of corporate officers and managerial employees of the unlicensed wholesale drug distributor.
        (8) A list of all owners of the unlicensed wholesale drug distributor that own more than ten percent (10%) of the unlicensed wholesale drug distributor, unless the unlicensed wholesale drug distributor is publicly traded.
        (9) A list of all disciplinary actions taken against the unlicensed wholesale drug distributor by state and federal agencies.
        (10) A description, including the address, dimensions, and other relevant information, of each facility used by the unlicensed wholesale drug distributor for
legend drug storage and distribution.
        (11) A description of legend drug import and export activities of the unlicensed wholesale drug distributor.
        (12) A description of the unlicensed wholesale drug distributor's procedures to ensure compliance with this chapter.
        (13) A statement:
            (A) as to whether; and
            (B) of the identity of each manufacturer for which;
        the unlicensed wholesale drug distributor is an authorized distributor.
    (c) Before the initial purchase of legend drugs from an unlicensed wholesale drug distributor, the licensed wholesale drug distributor shall:
        (1) request that the board obtain and consider the results of a national criminal history background check (as defined in IC 10-13-3-12) through the state police department of all individuals associated with the unlicensed wholesale drug distributor as specified for licensure of a wholesale drug distributor under section 16(b) of this chapter; and
        (2) verify the unlicensed wholesale drug distributor's status as an authorized distributor, if applicable.
    (d) If an unlicensed wholesale drug distributor's facility has not

been inspected by the board or the board's agent within three (3) years after a contemplated purchase described in subsection (a), the licensed wholesale drug distributor shall conduct an inspection of the unlicensed wholesale drug distributor's facility:
        (1) before the initial purchase of legend drugs from the unlicensed wholesale drug distributor; and
        (2) at least once every three (3) years unless the unlicensed wholesale drug distributor's facility has been inspected by the board, or the board's agent, during the same period;
to ensure compliance with applicable laws and regulations relating to the storage and handling of legend drugs. A third party may be engaged to conduct the site inspection on behalf of the licensed wholesale drug distributor.
    (e) At least annually, a licensed wholesale drug distributor that purchases legend drugs from an unlicensed wholesale drug distributor shall ensure that the unlicensed wholesale drug distributor maintains a record keeping system that meets the requirements of section 17(3) of this chapter.
    (f) If a licensed wholesale drug distributor that purchases legend drugs from an unlicensed wholesale drug distributor has reason to believe that a legend drug purchased from the unlicensed wholesale drug distributor is misbranded, adulterated, counterfeit, or suspected counterfeit, the licensed wholesale drug distributor shall conduct a for cause authentication of each distribution of the legend drug back to the manufacturer.
    (g) An unlicensed wholesale drug distributor that has engaged in the distribution of a legend drug for which a licensed wholesale drug distributor conducts a for cause authentication under subsection (f) shall provide, upon request, detailed information regarding the distribution of the legend drug, including the:
        (1) date of purchase of the legend drug;
        (2) lot number
of the legend drug;
        (3) sales invoice number of the legend drug; and
        (4) contact information, including name, address, telephone number, and any electronic mail address of the unlicensed wholesale drug distributor that sold the legend drug.
    (h) If a licensed wholesale drug distributor conducts a for cause authentication under subsection (f) and is unable to authenticate each distribution of the legend drug, the licensed wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration within ten (10) business days after completing the

attempted authentication.
    (i) If a licensed wholesale drug distributor authenticates the distribution of a legend drug back to the manufacturer under subsection (f), the licensed wholesale drug distributor shall maintain records of the authentication for three (3) years and shall provide the records to the board upon request.
    (j) A licensed wholesale drug distributor that purchases legend drugs from an unlicensed wholesale drug distributor shall, at least annually, conduct random authentications of required pedigrees on at least ten percent (10%) of sales units of distributions of legend drugs that were purchased from unlicensed wholesale drug distributors.
    (k) A licensed wholesale drug distributor that has purchased a legend drug that is on the specified list of susceptible products shall, at least quarterly, conduct random authentications of required pedigrees on at least ninety percent (90%) of sales units of distributions of legend drugs that:
        (1) are on the specified list of susceptible products; and
        (2) were purchased from unlicensed wholesale drug distributors.
    (l) An unlicensed wholesale drug distributor from which a licensed wholesale drug distributor has purchased legend drugs shall cooperate with the random authentications of pedigrees under this section and provide requested information in a timely manner.

     (m) If a wholesale drug distributor conducts a random authentication under subsection (j) or (k) and is unable to authenticate each distribution of the legend drug, the wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration not more than ten (10) business days after completing the attempted authentication.

SOURCE: IC 25-26-14-17.9; (05)ES0590.1.52. -->     SECTION 52. IC 25-26-14-17.9 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 17.9. A wholesale drug distributor licensed under this chapter may not use a trade name or business name identical to a trade name or business name used by another wholesale drug distributor licensed under this chapter.
SOURCE: IC 25-26-14-20; (05)ES0590.1.53. -->     SECTION 53. IC 25-26-14-20 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 20. (a) A person employed in wholesale distribution must have appropriate education or experience to assume responsibility for positions related to compliance

with licensing requirements.
    (b) Before employing a person to be engaged in the operation and handling of legend drugs, a wholesale drug distributor shall request that the board obtain and consider the results of a national criminal history background check (as defined in IC 10-13-3-12) through the state police department for the person.

SOURCE: IC 25-26-14-21.5; (05)ES0590.1.54. -->     SECTION 54. IC 25-26-14-21.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 21.5. (a) A person may not perform, cause the performance of, or aid the performance of the following:
        (1) The manufacture, repackaging, sale, delivery, holding, or offering for sale of a legend drug that is adulterated, misbranded, counterfeit, suspected counterfeit, or is otherwise unfit for distribution.
        (2) The adulteration, misbranding, or counterfeiting of a legend drug.
        (3) The receipt of a legend drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected counterfeit, and the delivery or proffered delivery of the legend drug for pay or otherwise.
        (4) The alteration, mutilation, destruction, obliteration, or removal of the whole or a part of the labeling of a legend drug or the commission of another act with respect to a legend drug that results in the legend drug being misbranded.
        (5) Forging, counterfeiting, simulating, or falsely representing a
legend drug using a mark, stamp, tag, label, or other identification device without the authorization of the manufacturer.
        (6) The purchase or receipt of a legend drug from a person that is not licensed to distribute legend drugs to the purchaser or recipient.
        (7) The sale or transfer of a legend drug to a person that is not authorized under the law of the jurisdiction in which the person receives the legend drug to purchase or receive legend drugs from the person selling or transferring the legend drug.
        (8) Failure to maintain or provide records as required under this chapter.
        (9) Providing the board, a representative of the board, or a state or federal official with false or fraudulent records or making false or fraudulent statements regarding a matter related to this chapter.
        (10) The wholesale distribution of a
legend drug that was:
            (A) purchased by a public or private hospital or other health care entity;
            (B) donated or supplied at a reduced price to a charitable organization; or
            (C) stolen or obtained by fraud or deceit.
        (11) Obtaining or attempting to obtain a legend drug by fraud, deceit, misrepresentation, or engaging in fraud, deceit, or misrepresentation in the distribution of a legend drug.
        (12) Failure to obtain, authenticate, or provide a required pedigree.
        (13) The receipt of a legend drug through wholesale distribution without first receiving a required pedigree attested to as accurate and complete by the wholesale drug distributor.
        (14) Distributing a legend drug that was previously dispensed by a retail pharmacy or distributed by a practitioner.
        (15) Failure to report an act prohibited by this section.
    (b) The board may impose the following sanctions if, after a hearing under IC 4-21.5-3, the board finds that a person has violated subsection (a):
        (1) Revoke the wholesale drug distributor's license issued under this chapter if the person is a wholesale drug distributor.
        (2) Assess a civil penalty against the person. A civil penalty assessed under this subdivision may not be more than ten thousand dollars ($10,000) per violation.

SOURCE: IC 25-26-14-26; (05)ES0590.1.55. -->     SECTION 55. IC 25-26-14-26 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 26. (a) A person that who knowingly or intentionally engages in the wholesale distribution of a legend drug without a license issued under this chapter commits a Class D felony.
    (b) A person who engages in the wholesale distribution of a legend drug and:
        (1) who, with intent to defraud or deceive:
            (A) fails to obtain or deliver to another person a complete and accurate required pedigree concerning a legend drug before:
                (i) obtaining the legend drug from another person; or
                (ii) transferring the legend drug to another person; or
            (B) falsely swears or certifies that the person has authenticated any documents related to the wholesale

distribution of legend drugs;
        (2) who knowingly or intentionally:
            (A) destroys, alters, conceals, or fails to maintain a complete and accurate required pedigree concerning a legend drug in the person's possession;
            (B) purchases or receives legend drugs from a person not authorized to distribute legend drugs in wholesale distribution;
            (C) sells, barters, brokers, or transfers a legend drug to a person not authorized to purchase
the legend drug in the jurisdiction in which the person receives the legend drug in a wholesale distribution;
            (D) forges, counterfeits, or falsely creates a pedigree;
            (E) falsely represents a factual matter contained in a pedigree; or
            (F) fails to record material information required to be recorded in a pedigree; or
        (3) who:
            (A) possesses a required pedigree concerning a legend drug;
            (B) knowingly or intentionally fails to authenticate the matters contained in the pedigree as required; and
            (C) distributes or attempts to further distribute the legend drug;
commits a Class D felony.

SOURCE: IC 25-26-14-27; (05)ES0590.1.56. -->     SECTION 56. IC 25-26-14-27 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 27. A wholesale drug distributor that fails to comply with the conditions and requirements described in section 17, 17.2, 17.3, 17.8, 17.9, or 20 of this chapter commits a Class D felony.
SOURCE: IC 25-26-15-10; (05)ES0590.1.57. -->     SECTION 57. IC 25-26-15-10 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 10. As used in this chapter, "prescription" means a written order or an order transmitted by other means of communication that is immediately reduced to writing by the pharmacist or, for electronically transmitted orders, recorded in an electronic format from an optometrist to or for an ultimate user for a drug or device, containing:
        (1) the name and address of the patient;
        (2) the date of issue;
        (3) the name and strength or size (if applicable) of the drug or device;
        (4) the amount to be dispensed (unless indicated by directions and

duration of therapy);
        (5) adequate directions for the proper use of the drug or device by the patient;
        (6) the name and certification number of the prescribing optometrist; and
        (7) the signature of the optometrist if the prescription:
             (A) is in written form, the signature of the optometrist; or
            (B) is in electronic form, the electronic signature of the optometrist.

SOURCE: IC 25-26-20-4; (05)ES0590.1.58. -->     SECTION 58. IC 25-26-20-4 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 4. (a) Except as provided in subsections (b) and (c), unadulterated drugs that meet the requirements set forth in IC 25-26-13-25(i) IC 25-26-13-25(j) may be donated without a prescription or drug order to the regional drug repository program by the following:
        (1) A pharmacist or pharmacy.
        (2) A wholesale drug distributor.
        (3) A hospital licensed under IC 16-21.
        (4) A health care facility (as defined in IC 16-18-2-161).
        (5) A hospice.
        (6) A practitioner.
    (b) An unadulterated drug that:
        (1) was returned under IC 25-26-13-25; and
        (2) was prescribed for a Medicaid recipient;
may not be donated under this section unless the Medicaid program has been credited for the product cost of the drug as provided in policies under the Medicaid program.
    (c) A controlled drug may not be donated under this section.
SOURCE: IC 27-13-38-2; (05)ES0590.1.59. -->     SECTION 59. IC 27-13-38-2 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2. Subject to IC 16-42-22:
        (1) a pharmacist shall not substitute; and
        (2) a health maintenance organization shall not require the substitution of;
a different single source brand name drug for a single source brand name drug written on a prescription form or electronically transmitted to a pharmacy unless the substitution is approved by the prescribing provider.
SOURCE: IC 34-24-1-1; (05)ES0590.1.60. -->     SECTION 60. IC 34-24-1-1 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 1. (a) The following may be seized:
        (1) All vehicles (as defined by IC 35-41-1), if they are used or are

intended for use by the person or persons in possession of them to transport or in any manner to facilitate the transportation of the following:
            (A) A controlled substance for the purpose of committing, attempting to commit, or conspiring to commit any of the following:
                (i) Dealing in or manufacturing cocaine, a narcotic drug, or methamphetamine (IC 35-48-4-1).
                (ii) Dealing in a schedule I, II, or III controlled substance (IC 35-48-4-2).
                (iii) Dealing in a schedule IV controlled substance (IC 35-48-4-3).
                (iv) Dealing in a schedule V controlled substance (IC 35-48-4-4).
                (v) Dealing in a counterfeit substance (IC 35-48-4-5).
                (vi) Possession of cocaine, a narcotic drug, or methamphetamine (IC 35-48-4-6).
                (vii) Dealing in paraphernalia (IC 35-48-4-8.5).
                (viii) Dealing in marijuana, hash oil, or hashish (IC 35-48-4-10).
            (B) Any stolen (IC 35-43-4-2) or converted property (IC 35-43-4-3) if the retail or repurchase value of that property is one hundred dollars ($100) or more.
            (C) Any hazardous waste in violation of IC 13-30-6-6.
            (D) A bomb (as defined in IC 35-41-1-4.3) or weapon of mass destruction (as defined in IC 35-41-1-29.4) used to commit, used in an attempt to commit, or used in a conspiracy to commit an offense under IC 35-47 as part of or in furtherance of an act of terrorism (as defined by IC 35-41-1-26.5).
        (2) All money, negotiable instruments, securities, weapons, communications devices, or any property used to commit, used in an attempt to commit, or used in a conspiracy to commit an offense under IC 35-47 as part of or in furtherance of an act of terrorism or commonly used as consideration for a violation of IC 35-48-4 (other than items subject to forfeiture under IC 16-42-20-5 or IC 16-6-8.5-5.1 before its repeal):
            (A) furnished or intended to be furnished by any person in exchange for an act that is in violation of a criminal statute;
            (B) used to facilitate any violation of a criminal statute; or
            (C) traceable as proceeds of the violation of a criminal statute.
        (3) Any portion of real or personal property purchased with money that is traceable as a proceed of a violation of a criminal

statute.
        (4) A vehicle that is used by a person to:
            (A) commit, attempt to commit, or conspire to commit;
            (B) facilitate the commission of; or
            (C) escape from the commission of;
        murder (IC 35-42-1-1), kidnapping (IC 35-42-3-2), criminal confinement (IC 35-42-3-3), rape (IC 35-42-4-1), child molesting (IC 35-42-4-3), or child exploitation (IC 35-42-4-4), or an offense under IC 35-47 as part of or in furtherance of an act of terrorism.
        (5) Real property owned by a person who uses it to commit any of the following as a Class A felony, a Class B felony, or a Class C felony:
            (A) Dealing in or manufacturing cocaine, a narcotic drug, or methamphetamine (IC 35-48-4-1).
            (B) Dealing in a schedule I, II, or III controlled substance (IC 35-48-4-2).
            (C) Dealing in a schedule IV controlled substance (IC 35-48-4-3).
            (D) Dealing in marijuana, hash oil, or hashish (IC 35-48-4-10).
        (6) Equipment and recordings used by a person to commit fraud under IC 35-43-5-4(11).
        (7) Recordings sold, rented, transported, or possessed by a person in violation of IC 24-4-10.
        (8) Property (as defined by IC 35-41-1-23) or an enterprise (as defined by IC 35-45-6-1) that is the object of a corrupt business influence violation (IC 35-45-6-2).
        (9) Unlawful telecommunications devices (as defined in IC 35-45-13-6) and plans, instructions, or publications used to commit an offense under IC 35-45-13.
        (10) Any equipment used or intended for use in preparing, photographing, recording, videotaping, digitizing, printing, copying, or disseminating matter in violation of IC 35-42-4-4.
        (11) Destructive devices used, possessed, transported, or sold in violation of IC 35-47.5.
        (12) Cigarettes that are sold in violation of IC 24-3-5.2, cigarettes that a person attempts to sell in violation of IC 24-3-5.2, and other personal property owned and used by a person to facilitate a violation of IC 24-3-5.2.
        (13) Tobacco products that are sold in violation of IC 24-3-5, tobacco products that a person attempts to sell in violation of IC 24-3-5, and other personal property owned and used by a person to facilitate a violation of IC 24-3-5.


         (14) If a person is convicted of an offense specified in IC 25-26-14-26(b) or IC 35-43-10, the following real or personal property:
            (A) Property used or intended to be used to commit, facilitate, or promote the commission of the offense.
            (B) Property constituting, derived from, or traceable to the gross proceeds that the person obtained directly or indirectly as a result of the offense.

    (b) A vehicle used by any person as a common or contract carrier in the transaction of business as a common or contract carrier is not subject to seizure under this section, unless it can be proven by a preponderance of the evidence that the owner of the vehicle knowingly permitted the vehicle to be used to engage in conduct that subjects it to seizure under subsection (a).
    (c) Equipment under subsection (a)(10) may not be seized unless it can be proven by a preponderance of the evidence that the owner of the equipment knowingly permitted the equipment to be used to engage in conduct that subjects it to seizure under subsection (a)(10).
    (d) Money, negotiable instruments, securities, weapons, communications devices, or any property commonly used as consideration for a violation of IC 35-48-4 found near or on a person who is committing, attempting to commit, or conspiring to commit any of the following offenses shall be admitted into evidence in an action under this chapter as prima facie evidence that the money, negotiable instrument, security, or other thing of value is property that has been used or was to have been used to facilitate the violation of a criminal statute or is the proceeds of the violation of a criminal statute:
        (1) IC 35-48-4-1 (dealing in or manufacturing cocaine, a narcotic drug, or methamphetamine).
        (2) IC 35-48-4-2 (dealing in a schedule I, II, or III controlled substance).
        (3) IC 35-48-4-3 (dealing in a schedule IV controlled substance).
        (4) IC 35-48-4-4 (dealing in a schedule V controlled substance) as a Class B felony.
        (5) IC 35-48-4-6 (possession of cocaine, a narcotic drug, or methamphetamine) as a Class A felony, Class B felony, or Class C felony.
        (6) IC 35-48-4-10 (dealing in marijuana, hash oil, or hashish) as a Class C felony.
SOURCE: IC 35-43-10; (05)ES0590.1.61. -->     SECTION 61. IC 35-43-10 IS ADDED TO THE INDIANA CODE AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]:
    Chapter 10. Legend Drug Deception
    Sec. 1. The definitions in IC 25-26-14 apply throughout this chapter.
    Sec. 2. A person who knowingly or intentionally:
        (1) possesses a contraband legend drug;
        (2) sells, delivers, or possesses with intent to sell or deliver a contraband legend drug;
        (3) forges, counterfeits, or falsely creates a label for a legend drug or falsely represents a factual matter contained on a label of a legend drug; or
        (4) manufactures, purchases, sells, delivers, brings into Indiana, or possesses a contraband legend drug;
commits legend drug deception, a Class D felony.
    Sec. 3. A person:
        (1) who knowingly or intentionally manufactures, purchases, sells, delivers, brings into Indiana, or possesses a contraband legend drug; and
        (2) whose act under subdivision (1) results in the death of an individual;
commits legend drug deception resulting in death, a Class A felony.

SOURCE: IC 35-48-3-9; (05)ES0590.1.62. -->     SECTION 62. IC 35-48-3-9 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 9. (a) Except for dosages medically required for a period of not more than forty-eight (48) hours that are dispensed by or on the direction of a practitioner or medication dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, no controlled substance in schedule II may be dispensed without the written prescription of a practitioner.
    (b) In emergency situations, as defined by rule of the board, schedule II drugs may be dispensed upon oral prescription of a practitioner, reduced promptly to writing and filed by the pharmacy. Prescriptions shall be retained in conformity with the requirements of section 7 of this chapter. No prescription for a schedule II substance may be refilled.
    (c) Except for dosages medically required for a period of not more than forty-eight (48) hours that are dispensed by or on the direction of a practitioner, or medication dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, a controlled substance included in schedule III or IV, which is a prescription drug as determined under IC 16-42-19, shall not be dispensed without a written or oral prescription of a practitioner. The prescription shall not be filled or refilled more than six (6) months after the date thereof or be refilled more than five (5) times, unless renewed by the practitioner.

Prescriptions for schedule III, IV, and V controlled substances may be transmitted by facsimile from the practitioner or the agent of the practitioner to a pharmacy. The facsimile prescription is equivalent to an original prescription to the extent permitted under federal law.
    (d) A controlled substance included in schedule V shall not be distributed or dispensed other than for a medical purpose.

SOURCE: IC 35-48-7-5; (05)ES0590.1.63. -->     SECTION 63. IC 35-48-7-5 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 5. As used in this chapter, "identification number" refers to the following:
        (1)
The unique number contained on any of the following:
            (1) (A) A valid driver's license of a recipient or a recipient's representative issued under Indiana law or the law of any other state.
            (2) (B) A recipient's or a recipient representative's valid military identification card.
            (3) (C) A valid identification card of a recipient or a recipient's representative issued by:
                (A) (i) the bureau of motor vehicles and described in IC 9-24-16-3; or
                (B) (ii) any other state and that is similar to the identification card issued by the bureau of motor vehicles.
            (4) (D) If the recipient is an animal:
                (A) (i) the valid driver's license issued under Indiana law or the law of any other state;
                (B) (ii) the valid military identification card; or
                (C) (iii) the valid identification card issued by the bureau of motor vehicles and described in IC 9-24-16-3 or a valid identification card of similar description that is issued by any other state;
            of the animal's owner.
         (2) The identification number or phrase designated by the central repository.
SOURCE: IC 35-48-7-8; (05)ES0590.1.64. -->     SECTION 64. IC 35-48-7-8 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 8. The advisory committee shall provide for a controlled substance prescription monitoring program that includes the following components:
        (1) Each time a controlled substance designated by the advisory committee under IC 35-48-2-5 through IC 35-48-2-10 is dispensed, the dispenser shall transmit to the central repository the following information:
            (A) The recipient's name.
            (B) The recipient's or the recipient representative's identification number or the identification number or phrase designated by the central repository.
            (C) The recipient's date of birth.
            (D) The national drug code number of the controlled substance dispensed.
            (E) The date the controlled substance is dispensed.
            (F) The quantity of the controlled substance dispensed.
            (G) The number of days of supply dispensed.
            (H) The dispenser's United States Drug Enforcement Agency registration number.
            (I) The prescriber's United States Drug Enforcement Agency registration number.
            (J) An indication as to whether the prescription was transmitted to the pharmacist orally or in writing.
        (2) The information required to be transmitted under this section must be transmitted not more than fifteen (15) days after the date on which a controlled substance is dispensed.
        (3) A dispenser shall transmit the information required under this section by:
            (A) an electronic device compatible with the receiving device of the central repository;
            (B) a computer diskette;
            (C) a magnetic tape; or
            (D) a pharmacy universal claim form;
        that meets specifications prescribed by the advisory committee.
        (4) The advisory committee may require that prescriptions for controlled substances be written on a one (1) part form that cannot be duplicated. However, the advisory committee may not apply such a requirement to prescriptions filled at a pharmacy with a Type II permit (as described in IC 25-26-13-17) and operated by a hospital licensed under IC 16-21, or prescriptions ordered for and dispensed to bona fide enrolled patients in facilities licensed under IC 16-28. The committee may not require multiple copy prescription forms and serially numbered prescription forms for any prescriptions written. The committee may not require different prescription forms for any individual drug or group of drugs. Prescription forms required under this subdivision must be jointly approved by the committee and by the Indiana board of pharmacy established by IC 25-26-13-3.
        (5) The costs of the program.
SOURCE: ; (05)ES0590.1.65. -->     SECTION 65. [EFFECTIVE JULY 1, 2005] (a) IC 25-26-14, as

amended by this act, applies:
        (1) after June 30, 2005, for an initial license issued under IC 25-26-14, as amended by this act; and
        (2) on the first expiration date occurring after December 31, 2005, for renewal of a license issued under IC 25-26-14, before amendment by this act.
    (b) The Indiana board of pharmacy established by IC 25-26-13-3 may establish an electronic pedigree pilot program to authenticate, track, and trace legend drugs. The pilot program must include participation of drug manufacturers, wholesale drug distributors, and pharmacies that are licensed in Indiana. The board may establish the requirements and guidelines for the pilot program.
    (c) Before June 30, 2007, the Indiana board of pharmacy established by IC 25-26-13-3 shall conduct a study of the electronic pedigree pilot program. The study must include consultation with manufacturers, distributers, and pharmacies that participate in the electronic pedigree pilot program. The study may include the consultation with manufacturers, distributers, and pharmacies that do not participate in the electronic pedigree pilot program. Based on the results of the study, the board shall determine a date to implement a mandatory electronic pedigree program. However, the board may not implement a mandatory electronic pedigree program until after the board has completed the study under this subsection.
    (d) This SECTION expires December 31, 2007.