SB 285-1_ Filed 01/20/2010, 11:50

COMMITTEE REPORT




MADAM PRESIDENT:

    The Senate Committee on Corrections, Criminal, and Civil Matters, to which was referred Senate Bill No. 285, has had the same under consideration and begs leave to report the same back to the Senate with the recommendation that said bill be AMENDED as follows:

SOURCE: Page 1, line 1; (10)AM028506.1. -->     Page 1, between the enacting clause and line 1, begin a new paragraph and insert:
SOURCE: IC 4-6-2-12; (10)AM028506.1. -->     "SECTION 1. IC 4-6-2-12 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2010]: Sec. 12. The attorney general shall enter into a memorandum of understanding with an entity to implement an electronic system to track the sale of ephedrine and pseudoephedrine as required by IC 35-48-4-14.9.
SOURCE: IC 25-26-13-4; (10)AM028506.2. -->     SECTION 2. IC 25-26-13-4, AS AMENDED BY P.L.182-2009(ss), SECTION 371, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2010]: 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.
        (3) Establishing standards and procedures before January 1, 2006, to ensure that a pharmacist:
            (A) has entered into a contract that accepts the return of expired drugs with; or
            (B) is subject to a policy that accepts the return of expired drugs of;
        a wholesaler, manufacturer, or agent of a wholesaler or manufacturer concerning the return by the pharmacist to the wholesaler, the manufacturer, or the agent of expired legend drugs or controlled drugs. In determining the standards and procedures, the board may not interfere with negotiated terms related to cost, expenses, or reimbursement charges contained in contracts between parties, but may consider what is a reasonable quantity of a drug to be purchased by a pharmacy. The standards and

procedures do not apply to vaccines that prevent influenza, medicine used for the treatment of malignant hyperthermia, and other drugs determined by the board to not be subject to a return policy. An agent of a wholesaler or manufacturer must be appointed in writing and have policies, personnel, and facilities to handle properly returns of expired legend drugs and controlled substances.
    (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.
    (e) The governor may direct the board to develop:
        (1) a prescription drug program that includes the establishment of criteria to eliminate or significantly reduce prescription fraud; and
        (2) a standard format for an official tamper resistant prescription drug form for prescriptions (as defined in IC 16-42-19-7(1)).
The board may adopt rules under IC 4-22-2 necessary to implement this subsection.
    (f) The standard format for a prescription drug form described in subsection (e)(2) must include the following:
        (1) A counterfeit protection bar code with human readable representation of the data in the bar code.
        (2) A thermochromic mark on the front and the back of the prescription that:
            (A) is at least one-fourth (1/4) of one (1) inch in height and width; and


            (B) changes from blue to clear when exposed to heat.
    (g) The board may contract with a supplier to implement and manage the prescription drug program described in subsection (e). The supplier must:
        (1) have been audited by a third party auditor using the SAS 70 audit or an equivalent audit for at least the three (3) previous years; and
        (2) be audited by a third party auditor using the SAS 70 audit or an equivalent audit throughout the duration of the contract;
in order to be considered to implement and manage the program.
     (h) The board shall adopt rules and procedures regarding a pharmacist or pharmacy that violates IC 35-48-4-14.8.".
SOURCE: Page 5, line 24; (10)AM028506.5. -->     Page 5, line 24, delete "an" and insert " a statewide".
    Page 5, line 25, after "and" insert " pseudoephedrine.".
    Page 5, delete lines 26 through 27.
    Page 6, line 2, delete "Except as provided in subsection".
    Page 6, line 3, delete "(f), a" and insert " A".
    Page 6, delete lines 5 through 13, begin a new paragraph and insert:
    " (f) A person shall begin entering data into the PSE tracking system not later than one hundred eighty (180) days after the attorney general enters into a memorandum of understanding described in section 14.9 of this chapter.".
    Page 6, line 16, delete "The state police".
    Page 6, line 17, delete "department" and insert " The attorney general".
    Page 6, delete line 18.
    Page 6, line 19, delete "concerning implementation of" and insert " an entity to implement".
    Page 6, line 21, delete "state police department" and insert " attorney general".
    Page 6, line 21, delete "National" and insert " entity.".
    Page 6, delete line 22.
    Page 6, line 23, delete "provide that:" and insert " provide:
        (1) that:
            (A) retailers; and
            (B) law enforcement agencies;
        may not be required to pay a fee for access to the system;
        (2) that for investigative purposes, a law enforcement officer shall have access to all information on the PSE tracking system;
        (3) that sales transaction data will be housed by an information technology company operating under strict

security standards;
        (4) that the data will be accessible only to authorized law enforcement officers;
        (5) that the entity will forward the data to the state police department weekly;
        (6) that the entity shall not modify sales transaction data that is provided to law enforcement; and
        (7) that the entity will ensure that the PSE tracking system will have stop sale capability throughout the state as set forth in section 14.8 of this chapter.
".
    Page 6, delete lines 24 through 35.
    Renumber all SECTIONS consecutively.
    (Reference is to SB 285 as introduced.)

and when so amended that said bill do pass .

Committee Vote: Yeas 8, Nays 2.

____________________________________

Senator Steele, Chairperson


AM 028506/DI 106    2010