SB 371-1_ Filed 04/01/2013, 11:09 Vandenburgh


Text Box


    PREVAILED      Roll Call No. _______
    FAILED        Ayes _______
    WITHDRAWN        Noes _______
    RULED OUT OF ORDER


[

HOUSE MOTION ____

]

MR. SPEAKER:

    I move that Engrossed Senate Bill 371 be amended to read as follows:

SOURCE: Page 2, line 13; (13)MO037125.2. -->     Page 2, between lines 13 and 14, begin a new paragraph and insert:
SOURCE: IC 16-18-2-101.5; (13)MO037125.4. -->     "SECTION 4. IC 16-18-2-101.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2013]: Sec. 101.5. "Drug label", for purposes of IC 16-42-25, has the meaning set forth in IC 16-42-25-1.
SOURCE: IC 16-18-2-116.5; (13)MO037125.5. -->     SECTION 5. IC 16-18-2-116.5 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2013]: Sec. 116.5. "Erectile dysfunction drug", for purposes of IC 16-42-25, has the meaning set forth in IC 16-42-25-2.".
SOURCE: Page 8, line 19; (13)MO037125.8. -->     Page 8, after line 19, begin a new paragraph and insert:
SOURCE: IC 16-42-25; (13)MO037125.7. -->     "SECTION 7. IC 16-42-25 IS ADDED TO THE INDIANA CODE AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2013]:
     Chapter 25. Drugs: Use of Erectile Dysfunction Drugs
    Sec. 1. As used in this chapter, "drug label" means the pamphlet or document accompanying an erectile dysfunction drug that:
        (1) outlines the protocol authorized by the federal Food and Drug Administration;
        (2) sets forth how the drug is to be used; and
        (3) has been agreed upon by the drug manufacturer applying for authorization of the drug by the Food and Drug Administration.
    Sec. 2. As used in this chapter, "erectile dysfunction drug" means a medicine, drug, or substance prescribed or dispensed with the intent of temporarily alleviating the symptoms of erectile dysfunction with the expectation that a man will achieve or maintain an erection long enough to engage in sexual intercourse. The term includes the off-label use of any drug known to maintain an erection if the drug is prescribed with the intent of temporarily alleviating the symptoms of erectile dysfunction.
    Sec. 3. (a) It is unlawful for an individual to knowingly give, sell, dispense, administer, prescribe, or otherwise provide an erectile dysfunction drug to a man for the purposes of temporarily alleviating the symptoms of erectile dysfunction unless the individual meets the following requirements:
        (1) The individual is a physician licensed under IC 25-22.5.
        (2) The individual satisfies the protocol outlined in the final print drug label, as approved by the Food and Drug Administration.
    (b) Before giving, selling, dispensing, administering, prescribing, or otherwise providing an erectile dysfunction drug to a man showing symptoms of erectile dysfunction, a physician licensed under IC 25-22.5 shall do the following:
        (1) Examine in person the man showing symptoms of erectile dysfunction.
        (2) Conduct a penile doppler ultrasound examination of the man's penis to determine whether an erectile dysfunction drug will alleviate the man's erectile dysfunction symptoms.
        (3) Provide the following information to the man diagnosed with erectile dysfunction:
            (A) A copy of the final printed drug label.
            (B) The name and telephone number for the physician who prescribed the erectile dysfunction medication and information for follow-up care.
    (c) A physician licensed under IC 25-22.5 who gives, sells, dispenses, administers, prescribes, or otherwise provides an erectile dysfunction drug to a man shall schedule a follow-up appointment with the man at approximately fourteen (14) days after prescribing the erectile dysfunction drug to:
        (1) conduct a physical exam, including an electrocardiogram, to ensure that the man is healthy enough for continued sexual activity; and
        (2) assess the degree to which the erectile dysfunction drug has aided in temporarily relieving the symptoms of erectile dysfunction.
    (d) The physician described in subsection (c) shall make a reasonable effort to ensure that the patient returns for the follow-up appointment described in subsection (c), including recording in the patient's medical records:
        (1) the date and time of the follow-up appointment;
        (2) a brief description of the efforts the physician and the physician's staff took to ensure the patient's return; and
        (3) the name of the individual who performed the efforts.
    Sec. 4. (a) A person who intentionally, knowingly, or recklessly violates this chapter commits an unlawful activity related to an erectile dysfunction drug, a Class A misdemeanor.
    (b) In addition to the criminal penalty under subsection (a), a person who violates this chapter may be subject to disciplinary sanctions under IC 25-1-9 and civil liability for wrongful death and medical malpractice.

SOURCE: IC 35-51-16-1; (13)MO037125.8. -->     SECTION 8. IC 35-51-16-1, AS ADDED BY P.L.70-2011, SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2013]: Sec. 1. The following statutes define crimes in IC 16:
        IC 16-19-12-1 (Concerning the state department of health).
        IC 16-20-9-1 (Concerning local health departments).
        IC 16-21-2-2.5 (Concerning licensure of hospitals).
        IC 16-21-5-3 (Concerning licensure of hospitals).
        IC 16-21-6-12 (Concerning hospital financial disclosure law).
        IC 16-21-7-5 (Concerning hospitals).
        IC 16-25-5-8 (Concerning hospices).
        IC 16-25-6-1 (Concerning hospices).
        IC 16-27-1-15 (Concerning home health agencies).
        IC 16-27-2-3 (Concerning home health agencies).
        IC 16-27-4-23 (Concerning home health agencies).
        IC 16-28-7-5 (Concerning monitors).
        IC 16-28-9-3 (Concerning monitors).
        IC 16-28-9-4 (Concerning monitors).
        IC 16-28-9-5 (Concerning monitors).
        IC 16-30-5-1 (Concerning health planning).
        IC 16-31-3-16 (Concerning emergency medical services).
        IC 16-31-3-22 (Concerning emergency medical services).
        IC 16-31-10-2 (Concerning emergency medical services).
        IC 16-34-2-5 (Concerning abortion).
        IC 16-34-2-6 (Concerning abortion).
        IC 16-34-2-7 (Concerning abortion).
        IC 16-36-4-15 (Concerning medical consent).
        IC 16-36-4-16 (Concerning medical consent).
        IC 16-36-5-27 (Concerning medical consent).
        IC 16-36-5-28 (Concerning medical consent).
        IC 16-37-1-12 (Concerning vital statistics).
        IC 16-37-1-13 (Concerning vital statistics).
        IC 16-37-2-2.1 (Concerning vital statistics).
        IC 16-37-2-19 (Concerning vital statistics).
        IC 16-37-3-16 (Concerning vital statistics).
        IC 16-38-5-4 (Concerning health registries).
        IC 16-39-7.1-3 (Concerning health records).
        IC 16-39-7.1-6 (Concerning health records).
        IC 16-41-1-3 (Concerning communicable diseases).
        IC 16-41-2-9 (Concerning communicable diseases).
        IC 16-41-3-3 (Concerning communicable diseases).
        IC 16-41-4-3 (Concerning communicable diseases).
        IC 16-41-5-3 (Concerning communicable diseases).
        IC 16-41-6-3 (Concerning communicable diseases).
        IC 16-41-7-5 (Concerning communicable diseases).
        IC 16-41-8-1 (Concerning communicable diseases).
        IC 16-41-8-3 (Concerning communicable diseases).
        IC 16-41-8-5 (Concerning communicable diseases).
        IC 16-41-9-1.5 (Concerning communicable diseases).
        IC 16-41-10-5 (Concerning communicable diseases).
        IC 16-41-10-7 (Concerning communicable diseases).
        IC 16-41-12-13 (Concerning communicable diseases).
        IC 16-41-12-14 (Concerning communicable diseases).
        IC 16-41-12-15 (Concerning communicable diseases).
        IC 16-41-13-3 (Concerning communicable diseases).
        IC 16-41-13-4 (Concerning communicable diseases).
        IC 16-41-13-6 (Concerning communicable diseases).
        IC 16-41-14-13 (Concerning communicable diseases).
        IC 16-41-14-15 (Concerning communicable diseases).
        IC 16-41-14-16 (Concerning communicable diseases).
        IC 16-41-14-17 (Concerning communicable diseases).
        IC 16-41-14-20 (Concerning communicable diseases).
        IC 16-41-15-18 (Concerning communicable diseases).
        IC 16-41-16-11 (Concerning communicable diseases).
        IC 16-41-18-6 (Concerning prevention and treatment programs).
        IC 16-41-19-10 (Concerning prevention and treatment programs).
        IC 16-41-20-13 (Concerning health, sanitation, and safety).
        IC 16-41-21-18 (Concerning health, sanitation, and safety).
        IC 16-41-21-19 (Concerning health, sanitation, and safety).
        IC 16-41-22-21 (Concerning health, sanitation, and safety).
        IC 16-41-22-22 (Concerning health, sanitation, and safety).
        IC 16-41-23-4 (Concerning health, sanitation, and safety).
        IC 16-41-24-11 (Concerning health, sanitation, and safety).
        IC 16-41-25-2 (Concerning health, sanitation, and safety).
        IC 16-41-27-34 (Concerning health, sanitation, and safety).
        IC 16-41-29-5 (Concerning regulation of lodging facilities and bedding materials).
        IC 16-41-32-30 (Concerning regulation of lodging facilities and bedding materials).
        IC 16-41-33-9 (Concerning pest control).
        IC 16-41-34-8 (Concerning pest control).
        IC 16-41-35-40 (Concerning radiation).
        IC 16-41-38-10 (Concerning radon gas).
        IC 16-42-1-16 (Concerning Uniform Food, Drug, and Cosmetic Act).
        IC 16-42-1-34 (Concerning Uniform Food, Drug, and Cosmetic Act).
        IC 16-42-2-8 (Concerning Uniform Food, Drug, and Cosmetic Act).
        IC 16-42-2-9 (Concerning Uniform Food, Drug, and Cosmetic Act).
        IC 16-42-3-12 (Concerning Uniform Food, Drug, and Cosmetic Act).
        IC 16-42-4-5 (Concerning Uniform Food, Drug, and Cosmetic Act).
        IC 16-42-5-26 (Concerning sanitary requirements for food establishments).
        IC 16-42-5-27 (Concerning sanitary requirements for food establishments).
        IC 16-42-10-13 (Concerning food).
        IC 16-42-18-7 (Concerning food).
        IC 16-42-19-27 (Concerning the Indiana Legend Drug Act).
        IC 16-42-21-4 (Concerning the Indiana Legend Drug Act).
         IC 16-42-25-4 (Concerning erectile dysfunction drugs).
        IC 16-44-1-1 (Concerning product labeling and inspection).
        IC 16-44-2-22 (Concerning product labeling and inspection).
        IC 16-46-6-12 (Concerning state health grants and programs).".
    Renumber all SECTIONS consecutively.
    (Reference is to ESB 371 as printed March 29, 2013.)

________________________________________

Representative VanDenburgh


MO037125/DI 92     2013