H*2691(Rat #0120, Act #0079 of 1981)  General Bill, By 
 House Medical, Military, Public and Municipal Affairs
 A Bill to amend Section 44-53-280, as amended, Sections 44-53-300, 44-53-310,
 44-53-330, 44-53-360, Code of Laws of South Carolina, 1976, relating to
 narcotics and controlled substances, so as to provide for the method of notice
 to be given a registrant who fails to renew his license to manufacture and
 distribute controlled substances; provide that licensing of a registrant also
 be based on past experience in distributing and dispensing controlled
 substances; provide requirements for research with narcotics and controlled
 substances; increase the civil fine of a registrant from one thousand dollars
 to twenty-five hundred dollars; provide that penalties apply to Article 3,
 Chapter 53, Title 44 and empower the Department of Health and Environmental
 Control to deny or revoke a controlled substance registration; provide notice
 of administrative action relating to controlled substances be supplied to
 licensing boards; and provide that labelling of drugs under Federal Law be
 considered prima facie evidence of approved uses for such drugs.

   04/08/81  House  Introduced, read first time, placed on calendar
                     without reference HJ-1712
   04/23/81  House  Amended HJ-2054
   04/23/81  House  Read second time HJ-2054
   04/24/81  House  Read third time and sent to Senate HJ-2063
   04/28/81  Senate Introduced and read first time SJ-15
   04/28/81  Senate Referred to Committee on Medical Affairs SJ-15
   04/30/81  Senate Committee report: Favorable Medical Affairs SJ-19
   05/05/81  Senate Read second time SJ-7
   05/12/81  Senate Read third time and enrolled SJ-26
   05/19/81  House  Ratified R 120 HJ-2469
   05/21/81         Signed By Governor
   05/21/81         Effective date 05/21/81
   05/21/81         Act No. 79
   06/02/81         Copies available

    AN ACT TO AMEND SECTION 44-53-280, AS AMENDED, SECTIONS 44-53-300, 44-53-310, 44-53-330, 44-53-360, CODE OF LAWS OF SOUTH CAROLINA, 1976, RELATING TO NARCOTICS AND CONTROLLED SUBSTANCES, SO AS TO PROVIDE FOR THE METHOD OF NOTICE TO BE GIVEN A REGISTRANT WHO FAILS TO RENEW HIS LICENSE TO MANUFACTURE AND DISTRIBUTE CONTROLLED SUBSTANCES; PROVIDE THAT LICENSING OF A REGISTRANT ALSO BE BASED ON PAST EXPERIENCE IN DISTRIBUTING AND DISPENSING CONTROLLED SUBSTANCES; PROVIDE REQUIREMENTS FOR RESEARCH WITH NARCOTICS AND CONTROLLED SUBSTANCES; INCREASE THE CIVIL FINE OF A REGISTRANT FROM ONE THOUSAND DOLLARS TO TWENTY-FIVE HUNDRED DOLLARS; PROVIDE THAT PENALTIES APPLY TO ARTICLE 3, CHAPTER 63, TITLE 44 AND EMPOWER THE DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL TO DENY OR REVOKE A CONTROLLED SUBSTANCE REGISTRATION; PROVIDE NOTICE OF ADMINISTRATIVE ACTION RELATING TO CONTROLLED SUBSTANCES BE SUPPLIED TO LICENSING BOARDS; AND PROVIDE THAT LABELLING OF DRUGS UNDER FEDERAL LAW BE CONSIDERED PRIMA FACIE EVIDENCE OF APPROVED USES FOR SUCH DRUGS.

Be it enacted by the General Assembly of the State of South Carolina:
Registrant may renew registration
    SECTION 1. Subsection (d) of Section 44-53-280 of the 1976 Code, as amended by Act 73 of 1977, is amended to read:
    "(d) Each registrant shall annually renew his registration at such time and in such manner as the Board may prescribe. Any registrant who fails to renew by October thirty-first of each calendar year shall be penalized in the amount of twenty-five dollars. If failure to renew shall continue beyond October thirty-first of the calendar year, the registrant shall be notified, by certified mail, return receipt requested, sent to his last known address, that continued failure to renew will result in the cancellation of his registration. The registration of any registrant who fails to renew by December thirty-first of the calendar year shall be canceled. Provided, however, that such registration may be reinstated upon payment of the renewal fees due and a penalty of one hundred dollars if the registrant is otherwise in good standing and presents a satisfactory explanation for his failure to renew. Refusal to renew after payment of such fee and penalty and presentation of an explanation shall constitute a refusal to renew under Section 44-53-320."
Licensing based on past experience
    SECTION 2. Subsection (a) of Section 44-53-300 of the 1976 Code is amended to read:
    "(a) The Department shall register an applicant to manufacture, distribute, or dispense controlled substances included in Sections 44-53-190, 44-53-210, 44-53-230, 44-53-250 and 44-53-270 if it determines that the issuance of such registration is consistent with the public interest. In determining the public interest, the following factors shall be considered:
        (1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;
        (2) Compliance with applicable state or federal law;
        (3) Promotion of technical advances in the art of manufacturing these substances and the development of new substances;
        (4) Prior conviction record of applicant under federal and state laws relating to the manufacture, distribution or dispensing of such substances;
        (5) Past experience in the manufacture, distribution, and dispensing of controlled substances and the existence in the establishment of effective controls against diversion;
        (6) Such other factors as may be relevant to and consistent with the public health and safety; and
        (7) Licensing by a federal agency."
Requirements for research
    SECTION 3. Subsection (c) of Section 44-53-300 of the 1976 Code is amended to read:
    "(c) Within the discretion of the Department, practitioners may be registered to dispense one or more controlled substances in Schedules II through V if they are authorized to dispense drugs under the law of this State. Such practitioners, properly registered with the Department to dispense controlled substances, may also conduct research with non-narcotic controlled substances in Schedules II through V without additional registration as a researcher, provided that prior to engaging in such research, the practitioner shall notify the Department in writing of the scope of such research and the name of the controlled substances to be utilized. Practitioners desiring to conduct research with Schedule I controlled substances or with narcotic controlled substances in Schedules II through V shall first obtain a separate researcher registration from the Department."
Civil fine increased
    SECTION 4. Subsection (b) of Section 44-53-310 of the 1976 Code is amended to read:
    "(b) The Department may place any registrant who violates this article on probation or levy a civil fine of not more than two thousand five hundred dollars, or both."
Department may suspend registration
    SECTION 5. Section 44 53-310 of the 1976 Code is amended by adding at the end:
    "(f) The Department may suspend, deny, or revoke the registration of any registrant or applicant upon a finding by the Department that the registrant or applicant has violated any statutory provision of this article."
Department may suspend, deny, etc. registration
    SECTION 6. Section 44-53-330 of the 1976 Code is amended to read:
    "Section 44-53-330. Upon the conviction of any person of the violation of any provision of this article, a certified copy of the judgment of conviction shall be sent by the clerk of the court to the licensing board by whom the convicted defendant has been licensed or registered to practice his profession or to carry on his business. Upon final order of the Department suspending, denying, modifying, or revoking the controlled substances registration of any registrant or applicant under this article, or upon the execution and approval of an administrative consent order provided for by Section 44-53-320, the Department shall forward a copy thereof to the licensing board by whom the affected registrant or applicant has been licensed or registered to practice his profession or carry on his business, if such licensing board be in existence."
Dispensing of controlled substances
    SECTION 7. Subsection (c) of Section 44-53-360 of the 1976 Code is amended to read:
    "(c) No controlled substances included in any schedule may be distributed or dispensed for other than a medical purpose. No practitioner shall dispense any Schedule II narcotic controlled substance for the purpose of maintaining the addiction of a narcotic dependent person outside of a facility or program approved by the South Carolina Methadone Council. No practitioner shall dispense any controlled substances outside of a bona fide physician-patient relationship. No practitioner shall dispense any controlled substance for any use other than the uses approved by the Federal Food and Drug Administration or unless an investigation of new drug application for the substance has been obtained and approved by the federal agency and a copy thereof filed with the Department.
    Provided, that the labelling required under federal law to accompany certain drug products (commonly known in the medically related professions as the 'package insert') shall be prima facie evidence of the approved uses for such drug, unless otherwise specifically provided by statute or regulation of the Department or the State Board of Medical Examiners, and such labelling shall be admissible as evidence in any judicial or administrative proceeding for the sole purpose of demonstrating the approved uses for such drug. In the event that there has been a change in labelling for a particular drug product, the content of the labelling which was current with the manufacturer of the drug product at the time of the incident from which the judicial or administrative action arises, shall be deemed to contain the 'approved use' of the drug product within the meaning of this section. Nothing in this section shall be deemed to modify any of the provisions of Section 40-47-65."
Time effective
    SECTION 8. This act shall take effect upon approval by the Governor.