sb418_SB_418_HCSFA

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10 SB 418/HCSFA

HOUSE SUBSTITUTE TO SENATE BILL 418

A BILL TO BE ENTITLED
AN ACT

To amend Chapter 13 of Title 16 of the Official Code of Georgia Annotated, relating to controlled substances, so as to provide for the establishment of a program to monitor the prescribing and dispensing of certain controlled substances; to provide for definitions; to require dispensers to submit certain information regarding the dispensing of such controlled substances; to provide for the confidentiality of submitted information except under certain circumstances; to provide for the establishment of an Electronic Database Review Advisory Committee; to provide for its membership, duties, and organization; to provide for the establishment of rules and regulations; to provide for limited liability; to provide for penalties; to provide for related matters; to provide for an effective date; to repeal conflicting laws; and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

SECTION 1.

Chapter 13 of Title 16 of the Official Code of Georgia Annotated, relating to controlled substances, is amended by revising Code Section 16-13-21, relating to definitions relative to regulation of controlled substances, as follows:

"16-13-21.

As used in this article, the term:

(1) 'Administer' means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or by any other means, to the body of a patient or research subject by:

(A) A practitioner or, in his or her presence, by his or her authorized agent; or

(B) The patient or research subject at the direction and in the presence of the practitioner.

(1.1) 'Agency' means the Georgia Drugs and Narcotics Agency.

(2) 'Agent' of a manufacturer, distributor, or dispenser means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. It does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman.

(3) 'Bureau' means the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(4) 'Controlled substance' means a drug, substance, or immediate precursor in Schedules I through V of Code Sections 16-13-25 through 16-13-29 and Schedules I through V of 21 C.F.R. Part 1308.

(5) 'Conveyance' means any object, including aircraft, vehicle, or vessel, but not including a person, which may be used to carry or transport a substance or object.

(6) 'Counterfeit substance' means:

(A) A controlled substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person who in fact manufactured, distributed, or dispensed the controlled substance;

(B) A controlled substance or noncontrolled substance, which is held out to be a controlled substance or marijuana, whether in a container or not which does not bear a label which accurately or truthfully identifies the substance contained therein; or

(C) Any substance, whether in a container or not, which bears a label falsely identifying the contents as a controlled substance.

(6.1) 'Dangerous drug' means any drug, other than a controlled substance, which cannot be dispensed except upon the issuance of a prescription drug order by a practitioner authorized under this chapter.

(6.2) 'DEA' means the United States Drug Enforcement Administration.

(7) 'Deliver' or 'delivery' means the actual, constructive, or attempted transfer from one person to another of a controlled substance, whether or not there is an agency relationship.

(8) 'Dependent,' 'dependency,' 'physical dependency,' 'psychological dependency,' or 'psychic dependency' means and includes the state of dependence by an individual toward or upon a substance, arising from the use of that substance, being characterized by behavioral and other responses which include the loss of self-control with respect to that substance, or a strong compulsion to use that substance on a continuous basis in order to experience some psychic effect resulting from the use of that substance by that individual, or to avoid any discomfort occurring when the individual does not use that substance.

(9) 'Dispense' means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery, or the delivery of a controlled substance by a practitioner, acting in the normal course of his or her professional practice and in accordance with this article, or to a relative or representative of the person for whom the controlled substance is prescribed.

(10) 'Dispenser' means a practitioner who dispenses a person that delivers a monitored controlled substance to the ultimate user but shall not include:

(A) A licensed pharmacy of a hospital that dispenses such substances for the purpose of inpatient or outpatient hospital care, a licensed pharmacy of a hospital that dispenses prescriptions for controlled substances at the time of dismissal or discharge from such a facility, or a licensed pharmacy of a hospital that dispenses or administers such substances for long-term care patients or inpatient hospice facilities;

(B) An institutional pharmacy that serves only a health care facility, including, but not limited to, a nursing home, an intermediate care home, a personal care home, or a hospice program, which provides inpatient care and which pharmacy dispenses such substances to be administered and used by a patient on the premises of the facility;

(D) A pharmacy operated by, on behalf of, or under contract with the Department of Corrections for the sole and exclusive purpose of providing services in a secure environment to prisoners within a penal institution, penitentiary, prison, detention center, or other secure correctional institution. This shall include correctional institutions operated by private entities in this state which house inmates under the Department of Corrections.

(11) 'Distribute' means to deliver a controlled substance, other than by administering or dispensing it.

(12) 'Distributor' means a person who distributes.

(12.05) 'FDA' means the United States Food and Drug Administration.

(12.1) 'Imitation controlled substance' means:

(A) A product specifically designed or manufactured to resemble the physical appearance of a controlled substance, such that a reasonable person of ordinary knowledge would not be able to distinguish the imitation from the controlled substance by outward appearances; or

(B) A product, not a controlled substance, which, by representations made and by dosage unit appearance, including color, shape, size, or markings, would lead a reasonable person to believe that, if ingested, the product would have a stimulant or depressant effect similar to or the same as that of one or more of the controlled substances included in Schedules I through V of Code Sections 16-13-25 through 16-13-29.

(13) 'Immediate precursor' means a substance which the State Board of Pharmacy has found to be and by rule identifies as being the principal compound commonly used or produced primarily for use, and which is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail, or limit manufacture.

(14) 'Isomers' means stereoisomers (optical isomers), geometrical isomers, and structural isomers (chain and positional isomers,) but shall not include functional isomers).

(15) 'Manufacture' means the production, preparation, propagation, compounding, conversion, or processing of a controlled substance, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, and includes any packaging or repackaging of the substance or labeling or relabeling of its container, except that this term does not include the preparation, compounding, packaging, or labeling of a controlled substance:

(A) By a practitioner as an incident to his or her administering or dispensing of a controlled substance in the course of his or her professional practice; or

(B) By a practitioner or by his or her authorized agent under his or her supervision for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale.

(16) 'Marijuana' means all parts of the plant of the genus Cannabis, whether growing or not, the seeds thereof, the resin extracted from any part of such plant, and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or resin; but shall not include samples as described in subparagraph (P) of paragraph (3) of Code Section 16-13-25 and shall not include the completely defoliated mature stalks of such plant, fiber produced from such stalks, oil, or cake, or the completely sterilized samples of seeds of the plant which are incapable of germination.

(16.1) 'Monitored controlled substance' means:

(A) A controlled substance that is classified as a Schedule II controlled substance under Code Section 16-13-26 or under the Federal Controlled Substances Act, 21 U.S.C. Section 812; and

(B) Hydrocodone and carisoprodol or a derivative of or a compound containing either such drug.

(17) 'Narcotic drug' means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(A) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate;

(B) Any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with to any of the substances referred to in subparagraph (A) of this paragraph, but not including the isoquinoline alkaloids of opium;

(D) Coca leaves and any salt, compound, derivative, stereoisomers of cocaine, or preparation of coca leaves, and any salt, compound, stereoisomers of cocaine, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine.

(18) 'Opiate' means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. It does not include, unless specifically designated as controlled under Code Section 16-13-22, the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextromethorphan). It does include its racemic and levorotatory forms.

(19) 'Opium poppy' means the plant of the species Papaver somniferum L., except its seeds.

(19.1) 'Patient' means the person who is the ultimate user of a drug for whom a prescription is issued or for whom a drug is dispensed.

(20) 'Person' means an individual, corporation, government, or governmental subdivision or agency, business trust, estate, trust, partnership, or association, or any other legal entity.

(21) 'Poppy straw' means all parts, except the seeds, of the opium poppy after mowing.

(22) 'Potential for abuse' means and includes a substantial potential for a substance to be used by an individual to the extent of creating hazards to the health of the user or the safety of the public, or the substantial potential of a substance to cause an individual using that substance to become dependent upon that substance.

(23) 'Practitioner' means:

(A) A physician, dentist, pharmacist, podiatrist, veterinarian, scientific investigator, or other person licensed, registered, or otherwise authorized under the laws of this state to distribute, dispense, conduct research with respect to, or to administer a controlled substance in the course of professional practice or research in this state;

(B) A pharmacy, hospital, or other institution licensed, registered, or otherwise authorized by law to distribute, dispense, conduct research with respect to, or to administer a controlled substance in the course of professional practice or research in this state;

(C) An advanced practice registered nurse acting pursuant to the authority of Code Section 43-34-25. For purposes of this chapter and Code Section 43-34-25, an advanced practice registered nurse is authorized to register with the federal Drug Enforcement Administration and appropriate state authorities; or

(D) A physician assistant acting pursuant to the authority of subsection (e.1) of Code Section 43-34-103. For purposes of this chapter and subsection (e.1) of Code Section 43-34-103, a physician assistant is authorized to register with the federal Drug Enforcement Administration and appropriate state authorities.

(23.1) 'Prescriber' means a physician, dentist, scientific investigator, or other person licensed, registered, or otherwise authorized under the laws of this state to prescribe, distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in this state.

(24) 'Production' includes the manufacture, planting, cultivation, growing, or harvesting of a controlled substance.

(25) 'Registered' or 'register' means registration as required by this article.

(26) 'Registrant' means a person who is registered under this article.

(27) 'State,' when applied to a part of the United States, includes any state, district, commonwealth, territory, insular possession thereof, or any area subject to the legal authority of the United States.

(28) 'Ultimate user' means a person who lawfully possesses a controlled substance for his or her own use, for the use of a member of his or her household, or for administering to an animal owned by him or her or by a member of his or her household or an agent or representative of the person.

(29) 'Noncontrolled substance' means any drug or other substance other than a controlled substance as defined by paragraph (4) of this Code section."

SECTION 2.

Said chapter is further amended by adding new Code sections to read as follows:

"16-13-57.

(a) Subject to funds as may be appropriated by the General Assembly or otherwise available for such purpose, the agency shall, in consultation with the Georgia Composite Medical Board and the State Board of Pharmacy, establish and maintain a method to electronically record into a data base prescription information which results in the dispensing of monitored controlled substances and to electronically review such prescription information that has been entered into such data base. The purpose of such electronic data base and review process shall be to assist in the reduction of the illegal abuse of monitored controlled substances and to reduce duplicative prescribing of monitored controlled substance practices.

(b) Such electronic data base and review process shall be administered by the agency at the direction and oversight of the advisory committee established in Code Section 16-13-61.

16-13-58.

(a) The agency shall apply for available grants and may accept any gifts, grants, donations, and other funds, including funds from the disposition of forfeited property, to assist in developing and maintaining the electronic data base established pursuant to Code Section 16-13-57.

(b) The agency shall be authorized to grant funds to dispensers for the purpose of covering costs for dedicated equipment and software for dispensers to use in complying with the reporting requirements of Code Section 16-13-59. Such grants shall be funded by gifts, grants, donations, or other funds, including funds from the disposition of forfeited property, received by the agency for the operation of the electronic data base established pursuant to Code Section 16-13-57. The agency shall be authorized to establish standards and specifications for any equipment and software purchased pursuant to a grant received by a dispenser pursuant to this Code section. Nothing in Code Sections 16-13-57 through 16-13-64 shall be construed to require a dispenser to incur costs to purchase equipment and software to comply with such Code sections.

16-13-59.

(a) For purposes of the electronic data base and review process established pursuant to Code Section 16-13-57, each dispenser shall submit to the agency by electronic means information regarding each prescription dispensed for a monitored controlled substance. The information submitted for each prescription shall include at a minimum, but shall not be limited to:

(1) United States Drug Enforcement Administration (DEA) permit number or approved dispenser facility controlled substance identification number;

(2) Date prescription dispensed;

(3) Prescription serial number;

(4) If the prescription is new or a refill;

(5) National Drug Code (NDC) for drug dispensed;

(6) Quantity and strength dispensed;

(7) Number of days supply of the drug;

(8) Patient's name;

(9) Patient's address;

(10) Patient's date of birth;

(11) Approved prescriber identification number or prescriber's DEA permit number;

(12) Date prescription issued by prescriber; and

(13) Other data elements consistent with standards established by the American Society for Automation in Pharmacy, if designated by regulations of the agency.

In the event that the agency adds any additional data elements pursuant to this subsection, the agency shall provide notice at least 30 days prior to any such proposed addition to the chairpersons of the Senate Health and Human Services Committee, the House Committee on Health and Human Services, the Senate Judiciary Committee, and the House Committee on Judiciary, Non-civil; provided, however, that this shall be in addition to the requirements contained in Code Section 16-13-62.

(b) Each dispenser shall submit the prescription information in accordance with transmission methods and frequency requirements established by the agency within 96 hours of dispensing or more frequently at the dispenser's discretion. If a dispenser is temporarily unable to comply with this subsection due to an equipment failure or other circumstances, such dispenser shall notify the agency.

(c) The agency may issue a waiver to a dispenser that is unable to submit prescription information by electronic means acceptable to the agency. Such waiver may permit the dispenser to submit prescription information to the agency by paper form or other means, provided all information required in subsection (a) of this Code section is submitted in this alternative format subject to the frequency requirements of subsection (b) of this Code section. Requests for waivers shall be submitted in writing to the agency.

(d) The agency shall not revise the information required to be submitted by dispensers pursuant to subsection (a) of this Code section more frequently than annually. Any such change to the required information shall neither be effective nor be applicable to dispensers until six months after the adoption of such changes.

(e) The agency shall not access electronic data base prescription information for more than two years after the date it was originally received and shall delete or destroy such information which is two years old or older in a timely and secure manner.

(f) A hospital, clinic, or other health care facility may apply to the agency for an exemption to be excluded from compliance with this Code section if compliance would impose an undue hardship on such facility. The agency shall provide guidelines and criteria for what constitutes an undue hardship which shall include criteria relating to the number of indigent patients served and the lack of electronic capabilities of the facility.

(g) If, due to a lack of funding, or for other reasons, the agency ceases its ability to operate the electronic data base or to collect information through the data base for any period of time, no dispenser shall be required to report prescription information to the agency during such period of time, nor shall any dispenser be held criminally or civilly liable for not reporting prescription information as required by Code Sections 16-13-57 through 16-13-64 during any such period of time.

16-13-60.

(a) Prescription information submitted to the agency pursuant to Code Section 16-13-59 shall be confidential and shall not be subject to open records requirements, as contained in Article 4 of Chapter 18 of Title 50, except as provided in subsections (c) and (d) of this Code section.

(b) The agency shall establish and maintain strict procedures to ensure that the privacy and confidentiality of patients and prescribers and patient and prescriber information collected, recorded, transmitted, and maintained pursuant to Code Sections 16-13-57 through 16-13-64 are protected. Such information shall not be disclosed to persons except as otherwise provided in Code Sections 16-13-57 through 16-13-64 and only in a manner which in no way would conflict with the requirements of the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996, P.L. 104-191.

(c) The agency shall be authorized to provide requested prescription information collected pursuant to Code Sections 16-13-57 through 16-13-64:

(1) To persons authorized to prescribe or dispense controlled substances for the purpose of providing medical or pharmaceutical care for their patients;

(2) Upon the request of a person about whom the prescription information requested concerns or upon the request on his or her behalf by his or her attorney;

(3) To the Georgia Composite Medical Board or any licensing board whose practitioners have the authority to prescribe or dispense controlled substances;

(4) To any local, state, or federal law enforcement, regulatory, or prosecutorial officials, upon receipt of a subpoena issued by a court of record, located within or outside of this state;

(5) To a state agency, board, or entity with administrative subpoena powers and which is authorized to receive such prescription information, upon receipt of an administrative subpoena issued by such state agency, board, or entity;

(6) Upon the lawful order of a court of competent jurisdiction; and

(7) To personnel of the agency for purposes of administration and enforcement of Code Sections 16-13-57 through 16-13-64 or any other applicable state law.

(d) The agency may provide data to government entities for statistical, research, educational, or grant application purposes after removing information that could be used to identify prescribers or individual patients or persons who received prescriptions from dispensers.

(e) The agency may prepare a plan to provide electronic data base prescription information to a prescription review program in another state if the confidentiality, security, privacy, and utilization standards of the requesting state are determined to be equivalent to those of the agency.

(f) Any person who receives electronic data base prescription information or related reports relating to Code Sections 16-13-57 through 16-13-64 from the agency shall not provide such data or reports to any other person except by order of a court of competent jurisdiction or as otherwise permitted pursuant to Code Sections 16-13-57 through 16-13-64.

(g) Any permissible user identified in Code Sections 16-13-57 through 16-13-64 who directly accesses electronic data base prescription information shall implement and maintain a comprehensive information security program that contains administrative, technical, and physical safeguards that are appropriate to the user's size and complexity and to the sensitivity of the personal information obtained. The permissible user shall identify reasonably foreseeable internal and external risks to the security, confidentiality, and integrity of personal information that could result in the unauthorized disclosure, misuse, or other compromise of the information and shall assess the sufficiency of any safeguards in place to control the risks.

16-13-61.

(a) There is established an Electronic Database Review Advisory Committee for the purposes of consulting with and advising the agency solely on matters related to implementation of Code Sections 16-13-57 through 16-13-64. This shall include, but shall not be limited to, data collection, regulation of access to data, evaluation of data to identify irregular patterns indicating possible illegal abuse, communication to prescribers and dispensers as to the intent of the data collection and analysis and how to use the data base, and security of data collected.

(b) The advisory committee shall consist of eight members as follows:

(1) A representative from the agency;

(2) A representative from the Georgia Composite Medical Board, appointed by the Governor;

(3) A representative from the Georgia Board of Dentistry, appointed by the Lieutenant Governor;

(4) A consumer representative, appointed by the Speaker of the House of Representatives;

(5) A representative from the Georgia Chapter of the American Society of Addictive Medicine, appointed by the Governor;

(6) A representative from the Georgia Society of Clinical Oncology, appointed by the Speaker of the House of Representatives;

(7) A representative from a hospice or hospice organization, appointed by the Lieutenant Governor; and

(8) A representative from the State Board of Pharmacy, appointed by the Governor.

(c) Each member of the advisory committee shall serve a three-year term or until the appointment and qualification of such member's successor.

(d) The advisory committee shall elect a chairperson and vice chairperson from among its membership to serve a term of one year; provided, however, that the member appointed pursuant to paragraph (1) of subsection (b) of this Code section shall not be eligible to serve as the chairperson or vice chairperson. The vice chairperson shall serve as the chairperson at times when the chairperson is absent.

(e) The advisory committee shall meet at the call of the chairperson or upon request by at least three of the members and shall meet at least one time per year. Five members of the committee shall constitute a quorum.

(f) The members shall receive no compensation or reimbursement of expenses from the state for their services as members of the advisory committee.

16-13-62.

(a) The advisory committee established in Code Section 16-13-61 shall establish rules and regulations to implement the requirements of Code Sections 16-13-57 through 16-13-64. Nothing in Code Sections 16-13-57 through 16-13-64 shall be construed to authorize the advisory committee to establish policies, rules, or regulations which limit, revise, or expand or purport to limit, revise, or expand any prescription or dispensing authority of any prescriber or dispenser subject to Code Sections 16-13-57 through 16-13-64. Nothing in Code Sections 16-13-57 through 16-13-64 shall be construed to impede, impair, or limit a prescriber from prescribing pain medication in accordance with the pain management guidelines developed and adopted by the Georgia Composite Medical Board.

(b) Rules established by the advisory committee pursuant to this Code section shall be adopted, promulgated, and implemented as provided in this Code section and in Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act,' except that the advisory committee shall not be required to comply with subsections (c) through (g) of Code Section 50-13-4.

(c) The advisory committee shall transmit three copies of the notice provided for in paragraph (1) of subsection (a) of Code Section 50-13-4 to the legislative counsel. The copies shall be transmitted at least 30 days prior to the advisory committee's intended action. Within five days after receipt of the copies, if possible, the legislative counsel shall furnish the presiding officer of each house with a copy of the notice and mail a copy of the notice to each member of the Senate Health and Human Services Committee, the House Committee on Health and Human Services, the Senate Judiciary Committee, and the House Committee on Judiciary, Non-civil. Each such rule and any part thereof shall be subject to the making of an objection by any such committee within 30 days of transmission of the rule to the members of such committees. Any rule or part thereof to which no objection is made by two or more such committees may become adopted by the advisory committee at the end of such 30 day period. The advisory committee shall not adopt any such rule or part thereof which has been changed since having been submitted to those committees unless:

(1) That change is to correct only typographical errors;

(2) That change is approved in writing by such committees and that approval expressly exempts that change from being subject to the public notice and hearing requirements of subsection (a) of Code Section 50-13-4;

(3) That change is approved in writing by such committees and is again subject to the public notice and hearing requirements of subsection (a) of Code Section 50-13-4; or

(4) That change is again subject to the public notice and hearing requirements of subsection (a) of Code Section 50-13-4 and the change is submitted and again subject to committee objection as provided in this subsection.

Nothing in this subsection shall prohibit the advisory committee from adopting any rule or part thereof without adopting all of the rules submitted to the committees if the rule or part so adopted has not been changed since having been submitted to the committees and objection thereto was not made by such committees.

(d) Any rule or part thereof to which an objection is made by two or more committees within the 30 day objection period under subsection (c) of this Code section shall not be adopted by the advisory committee and shall be invalid if so adopted. A rule or part thereof thus prohibited from being adopted shall be deemed to have been withdrawn by the advisory committee unless the advisory committee, within the first 15 days of the next regular session of the General Assembly, transmits written notification to each member of the objecting committees that the advisory committee does not intend to withdraw that rule or part thereof but intends to adopt the specified rule or part effective the day following adjournment sine die of that regular session. A resolution objecting to such intended adoption may be introduced in either branch of the General Assembly after the fifteenth day but before the thirtieth day of the session in which occurs the notification of intent not to withdraw a rule or part thereof. In the event the resolution is adopted by the branch of the General Assembly in which the resolution was introduced, it shall be immediately transmitted to the other branch of the General Assembly. It shall be the duty of the presiding officer of the other branch to have that branch, within five days after receipt of the resolution, consider the resolution for purposes of objecting to the intended adoption of the rule or part thereof. Upon such resolution being adopted by two-thirds of the vote of each branch of the General Assembly, the rule or part thereof objected to in that resolution shall be disapproved and not adopted by the advisory committee. If the resolution is adopted by a majority but by less than two-thirds of the vote of each such branch, the resolution shall be submitted to the Governor for his or her approval or veto. In the event of a veto, or if no resolution is introduced objecting to the rule, or if the resolution introduced is not approved by at least a majority of the vote of each such branch, the rule shall automatically become adopted the day following adjournment sine die of that regular session. In the event of the Governor's approval of the resolution, the rule shall be disapproved and not adopted by the advisory committee.

(e) Any rule or part thereof which is objected to by only one committee under subsection (c) of this Code section and which is adopted by the advisory committee may be considered by the branch of the General Assembly whose committee objected to its adoption by the introduction of a resolution for the purpose of overriding the rule at any time within the first 30 days of the next regular session of the General Assembly. It shall be the duty of the advisory committee in adopting a proposed rule over such objection to notify the chairpersons of the Senate Health and Human Services Committee, the House Committee on Health and Human Services, the Senate Judiciary Committee, and the House Committee on Judiciary, Non-civil within ten days after the adoption of the rule. In the event the resolution is adopted by such branch of the General Assembly, it shall be immediately transmitted to the other branch of the General Assembly. It shall be the duty of the presiding officer of the other branch of the General Assembly to have such branch, within five days after the receipt of the resolution, consider the resolution for the purpose of overriding the rule. In the event the resolution is adopted by two-thirds of the votes of each branch of the General Assembly, the rule shall be void on the day after the adoption of the resolution by the second branch of the General Assembly. In the event the resolution is ratified by a majority but by less than two-thirds of the votes of either branch, the resolution shall be submitted to the Governor for his or her approval or veto. In the event of a veto, the rule shall remain in effect. In the event of the Governor's approval, the rule shall be void on the day after the date of approval.

(f) Any proceeding to contest any rule on the ground of noncompliance with this Code section must be commenced within two years from the effective date of the rule.

(g) For purposes of this Code section, 'rules' shall mean rules and regulations.

(h) The agency shall ensure that the prescription information in the data base shall only be used or reviewed for the purposes delineated in Code Section 16-13-57. No review or access to prescription information shall be authorized except in accordance with the guidelines established by the advisory committee. No prescription information shall be accessed on a random basis but shall only be accessed based on patterns detected through the data base indicating possible illegal abuse, which may include factors such as multiple prescriptions in a relatively short period of time to the same individual for the same monitored controlled substance from the same prescriber. No agency staff member, contractor, or agent or other individual accessing the data base shall be authorized to review or access individual or other prescription information in the data base except in accordance with this Code section.

(i) Upon detection of a pattern indicating possible illegal abuse, the agency shall be authorized to investigate the circumstances and, based on their findings, shall be authorized to refer an incident, as appropriate, to the board responsible for regulating the dispenser or prescriber, to appropriate law enforcement authorities, or to both.

(j) The agency shall annually report to the General Assembly aggregated, nonidentifying data on the number of occurrences identified for investigation and the resolution, if known.

16-13-63.

Nothing in Code Sections 16-13-57 through 16-13-64 shall require a dispenser or prescriber to obtain information about a patient from the prescription monitoring program established pursuant to Code Sections 16-13-57 through 16-13-64. A dispenser or prescriber shall not have a duty and shall not be held liable for damages to any person in any civil, criminal, or administrative action for injury, death, or loss to person or property on the basis that the dispenser or prescriber did or did not seek or obtain information from the electronic prescriptions data base established pursuant to Code Section 16-13-57.

16-13-64.

(a) A dispenser who knowingly and intentionally fails to submit electronic data base prescription information to the agency as required by Code Sections 16-13-57 through 16-13-64 or knowingly and intentionally submits incorrect prescription information shall be guilty of a misdemeanor and, upon conviction thereof, shall be punished for each such offense by imprisonment for a period not to exceed 12 months, a fine not to exceed $1,000.00, or both, and such actions shall be reported to the board responsible for issuing such dispenser's dispensing license for action to be taken against such dispenser's license.

(b)(1) An individual authorized to access electronic data base prescription information pursuant to Code Sections 16-13-57 through 16-13-64 who negligently uses, releases, or discloses such information in a manner or for a purpose in violation of Code Sections 16-13-57 through 16-13-64 shall be guilty of a misdemeanor. Any person who is convicted of negligently using, releasing, or disclosing such information in violation of Code Sections 16-13-57 through 16-13-64 shall, upon the second or subsequent conviction, be guilty of a felony and shall be punished by imprisonment for not less than one nor more than three years, by a fine not to exceed $5,000.00, or by both.

(2) Any individual who accesses electronic data base prescription information who knowingly and intentionally uses, releases, or discloses such information in a manner or for a purpose in violation of Code Sections 16-13-57 through 16-13-64 shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment for not less than two nor more than ten years, by a fine not to exceed $100,000.00, or by both. Any person who is convicted of knowingly and intentionally using, releasing, or disclosing such information in violation of Code Sections 16-13-57 through 16-13-64 shall, upon the second or subsequent conviction, be guilty of a felony and shall be punished by imprisonment for not less than three nor more than 15 years, by a fine not to exceed $250,000.00, or by both.

(c) Any person who knowingly requests, obtains, or attempts to obtain electronic data base prescription information pursuant to Code Sections 16-13-57 through 16-13-64 under false pretenses, or who knowingly communicates or attempts to communicate electronic data base prescription information to any board, agency, or person except in accordance with Code Sections 16-13-57 through 16-13-64, or any member, officer, employee, or agent of the agency or the advisory council, or any person who knowingly falsifies electronic data base prescription information or any records relating thereto shall be guilty of a felony and, upon conviction thereof, shall be punished for each such offense by imprisonment for not less than one year nor more than two years, by a fine not to exceed $5,000.00, or by both.

(d) Any person who is injured by reason of any violation of Code Sections 16-13-57 through 16-13-64 shall have a cause of action for the actual damages sustained and, where appropriate, punitive damages. Such person may also recover attorney's fees in the trial and appellate courts and the costs of investigation and litigation reasonably incurred.

(e) The penalties provided by this Code section are intended to be cumulative of other penalties which may be applicable and are not intended to repeal such other penalties."

SECTION 3.

This Act shall become effective on July 1, 2010.

SECTION 4.

All laws and parts of laws in conflict with this Act are repealed.