1997 Regular Session
To: Judiciary A
By: Representative McCoy
House Bill 476
AN ACT TO CREATE THE ANTI-DRUG DIVERSION ACT; TO DEFINE CERTAIN TERMS; TO REQUIRE DISPENSERS TO TRANSFER CERTAIN INFORMATION TO A CENTRAL REPOSITORY; TO PROVIDE FOR CONFIDENTIALITY AND DISCLOSURE OF INFORMATION; TO PROVIDE FOR DUTIES AND POWERS RELATED TO THE CENTRAL REPOSITORY; TO REQUIRE THE BUREAU OF NARCOTICS TO DEVELOP CRITERIA OF EXCEPTION REPORTS OUT OF INFORMATION COLLECTED; TO PROVIDE FOR THE PROMULGATION OF RULES AND REGULATIONS TO IMPLEMENT THIS ACT; TO BRING FORWARD FOR PURPOSES OF AMENDMENT SECTIONS 41-29-125, 41-29-127, 41-29-129, 41-29-131, 41-29-133, 41-29-135 AND 41-29-137, MISSISSIPPI CODE OF 1972, WHICH PROVIDE FOR REGISTRATION AND CONTROL OF THE MANUFACTURE, DISTRIBUTION AND DISPENSING OF CONTROLLED SUBSTANCES AND REGULATION OF SUCH REGISTRANTS; AND FOR RELATED PURPOSES.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
SECTION 1. Sections 1 through 8 of this act shall be known and may be cited as the "Anti-Drug Diversion Act."
SECTION 2. For the purposes of the Anti-Drug Diversion Act:
(a) "Bureau" means the Mississippi Bureau of Narcotics;
(b) "Dispenser" means a person who distributes a Schedule II through V as described in Sections 41-29-115 through 41-29-121 controlled substance, but does not include a licensed hospital pharmacy or a licensed nurse or medication aide who administers such a substance at the direction of a licensed practitioner as defined in Section 41-29-105(y);
(c) "Dispenser's registration number" means the dispenser's Mississippi Bureau of Narcotics registration number or, in the case of a pharmacist, the National Association of Boards of Pharmacy number for the pharmacy where the dispensation is made;
(d) "Exception report" means an output of data indicating Schedule II through V controlled substance dispensation which is outside expected norms for a prescriber practicing a particular specialty or field of health care, for a dispenser doing business in a particular location, or for a recipient;
(e) "Recipient's Identification Number" means the unique number contained on a Schedule II through V controlled substance recipient's valid driver's license issued by the State of Mississippi or social security card issued to the recipient by the Social Security Administration. If the recipient is under 18 years of age and has no such identification, the unique number contained on the recipient's parent's or guardian's valid driver's license or social security card shall be the recipient's identification number. If the controlled substance is obtained for an animal, the unique number contained on the animal's owner's valid driver's license or social security card shall be the recipient's identification number;
(f) "State" means any state, territory, or possession of the United States, the District of Columbia, or foreign nation.
SECTION 3. (1) Beginning July 1, 1997, the dispenser of a Schedule II through V controlled substance shall transmit to a central repository designated by the bureau the following information for each dispensation:
(a) Recipient's name, when feasible to submit;
(b) Recipient's identification number;
(c) National Drug Code number of the substance dispensed;
(d) Date of the dispensation;
(e) Quantity of the substance dispensed;
(f) Prescriber's U.S. Drug Enforcement Agency registration number; and
(g) Dispenser's registration number and location.
(2) The information required by this section shall be transmitted:
(a) On an electronic device which is compatible with the receiving device of the central repository or by computer diskette, magnetic tape, or pharmacy universal claim form, which meets the specifications provided by rules of the bureau; and
(b) Within fifteen (15) days of the time that the substance is dispensed.
(3) Wilful failure to transmit information as required by this section shall be a misdemeanor punishable, upon conviction, by not more than one (1) year in the county jail or a fine of not more than One Thousand Dollars ($1,000.00) or both.
SECTION 4. (1) The information collected at the central repository pursuant to the Anti-Drug Diversion Act shall be confidential and shall not be open to the public. Access to the information shall be limited to:
(a) Special contract agents of the bureau pursuant to Section 41-29-112;
(b) The United States Drug Enforcement Administration Diversion Group Supervisor;
(c) The executive director or chief investigator as designated by each board, of the State Boards of Dental Examiners, Pharmacy, Medical Licensure and Veterinary Medical Examiners, provided, however, that the executive director or chief investigator of each of these boards shall be limited to access to information relevant to licensees of his employing board; and
(d) A statewide grand jury properly convened pursuant to the Statewide Grand Jury Act, as provided by Section 13-7-1 et seq.
(2) This section shall not prevent the disclosure, at the discretion of the Director of the bureau, of investigative information to peace officers and investigative agents of federal, state, county or municipal law enforcement agencies, district attorneys and the Attorney General in furtherance of criminal investigations or prosecutions within their respective jurisdictions.
(3) Any unauthorized disclosure of any information collected at the central repository provided by the Anti-Drug Diversion Act shall be a misdemeanor. Violation of the provisions of this section shall be deemed willful neglect of duty and shall be grounds for removal from office.
SECTION 5. All access to information in the central repository shall be controlled by and made through the bureau.
SECTION 6. (1) The central repository provided by the Anti-Drug Diversion Act shall:
(a) Be capable of providing the collected information in forms required by the bureau, including but not limited to, dispensations by prescriber name or registration number, dispenser name, or registration number, recipient name or identification number, type of substance, frequency, quantity, and location of dispensation;
(b) Provide the bureau with continual, twenty-four-hour per day, on-line access to the collected information;
(c) Secure the collected information against access by unauthorized persons;
(d) Provide the bureau, in a reasonable time, with all collected information in a format readily usable by the bureau, in the event the relationship between the state and central repository is terminated; and
(e) Not withhold access to the collected information for any reason other than failure of the bureau to timely pay agreed fees and charges for use of the central repository.
(2) The bureau is authorized to enter into a contract with a vendor to serve as the central repository provided for in the Anti-Drug Diversion Act or to purchase the necessary equipment to create the central repository within the bureau.
SECTION 7. The bureau shall develop criteria for the production of exception reports out of the information collected at the central repository. The bureau shall seek the counsel of the State boards of Dental Examiners, Pharmacy, Medical Licensure, and Veterinary Medical Examiners, and Mississippi Dental Association, Mississippi Pharmaceutical Association, Mississippi State Medical Association, and Mississippi Veterinary Medical Association in developing these criteria.
SECTION 8. The director of the bureau shall promulgate and adopt rules to implement and enforce the Anti-Drug Diversion Act.
SECTION 9. Section 41-29-125, Mississippi Code of 1972, is brought forward as follows:
41-29-125. The State Board of Pharmacy may promulgate rules and regulations relating to the registration and control of the manufacture, distribution and dispensing of controlled substances within this state.
(a) Every person who manufactures, distributes or dispenses any controlled substance within this state, or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance within this state, must obtain a registration issued by the State Board of Pharmacy, State Board of Medical Licensure or State Board of Dental Examiners, as appropriate, in accordance with its rules. Such registration shall be obtained annually or biennially, as specified by the issuing board, and a reasonable fee may be charged by the issuing board for such registration.
(b) Persons registered by the State Board of Pharmacy, with the consent of the United States Drug Enforcement Administration and the State Board of Medical Licensure or State Board of Dental Examiners, to manufacture, distribute, dispense or conduct research with controlled substances may possess, manufacture, distribute, dispense or conduct research with those substances to the extent authorized by their registration and in conformity with the other provisions of this article.
(c) The following persons need not register and may lawfully possess controlled substances under this article:
(1) An agent or employee of any registered manufacturer, distributor or dispenser of any controlled substance if he is acting in the usual course of his business or employment;
(2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of any controlled substance is in the usual course of business or employment;
(3) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or in lawful possession of a Schedule V substance as defined in Section 41-29-121.
(d) The State Board of Pharmacy may waive by rule the requirement for registration of certain manufacturers, distributors or dispensers if it finds it consistent with the public health and safety.
(e) A separate registration is required at each principal place of business or professional practice where the applicant manufactures, distributes or dispenses controlled substances.
(f) The State Board of Pharmacy, Mississippi Bureau of Narcotics, the State Board of Medical Licensure and the State Board of Dental Examiners may inspect the establishment of a registrant or applicant for registration in accordance with the regulations of these agencies as approved by the board.
SECTION 10. Section 41-29-127, Mississippi Code of 1972, is brought forward as follows:
41-29-127. (a) The State Board of Pharmacy shall register an applicant to manufacture or distribute controlled substances included in sections 41-29-113 to 41-29-121 unless it determines that the issuance of that registration would be inconsistent with the public interest. In determining the public interest, the state board of pharmacy shall consider the following factors:
(1) Maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific, or industrial channels;
(2) Compliance with applicable state and local law;
(3) Any convictions of the applicant under any federal and state laws relating to any controlled substance;
(4) Past experience in the manufacture or distribution of controlled substances and the existence in the applicant's establishment of effective controls against diversion;
(5) Furnishing by the applicant of false or fraudulent material in any application filed under this article;
(6) Suspension or revocation of the applicant's federal registration to manufacture, distribute, or dispense controlled substances as authorized by federal law; and
(7) Any other factors relevant to and consistent with the public health and safety.
(b) Registration under subsection (a) does not entitle a registrant to manufacture and distribute controlled substances in Schedule I or II, as set out in Sections 41-29-113 and 41-29-115, other than those specified in the registration.
(c) Practitioners must be registered to dispense any controlled substances or to conduct research with controlled substances in Schedules II through V, as set out in Sections 41-29-115 to 41-29-121, if they are authorized to dispense or conduct research under the law of this state. The State Board of Pharmacy need not require separate registration under this section for practitioners engaging in research with nonnarcotic controlled substances in the said Schedules II through V where the registrant is already registered therein in another capacity. Practitioners registered under federal law to conduct research with Schedule I substances, as set out in Section 41-29-113, may conduct research with Schedule I substances within this state upon furnishing the state board of health evidence of that federal registration.
(d) Compliance by manufacturers and distributors with the provisions of the federal law respecting registration (excluding fees) entitles them to be registered under this article.
SECTION 11. Section 41-29-129, Mississippi Code of 1972, is brought forward as follows:
41-29-129. (1) A registration to manufacture, distribute, or dispense a controlled substance may be suspended or revoked by the State Board of Pharmacy upon a finding that the registrant:
(a) Has willfully furnished false or fraudulent material information in any application filed under this article;
(b) Has been convicted of a felony within the past five (5) years and has not been pardoned and his citizenship restored under any state or federal law relating to any controlled substance;
(c) Has had his federal registration suspended or revoked to manufacture, distribute, or dispense controlled substances;
(d) Has violated or failed to comply with any duly promulgated regulation of the State Board of Pharmacy which reflects adversely on the registrant's reliability and integrity with respect to controlled substances;
(e) Has violated the Uniform Controlled Substances Law of the State of Mississippi;
(f) Has violated any duly promulgated rule or regulation of the State Board of Pharmacy pertaining to the manufacture, distribution, storage, possession, control or dispensing of controlled substances;
(g) Has been convicted of a violation relating to any substance defined in this article as a controlled substance.
(2) The State Board of Pharmacy may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exist.
(3) If the board or the State Board of Pharmacy suspends or revokes a registration, all controlled substances owned or possessed by the registrant at the time of suspension or the effective date of the revocation order may be placed under seal. No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court, upon application therefor, orders the sale of perishable substances and the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all controlled substances may be forfeited to the state. All state professional or business licensing agencies shall promptly notify the bureau of all orders of suspensions or revocations which are the result of drug violations or drug-related matters.
(4) The bureau shall promptly notify the federal bureau of narcotics and dangerous drugs of all orders suspending or revoking registration and all forfeitures of controlled substances.
SECTION 12. Section 41-29-131, Mississippi Code of 1972, is brought forward as follows:
41-29-131. (1) Upon presentation before the state board of pharmacy by any person showing grounds for denying, suspending or revoking a controlled substance registration, or refusing a renewal of registration, the State Board of Pharmacy may, in its discretion, deny such registration, revoke or suspend such registration or refuse a renewal of such registration.
(2) Before denying, suspending or revoking a registration, or refusing a renewal of registration, the state board of pharmacy shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked or suspended, or why the renewal should not be refused. The order to show cause shall contain a statement of the basis therefor and shall call upon the applicant or registrant to appear before the State Board of Pharmacy at a time and place not less than twenty (20) days after the date of service of the order, but in the case of a denial or renewal of registration, the show cause order shall be served not later than thirty (30) days before the expiration of the registration. Such order may be served by mailing a copy thereof by United States, first-class, certified mail, postage prepaid, to the last-known residence or business address of such registrant. The hearings on such charges shall be at such time and place as the board may prescribe.
(3) At such hearings, all witnesses shall be sworn by a member of the board, and stenographic notes of the proceedings may be taken and filed as a part of the record in the case. Any party to the proceedings requesting it shall be furnished with a copy of such stenographic notes upon payment to the board of such fees as it shall prescribe, not exceeding, however, the actual cost thereof.
(4) The board is hereby authorized and empowered to issue subpoenas for the attendance of witnesses and the production of books and papers. The process issued by the board shall extend to all parts of the state and such process shall be served by any person designated by the board for such service. The person serving such process shall receive such compensation as may be allowed by the board, not to exceed the fee prescribed by law for similar services. All witnesses who shall be subpoenaed, and who shall appear in any proceedings before the board, shall receive the same fees and mileage as allowed by law and all such fees shall be taxed as part of the costs in the case.
(5) Where in any proceeding before the board any witness shall fail or refuse to attend upon subpoena issued by the board, shall refuse to testify, or shall refuse to produce any books and papers, the production of which is called for by the subpoena, the attendance of such witness and the giving of his testimony and the production of the books and papers shall be enforced by any court of competent jurisdiction of this state in the manner provided for the enforcement of attendance and testimony of witnesses in civil cases in the courts of this state.
(6) The board shall conduct said hearing in an orderly and continuous manner, granting continuances only when the ends of justice may be served. The board shall, within sixty (60) days after the conclusion of the hearing, reduce its decision to writing and forward an attested true copy thereof to the last-known residence or business address of such applicant, registrant or holder of a registration, by way of United States, first-class, certified mail, postage prepaid.
(7) Such applicant, registrant, holder of a registration or person aggrieved shall have the right of appeal from an adverse ruling or order or decision of the board to the chancery court, upon forwarding notice of appeal to the board thirty (30) days after the decision of the board is mailed in the manner here contemplated. An appeal will not be allowed in the event notice of appeal, together with the appeal bond hereinafter required, shall not have been forwarded for the board within said period of thirty (30) days.
(8) Appeal shall be to the chancery court of the county and judicial district of the residence of the appellant, or to the Chancery Court of the First Judicial District of Hinds County, Mississippi, at the election of the appellant. The notice of appeal shall elect venue, unless the appellant be a nonresident of the State of Mississippi, in which event the board shall certify all documents and evidence directly to the Chancery Court of the First Judicial District of Hinds County for further proceedings. The appeal shall thereupon be heard in due course by said court, which shall review the record and make its determination thereon.
(9) The appellant shall, together with the notice of appeal, forward to and post with the board a satisfactory bond in the amount of two hundred dollars ($200.00) for the payment of any costs which may be adjudged against him.
(10) Any order, rule or decision of the board shall not take effect until after the time for appeal shall have expired. In the event of an appeal, such appeal shall act as a supersedeas and the court shall dispose of said appeal and enter its decision promptly. The hearing on the appeal may, in the discretion of the chancellor, be tried in vacation.
(11) These proceedings shall be conducted in accordance with present administrative procedures without regard to any criminal prosecution or other proceeding. Proceedings to refuse renewal of registration shall not abate the existing registration, which shall remain in effect pending the outcome of the administrative hearing.
(12) The Mississippi Bureau of Drug Enforcement or the State Board of Pharmacy may suspend, without an order to show cause, any registration simultaneously with the institution of proceedings under Section 41-29-129, or where renewal of registration is refused, if it finds that there is an imminent danger to the public health or safety which warrants this action. The suspension shall continue in effect until the conclusion of the proceedings, including judicial review thereof, unless sooner withdrawn by the suspending agency or dissolved by a court of competent jurisdiction.
SECTION 13. Section 41-29-133, Mississippi Code of 1972, is brought forward as follows:
41-29-133. Persons registered to manufacture, distribute, or dispense controlled substances under this article shall keep records and maintain inventories in conformance with the record-keeping and inventory requirements of federal law and with any additional rules the State Board of Pharmacy, State Board of Medical Licensure or State Board of Dental Examiners may issue.
SECTION 14. Section 41-29-135, Mississippi Code of 1972, is brought forward as follows:
41-29-135. Controlled substances in Schedules I and II of Sections 41-29-113 and 41-29-115, shall be distributed by a registrant to another registrant only pursuant to an order form. Compliance with the provisions of federal law respecting order forms shall be deemed compliance with this section.
SECTION 15. Section 41-29-137, Mississippi Code of 1972, is brought forward as follows:
41-29-137. (a) Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, no controlled substance in Schedule II, as set out in Section 41-29-115, may be dispensed without the written prescription of a practitioner. A practitioner shall keep a record of all controlled substances in Schedule I, II and III administered, dispensed or professionally used by him otherwise than by prescription.
In emergency situations, as defined by rule of the State Board of Pharmacy, said 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 41-29-133. No prescription for a Schedule II substance may be refilled unless renewed by prescription issued by a licensed medical doctor.
(b) Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, a controlled substance included in Schedule III or IV, as set out in Sections 41-29-117 and 41-29-119, which is a prescription drug as determined under Federal Control Substance Act, shall not be dispensed without a written or oral prescription of a practitioner. The prescription shall not be filled or refilled more than six months after the date thereof or be refilled more than five times, unless renewed by the practitioner.
(c) A controlled substance included in Schedule V, as set out in Section 41-29-121, shall not be distributed or dispensed other than for a medical purpose.
SECTION 16. This act shall take effect and be in force from and after July 1, 1997.