To repeal sections 338.043, 338.057, 338.059, 338.060, 338.065, 338.070, 338.100, 338.120, 338.130, 338.140, 338.196, 338.220 and 338.365, RSMo 1994, and section 338.056, RSMo Supp. 1996, relating to the state board of pharmacy, and to enact in lieu thereof fifteen new sections relating to the same subject.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF MISSOURI, AS FOLLOWS:

     Section A. Sections 338.043, 338.057, 338.059, 338.060, 338.065, 338.070, 338.100, 338.120, 338.130, 338.140, 338.196, 338.220 and 338.365, RSMo 1994, and section 338.056, RSMo Supp. 1996, are repealed and fifteen new sections enacted in lieu thereof, to be known as sections 338.013, 338.043, 338.056, 338.057, 338.059, 338.060, 338.065, 338.070, 338.100, 338.120, 338.130, 338.140, 338.220, 338.363 and 338.365, to read as follows:

     338.013. 1. Any person desiring to assist a pharmacist in the practice of pharmacy as defined in this chapter shall apply to the board of pharmacy for registration as a pharmacy technician. Such applicant shall not have engaged in conduct or behavior determined to be grounds for discipline pursuant to this chapter. Such applicant shall forward to the board the appropriate fee and written application on a form provided by the board. Such registration shall be the sole authorization permitted to allow persons to assist licensed pharmacists in the practice of pharmacy as defined in this chapter.

     2. If an applicant has submitted the required fee and an application for registration to the board of pharmacy, the applicant for registration as a pharmacy technician may assist a licensed pharmacist in the practice of pharmacy as defined in this chapter for a period of up to ninety days prior to the issuance of a certificate of registration. The applicant shall keep a copy of the submitted application on the premises where the applicant is employed.

     3. A certificate of registration issued by the board shall be conspicuously displayed in the pharmacy or place of business where the registrant is employed.

     4. Every pharmacy technician who desires to continue to be registered as provided in this section shall, within thirty days before the registration expiration date, file an application for the renewal, accompanied by the fee prescribed by the board. No registration as provided in this section shall be valid if the registration has expired and has not been renewed as provided in this subsection.

     5. The board shall maintain an employment disqualification list of the names of all pharmacy technicians who have been adjudicated and found guilty, or has entered a plea of guilty or nolo contendere to violation of any state, territory or federal drug law, been found guilty, pled guilty or nolo contendere to any felony or has violated any provision of subdivision (2), (3), (4), (6), (7), (11), (12) or (15) of subsection 2 of section 338.055.

     6. After an investigation and a determination has been made to place a person's name on the employment disqualification list, the board shall notify such person in writing mailed to the person's last known address that:

     (1) An allegation has been made against the person, the substance of the allegation and that an investigation has been conducted which tends to substantiate the allegation;

     (2) Such person's name will be included in the employment disqualification list of the board;

     (3) The consequences to the person of being listed and the length of time the person's name will be on the list; and

     (4) The person's rights and the procedure to challenge the inclusion of the person's name on the disqualification list.

     7. If no reply has been received by the board within thirty days after the board mailed the notice, the board may include the name of such person on such disqualification list. The length of time a person's name shall remain on the disqualification list shall be determined by the board. The board may, also, provide for alternative sanctions, including, but not limited to, conditional employment based on a requirement that the person submit certain documentation within a certain period of time. Any person who receives notice that the board intends to place the person's name on the employment disqualification list may file an appeal with the administrative hearing commission as provided in chapter 621, RSMo.

     8. No licensed pharmacy shall knowingly employ any person whose name appears on the employee disqualification list. Any licensed pharmacy permit holder who refuses to employ or terminates a person whose name appears on the employee disqualification list shall not be subject to any civil damages from any suit brought by a person, or on behalf of a person, based on a failure to employ, or for the termination of, a person whose name is on the employee disqualification list.

     338.043. 1. Notwithstanding any provision of law to the contrary, the board of pharmacy may grant a temporary license [to any graduate of a school or college of pharmacy whose requirements for graduation are satisfactory to and approved by the board of pharmacy and who holds a license to practice pharmacy by examination in another state and] to an applicant that meets such [other] requirements as the board may prescribe by rule and regulation.

     2. The temporary license provided in subsection 1 of this section shall limit the right of the licensee to practice only in locations approved by the board under the supervision of a pharmacist licensed to practice pharmacy in this state.

     3. The license shall be renewable at the discretion of and with the approval of the board of pharmacy. A temporary license fee shall accompany the original application for a temporary license and a similar amount shall be paid in the event the temporary license is renewed.

     338.056. 1. Except as provided in subsection 2 of this section, the pharmacist filling prescription orders for drug products prescribed by trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity and dosage form, and of the same generic drug type, as determined by the United States Adopted Names and accepted by the Federal Food and Drug Administration. Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subsection 2 of this section. The pharmacist who selects the drug product to be dispensed pursuant to this section shall assume the same responsibility for selecting the dispensed drug product as would be incurred in filling a prescription for a drug product prescribed by generic name. The pharmacist shall not select a drug product pursuant to this section unless the product selected [costs the patient less] is more cost effective than the prescribed product.

     2. A pharmacist who receives a prescription for a brand name drug may, unless requested otherwise by the purchaser, select a [less expensive] more cost effective generically equivalent product under the following circumstances:

     (1) If a written prescription is involved, the [prescription form used shall have two signature lines at opposite ends at the bottom of the form. Under the line at the right side shall be clearly printed the words: "Dispense as Written". Under the line at the left side shall be clearly printed the words "Substitution Permitted". The prescriber shall communicate the instructions to the pharmacist by signing the appropriate line. No] prescription shall not be valid without the signature of the prescriber [on one of these lines]. The pharmacist may substitute the most cost effective generic equivalent product, unless the prescriber, in the prescriber's own handwriting, clearly states on the face of the prescription "brand medication necessary" or words of like intent;

     (2) If an oral prescription is involved, the practitioner or the practitioner's agent[,] communicating the instructions to the pharmacist[, shall] may instruct the pharmacist as to whether or not a therapeutically equivalent generic drug may be substituted. The pharmacist shall note the instructions on the file copy of the prescription.

     3. [All prescriptions written in the state of Missouri by practitioners authorized to write prescriptions shall be on forms which comply with subsection 2 hereof.

     4.] Notwithstanding the provisions of subsection 2 of this section to the contrary, a pharmacist may fill a prescription for a brand name drug by substituting a generically equivalent drug when generic substitution is allowed in accordance with the laws of the state where the prescribing practitioner is located.

     [5.] 4. Violations of this section are infractions.

     338.057. 1. The [department of economic development] board of pharmacy shall publish a list of drug products for which substitution as provided in section 338.056 shall not be permitted. The list of drug products to be included on this list shall be based upon a joint determination made by the department of health, the state board of registration for the healing arts, and the state board of pharmacy. The [department of economic development] board of pharmacy shall publish the list not less often than semiannually, and shall publish amendments to the list as required.

     2. Notwithstanding any other provision of section 338.056 or subsection 1 of this section to the contrary, no person, agency or any other entity may mandate the substitution of any other drug, whether more cost effective or not, for any drug which has been determined by the federal Food and Drug Administration to be classified as a narrow therapeutic index drug, unless expressly authorized by the prescribing health care professional.

     338.059. 1. It shall be the duty of a licensed pharmacist or a physician to affix or have affixed by someone under [his] the pharmacist's or physician's supervision a label to each and every container provided to a consumer in which is placed any prescription drug upon which is typed or written the following information:

     (1) The date [of] the prescription is filled;

     (2) The sequential number;

     (3) The patient's name;

     (4) The prescriber's directions for usage;

     (5) The [prescribing doctor's] prescriber's name;

     (6) The name and address of the pharmacy;

     (7) The exact name and dosage of the drug dispensed;

     (8) There may be one line under the [words written] information provided in subdivisions (1) to (7) of this subsection stating "Refill" with a blank line or squares following[; immediately under the word "Refill"] or the words "No Refill";

     (9) When a generic substitution is dispensed, the name of the manufacturer or an abbreviation thereof shall appear on the label or in the pharmacist's records as required in section 338.100.

     2. The label of any drug which is sold at wholesale in this state and which requires a prescription to be dispensed at retail shall contain the name of the manufacturer, expiration date, if applicable, batch or lot number and national drug code.

     338.060. 1. Every licensed pharmacist or permit holder who desires to continue in the practice of this profession shall, within thirty days before the license expiration date, file an application for the renewal, which application shall be accompanied by the fee [herein] prescribed in sections 338.010 to 338.198.

     2. If any pharmacist [shall fail] fails, for a period of sixty days after the expiration of [his] the pharmacist's license, to make application to the board for its renewal, [his] the pharmacist's name shall be [erased] removed from the register of licensed pharmacists, and such person, in order to again become registered as a licensed pharmacist, shall be required to pay all delinquent fees. Any pharmacist who fails to renew [his] the pharmacist's license within two years of its expiration and then desires to be reregistered shall be treated in the same manner as a person who has never been licensed. Any registered pharmacist whose certificate of registration has expired while [he] the pharmacist has been engaged in active duty with the United States Army, United States Navy, United States Air Force, the Marine Corps, Coast Guard, or any other branch of the armed services or the state militia called into the service or training of the United States of America, or in training or education under the supervision of the United States preliminary to induction into the military services may have [his] the pharmacist's certificate of registration renewed without paying any lapse, renewal or registration fee or without passing any examination, if within one year after the termination of such service, training or education, other than by dishonorable discharge, [he] the pharmacist furnishes the board with an affidavit to the effect that [he] the pharmacist has been so engaged and that [his] the pharmacist's service, training or education has [been so] terminated.

     3. Except as provided in subsection 5 of this section, when applying for a renewal of the license as required by the provisions of this section, each licensed pharmacist shall submit proof of the completion of at least [ten] twenty-five hours of board-approved continuing education courses during the twelve-month period immediately preceding the date of the application for renewal of the license. The board shall prescribe the form to be completed. No license shall be renewed unless the holder thereof has complied with the provisions of this subsection.

     4. The proof of completion of such continuing education shall be in such form as the board may require. The approved courses shall include those offered by correspondence, but the board shall approve all courses of instruction which may be used to satisfy the education requirements of subsection 3 of this section.

     5. Each licensed pharmacist may, instead of submitting proof of the completion of the required continuing education courses, apply for an inactive license at the time [he] the pharmacist makes application for the renewal of [his] the pharmacist's license and pay the required renewal fee. An inactive license shall then be issued, and may be renewed annually. While the inactive license is in effect the pharmacist shall not practice pharmacy. The inactive license may be changed to a regular license without other examination whenever the pharmacist submits proof of the completion of continuing education courses for the total amount of such courses not completed since [he] the pharmacist was last licensed on an active basis.

     338.065. 1. After August 28, 1990, at such time as the final trial proceedings are concluded whereby a [pharmacist] licensee or registrant has been adjudicated and found guilty, or has entered a plea of guilty or nolo contendere, in a felony prosecution [under] pursuant to the laws of the state of Missouri, the laws of any other state, territory or the laws of the United States of America for any offense reasonably related to the qualifications, functions or duties of a [pharmacist] licensee or registrant pursuant to this chapter or any felony offense, an essential element of which is fraud, dishonesty or an act of violence, or for any felony offense involving moral turpitude, whether or not sentence is imposed, the board of pharmacy may hold a disciplinary hearing to singly or in combination censure or place the pharmacist named in the complaint on probation on such terms and conditions as the board deems appropriate for a period not to exceed five years, or may suspend, for a period not to exceed three years, or revoke the license, certificate, registration or permit.

     2. Anyone who has been revoked or denied a license, permit or certificate to practice in another state may automatically be denied a license or permit to practice in this state. However, the board of pharmacy may establish other qualifications by which a person may ultimately be qualified and licensed to practice in Missouri.

     338.070. 1. The board of pharmacy shall set the amount of the fees which this chapter authorizes and requires by rules and regulations promulgated pursuant to [section 536.021] chapter 536, RSMo. The fees shall be set at a level to produce revenue which shall not substantially exceed the cost and expense of administering this chapter. All fees shall be paid before an applicant may be admitted to examination or his or her name placed upon the register of pharmacists, or before any license or permit, or any renewal thereof, is issued by the board.

     2. All fees payable [under] pursuant to the provisions of this chapter shall be collected by the division of professional registration and transmitted to the department of revenue for deposit in the state treasury to the credit of the fund to be known as the "Board of Pharmacy Fund".

     3. The provisions of section 33.080, RSMo, to the contrary notwithstanding, money in this fund shall not be transferred and placed to the credit of general revenue until the amount in the fund at the end of the biennium exceeds two times the amount of the appropriation from the board's funds for the preceding fiscal year or, if the board requires by rule permit renewal less frequently than yearly, then three times the appropriation from the board's funds for the preceding fiscal year. The amount, if any, in the fund which shall lapse is that amount in the fund which exceeds the appropriate multiple of the appropriations from the board's funds for the preceding fiscal year.

     4. Notwithstanding any other provisions of this chapter to the contrary, the board of pharmacy is not required to collect or process fees required for testing, if the fees are paid by license applicants or licensees directly to a testing service and if no part of the fee is remitted to the board from the testing service.

     338.100. 1. Every permit holder of a licensed pharmacy shall cause to be kept in a uniform fashion consistent with this section a suitable file in which shall be preserved, for a period of not less than [five] three years, the original or order of each drug which has been compounded or dispensed at such pharmacy, numbering, dating and filing them in the order in which they are compounded or dispensed, and shall produce the same in court or before any grand jury whenever lawfully required. The pharmacist in charge shall be responsible for complying with the permit holder's record keeping system in compliance with this section. Records maintained by a pharmacy that contain medical or drug information on patients or their care shall be considered as confidential and shall only be released accordingly to standards provided through rules promulgated by the board pursuant to the provisions of chapter 536, RSMo. Upon request, the pharmacist in charge of such pharmacy shall furnish to the prescriber, and may, except when otherwise instructed by the prescriber, furnish to the person for whom such prescription was compounded or dispensed, a true and correct copy of the original prescription, and the file of original prescriptions shall at all times be open for inspection by duly authorized officers of the law.

     2. An institutional pharmacy located in a hospital shall be responsible for maintaining records of the transactions of the pharmacy as required by federal and state laws and as necessary to maintain adequate control and accountability of all drugs. This shall include a system of controls and records for the requisitioning and dispensing of pharmaceutical supplies where applicable to patients, nursing care units and to other departments or services [on] of the institution. Inspection performed pursuant to this subsection shall be consistent with the provisions of section 197.100, RSMo.

     338.120. Annually the board of pharmacy shall organize by the election of a president and [secretary] vice-president who shall hold their offices for one year and until their successors shall have been elected and qualified.

     338.130. 1. [The secretary, if a member of the board, shall receive such salary as is prescribed by the board of pharmacy not to exceed the sum of five hundred dollars monthly and his necessary expenses while engaged in the performance of his official duties.] Each member of the board shall receive as compensation an amount set by the board not to exceed fifty dollars for each day devoted to the affairs of the board, and shall be entitled to reimbursement of [his] the member's expenses necessarily incurred in the discharge of [his] the member's official duties.

     2. The board may employ such board personnel, as defined in subdivision (4) of subsection [16] 15 of section 620.010, RSMo, as it deems necessary to carry out the provisions of this chapter. The compensation and expenses of such personnel and all expenses incurred by the board in carrying into execution the provisions of this chapter, shall be paid out of the board of pharmacy fund upon a warrant on the state treasurer.

     338.140. 1. The board of pharmacy shall have a common seal, and shall have power to adopt such rules and bylaws not inconsistent with law as may be necessary for the regulation of its proceedings and for the discharge of the duties imposed [under] pursuant to sections 338.010 to [338.190] 338.198, and shall have power to employ an attorney to conduct prosecutions or to assist in the conduct of prosecutions [under] pursuant to sections 338.010 to [338.190] 338.198.

     2. The board shall keep a record of its proceedings.

     3. The board of pharmacy shall make annually to the governor and, upon written request, to persons licensed [under] pursuant to the provisions of this chapter a written report of its proceedings.

     4. The board of pharmacy shall appoint an advisory committee composed of five members, one of whom shall be a representative of pharmacy but who shall not be a member of the pharmacy board, three of whom shall be representatives of wholesale drug distributors as defined in section 338.330, and one of whom shall be a representative of drug manufacturers. The committee shall review and make recommendations to the board on the merit of all rules and regulations dealing with pharmacy distributors, wholesale drug distributors and drug manufacturers which are proposed by the board.

     5. A majority of the board shall constitute a quorum for the transaction of business.

     6. The board may subpoena witnesses and issue subpoenas duces tecum to require the production of documents, records, reports and similar material in connection with any investigation or hearing conducted by the board. Any member of the board may administer oaths or affirmation to witnesses appearing before the board. If any witness refuses to obey a subpoena or refuses to testify or to produce evidence as authorized, the board may petition the court to issue such subpoena and compel such attendance and production.

     7. Notwithstanding any other provisions of law to the contrary, the board may issue letters of reprimand, censure or warning to any holder of a license or registration required pursuant to this chapter for any violations that could result in disciplinary action as defined in section 338.055. The board may impose limitations, conditions or restrictions on a license or registration that is reprimanded pursuant to this section.

     8. Notwithstanding any other provisions of law to the contrary, the board may seek civil damages in the court, with the assistance of the attorney general's office, for violations of this section that includes one or more of the following acts:

     (1) Engaging in any practice or business authorized by a certificate of registration or authority, permit or license issued pursuant to this chapter without first obtaining a license or renewal of a license that is required by this chapter;

     (2) Failure to complete any requirements concerning a change in a pharmacist in charge of a pharmacy or a manager in charge of a drug distributor operation;

     (3) Distributing misbranded or adulterated drugs;

     (4) Violation of federal drug sample laws;

     (5) Maintenance of unsanitary conditions within a licensed or registered facility;

     (6) Noncompliance with state or federal record keeping laws or regulations, except that any evidence of such noncompliance for purposes of determining civil damages shall be evident on at least two successive inspections of a licensed location;

     (7) Failure to comply with laws governing patient counseling or pharmaceutical care.

     9. Civil damages shall be assessed for each violation of subdivisions (1), (3), (4) and (7) of subsection 8 of this section in an amount of not less than one hundred dollars and not more than one thousand dollars and for subdivisions (2), (5) and (6) of subsection 8 of this section in an amount of not less than fifty dollars and not more than five hundred dollars.

     [338.196. Notwithstanding the provisions of section 338.056 to the contrary, a pharmacist may fill a prescription written by a practitioner licensed in a state other than Missouri according to the practitioner's direction as to generic substitution.]

     338.220. 1. It shall be unlawful for any person, copartnership, association [or], corporation or any other business entity to open, establish, operate or maintain any pharmacy, as defined by statute without first obtaining a permit to do so from the Missouri board of pharmacy. The board of pharmacy may promulgate regulations establishing various permit classifications and standards for the operation of pharmacies. Standards for permit classifications may vary, depending upon the population served, but shall be consistently and uniformly enforced.

     2. Application for such permit shall be made upon a form furnished to the applicant; shall contain a statement that it is made under oath or affirmation and that its representations are true and correct to the best knowledge and belief of the person signing same, subject to the penalties of making a false affidavit or declaration; and shall be accompanied by a permit fee. The permit issued shall be renewable upon payment of a renewal fee. Separate applications shall be made and separate permits required for each pharmacy opened, established, operated or maintained by the same owner.

     3. All permits or renewal fees collected [under] pursuant to the provisions of sections 338.210 to 338.370 shall be deposited in the state treasury to the credit of the Missouri board of pharmacy fund, to be used by the Missouri board of pharmacy in the enforcement of the provisions of sections 338.210 to 338.370, when appropriated for that purpose by the general assembly.

     338.363. Any person, organization, association, corporation or any other business entity who reports or provides information to the board of pharmacy pursuant to the provisions of this chapter and does so in good faith shall not be subject for civil damages pursuant to any civil action.

     338.365. 1. Upon proper application by the board of pharmacy, a court of competent jurisdiction may grant an injunction, restraining order or other order as may be appropriate to enjoin a person from:

     (1) Offering to engage or engaging in the performance of any acts or practices for which a certificate of registration or authority, permit or license is required [in sections 338.010 to 338.370] by this chapter upon a showing that such acts or practices were performed or offered to be performed without a certificate of registration or authority, permit or license[.]; or

     (2) Engaging in any practice or business authorized by a certificate of registration or authority, permit or license issued pursuant to this chapter upon a showing that the holder presents a probability of serious danger to the health, safety or welfare of any resident of the state or client or patient.

     2. Any such actions shall be commenced either in the county in which such conduct occurred or in the county in which defendant resides.

     3. Any action brought [under] pursuant to this section shall be in addition and not in lieu of any penalty provided by law and may be brought concurrently with other actions to enforce this chapter.