SECOND REGULAR SESSION

HOUSE BILL NO. 1743

90TH GENERAL ASSEMBLY


INTRODUCED BY REPRESENTATIVES FOLEY AND NAEGER (Co-sponsors).

Read 1st time January 26, 2000, and 1000 copies ordered printed.

ANNE C. WALKER, Chief Clerk

3675L.01I


AN ACT

To repeal sections 338.010, 338.015, 338.030, 338.043, 338.347 and 338.353, RSMo 1994, and sections 338.055 and 338.056, RSMo Supp. 1999, relating to pharmacies, and to enact in lieu thereof eight new sections relating to the same subject, with a penalty provision.




Be it enacted by the General Assembly of the state of Missouri, as follows:

Section A. Sections 338.010, 338.015, 338.030, 338.043, 338.347 and 338.353, RSMo 1994, and sections 338.055 and 338.056, RSMo Supp. 1999, are repealed and eight new sections enacted in lieu thereof, to be known as sections 338.010, 338.015, 338.030, 338.043, 338.055, 338.056, 338.347 and 338.353, to read as follows:

338.010. 1. The "practice of pharmacy" [shall mean] means the interpretation, implementation and evaluation of [prescription] orders relating to drug therapy; the compounding, dispensing [and], labeling and administration of drugs and devices pursuant to prescription orders; the participation in drug and related device selection according to state law and participation in drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records thereof; consultation with patients and other health care practitioners about the safe and effective use of drugs and devices, including but not limited to, the advising of therapeutic values, hazards, adverse reactions, drug interactions or drug use; the monitoring of drug use; the initiating or modifying of drug therapy in accordance with written guidelines or protocols previously established for the pharmacist's practice by a practitioner authorized to prescribe drugs; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management and control of a pharmacy or pharmaceutical care practice in all areas of patient care.

2. A licensed pharmacist who has received training approved by the board of pharmacy, including but not limited to, training inpatient clinical assessment skills appropriate to the pharmacist's practice, may, after the diagnosis and referral of the patient by a practitioner authorized to prescribe drugs, engage in initiating or modifying drug therapy. Such activities shall be in accordance with and solely dependent upon written guidelines or protocols previously established for the pharmacist's practice by the referring practitioner. The practice locations of the practitioner and pharmacist shall not be greater than within a fifty-mile radius of each other. Guidelines or protocols shall not be written in such a way to alter or change the orders of another practitioner.

3. A licensed pharmacist who has completed academic clinical study greater than a bachelor of science in pharmacy from a nationally accredited college or university, or a certification of equivalence issued by a nationally recognized professional organization and approved by the board of pharmacy, may, after the diagnosis and referral of the patient by a licensed practitioner of medicine, dentistry, podiatry, veterinary medicine or optometry authorized to prescribe drugs, independently engage in initiating, modifying or prescribing drug therapy in accordance with written guidelines, collaborative practice arrangements or protocols previously established for the pharmacist's practice. The practice locations of the practitioner and pharmacist shall not be greater than within a fifty-mile radius of each other. Guidelines or protocols shall not be written in such a way to alter or change the orders of another practitioner.

4. No person shall engage in the practice of pharmacy unless [he] such person is licensed [under] pursuant to the provisions of this chapter. This chapter shall not be construed to prohibit the use of auxiliary personnel under the direct supervision of a pharmacist from assisting the pharmacist in any of his or her duties. This assistance in no way is intended to relieve the pharmacist from [his] the pharmacist's responsibilities for compliance with this chapter and [he] the pharmacist will be responsible for the actions of the auxiliary personnel acting in his or her assistance. This chapter shall also not be construed to prohibit or interfere with any legally registered practitioner of medicine, dentistry, podiatry, or veterinary medicine, or the practice of optometry in accordance with and as provided in [sections 195.070 and 336.220] section 195.070, RSMo, in the compounding or dispensing of his own prescriptions.

[2.] 5. Nothing in this section shall be construed as to prevent any person, firm or corporation from owning a pharmacy regulated by sections 338.210 to 338.315, provided that a licensed pharmacist is in charge of such pharmacy.

[3.] 6. Nothing in this section shall be construed to apply to or interfere with the sale of nonprescription drugs and the ordinary household remedies and such drugs or medicines as are normally sold by those engaged in the sale of general merchandise.

338.015. 1. The provisions of sections 338.010 to 338.015 shall not be construed to inhibit the patient's freedom of choice to obtain prescription services from any licensed pharmacist. However, nothing in sections 338.010 to 338.315 abrogates the patient's ability to waive freedom of choice under any contract with regard to payment or coverage of prescription expense.

2. All pharmacists [may provide] shall offer pharmaceutical consultation and advice to persons concerning the safe and therapeutic use of their prescription drugs.

3. All patients shall have the right to receive a written prescription from their prescriber to take to the facility of their choice.

338.030. An applicant for examination shall be twenty-one years of age and in addition shall furnish satisfactory evidence of his or her good moral character and [a certificate of graduation from an accredited high school or its equivalent,] have had one year practical experience under the supervision of a licensed pharmacist within a licensed pharmacy, or other location approved by the board, and shall be a graduate of a school or college of pharmacy whose requirements for graduation are satisfactory to and approved by the board of pharmacy.

338.043. 1. Notwithstanding any provision of law to the contrary, the board of pharmacy may grant a temporary license to an applicant who meets such 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.

338.055. 1. The board may refuse to issue any certificate of registration or authority, permit or license required pursuant to this chapter for one or any combination of causes stated in subsection 2 of this section. The board shall notify the applicant in writing of the reasons for the refusal and shall advise the applicant of his or her right to file a complaint with the administrative hearing commission as provided by chapter 621, RSMo.

2. The board may cause a complaint to be filed with the administrative hearing commission as provided by chapter 621, RSMo, against any holder of any certificate of registration or authority, permit or license required by this chapter or any person who has failed to renew or has surrendered his or her certificate of registration or authority, permit or license for any one or any combination of the following causes:

(1) Use of any controlled substance, as defined in chapter 195, RSMo, or alcoholic beverage to an extent that such use impairs a person's ability to perform the work of any profession licensed or regulated by this chapter;

(2) The person has been finally adjudicated and found guilty, or entered a plea of guilty or nolo contendere, in a criminal prosecution [under] pursuant to the laws of any state or of the United States, for any offense reasonably related to the qualifications, functions or duties of any profession licensed or regulated [under] pursuant to this chapter, for any offense an essential element of which is fraud, dishonesty or an act of violence, or for any offense involving moral turpitude, whether or not sentence is imposed;

(3) Use of fraud, deception, misrepresentation or bribery in securing any certificate of registration or authority, permit or license issued pursuant to this chapter or in obtaining permission to take any examination given or required pursuant to this chapter;

(4) Obtaining or attempting to obtain any fee, charge, tuition or other compensation by fraud, deception or misrepresentation;

(5) Incompetency, misconduct, gross negligence, fraud, misrepresentation or dishonesty in the performance of the functions or duties of any profession licensed or regulated by this chapter;

(6) Violation of, or assisting or enabling any person to violate, any provision of this chapter, or of any lawful rule or regulation adopted pursuant to this chapter;

(7) Impersonation of any person holding a certificate of registration or authority, permit or license or allowing any person to use his or her certificate of registration or authority, permit, license or diploma from any school;

(8) Disciplinary action against the holder of a license or other right to practice any profession regulated by this chapter granted by another state, territory, federal agency or country upon grounds for which revocation or suspension is authorized in this state;

(9) A person is finally adjudged incapacitated by a court of competent jurisdiction;

(10) Assisting or enabling any person to practice or offer to practice any profession licensed or regulated by this chapter who is not registered and currently eligible to practice [under] pursuant to this chapter;

(11) Issuance of a certificate of registration or authority, permit or license based upon a material mistake of fact;

(12) Failure to display a valid certificate or license if so required by this chapter or any rule promulgated hereunder;

(13) Violation of any professional trust or confidence;

(14) Use of any advertisement or solicitation which is false, misleading or deceptive to the general public or persons to whom the advertisement or solicitation is primarily directed;

(15) Violation of the drug laws or rules and regulations of this state, any other state or the federal government;

(16) The intentional act of substituting or otherwise changing the content, formula or brand of any drug prescribed by written or oral prescription without prior written or oral approval from the prescriber for the respective change in each prescription; provided, however, that nothing contained herein shall prohibit a pharmacist from substituting or changing the brand of any drug as provided [under] pursuant to section 338.056, and any such substituting or changing of the brand of any drug as provided for in section 338.056 shall not be deemed unprofessional or dishonorable conduct unless a violation of section 338.056 occurs;

(17) Personal use or consumption of any controlled substance unless it is prescribed, dispensed or administered by a health care provider who is authorized by law to do so.

3. After the filing of such complaint, the proceedings shall be conducted in accordance with the provisions of chapter 621, RSMo. Upon a finding by the administrative hearing commission that the grounds, provided in subsection 2, for disciplinary action are met, the board may, singly or in combination, censure or place the person 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[,] or permit. The board may impose additional discipline on a licensee, registrant or permittee found to have violated any disciplinary terms previously imposed [under] pursuant to this section or by agreement. The additional discipline may include, singly or in combination, censure, placing the licensee, registrant or permittee named in the complaint on additional probation on such terms and conditions as the board deems appropriate, which additional probation shall not exceed five years, or suspension for a period not to exceed three years, or revocation of the license, certificate or permit.

4. If the board concludes that a pharmacist has committed an act or is engaging in a course of conduct which would be grounds for disciplinary action which constitutes a clear and present danger to the public health and safety, the board may file a complaint before the administrative hearing commission requesting an expedited hearing and specifying the activities which give rise to the danger and the nature of the proposed restriction or suspension of the pharmacist's license. Within fifteen days after service of the complaint on the pharmacist, the administrative hearing commission shall conduct a preliminary hearing to determine whether the alleged activities of the pharmacist appear to constitute a clear and present danger to the public health and safety which justify that the pharmacist's license be immediately restricted or suspended. The burden of proving that a pharmacist is a clear and present danger to the public health and safety shall be upon the state board of pharmacy. The administrative hearing commission shall issue its decision immediately after the hearing and shall either grant to the board the authority to suspend or restrict the license or dismiss the action.

5. If the administrative hearing commission grants temporary authority to the board to restrict or suspend the pharmacist's license, such temporary authority of the board shall become final authority if there is no request by the pharmacist for a full hearing within thirty days of the preliminary hearing. The administrative hearing commission shall, if requested by the pharmacist named in the complaint, set a date to hold a full hearing [under] pursuant to the provisions of chapter 621, RSMo, regarding the activities alleged in the initial complaint filed by the board.

6. If the administrative hearing commission dismisses the action filed by the board pursuant to subsection 4 of this section, such dismissal shall not bar the board from initiating a subsequent action on the same grounds.

7. After first providing the licensee or registrant with an opportunity to respond in writing or appear in person to respond to a board investigation, the board may, at its discretion and without formal notice or hearing, issue public letters of reprimand, censure or warning to any holder of a license or registration required pursuant to this chapter for any one or any combination of causes stated in subsection 2 of this section. Any letter proposed to be issued pursuant to this subsection shall be served upon the licensee or registrant along with a notice that the licensee or registrant shall have thirty days from the licensee's or registrant's receipt of the notice to request in writing a hearing before the administrative hearing commission. Any letter issued pursuant to this subsection shall contain the basis for issuance of the letter along with any required corrective action that is expected as a result thereof. A licensee or registrant who receives a letter pursuant to this subsection may file a written request for review with the administrative hearing commission within thirty days of the date of the licensee's or registrant's receipt of the letter seeking review of the board's decision to issue a letter of reprimand, censure or warning. After a request for review has been filed with the administrative hearing commission, the public issuance of the letter shall be stayed until a final decision is issued by the administrative hearing commission. The board shall not be limited to issuing the public letter as the only discipline it may impose if the administrative hearing commission determines cause exists for discipline. If no written request for hearing is received by the administrative hearing commission within the thirty-day period, the right to seek review of the board's decision shall be considered waived and the letter shall be made part of the public record.

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 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 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 be valid without the signature of the prescriber on one of these lines;

(2) Any prescriptions or orders for medications for patients in a long-term care, hospice or home health care setting that are provided to a pharmacist for the purpose of compounding or dispensing drugs or devices shall be exempt from the provisions outlined in subdivision (1) of this subsection. Any such prescription or order for medications received by a pharmacist must provide a clear and concise method of relating to the pharmacist whether a generic substitute is permitted.

(3) If an oral prescription is involved, the practitioner or the practitioner's agent, communicating the instructions to the pharmacist, shall 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. Violations of this section are infractions.

338.347. 1. Application blanks for renewal of license shall be mailed to each licensee on or before the first day of the month in which the license expires and, if application for renewal of license with required fee is not made before the first day of the following month, the existing license, or renewal thereof, shall lapse and become null and void upon the last day of that month.

2. The board is hereby empowered to levy a penalty not to exceed ten thousand dollars for any person who offers to engage in or engages in any acts or practices for which a drug distributor license is required upon a showing that such acts or practices were performed or offered to be performed without a license to do so.

338.353. 1. The board of pharmacy is hereby authorized and empowered, when complaints, examinations or inspection of a wholesale drug distributor or pharmacy distributor disclose to the board that a wholesale drug distributorship or pharmacy distributorship is not being operated or conducted according to such legal rules and regulations and the laws of Missouri or any other state or the federal government with respect thereto, to cause a complaint to be filed before the administrative hearing commission pursuant to section 338.055 and chapter 621, RSMo, charging the holder of a license to operate a drug distributorship or pharmacy wholesale operation constituting grounds for probation, suspension or revocation of the distributor license.

2. If the board concludes that a wholesale drug distributor or pharmacy distributor has committed an act or is engaging in a course of conduct which constitutes a clear and present danger to the public health and safety in Missouri, the board may file a complaint before the administrative hearing commission requesting an expedited hearing and specifying the activities which give rise to the danger and the nature of the proposed restriction or suspension of the wholesale drug distributor's or pharmacy distributor's license. Within fifteen days after service of the complaint on a wholesale drug distributor or pharmacy distributor, the administrative hearing commission shall conduct a preliminary hearing to determine whether the alleged activities of the wholesale drug distributor or pharmacy distributor appear to constitute a clear and present danger to the public health and safety which justify that the wholesale drug distributor's or pharmacy distributor's license be immediately restricted or suspended. The burden of proving that a wholesale drug distributor or pharmacy distributor is a clear and present danger to the public health and safety shall be upon the state board of pharmacy. The administrative hearing commission shall issue its decision immediately after the hearing and shall either grant to the board the authority to suspend or restrict the license or dismiss the action.

3. If the administrative hearing commission grants temporary authority to the board to restrict or suspend the wholesale drug distributor's or pharmacy distributor's license, such temporary authority of the board shall become final authority if there is no request by the wholesale drug distributor or pharmacy distributor for a full hearing within thirty days of the preliminary hearing. The administrative hearing commission shall, if requested by the wholesale drug distributor or pharmacy distributor named in the complaint, set a date to hold a full hearing [under] pursuant to the provisions of chapter 621, RSMo, regarding the activities alleged in the initial complaint filed by the board.

4. If the administrative hearing commission dismisses the action filed by the board pursuant to subsection 2 of this section, such dismissal shall not bar the board from initiating a subsequent action on the same grounds.



Missouri House of Representatives