Missouri Revised Statutes

Chapter 338
Pharmacists and Pharmacies

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Practice of pharmacy defined--auxiliary personnel--written protocolrequired, when--nonprescription drugs--rulemakingauthority--therapeutic plan requirements--veterinariandefined--additional requirements--report.

338.010. 1. The "practice of pharmacy" means the interpretation, implementation, and evaluation of medical prescription orders, including any legend drugs under 21 U.S.C. Section 353; receipt, transmission, or handling of such orders or facilitating the dispensing of such orders; the designing, initiating, implementing, and monitoring of a medication therapeutic plan as defined by the prescription order so long as the prescription order is specific to each patient for care by a pharmacist; the compounding, dispensing, labeling, and administration of drugs and devices pursuant to medical prescription orders and administration of viral influenza, pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, tetanus, pertussis, and meningitis vaccines by written protocol authorized by a physician for persons twelve years of age or older as authorized by rule or the administration of pneumonia, shingles, hepatitis A, hepatitis B, diphtheria, tetanus, pertussis, and meningitis vaccines by written protocol authorized by a physician for a specific patient as authorized by rule; the participation in drug 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, and veterinarians and their clients about legend drugs, about the safe and effective use of drugs and devices; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management and control of a pharmacy. No person shall engage in the practice of pharmacy unless he is licensed under 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 or her responsibilities for compliance with this chapter and he or she 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, or podiatry, or veterinary medicine only for use in animals, or the practice of optometry in accordance with and as provided in sections 195.070 and 336.220 in the compounding, administering, prescribing, or dispensing of his or her own prescriptions.

2. Any pharmacist who accepts a prescription order for a medication therapeutic plan shall have a written protocol from the physician who refers the patient for medication therapy services. The written protocol and the prescription order for a medication therapeutic plan shall come from the physician only, and shall not come from a nurse engaged in a collaborative practice arrangement under section 334.104, or from a physician assistant engaged in a supervision agreement under section 334.735.

3. 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.

4. 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.

5. No health carrier as defined in chapter 376 shall require any physician with which they contract to enter into a written protocol with a pharmacist for medication therapeutic services.

6. This section shall not be construed to allow a pharmacist to diagnose or independently prescribe pharmaceuticals.

7. The state board of registration for the healing arts, under section 334.125, and the state board of pharmacy, under section 338.140, shall jointly promulgate rules regulating the use of protocols for prescription orders for medication therapy services and administration of viral influenza vaccines. Such rules shall require protocols to include provisions allowing for timely communication between the pharmacist and the referring physician, and any other patient protection provisions deemed appropriate by both boards. In order to take effect, such rules shall be approved by a majority vote of a quorum of each board. Neither board shall separately promulgate rules regulating the use of protocols for prescription orders for medication therapy services and administration of viral influenza vaccines. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2007, shall be invalid and void.

8. The state board of pharmacy may grant a certificate of medication therapeutic plan authority to a licensed pharmacist who submits proof of successful completion of a board-approved course of academic clinical study beyond a bachelor of science in pharmacy, including but not limited to clinical assessment skills, 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.

9. Any pharmacist who has received a certificate of medication therapeutic plan authority may engage in the designing, initiating, implementing, and monitoring of a medication therapeutic plan as defined by a prescription order from a physician that is specific to each patient for care by a pharmacist.

10. Nothing in this section shall be construed to allow a pharmacist to make a therapeutic substitution of a pharmaceutical prescribed by a physician unless authorized by the written protocol or the physician's prescription order.

11. "Veterinarian", "doctor of veterinary medicine", "practitioner of veterinary medicine", "DVM", "VMD", "BVSe", "BVMS", "BSe (Vet Science)", "VMB", "MRCVS", or an equivalent title means a person who has received a doctor's degree in veterinary medicine from an accredited school of veterinary medicine or holds an Educational Commission for Foreign Veterinary Graduates (EDFVG) certificate issued by the American Veterinary Medical Association (AVMA).

12. In addition to other requirements established by the joint promulgation of rules by the board of pharmacy and the state board of registration for the healing arts:

(1) A pharmacist shall administer vaccines in accordance with treatment guidelines established by the Centers for Disease Control and Prevention (CDC);

(2) A pharmacist who is administering a vaccine shall request a patient to remain in the pharmacy a safe amount of time after administering the vaccine to observe any adverse reactions. Such pharmacist shall have adopted emergency treatment protocols;

(3) In addition to other requirements by the board, a pharmacist shall receive additional training as required by the board and evidenced by receiving a certificate from the board upon completion, and shall display the certification in his or her pharmacy where vaccines are delivered.

13. A pharmacist shall provide a written report within fourteen days of administration of a vaccine to the patient's primary health care provider, if provided by the patient, containing:

(1) The identity of the patient;

(2) The identity of the vaccine or vaccines administered;

(3) The route of administration;

(4) The anatomic site of the administration;

(5) The dose administered; and

(6) The date of administration.

(RSMo 1939 § 10005, A.L. 1951 p. 737, A.L. 1989 S.B. 39, A.L. 1990 H.B. 1287, A.L. 2007 S.B. 195, A.L. 2009 S.B. 296, A.L. 2011 H.B. 412 merged with S.B. 325, A.L. 2014 S.B. 716 merged with S.B. 754 merged with S.B. 808)

Prior revisions: 1929 § 13140; 1919 § 4712; 1909 § 5764

Pharmacy technician to register with board of pharmacy, fees,application, renewal--refusal to issue, when--employeedisqualification list maintained, use.

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 be, at a minimum, legal working age and 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. The board may refuse to issue a certificate of registration as a pharmacy technician to an applicant that has been adjudicated and found guilty, or has entered a plea of guilty or nolo contendere, of a violation of any state, territory or federal drug law, or to any felony or has violated any provision of subsection 2 of section 338.055. Alternately, the board may issue such person a registration, but may authorize the person to work as a pharmacy technician provided that person adheres to certain terms and conditions imposed by the board. The board shall place on the employment disqualification list the name of an applicant who the board has refused to issue a certificate of registration as a pharmacy technician, or the name of a person who the board has issued a certificate of registration as a pharmacy technician but has authorized to work under certain terms and conditions. The board shall notify the applicant of the applicant's right to file a complaint with the administrative hearing commission as provided by chapter 621.

3. 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. The applicant shall keep a copy of the submitted application on the premises where the applicant is employed. If the board refuses to issue a certificate of registration as a pharmacy technician to an applicant, the applicant shall immediately cease assisting a licensed pharmacist in the practice of pharmacy.

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

5. 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. The registration shall lapse and become null and void thirty days after the expiration date.

6. The board shall maintain an employment disqualification list. No person whose name appears on the employment disqualification list shall work as a pharmacy technician, except as otherwise authorized by the board. The board may authorize a person whose name appears on the employment disqualification list to work or continue to work as a pharmacy technician provided the person adheres to certain terms and conditions imposed by the board.

7. The board may place on the employment disqualification list the name of a pharmacy technician who has been adjudicated and found guilty, or has entered a plea of guilty or nolo contendere, of a violation of any state, territory or federal drug law, or to any felony or has violated any provision of subsection 2 of section 338.055.

8. 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:

(1) That 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) That such person's name has been added 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 right to file a complaint with the administrative hearing commission as provided in chapter 621.

9. The length of time a person's name shall remain on the disqualification list shall be determined by the board.

10. No hospital or licensed pharmacy shall knowingly employ any person whose name appears on the employee disqualification list, except that a hospital or licensed pharmacy may employ a person whose name appears on the employment disqualification list but the board has authorized to work under certain terms and conditions. Any hospital or licensed pharmacy shall report to the board any final disciplinary action taken against a pharmacy technician or the voluntary resignation of a pharmacy technician against whom any complaints or reports have been made which might have led to final disciplinary action that can be a cause of action for discipline by the board as provided for in subsection 2 of section 338.055. Compliance with the foregoing sentence may be interposed as an affirmative defense by the employer. Any hospital or licensed pharmacy which reports to the board in good faith shall not be liable for civil damages.

(L. 1997 S.B. 141, A.L. 2004 S.B. 1122, A.L. 2009 S.B. 296)

Patient's freedom of choice to obtain prescription services,waiver--consultation and advice.

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 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.

(L. 1990 H.B. 1287)

Application forlicense--requirements--examination--oath--penalty--militaryservice, effect of.

338.020. 1. Every person who shall hereafter desire to be licensed as a pharmacist shall file with the board of pharmacy an application setting forth his name and age, the place, or places, at which and the time spent in the study of the science and art of pharmacy, and the practical experience which the applicant has had under the direction of a legally licensed pharmacist, and shall appear at a time and place designated by the board of pharmacy and submit to an examination as to his qualifications for registration as a licensed pharmacist. Each application 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.

2. So long as the person involved does not represent or hold himself or herself out as a pharmacist licensed to practice in this state, a Missouri pharmacist license shall not be required for a legally qualified pharmacist serving in the Armed Forces of the United States or a legally qualified pharmacist employed by the government of the United States or any bureau, division, or agency thereof who is engaged in the practice of pharmacy while in the discharge of his or her official duties.

(RSMo 1939 § 10006, A.L. 1947 V. I p. 277, A. 1949 H.B. 2075, A.L. 1981 S.B. 16, A.L. 1990 H.B. 1287, A.L. 2014 S.B. 808)

Prior revisions: 1929 § 13141; 1919 § 4713; 1909 § 5765

Applicant--requirements for qualification.

338.030. An applicant for examination shall be twenty-one years of age and in addition shall furnish satisfactory evidence of his good moral character and 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.

(RSMo 1939 § 10014, A. 1949 H.B. 2075, A.L. 1951 p. 737, A.L. 1981 S.B. 16, A.L. 1990 H.B. 1287, A.L. 2001 H.B. 567)

Prior revisions: 1929 § 13142; 1919 § 4714; 1909 § 5766

Application, contents--intern pharmacist--board shall promulgaterules, procedure.

338.035. 1. Every person who desires to be licensed as an intern pharmacist shall file with the board of pharmacy an application, on a form to be provided by the board of pharmacy.

2. If an applicant for an intern pharmacist license has complied with the requirements of this section and with the rules and regulations of the board of pharmacy and is not denied a license on any of the grounds listed in section 338.055, the board of pharmacy may issue to him a license to practice as an intern pharmacist.

3. Any intern pharmacist who wishes to renew his license shall within thirty days before the license expiration date file an application for a renewal.

4. A licensed intern pharmacist may practice pharmacy only under the direct supervision of a pharmacist licensed by the board.

5. The board of pharmacy shall promulgate rules and regulations which shall further regulate the duties of intern pharmacists and shall set the amount of the fees which shall accompany the license and renewal applications for intern pharmacists.

6. No rule or portion of a rule promulgated under the authority of this chapter shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

(L. 1990 H.B. 1287, A.L. 1993 S.B. 52, A.L. 1995 S.B. 3, A.L. 2007 S.B. 272)

License issued without examination, when--reciprocity--equivalencyexamination--fees.

338.040. 1. The board of pharmacy shall issue licenses to practice pharmacy in the state without examination to persons who have been legally registered or licensed as pharmacists in other states. Any applicant for a license under this section shall present satisfactory evidence of qualifications equal to those required from licensees in this state, that he was registered or licensed by examination in another state, and that the standard of competence required in the other state is not lower than that required in this state; but no license shall be issued until the board is satisfied that the other state accords similar recognition to the licensees of this state. Applicants for license under this section shall, with their application, forward a fee for the license as is determined by the board of pharmacy.

2. The board may by rule and regulation require any applicant under subsection 1 of this section to successfully complete any equivalency examination, practical examination, or any examination on Missouri laws pursuant to any rule or regulation as promulgated by the board.

3. Any individual who is registered or licensed in a foreign country may be licensed under the provisions of sections 338.010 to 338.315 upon presentation of satisfactory evidence of qualifications equal to those required of licensees in this state.

4. The board may require any applicant under subsection 3 of this section to successfully complete any equivalency examination, practical examination or any examination on Missouri laws pursuant to any rule and regulation as promulgated by the board.

(RSMo 1939 § 10008, A.L. 1961 p. 501, A.L. 1969 S.B. 390, A.L. 1981 S.B. 16, A.L. 1990 H.B. 1287)

Prior revisions: 1929 § 13144; 1919 § 4716; 1909 § 5768

Temporary license--eligibility--renewal.

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 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.

(L. 1990 H.B. 1287, A.L. 1997 S.B. 141, A.L. 2001 H.B. 567)

Pharmacist license, issued when, period covered.

338.050. If the applicant for license as a pharmacist has complied with all the requirements of sections 338.010 and 338.020, the board of pharmacy shall enroll his name upon the register of pharmacists and issue to him a license which shall entitle him to practice as a pharmacist for a period ending with the expiration date of the license.

(RSMo 1939 § 10007, A. 1949 H.B. 2075, A.L. 1961 p. 501, A.L. 1971 S.B. 145, A.L. 1981 S.B. 16)

Prior revisions: 1929 § 13143; 1919 § 4715; 1909 § 5767

Denial, revocation or suspension of license, grounds for--expeditedprocedure--additional discipline authorized, when.

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 or if the designated pharmacist-in-charge, manager-in-charge, or any officer, owner, manager, or controlling shareholder of the applicant has committed any act or practice 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.

2. The board may cause a complaint to be filed with the administrative hearing commission as provided by chapter 621 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, 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 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 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) Incompetence, 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) Denial of licensure to an applicant or disciplinary action against an applicant or 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 whether or not voluntarily agreed to by the licensee or applicant, including, but not limited to, surrender of the license upon grounds for which denial or discipline 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 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 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. Upon a finding by the administrative hearing commission that the grounds, provided in subsection 2 of this section, 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 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 licensee or registrant 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 licensee's or registrant's license. Within fifteen days after service of the complaint on the licensee or registrant, the administrative hearing commission shall conduct a preliminary hearing to determine whether the alleged activities of the licensee or registrant appear to constitute a clear and present danger to the public health and safety which justify that the licensee's or registrant's license or registration be immediately restricted or suspended. The burden of proving that the actions of a licensee or registrant constitute 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 licensee's or registrant's license, such temporary authority of the board shall become final authority if there is no request by the licensee or registrant for a full hearing within thirty days of the preliminary hearing. The administrative hearing commission shall, if requested by the licensee or registrant named in the complaint, set a date to hold a full hearing under the provisions of chapter 621 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.

(L. 1971 S.B. 145, A.L. 1978 H.B. 933, A.L. 1981 S.B. 16, A.L. 1986 H.B. 999, A.L. 1998 H.B. 1601, et al., A.L. 2001 H.B. 567, A.L. 2004 S.B. 1122, A.L. 2011 H.B. 412 merged with S.B. 284)

Generic substitutions may be made, when, form required forprescription blanks, exception--penalty.

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 or interchangeable biological product 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 or interchangeable biological product to be dispensed pursuant to this section shall assume the same responsibility for selecting the dispensed drug or biological product as would be incurred in filling a prescription for a drug or interchangeable biological product prescribed by generic or interchangeable biologic name. The pharmacist shall not select a drug or interchangeable biological 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 or biological product may, unless requested otherwise by the purchaser, select a less expensive generically equivalent or interchangeable biological 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) 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 or interchangeable biological product 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 or interchangeable biological product when substitution is allowed in accordance with the laws of the state where the prescribing practitioner is located.

5. Violations of this section are infractions.

(L. 1978 H.B. 933, A.L. 1996 H.B. 1237, A.L. 2016 S.B. 875)

Prescriptions, how labeled.

338.059. 1. It shall be the duty of a licensed pharmacist or a physician to affix or have affixed by someone under 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 or biological product upon which is typed or written the following information:

(1) The date the prescription is filled;

(2) The sequential number or other unique identifier;

(3) The patient's name;

(4) The prescriber's directions for usage;

(5) The 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 information provided in subdivisions (1) to (7) of this subsection stating "Refill" with a blank line or squares following or the words "No Refill";

(9) When a generic or interchangeable biological 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 or biological product 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.

(L. 1971 S.B. 145, A.L. 1973 S.B. 42, A.L. 1978 H.B. 933, A.L. 1997 S.B. 141, A.L. 2014 S.B. 754 merged with S.B. 808, A.L. 2016 S.B. 875)

Renewal of license or permit--late renewal or failure to renew,effect--continuing education requirements--inactive license issuedwhen--changed to active, procedure.

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 prescribed in sections 338.010 to 338.198.

2. If any pharmacist fails, after the expiration of the pharmacist's license, to make application to the board for its renewal, the pharmacist's name shall be 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 the pharmacist's license within two years of its expiration and then desires to be preregistered 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 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 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, the pharmacist furnishes the board with an affidavit to the effect that the pharmacist has been so engaged and that the pharmacist's service, training or education has 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 fifteen hours of board-approved continuing education courses during each 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 the pharmacist makes application for the renewal of the pharmacist's license and pay the required renewal fee. An inactive license shall then be issued, and may be renewed biennially. 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 the pharmacist was last licensed on an active basis.

(RSMo 1939 § 10009, A.L. 1943 p. 521, A.L. 1947 V. I p. 277, A. 1949 H.B. 2075, A.L. 1951 p. 737, A.L. 1981 S.B. 16, A.L. 1984 S.B. 478, A.L. 1997 S.B. 141, A.L. 1999 H.B. 343)

Prior revisions: 1929 § 13145; 1919 § 4717; 1909 § 5769

Disciplinary hearings--grounds for discipline.

338.065. 1. At such time as the final trial proceedings are concluded whereby a licensee or registrant, or any person who has failed to renew or has surrendered his or her certificate of registration or authority, permit, or license, has been adjudicated and found guilty, or has entered a plea of guilty or nolo contendere, in a felony prosecution 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 licensee, permittee, 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 licensee, permittee, or registrant 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.

(L. 1990 H.B. 1287, A.L. 1997 S.B. 141, A.L. 1999 H.B. 343, A.L. 2004 S.B. 1122)

Revocation and restoration of license--conditions.

338.067. 1. In any order of revocation, the board may provide that the person may not apply for reinstatement of his license for a period of time ranging from two to seven years following the date of the order of revocation. All stay orders shall toll this time period.

2. Before restoring to good standing a license, certificate or permit issued under sections 338.010 to 338.315 which has been in a revoked, suspended or inactive state for any cause for more than two years, the board may require the applicant to attend such continuing pharmaceutical education courses and pass such examinations as the board may direct.

(L. 1990 H.B. 1287)

Fees, amount, how set, collection, disposition--fund, created, use,funds transferred to general revenue, when.

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 chapter 536. 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 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 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.

(RSMo 1939 § 10015, A.L. 1947 V. I p. 277, A.L. 1953 p. 613, A.L. 1961 p. 501, A.L. 1969 S.B. 390, A.L. 1981 S.B. 16, A.L. 1985 S.B. 99, A.L. 1997 S.B. 141)

Prior revisions: 1929 § 13151; 1919 § 4723; 1909 § 5775

Adverse actions against licensee, notification to board of pharmacy,when--rulemaking authority.

338.075. 1. All licensees, registrants, and permit holders of the board of pharmacy shall report to the board of pharmacy:

(1) Any final adverse action taken by another licensing state, jurisdiction, or government agency against any license, permit, or authorization held by the person or entity to practice or operate as a pharmacist, intern pharmacist, pharmacy technician, pharmacy, drug distributor, drug manufacturer, or drug outsourcing facility. For purposes of this section, "adverse action" shall include, but is not limited to, revocation, suspension, censure, probation, disciplinary reprimand, or disciplinary restriction of a license, permit, or other authorization or a voluntary surrender of such license, permit, or other authorization in lieu of discipline or adverse action;

(2) Any surrender of a license or authorization to practice or operate as a pharmacist, intern pharmacist, pharmacy technician, pharmacy, drug distributor, drug manufacturer, or drug outsourcing facility while under disciplinary investigation by another licensing state, jurisdiction, or governmental agency; and

(3) Any exclusion to participate in any state or federally funded health care program such as Medicare, Medicaid, or MO HealthNet for fraud, abuse, or submission of any false or fraudulent claim, payment, or reimbursement request.

2. Reports shall be submitted as provided by the board of pharmacy by rule.

3. The board of pharmacy shall promulgate rules to implement the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2016, shall be invalid and void.

(L. 2016 S.B. 865 & 866)

Display of license or renewal required.

338.080. Every license to practice as a pharmacist, and every permit issued to any person under the provisions of this chapter to establish a pharmacy, and every renewal of such license or permit, shall be conspicuously exposed in the pharmacy or place of business of which the pharmacist or other person to whom it is issued is the owner or manager or in which he is employed.

(RSMo 1939 § 10009, A.L. 1943 p. 521, A.L. 1947 V. I p. 277, A. 1949 H.B. 2075, A.L. 1990 H.B. 1287)

Prior revisions: 1929 § 13145; 1919 § 4717; 1909 § 5769

Interchangeable biological products, pharmacist may dispense assubstitute, when--recordkeeping--rulemaking authority.

338.085. 1. As used in this chapter, the following terms shall mean:

(1) "Biological product", the same meaning as such term is defined under 42 U.S.C. Section 262;

(2) "Interchangeable biological product", a biological product that the Food and Drug Administration:

(a) Has licensed and determined meets the standards for interchangeability under 42 U.S.C. Section 262(k)(4); or

(b) Has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

2. A pharmacist may substitute an interchangeable biological product for a prescribed product only if all of the following conditions are met:

(1) The substituted product has been determined by the Food and Drug Administration to be an interchangeable biological product with the prescribed biological product;

(2) The substitution occurs according to the provisions of section 338.056; and

(3) The pharmacy informs the patient of the substitution.

3. Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient including the name of the product and manufacturer. The communication shall be conveyed by making an entry that can be electronically accessed by the prescriber through one of the following means:

(1) An interoperable electronic medical records system;

(2) An electronic prescribing technology;

(3) A pharmacy benefit management system; or

(4) A pharmacy record.

4. Entry into an electronic records system as described in this subsection is presumed to provide notice to the prescriber. Otherwise, if an entry cannot be made under the provisions of subsection 3 of this section, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, except that communication shall not be required if:

(1) There is no Food and Drug Administration approved interchangeable biological product for the product prescribed; or

(2) A refill prescription is not changed from the product dispensed on the prior filling of the prescription.

5. The pharmacist shall maintain records in a manner consistent with section 338.100.

6. The pharmacist shall label prescriptions in a manner consistent with section 338.059.

7. The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the Food and Drug Administration to be interchangeable with a specific biological product.

8. The board of pharmacy may promulgate rules for compliance with the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2016, shall be invalid and void.

(L. 2016 S.B. 875)

Sale of poisons--regulations.

338.090. 1. It shall be unlawful for any person to retail any poisons enumerated in schedules "A" and "B", except as follows: Schedule "A" arsenic and its preparations, biniodide of mercury, cyanide of potassium, hydrocyanic acid, strychnia, and all other poisonous vegetable alkaloids and their salts, and the essential oil of bitter almonds. Schedule "B" opium and its preparations, except paregoric and other preparations of opium containing less than two grains to the ounce, aconite, bella donna, colchicum, conium, nux vomica, henbane, savin, ergot, cotton root, cantharides, creosote, veratrum, digitalis, and their pharmaceutical preparations, croton oil, chloroform, chloral hydrate, sulphate of zinc, corrosive sublimate, red precipitate, white precipitate, mineral acids, carbolic acid, oxalic acid, without labeling the box, vessel or paper in which the said poison is contained, and also the outside wrapper or cover with the name of the article, the word "poison" and the name and place of business of the seller.

2. Nor shall it be lawful for any person to sell or deliver any poisons enumerated in schedules "A" and "B" unless, upon due inquiry, it is found that the purchaser is aware of its poisonous character and represents that it is to be used for legitimate purposes. Nor shall it be lawful for any registered pharmacists to sell any poisons included in schedule "A" without, before delivering the same to the purchaser, causing an entry to be made in a book kept for that purpose, stating the date of sale, name and address of purchaser, the name of the poison sold, the purpose for which it was represented by the purchaser to be required and the name of the dispenser, such book to be always open for inspection by the proper authorities, and to be preserved for at least five years.

3. The provisions of this section shall not apply to the dispensing of poison in not unusual quantities or doses upon the prescription of practitioners of medicine.

(RSMo 1939 § 10018, A. 1949 H.B. 2075)

Prior revisions: 1929 § 13152; 1919 § 4724; 1909 § 5776

CROSS REFERENCE:

Pesticides registration, 281.210 to 281.310

Prescription, drug order, defined--telephone prescription,defined--prescription and medical information may be provided,when.

338.095. 1. The terms "prescription" and "prescription drug order" are hereby defined as a lawful order for medications or devices issued and signed by an authorized prescriber within the scope of his professional practice which is to be dispensed or administered by a pharmacist or dispensed or administered pursuant to section 334.104 to and for the ultimate user. The terms "prescription" and "drug order" do not include an order for medication requiring a prescription to be dispensed, which is provided for the immediate administration to the ultimate user or recipient.

2. The term "telephone prescription" is defined as an order for medications or devices transmitted to a pharmacist by telephone or similar electronic medium by an authorized prescriber or his authorized agent acting in the course of his professional practice which is to be dispensed or administered by a pharmacist or dispensed or administered pursuant to section 334.104 to and for the ultimate user. A telephone prescription shall be promptly reduced to written or electronic medium by the pharmacist and shall comply with all laws governing prescriptions and record keeping.

3. A licensed pharmacist may lawfully provide prescription or medical information to a licensed health care provider or his agent who is legally qualified to administer medications and treatments and who is involved in the treatment of the patient. The information may be derived by direct contact with the prescriber or through a written protocol approved by the prescriber. Such information shall authorize the provider to administer appropriate medications and treatments.

4. Nothing in this section shall be construed to limit the authority of other licensed health care providers to prescribe, administer, or dispense medications and treatments within the scope of their professional practice.

5. It shall be an unauthorized practice of pharmacy and hence unlawful for any person other than the patient or the patient's authorized representative to accept a prescription presented to be dispensed unless that person is located on a premises licensed by the board as a pharmacy.

(L. 1993 H.B. 564, A.L. 2007 S.B. 195)

Records required to be kept--requirements.

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 book, file, or electronic record-keeping system in which shall be preserved, for a period of not less than five years, the original or order of each drug or biological product which has been compounded or dispensed at such pharmacy, according to and in compliance with standards provided by the board, and shall produce the same in court or before any grand jury whenever lawfully required. A licensed pharmacy may maintain its prescription file on readable microfilm for records maintained over three years. After September, 1999, a licensed pharmacy may preserve prescription files on microfilm or by electronic media storage for records maintained over three years. 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 according to standards provided by the board. Upon request, the pharmacist in charge of such pharmacy shall furnish to the prescriber, and may furnish to the person for whom such prescription was compounded or dispensed, a true and correct copy of the original prescription. The file of original prescriptions kept in any format in compliance with this section, and other confidential records, as defined by law, shall at all times be open for inspection by board of pharmacy representatives. Records maintained in an electronic record-keeping system shall contain all information otherwise required in a manual record-keeping system. Electronic records shall be readily retrievable. Pharmacies may electronically maintain the original prescription or prescription order for each drug or biological product and may electronically annotate any change or alteration to a prescription record in the electronic record-keeping system as authorized by law; provided however, original written and faxed prescriptions shall be physically maintained on file at the pharmacy under state and federal controlled substance laws.

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 of the institution. Inspection performed pursuant to this subsection shall be consistent with the provisions of section 197.100.

3. "Electronic record-keeping system", as used in this section, shall mean a system, including machines, methods of organization, and procedures, that provides input, storage, processing, communications, output, and control functions for digitized images of original prescriptions.

(RSMo 1939 § 10019, A.L. 1971 S.B. 145, A.L. 1990 H.B. 1287, A.L. 1997 S.B. 141, A.L. 1999 H.B. 343, A.L. 2010 S.B. 754, A.L. 2016 S.B. 875)

Prior revisions: 1929 § 13153; 1919 § 4725; 1909 § 5777

Board of pharmacy, members, qualifications, terms.

338.110. 1. The board of pharmacy shall consist of seven persons not connected with any school of pharmacy. Six members shall be licensed as pharmacists and actively engaged in the practice of pharmacy within this state, and at least one of these shall be a person who provides, on a full-time basis, pharmaceutical services to a hospital, skilled nursing facility or an intermediate care facility. The other member shall be a voting public member. All members shall be appointed by the governor, with the approval of the senate, and shall hold their office for five years from the date of their appointment and until their successors shall have been appointed and qualified.

2. Annually the Missouri Pharmaceutical Association may submit to the director of the division of professional registration the names of five persons licensed as pharmacists within this state, and from this number, or from others, the governor, with the approval of the senate, shall appoint one member to fill the vacancy annually occurring in the board of pharmacy, and vacancies occurring from any other cause shall be filled in like manner. This subsection shall not apply to public member vacancies.

3. The public member shall be at the time of his or her appointment a citizen of the United States; a resident of this state for a period of one year and a registered voter; a person who is not and never was a member of any profession licensed or regulated pursuant to this chapter or the spouse of such person; and a person who does not have and never has had a material, financial interest in either the providing of the professional services regulated by this chapter, or an activity or organization directly related to any profession licensed or regulated pursuant to this chapter. All members, including public members, shall be chosen from lists submitted by the director of the division of professional registration. The duties of the public member shall not include the determination of the technical requirements to be met for licensure or whether any person meets such technical requirements or of the technical competence or technical judgment of a licensee or a candidate for licensure.

(RSMo 1939 § 10010, A. 1949 H.B. 2075, A.L. 1981 S.B. 16, A.L. 1999 H.B. 343)

Prior revisions: 1929 § 13146; 1919 § 4718; 1909 § 5770

Board of pharmacy--organization.

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

(RSMo 1939 § 10011, A.L. 1981 S.B. 16, A.L. 1997 S.B. 141)

Prior revisions: 1929 § 13147; 1919 § 4719; 1909 § 5771

Compensation of board members, personnel.

338.130. 1. 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 the member's expenses necessarily incurred in the discharge of the member's official duties.

2. The board may employ such board personnel, as defined in subdivision (4) of subsection 10 of section 324.001, 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.

(RSMo 1939 § 10017, A. 1949 H.B. 2075, A.L. 1961 p. 503, A.L. 1969 S.B. 390, A.L. 1981 S.B. 16, A.L. 1997 S.B. 141, A.L. 2008 S.B. 788)

Prior revisions: 1929 § 13149; 1919 § 4721; 1909 § 5773

Board of pharmacy, salary schedule for employees to be established.

338.132. Any provision of the law to the contrary notwithstanding, the board of pharmacy shall prepare and maintain an equitable salary schedule for professional staff that are employees of the board. The positions and classification plan for personnel attributed to the inspection of licensed entities within this chapter shall allow for a comparison of such positions with similar positions in adjoining states. Board of pharmacy professional positions shall not be compensated at more than ninety percent parity for corresponding positions within adjoining states for pharmacists employed in those positions.

(L. 2005 S.B. 177 § 1)

Board of pharmacy, powers, duties--advisory committee, appointment,duties--letters of reprimand, censure or warning.

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 pursuant to sections 338.010 to 338.198, and shall have power to employ an attorney to conduct prosecutions or to assist in the conduct of prosecutions pursuant to sections 338.010 to 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 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 six 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, one of whom shall be a representative of drug manufacturers, and one of whom shall be a licensed veterinarian recommended to the board of pharmacy by the board of veterinary medicine. 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, drug manufacturers, and veterinary legend drugs which are proposed by the board.

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

6. 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.

(RSMo 1939 § 10012, A.L. 1981 S.B. 16, A.L. 1989 S.B. 39, A.L. 1997 S.B. 141, A.L. 2011 H.B. 412 merged with S.B. 325)

Prior revisions: 1929 § 13148; 1919 § 4720; 1909 § 5772

Board president may administer oaths and issue subpoenas--enforcementof subpoenas.

338.145. 1. The president of the board may, upon majority vote of the board, administer oaths, issue subpoenas duces tecum, and require production of documents and records from any person or entity not licensed by the board when such documents and records are not otherwise available to the board pursuant to the board's inspection authority granted in sections 338.100 and 338.150. Subpoenas duces tecum shall be served by a person authorized to serve subpoenas of courts of record. In lieu of requiring attendance of a person to produce original documents in response to a subpoena duces tecum, the board may require sworn copies of such documents to be filed with it or delivered to its designated representative.

2. The board may enforce its subpoenas duces tecum by applying to the circuit court of Cole County, the county of the investigation, hearing or proceeding, or any county where the records reside or may be found for an order upon any person who shall fail to obey a subpoena duces tecum to show cause why such subpoena duces tecum should not be enforced, which such order and a copy of the application therefor shall be served upon the person in the same manner as a summons in a civil action. If the circuit court shall, after a hearing, determine that the subpoena duces tecum should be sustained and enforced, such court shall proceed to enforce the subpoena duces tecum in the same manner as though the subpoena had been issued in a civil case in the circuit court.

(L. 2004 S.B. 1122)

Inspections by authorized representatives of board, where--testingprogram authorized--rulemaking authority.

338.150. 1. Any person authorized by the board of pharmacy is hereby given the right of entry and inspection upon all open premises purporting or appearing to be drug or chemical stores, apothecary shops, pharmacies or places of business for exposing for sale, or the dispensing or selling of drugs, pharmaceuticals, medicines, chemicals or poisons or for the compounding of physicians' or veterinarians' prescriptions.

2. The board may establish and implement a program for testing drugs or drug products maintained, compounded, filled, or dispensed by licensees, registrants, or permit holders of the board. The board shall pay all testing costs and shall reimburse the licensee, registrant, or permit holder for the reasonable, usual, and customary cost of the drug or drug product requested for testing.

3. The board shall promulgate rules to implement the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2013, shall be invalid and void.

(RSMo 1939 § 10016, A.L. 1951 p. 737, A.L. 1961 p. 503, A.L. 1980 H.B. 1266, A.L. 1981 S.B. 16, A.L. 2011 H.B. 412 merged with S.B. 325, A.L. 2013 H.B. 315 merged with S.B. 306)

Immunity from civil liability, when.

338.155. 1. Any person who in good faith and without malice reports, provides information, or cooperates in any manner with the board, or assists the board in any manner including, but not limited to, any applicant or licensee, whether or not the applicant or licensee is the subject of an investigation, record custodians, consultants, attorneys, board members, agents, employees, staff or expert witnesses, in the course of any investigation, hearing or other proceeding conducted by or before the board pursuant to the provisions of this chapter shall not be subject to an action for civil damages as a result of providing such information and cooperating with the board.

2. No physician or other authorized prescriber who, in good faith, cooperates with the board by writing a prescription or drug order at the request of the board pursuant to a routine inspection or a lawful investigation shall, by virtue of that cooperation, be in violation of this chapter or any drug laws of this state and shall be acting as an agent of the state and, as such, shall have sovereign immunity for those actions.

3. No licensee, registrant, permit holder, or other individual or entity subject to the board's jurisdiction who, in good faith, fills a prescription presented by the board as part of an inspection or investigation shall, by virtue of that act, be in violation of this chapter or the drug laws of this state, provided the prescription is otherwise prepared and dispensed in a lawful manner.

(L. 2004 S.B. 1122)

Class B pharmacies subject to department inspection,when--definitions--rulemaking authority--certificate ofmedication therapeutic plan authority required, when--dispensingof medications, requirements--advisory committee.

338.165. 1. As used in this section, the following terms mean:

(1) "Board", the Missouri board of pharmacy;

(2) "Hospital", a hospital as defined in section 197.020;

(3) "Hospital clinic or facility", a clinic or facility under the common control, management, or ownership of the same hospital or hospital system;

(4) "Medical staff committee", the committee or other body of a hospital or hospital system responsible for formulating policies regarding pharmacy services and medication management;

(5) "Medication order", an order for a legend drug or device that is:

(a) Authorized or issued by an authorized prescriber acting within the scope of his or her professional practice or pursuant to a protocol or standing order approved by the medical staff committee; and

(b) To be distributed or administered to the patient by a health care practitioner or lawfully authorized designee at a hospital or a hospital clinic or facility;

(6) "Patient", an individual receiving medical diagnosis, treatment or care at a hospital or a hospital clinic or facility.

2. The department of health and senior services shall have sole authority and responsibility for the inspection and licensure of hospitals as provided by chapter 197 including, but not limited to all parts, services, functions, support functions and activities which contribute directly or indirectly to patient care of any kind whatsoever. However, the board may inspect a class B pharmacy or any portion thereof that is not under the inspection authority vested in the department of health and senior services by chapter 197 to determine compliance with this chapter or the rules of the board. This section shall not be construed to bar the board from conducting an investigation pursuant to a public or governmental complaint to determine compliance by an individual licensee or registrant of the board with any applicable provisions of this chapter or the rules of the board.

3. The department of health and senior services shall have authority to promulgate rules in conjunction with the board governing medication distribution and the provision of medication therapy services by a pharmacist at or within a hospital. Rules may include, but are not limited to, medication management, preparation, compounding, administration, storage, distribution, packaging and labeling. Until such rules are jointly promulgated, hospitals shall comply with all applicable state law and department of health and senior services rules governing pharmacy services and medication management in hospitals. The rulemaking authority granted herein to the department of health and senior services shall not include the dispensing of medication by prescription.

4. All pharmacists providing medication therapy services shall obtain a certificate of medication therapeutic plan authority as provided by rule of the board. Medication therapy services may be provided by a pharmacist for patients of a hospital pursuant to a protocol with a physician as required by section 338.010 or pursuant to a protocol approved by the medical staff committee. However, the medical staff protocol shall include a process whereby an exemption to the protocol for a patient may be granted for clinical efficacy should the patient's physician make such request. The medical staff protocol shall also include an appeals process to request a change in a specific protocol based on medical evidence presented by a physician on staff.

5. Medication may be dispensed by a class B hospital pharmacy pursuant to a prescription or a medication order.

6. A drug distributor license shall not be required to transfer medication from a class B hospital pharmacy to a hospital clinic or facility for patient care or treatment.

7. Medication dispensed by a class A pharmacy located in a hospital to a hospital patient for use or administration outside of the hospital under a medical staff-approved protocol for medication therapy shall be dispensed only by a prescription order for medication therapy from an individual physician for a specific patient.

8. Medication dispensed by a hospital to a hospital patient for use or administration outside of the hospital shall be labeled as provided by rules jointly promulgated by the department of health and senior services and the board including medication distributed for administration by or under the supervision of a health care practitioner at a hospital clinic or facility.

9. This section shall not be construed to preempt any law or rule governing controlled substances.

10. Any rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall only become effective if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly under chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2014, shall be invalid and void.

11. The board shall appoint an advisory committee to review and make recommendations to the board on the merit of all rules and regulations to be jointly promulgated by the board and the department of health and senior services pursuant to the joint rulemaking authority granted by this section. The advisory committee shall consist of:

(1) Two representatives designated by the Missouri Hospital Association, one of whom shall be a pharmacist;

(2) One pharmacist designated by the Missouri Society of Health System Pharmacists;

(3) One pharmacist designated by the Missouri Pharmacy Association;

(4) One pharmacist designated by the department of health and senior services from a hospital with a licensed bed count that does not exceed fifty beds or from a critical access hospital as defined by the department of social services for purposes of MO HealthNet reimbursement;

(5) One pharmacist designated by the department of health and senior services from a hospital with a licensed bed count that exceeds two hundred beds; and

(6) One pharmacist designated by the board with experience in the provision of hospital pharmacy services.

12. Nothing in this section shall be construed to limit the authority of a licensed health care provider to prescribe, administer, or dispense medications and treatments within the scope of their professional practice.

(L. 2014 S.B. 754 merged with S.B. 808)

Title of pharmacist--used by whom.

338.170. It shall be unlawful for any person not legally licensed as a pharmacist to take, use or exhibit the title of pharmacist, or licensed or registered pharmacist, or the title druggist or apothecary, or any other title or description of like import.

(RSMo 1939 § 10020, A.L. 1951 p. 737)

Prior revisions: 1929 § 13154; 1919 § 4726; 1909 § 5778

Prosecution of offenders.

338.180. Upon receiving information that any provision of sections 338.010 to 338.190 has been or is being violated, the secretary of the board of pharmacy shall investigate the matter, and upon probable cause appearing, shall, under the direction of the board, file a complaint and prosecute the offender therefor. It shall be the duty of the prosecuting attorney, upon the request of the secretary, to take charge of and conduct such prosecutions.

(RSMo 1939 § 10013, A. 1949 H.B. 2075)

Prior revisions: 1929 § 13150; 1919 § 4722; 1909 § 5774

Board has access to certain court records.

338.185. After August 28, 1990, notwithstanding any other provisions of law, the board of pharmacy shall have access to records involving an applicant for a license or permit or renewal of a license or permit as provided within this chapter, where the applicant has been adjudicated and found guilty or entered a plea of guilty or nolo contendere in a prosecution under 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 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.

(L. 1990 H.B. 1287)

Violation of law by licensee--penalty.

338.190. Any person who is licensed under this chapter who violates any provision of sections 338.010 to 338.190 shall, upon conviction, be adjudged guilty of a class A misdemeanor.

(RSMo 1939 § 10022, A.L. 1951 p. 737, A.L. 1981 S.B. 16, A.L. 1990 H.B. 1287)

Prior revisions: 1929 § 13156; 1919 § 4728; 1909 § 5780

Violation of law by person notlicensed--penalty.

338.195. Any person, who is not licensed under this chapter, who violates any provision of sections 338.010 to 338.315 shall, upon conviction, be adjudged guilty of a class D felony.

(L. 1990 H.B. 1287, A.L. 2014 S.B. 491)

Effective 1-01-17

Prescription by practitioner licensed in another state, may befilled, requirement.

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.

(L. 1991 H.B. 444 § 5)

Pharmacist may fill prescription forwarded by authorized agent.

338.198. Other provisions of law to the contrary notwithstanding, a pharmacist may fill a physician's prescription or the prescription of an advanced practice nurse working under a collaborative practice arrangement with a physician, when it is forwarded to the pharmacist by a registered professional nurse or registered physician's assistant or other authorized agent. The written collaborative practice arrangement shall specifically state that the registered professional nurse or registered physician assistant is permitted to authorize a pharmacist to fill a prescription on behalf of the physician.

(L. 1993 H.B. 564)

Pharmacist may dispense emergency prescription, when,requirements--rulemaking authority.

338.200. 1. In the event a pharmacist is unable to obtain refill authorization from the prescriber due to death, incapacity, or when the pharmacist is unable to obtain refill authorization from the prescriber, a pharmacist may dispense an emergency supply of medication if:

(1) In the pharmacist's professional judgment, interruption of therapy might reasonably produce undesirable health consequences;

(2) The pharmacy previously dispensed or refilled a prescription from the applicable prescriber for the same patient and medication;

(3) The medication dispensed is not a controlled substance;

(4) The pharmacist informs the patient or the patient's agent either verbally, electronically, or in writing at the time of dispensing that authorization of a prescriber is required for future refills; and

(5) The pharmacist documents the emergency dispensing in the patient's prescription record, as provided by the board by rule.

2. (1) If the pharmacist is unable to obtain refill authorization from the prescriber, the amount dispensed shall be limited to the amount determined by the pharmacist within his or her professional judgment as needed for the emergency period, provided the amount dispensed shall not exceed a seven-day supply.

(2) In the event of prescriber death or incapacity or inability of the prescriber to provide medical services, the amount dispensed shall not exceed a thirty-day supply.

3. Pharmacists or permit holders dispensing an emergency supply pursuant to this section shall promptly notify the prescriber or the prescriber's office of the emergency dispensing, as required by the board by rule.

4. An emergency supply may not be dispensed pursuant to this section if the pharmacist has knowledge that the prescriber has otherwise prohibited or restricted emergency dispensing for the applicable patient.

5. The determination to dispense an emergency supply of medication under this section shall only be made by a pharmacist licensed by the board.

6. The board shall promulgate rules to implement the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2013, shall be invalid and void.

(L. 2013 H.B. 315, A.L 2016 S.B. 608 merged with S.B. 635)

Effective 8-28-16 (S.B. 635)

*10-14-16 (S.B. 608), see § 21.250

*S.B. 608 was vetoed July 5, 2016. The veto was overridden on September 14, 2016.

Maintenance medications, pharmacist may exercise professional judgmenton quantity dispensed, when.

338.202. 1. Notwithstanding any other provision of law to the contrary, unless the prescriber has specified on the prescription that dispensing a prescription for a maintenance medication in an initial amount followed by periodic refills is medically necessary, a pharmacist may exercise his or her professional judgment to dispense varying quantities of maintenance medication per fill up to the total number of dosage units as authorized by the prescriber on the original prescription, including any refills. Dispensing of the maintenance medication based on refills authorized by the physician or prescriber on the prescription shall be limited to no more than a ninety-day supply of the medication, and the maintenance medication shall have been previously prescribed to the patient for at least a three-month period.

2. For the purposes of this section, "maintenance medication" is and means a medication prescribed for chronic, long-term conditions and that is taken on a regular, recurring basis; except that, it shall not include controlled substances, as defined in and under section 195.010.

(L. 2016 H.B. 1682 merged with H.B. 1816 merged with S.B. 608 merged with S.B. 865 & 866 merged with S.B. 973)

Effective 8-28-16 (H.B. 1682)

8-28-16 (H.B. 1816)

8-28-16 (S.B. 865 & 866)

8-28-16 (S.B. 973)

*10-14-16 (S.B. 608), see § 21.250

*S.B. 608 was vetoed July 5, 2016. The veto was overridden on September 14, 2016.

Opioid antagonist, storage and dispensing of without a license, when.

338.205. 1. Notwithstanding any other law or regulation to the contrary, any person or organization acting under a standing order issued by a health care professional who is otherwise authorized to prescribe an opioid antagonist may store an opioid antagonist without being subject to the licensing and permitting requirements of this chapter and may dispense an opioid antagonist if the person does not collect a fee or compensation for dispensing the opioid antagonist.

2. As used in this section, the term "emergency opioid antagonist" means naloxone hydrochloride that blocks the effects of an opioid overdose that is administered in a manner approved by the United States Food and Drug Administration, or any accepted medical practice of administering.

(L. 2016 H.B. 1568)

Pharmacy defined--practice of pharmacy to be conducted at pharmacylocation--rulemaking authority.

338.210. 1. Pharmacy refers to any location where the practice of pharmacy occurs or such activities are offered or provided by a pharmacist or another acting under the supervision and authority of a pharmacist, including every premises or other place:

(1) Where the practice of pharmacy is offered or conducted;

(2) Where drugs, chemicals, medicines, any legend drugs under 21 U.S.C. Section 353, prescriptions, or poisons are compounded, prepared, dispensed or sold or offered for sale at retail;

(3) Where the words "pharmacist", "apothecary", "drugstore", "drugs", and any other symbols, words or phrases of similar meaning or understanding are used in any form to advertise retail products or services;

(4) Where patient records or other information is maintained for the purpose of engaging or offering to engage in the practice of pharmacy or to comply with any relevant laws regulating the acquisition, possession, handling, transfer, sale or destruction of drugs, chemicals, medicines, prescriptions or poisons.

2. All activity or conduct involving the practice of pharmacy as it relates to an identifiable prescription or drug order shall occur at the pharmacy location where such identifiable prescription or drug order is first presented by the patient or the patient's authorized agent for preparation or dispensing, unless otherwise expressly authorized by the board.

3. The requirements set forth in subsection 2 of this section shall not be construed to bar the complete transfer of an identifiable prescription or drug order pursuant to a verbal request by or the written consent of the patient or the patient's authorized agent.

4. The board is hereby authorized to enact rules waiving the requirements of subsection 2 of this section and establishing such terms and conditions as it deems necessary, whereby any activities related to the preparation, dispensing or recording of an identifiable prescription or drug order may be shared between separately licensed facilities.

5. If a violation of this chapter or other relevant law occurs in connection with or adjunct to the preparation or dispensing of a prescription or drug order, any permit holder or pharmacist-in-charge at any facility participating in the preparation, dispensing, or distribution of a prescription or drug order may be deemed liable for such violation.

6. Nothing in this section shall be construed to supersede the provisions of section 197.100.

(L. 1951 p. 734 § 1(a), A.L. 2001 H.B. 567, A.L. 2011 H.B. 412 merged with S.B. 325)

Operation of pharmacy without permit or license unlawful--applicationfor permit, classifications, fee--duration of permit.

338.220. 1. It shall be unlawful for any person, copartnership, association, corporation or any other business entity to open, establish, operate, or maintain any pharmacy as defined by statute without first obtaining a permit or license to do so from the Missouri board of pharmacy. A permit shall not be required for an individual licensed pharmacist to perform nondispensing activities outside of a pharmacy, as provided by the rules of the board. A permit shall not be required for an individual licensed pharmacist to administer drugs, vaccines, and biologicals by protocol, as permitted by law, outside of a pharmacy. The following classes of pharmacy permits or licenses are hereby established:

(1) Class A: Community/ambulatory;

(2) Class B: Hospital pharmacy;

(3) Class C: Long-term care;

(4) Class D: Nonsterile compounding;

(5) Class E: Radio pharmaceutical;

(6) Class F: Renal dialysis;

(7) Class G: Medical gas;

(8) Class H: Sterile product compounding;

(9) Class I: Consultant services;

(10) Class J: Shared service;

(11) Class K: Internet;

(12) Class L: Veterinary;

(13) Class M: Specialty (bleeding disorder);

(14) Class N: Automated dispensing system (health care facility);

(15) Class O: Automated dispensing system (ambulatory care);

(16) Class P: Practitioner office/clinic.

2. Application for such permit or license 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 or license fee. The permit or license issued shall be renewable upon payment of a renewal fee. Separate applications shall be made and separate permits or licenses required for each pharmacy opened, established, operated, or maintained by the same owner.

3. All permits, licenses or renewal fees collected 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.

4. Class L: veterinary permit shall not be construed to prohibit or interfere with any legally registered practitioner of veterinary medicine in the compounding, administering, prescribing, or dispensing of their own prescriptions, or medicine, drug, or pharmaceutical product to be used for animals.

5. Except for any legend drugs under 21 U.S.C. Section 353, the provisions of this section shall not apply to the sale, dispensing, or filling of a pharmaceutical product or drug used for treating animals.

6. A "class B hospital pharmacy" shall be defined as a pharmacy owned, managed, or operated by a hospital as defined by section 197.020 or a clinic or facility under common control, management or ownership of the same hospital or hospital system. This section shall not be construed to require a class B hospital pharmacy permit or license for hospitals solely providing services within the practice of pharmacy under the jurisdiction of, and the licensure granted by, the department of health and senior services under and pursuant to chapter 197.

7. Upon application to the board, any hospital that holds a pharmacy permit or license on August 28, 2014, shall be entitled to obtain a class B pharmacy permit or license without fee, provided such application shall be submitted to the board on or before January 1, 2015.

(L. 1951 p. 734 § 1, A.L. 1969 S.B. 390, A.L. 1981 S.B. 16, A.L. 1989 S.B. 39, A.L. 1997 S.B. 141, A.L. 1999 H.B. 343, A.L. 2001 H.B. 567, A.L. 2004 S.B. 1122, A.L. 2007 H.B. 780 merged with S.B. 272, A.L. 2009 S.B. 296, A.L. 2011 H.B. 412 merged with S.B. 325, A.L. 2013 H.B. 315, A.L. 2014 S.B. 754 merged with S.B. 808)

Disposition of fees.

338.230. All fees collected under 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.

(L. 1951 p. 734 § 3, A.L. 1989 S.B. 39)

Evidence required for issuance of permit--veterinary permit pharmacy,designation of supervising registered pharmacist, when.

338.240. 1. Upon evidence satisfactory to the said Missouri board of pharmacy:

(1) That the pharmacy for which a permit, or renewal thereof, is sought, will be conducted in full compliance with sections 338.210 to 338.300, with existing laws, and with the rules and regulations as established hereunder by said board;

(2) That the equipment and facilities of such pharmacy are such that it can be operated in a manner not to endanger the public health or safety;

(3) That such pharmacy is equipped with proper pharmaceutical and sanitary appliances and kept in a clean, sanitary and orderly manner;

(4) That the management of said pharmacy is under the supervision of either a registered pharmacist, or an owner or employee of the owner, who has at his or her place of business a registered pharmacist employed for the purpose of compounding physician's or veterinarian's prescriptions in the event any such prescriptions are compounded or sold;

(5) That said pharmacy is operated in compliance with the rules and regulations legally prescribed with respect thereto by the Missouri board of pharmacy, a permit or renewal thereof shall be issued to such persons as the said board of pharmacy shall deem qualified to conduct such pharmacy.

2. In lieu of a registered pharmacist as required by subdivision (4) of subsection 1 of this section, a pharmacy permit holder that only holds a class L veterinary permit and no other pharmacy permit may designate a supervising registered pharmacist who shall be responsible for reviewing the activities and records of the class L pharmacy permit holder as established by the board by rule. The supervising registered pharmacist shall not be required to be physically present on site during the business operations of a class L pharmacy permit holder identified in subdivision (5) of subsection 1 of this section when noncontrolled legend drugs under 21 U.S.C. Section 353 are being dispensed for use in animals, but shall be specifically present on site when any noncontrolled drugs for use in animals are being compounded.

(L. 1951 p. 734 § 2, A.L. 2011 H.B. 412 merged with S.B. 325)

Equipment required--manner of operation of pharmacy--compliance withstate and federal laws required.

338.250. No pharmacy shall be licensed under the provisions of this chapter unless it is equipped with proper pharmaceutical equipment and reference manuals, so that the practice of pharmacy may be accurately and properly performed. The board shall prescribe the minimum of technical equipment which the pharmacy shall at all times possess. Such requirements may vary, depending upon the population served, but shall be consistently and uniformly enforced. No permit shall be issued or renewed for the operation of a pharmacy unless the pharmacy shall be operated in a manner and according to the rules and regulations prescribed by law and by the Missouri board of pharmacy with respect to obtaining and maintaining such a permit. Any pharmacy that receives or possesses drugs or devices shall be held responsible for compliance with all laws within this chapter as well as state and federal drug laws on all drugs received or possessed, including but not limited to drugs and devices received or possessed pursuant to a consignment arrangement.

(L. 1951 p. 734 § 6, A.L. 1990 H.B. 1287, A.L. 1998 S.B. 940)

Specific prescription or nonprescription drugs or devices, norequirement to carry.

338.255. Notwithstanding any other provision of law, no pharmacy licensed in this state shall be required to carry or maintain in inventory any specific prescription or nonprescription drug or device.

(L. 2013 S.B. 126)

Business name not to include certain words unless supervised bypharmacist--historical names permitted--board of pharmacy mayenforce.

338.260. 1. No person shall carry on, conduct or transact a business under a name which contains as part of the name the words "pharmacist", "pharmacy", "apothecary", "apothecary shop", "chemist shop", "drug store", "druggist", "drugs", "consultant pharmacist", or any word of similar or like import, unless the place of business is supervised by a licensed pharmacist.

2. Nothing in this chapter shall be construed to prevent any person from using a historical name in reference to any building, structure, or business so long as the person is not engaged in the practice of pharmacy as defined in section 338.010.

3. Notwithstanding the provisions of subsection 2 of this section, the board of pharmacy shall retain authority to enforce the provisions of subsection 1 of this section against any person offering for sale any naturopathic or homeopathic service or any herbal, nutritional, vitamin, dietary, mineral, or other supplement intended for human application, absorption, or consumption.

(L. 1951 p. 737 § 338.170, A.L. 1990 H.B. 1287, A.L. 2009 S.B. 394)

Renewal applications to be made, when.

338.270. 1. Application blanks for renewal permits shall be mailed to each permittee on or before the first day of the month in which the permit expires and, if application for renewal of permit is not made before the first day of the following month, the existing permit, or renewal thereof, shall lapse and become null and void upon the last day of that month.

2. The board of pharmacy shall not renew a nonresident pharmacy license if the renewal applicant does not hold a current pharmacy license or its equivalent in the state in which the nonresident pharmacy is located.

(L. 1951 p. 734 § 3, A.L. 1981 S.B. 16, A.L. 2016 S.B. 865 & 866)

Board of pharmacy, rules and regulations.

338.280. The Missouri board of pharmacy may make such rules and regulations, not inconsistent with law, as may be necessary to carry out the purposes and enforce the provisions of sections 338.210 to 338.300.

(L. 1951 p. 734 § 4, A.L. 1971 S.B. 145, A.L. 1981 S.B. 16)

Board may file complaint, when, where filed.

338.285. The board is hereby authorized and empowered, when examination or inspection of a pharmacy shall disclose to the board that the pharmacy is not being operated or conducted according to such legal rules and regulations and the laws of Missouri with respect thereto, to cause a complaint to be filed before the administrative hearing commission pursuant to chapter 621 charging the holder of a permit to operate a pharmacy with conduct constituting grounds for discipline in accordance with section 338.055.

(L. 1971 S.B. 145, A.L. 2001 H.B. 567)

Appeals from decision of board, notice of right.

338.290. Any person denied a permit to establish or operate a pharmacy, or renewal of such permit, may appeal the decision of the board of pharmacy in the manner provided by law, and shall be notified of this right at the time of denial.

(L. 1951 p. 734 § 5, A.L. 1981 S.B. 16)

Permit to be posted--not transferable.

338.300. The permit, or renewal thereof, issued under the provisions of sections 338.210 to 338.300, and under which a pharmacy is being operated, shall be posted and exposed in a conspicuous place in such pharmacy; such permit or renewal of permit shall not be transferable.

(L. 1951 p. 734 § 3, A.L. 1981 S.B. 16)

Violation, a misdemeanor.

338.310. Every person who violates any provision of sections 338.210 to 338.300 shall, upon conviction thereof, be adjudged guilty of a class C misdemeanor.

(L. 1951 p. 734 § 7, A.L. 1981 S.B. 16)

Inspection of pharmacy within certain facilitiesauthorized--applicability of law.

338.314. Nothing in sections 338.010 to 338.315 shall authorize the board of pharmacy to conduct an inspection of a long-term care facility licensed under the provisions of chapter 198 by the Missouri department of health and senior services, except that the board of pharmacy may inspect any licensed pharmacy located within a long-term care facility. However, the provisions of sections 338.010 to 338.315 shall apply to all individuals licensed as a pharmacist and practicing pharmacy as defined in section 338.010.

(L. 1990 H.B. 1287, A.L. 2014 H.B. 1299 Revision)

Receipt of drugs from unlicenseddistributor or pharmacy, unlawful--penalty--pharmacy-to-pharmacytransfers, limit--legend drugs, inventories andrecords--rulemaking authority.

338.315. 1. Except as otherwise provided by the board by rule, it shall be unlawful for any pharmacist, pharmacy owner or person employed by a pharmacy to knowingly purchase or receive any legend drugs under 21 U.S.C. Section 353 from other than a licensed or registered drug distributor or licensed pharmacy. Any person who violates the provisions of this section shall, upon conviction, be adjudged guilty of a class A misdemeanor. Any subsequent conviction shall constitute a class E felony.

2. Notwithstanding any other provision of law to the contrary, the sale, purchase, or trade of a prescription drug by a pharmacy to other pharmacies is permissible if the total dollar volume of such sales, purchases, or trades are in compliance with the rules of the board and do not exceed five percent of the pharmacy's total annual prescription drug sales.

3. Pharmacies shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of legend drugs. Such records shall be maintained for two years and be readily available upon request by the board or its representatives.

4. The board shall promulgate rules to implement the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2012, shall be invalid and void.

(L. 1989 S.B. 39, A.L. 2011 S.B. 325, A.L. 2012 H.B. 1563, A.L. 2014 S.B. 491)

Effective 1-01-17

Committee established, purpose, members, duties--sunset provision.

338.320. 1. There is hereby established the "Missouri Electronic Prior Authorization Committee" in order to facilitate, monitor, and report to the general assembly on Missouri-based efforts to contribute to the establishment of national electronic prior authorization standards. Such efforts shall include the Missouri-based electronic prior authorization pilot program established under subsection 5 of this section and the study and dissemination of information by the committee of the efforts of the National Council on Prescription Drug Programs (NCPDP) to develop national electronic prior authorization standards. The committee shall advise the general assembly and the department of insurance, financial institutions and professional registration as to whether there is a need for administrative rules to be promulgated by the department of insurance, financial institutions and professional registration as soon as practically possible.

2. The Missouri electronic prior authorization committee shall consist of the following members:

(1) Two members of the senate, appointed by the president pro tempore of the senate;

(2) Two members of the house of representatives, appointed by the speaker of the house of representatives;

(3) One member from an organization of licensed physicians in the state;

(4) One member who is a physician licensed in Missouri pursuant to chapter 334;

(5) One member who is a representative of a Missouri pharmacy benefit management company;

(6) One member from an organization representing licensed pharmacists in the state;

(7) One member from the business community representing businesses on health insurance issues;

(8) One member from an organization representing the leading research-based pharmaceutical and biotechnology companies;

(9) One member from an organization representing the largest generic pharmaceutical trade association;

(10) One patient advocate;

(11) One member from an electronic prescription network that facilitates the secure electronic exchange of clinical information between physicians, pharmacies, payers, and pharmacy benefit managers and other health care providers;

(12) One member from a Missouri-based electronic health records company;

(13) One member from an organization representing the largest number of hospitals in the state;

(14) One member from a health carrier as such term is defined under section 376.1350;

(15) One member from an organization representing the largest number of health carriers in the state, as such term is defined under section 376.1350;

(16) The director of the department of social services, or the director's designee;

(17) The director of the department of insurance, financial institutions and professional registration, who shall be chair of the committee.

3. All of the members, except for the members from the general assembly, shall be appointed by the governor no later than September 1, 2012, with the advice and consent of the senate. The staff of the department of insurance, financial institutions and professional registration shall provide assistance to the committee.

4. The duties of the committee shall be as follows:

(1) Before February 1, 2019, monitor and report to the general assembly on the Missouri-based electronic prior authorization pilot program created under subsection 5 of this section including a report of the outcomes and best practices developed as a result of the pilot program and how such information can be used to inform the national standard-setting process;

(2) Obtain specific updates from the NCPDP and other pharmacy benefit managers and vendors that are currently engaged in pilot programs working toward national electronic prior authorization standards;

(3) Correspond and collaborate with the NCPDP and other such pilots through the exchange of information and ideas;

(4) Assist, when asked by the pharmacy benefit manager, with the development of the pilot program created under subsection 5 of this section with an understanding of information on the success and failures of other pilot programs across the country;

(5) Prepare a report at the end of each calendar year to be distributed to the general assembly and governor with a summary of the committee's progress and plans for the next calendar year, including a report on Missouri-based efforts to contribute to the establishment of national electronic prior authorization standards. Such annual report shall continue until such time as the NCPDP has established national electronic prior authorization standards or this section has expired, whichever is sooner. The first report shall be completed before January 1, 2013;

(6) Upon the adoption of national electronic prior authorization standards by the NCPDP, prepare a final report to be distributed to the general assembly and governor that identifies the appropriate Missouri administrative regulations, if any, that will need to be promulgated by the department of insurance, financial institutions and professional registration, in order to make those standards effective as soon as practically possible, and advise the general assembly and governor if there are any legislative actions necessary to the furtherance of that end.

5. The department of insurance, financial institutions and professional registration and the Missouri electronic prior authorization committee shall recruit a Missouri-based pharmacy benefits manager doing business nationally to volunteer to conduct an electronic prior authorization pilot program in Missouri. The pharmacy benefits manager conducting the pilot program shall ensure that there are adequate Missouri licensed physicians and an electronic prior authorization vendor capable and willing to participate in a Missouri-based pilot program. Such pilot program established under this section shall be operational by January 1, 2014. The department and the committee may provide advice or assistance to the pharmacy benefit manager conducting the pilot program but shall not maintain control or lead with the direction of the pilot program.

6. Pursuant to section 23.253 of the Missouri sunset act:

(1) The provisions of the new program authorized under this section shall sunset automatically six years after August 28, 2012, unless reauthorized by an act of the general assembly; and

(2) If such program is reauthorized, the program authorized under this section shall sunset automatically twelve years after the effective date of the reauthorization of this section; and

(3) This section shall terminate on September first of the calendar year immediately following the calendar year in which the program authorized under this section is sunset.

(L. 2012 H.B. 1563 merged with H.B. 1827)

Sunset date 8-28-18

Termination date 9-1-19

Definitions.

338.330. As used in sections 338.300 to 338.370, the following terms mean:

(1) "Legend drug":

(a) Any drug or biological product:

a. Subject to Section 503(b) of the Federal Food, Drug and Cosmetic Act, including finished dosage forms and active ingredients subject to such Section 503(b); or

b. Required under federal law to be labeled with one of the following statements prior to being dispensed or delivered:

(i) "Caution: Federal law prohibits dispensing without prescription";

(ii) "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian"; or

(iii) "Rx Only"; or

c. Required by any* applicable federal or state law or regulation to be dispensed by prescription only or that is restricted to use or dispensed by practitioners only; and

(b) The term "drug", "prescription drug", or "legend drug" shall not include:

a. An investigational new drug, as defined by 21 CFR 312.3(b), that is being utilized for the purposes of conducting a clinical trial or investigation of such** drug or product that is governed by, and being conducted under and pursuant to, 21 CFR 312, et. seq.;

b. Any drug product being utilized for the purposes of conducting a clinical trial or investigation that is governed by, and being conducted under and pursuant to, 21 CFR 312, et. seq.; or

c. Any drug product being utilized for the purposes of conducting a clinical trial or investigation that is governed or approved by an institutional review board subject to 21 CFR Part 56 or 45 CFR Part 46;

(2) "Out-of-state wholesale drug distributor", a wholesale drug distributor with no physical facilities located in the state;

(3) "Pharmacy distributor", any licensed pharmacy, as defined in section 338.210, engaged in the delivery or distribution of legend drugs to any other licensed pharmacy where such delivery or distribution constitutes at least five percent of the total gross sales of such pharmacy;

(4) "Wholesale drug distributor", anyone engaged in the delivery or distribution of legend drugs from any location and who is involved in the actual, constructive or attempted transfer of a drug or drug-related device in this state, other than to the ultimate consumer. This shall include, but not be limited to, drug wholesalers, repackagers and manufacturers which are engaged in the delivery or distribution of drugs in this state, with facilities located in this state or in any other state or jurisdiction. A wholesale drug distributor shall not include any common carrier or individual hired solely to transport legend drugs. Any locations where drugs are delivered on a consignment basis, as defined by the board, shall be exempt from licensure as a drug distributor, and those standards of practice required of a drug distributor but shall be open for inspection by board of pharmacy representatives as provided for in section 338.360.

(L. 1989 S.B. 39, A.L. 1993 S.B. 27, A.L. 1998 S.B. 940, A.L. 2011 H.B. 412 merged with S.B. 284 merged with S.B. 325)

Effective 6-10-11(H.B. 412)

7-07-11 (S.B. 325)

7-11-11 (S.B. 284)

*Word "an" appears in original rolls of H.B. 412, 2011.

**Word "that" appears in original rolls of H.B. 412, 2011.

License required, temporary licenses may be granted--out-of-statedistributors, reciprocity allowed, when.

338.333. 1. Except as otherwise provided by the board of pharmacy by rule in the event of an emergency or to alleviate a supply shortage, no person or distribution outlet shall act as a wholesale drug distributor or pharmacy distributor without first obtaining license to do so from the Missouri board of pharmacy and paying the required fee. The board may grant temporary licenses when the wholesale drug distributor or pharmacy distributor first applies for a license to operate within the state. Temporary licenses shall remain valid until such time as the board shall find that the applicant meets or fails to meet the requirements for regular licensure. No license shall be issued or renewed for a wholesale drug distributor or pharmacy distributor to operate unless the same shall be operated in a manner prescribed by law and according to the rules and regulations promulgated by the board of pharmacy with respect thereto. Separate licenses shall be required for each distribution site owned or operated by a wholesale drug distributor or pharmacy distributor, unless such drug distributor or pharmacy distributor meets the requirements of section 338.335.

2. An agent or employee of any licensed or registered wholesale drug distributor or pharmacy distributor need not seek licensure under this section and may lawfully possess pharmaceutical drugs, if he is acting in the usual course of his business or employment.

3. The board may permit out-of-state wholesale drug distributors or out-of-state pharmacy distributors to be licensed as required by sections 338.210 to 338.370 on the basis of reciprocity to the extent that an out-of-state wholesale drug distributor or out-of-state pharmacy distributor both:

(1) Possesses a valid license granted by another state pursuant to legal standards comparable to those which must be met by a wholesale drug distributor or pharmacy distributor of this state as prerequisites for obtaining a license under the laws of this state; and

(2) Distributes into Missouri from a state which would extend reciprocal treatment under its own laws to a wholesale drug distributor or pharmacy distributor of this state.

(L. 1989 S.B. 39 § 338.340, A.L. 2010 H.B. 2226, et al., A.L. 2012 H.B. 1563)

Separate licenses required, when--exemptions.

338.335. 1. Separate licenses shall be required for each distribution site owned or operated by a wholesale drug distributor or pharmacy distributor unless drugs are delivered only on a consignment basis as defined by the board, or the entity meets the requirements of subsection 2 of this section.

2. A wholesale drug distributor distributing drug-related devices in Missouri is not required to obtain a license from the board for out-of-state distribution sites owned by the wholesale drug distributor if:

(1) The wholesale drug distributor has one or more distribution sites located in Missouri, and all such in-state distribution sites receiving shipments of drug-related devices are licensed by the board as a distributor;

(2) The wholesale drug distributor's out-of-state distribution sites shipping to the in-state distribution site are in compliance with their respective state's licensing laws;

(3) The wholesale drug distributor's out-of-state distribution sites that deliver drug-related devices regulated by the board into Missouri for patient use deliver such devices only to the licensed wholesale drug distributor's in-state distribution site.

3. A Missouri wholesale drug distributor receiving shipments of drug-related devices from an out-of-state facility that is not required to be licensed as a distributor pursuant to subsection 2 of this section shall be responsible for all shipments received.

(L. 1998 S.B. 940, A.L. 2010 H.B. 2226, et al.)

Out-of-state distributors, licenses required, exception.

338.337. It shall be unlawful for any out-of-state wholesale drug distributor or out-of-state pharmacy acting as a distributor to do business in this state without first obtaining a license to do so from the board of pharmacy and paying the required fee, except as otherwise provided by section 338.335 and this section. Application for an out-of-state wholesale drug distributor's license under this section shall be made on a form furnished by the board. The issuance of a license under sections 338.330 to 338.370 shall not change or affect tax liability imposed by the Missouri department of revenue on any out-of-state wholesale drug distributor or out-of-state pharmacy. Any out-of-state wholesale drug distributor that is a drug manufacturer and which produces and distributes from a facility which has been inspected and approved by the Food and Drug Administration, maintains current approval by the federal Food and Drug Administration, and has provided a copy of the most recent Food and Drug Administration Establishment Inspection Report to the board, and which is licensed by the state in which the distribution facility is located, or, if located within a foreign jurisdiction, is authorized and in good standing to operate as a drug manufacturer within such jurisdiction, need not be licensed as provided in this section but such out-of-state distributor shall register its business name and address with the board of pharmacy and pay a filing fee in an amount established by the board.

(L. 1989 S.B. 39 § 338.350, A.L. 2009 H.B. 191 merged with S.B. 296, A.L. 2010 H.B. 2226, et al.)

Sale of drugs, out-of-state distributor, license required.

338.340. No person acting as principal or agent for any out-of-state wholesale drug distributor or out-of-state pharmacy distributor shall sell or distribute drugs in this state unless the wholesale drug distributor or pharmacy distributor has obtained a license pursuant to the provisions of sections 338.330 to 338.370.

(L. 1989 S.B. 39 § 338.360)

Records to be maintained and be available for board inspection.

338.343. Any licensee licensed under the provisions of sections 338.330 to 338.340 must maintain required records to guarantee security, storage and accountability. These records shall be available for inspection by the board.

(L. 1989 S.B. 39 § 338.370, A.L. 1993 S.B. 27)

Renewal of license, application.

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 of pharmacy shall not renew an out-of-state wholesale drug distributor, out-of-state pharmacy distributor, or drug distributor license or registration if the renewal applicant does not hold a current distributor license or its equivalent in the state or jurisdiction in which the distribution facility is located or, if a drug distributor registrant, the entity is not authorized and in good standing to operate as a drug manufacturer with the Food and Drug Administration or within the state or jurisdiction where the facility is located.

(L. 1989 S.B. 39 § 338.380, A.L. 2016 S.B. 865 & 866)

Board of pharmacy to promulgate rules and regulations--procedure.

338.350. The Missouri board of pharmacy may make such rules and regulations, not inconsistent with law, as may be necessary to carry out the purposes and enforce the provisions of sections 338.330 to 338.370. Such rules and regulations shall not be contrary to or more restrictive than any laws or rules pertaining to practices which are regulated by the federal Food and Drug Administration or the federal Drug Enforcement Administration when the laws or rules specifically state what requirements must be met for compliance. As used in this section, rules of the federal government shall not include guidelines or policies that may be enacted by federal agencies. No rule or portion of a rule promulgated under the authority of this chapter shall become effective unless it has been promulgated pursuant to the provisions of section 536.024.

(L. 1989 S.B. 39 § 338.390, A.L. 1993 S.B. 27 merged with S.B. 52, A.L. 1995 S.B. 3)

Discipline of licensee, grounds--procedure--administrative hearingcommission to conduct hearing.

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 chapter 621 charging the holder of a license to operate a drug distributorship or pharmacy wholesale operation constituting grounds for discipline in accordance with section 338.055.

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 the provisions of chapter 621 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.

(L. 1989 S.B. 39 § 338.395, A.L. 2001 H.B. 567)

Sanction imposed by board, when.

338.357. Any probation, restriction, suspension or revocation imposed on a licensee by the board of pharmacy for violations of this chapter shall be determined by the board upon a finding in favor of the board following the hearing held pursuant to section 338.353.

(L. 1989 S.B. 39 § 338.400)

Inspection of premises allowed, when.

338.360. Any person authorized by the board of pharmacy is hereby given the right of entry for inspection during normal business hours upon all open premises purporting or appearing to be used by a wholesale drug distributor or pharmacy distributor in Missouri. Any wholesale drug distributor who provides adequate documentation of the most recent inspection less than two years old by the Food and Drug Administration or other comparable state agency as determined by the board with a satisfactory rating shall be exempt from further inspection by the board of pharmacy. Such an exemption shall not bar the board of pharmacy from initiating an investigation pursuant to a public or governmental complaint received by the board of pharmacy regarding a wholesale drug distributor not licensed by the Food and Drug Administration.

(L. 1989 S.B. 39 § 338.410, A.L. 1993 S.B. 27)

Injunction may be issued, when, procedure.

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 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 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.

(L. 1989 S.B. 39 § 338.415, A.L. 1997 S.B. 141)

Penalties.

338.370. Every person who violates any provision of sections 338.333, 338.337, and 338.340 shall, upon conviction thereof, be adjudged guilty of a class D felony.

(L. 1989 S.B. 39 § 338.420, A.L. 2014 S.B. 491)

Effective 1-01-17

Refusal to issue a certificate, when--impaired license committeeauthorized, duties, procedures.

338.380. 1. As used in this section the term "committee" means the well-being committee established under subsection 3 of this section.

2. The board may refuse to issue any certificate of registration or authority, permit or license required under this chapter for one or any combination of causes stated in subsection 2 of section 338.055, or the board may, as a condition to issuing or renewing any such certificate of registration or authority, permit or license, require a person to submit himself or herself for identification, intervention, treatment, or rehabilitation by the well-being committee as provided in 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.

3. The board may establish an impaired licensee committee, to be designated as the "Well-being Committee", to promote the early identification, intervention, treatment, and rehabilitation of licensees identified within this chapter, who may be impaired by reasons of illness, substance abuse, or as a result of any physical or mental condition. The board may enter into a contractual agreement for the purpose of creating, supporting and maintaining such a committee. The board may promulgate rules subject to the provisions of this section to effectuate and implement any committee formed under this section. The board may expend appropriated funds necessary to provide for operational expenses of the committee formed under this section. Any member of the committee, as well as any administrator, staff member, consultant, agent or employee of the committee, acting within the scope of his or her duties and without actual malice and all other persons who furnish information to the committee in good faith and without actual malice, shall not be liable for any claim of damages as a result of any statement, decision, opinion, investigation or action taken by the committee or by any individual member of the committee.

4. All information, interviews, reports, statements, memoranda or other documents furnished to or produced by the committee, as well as communications to or from the committee, any findings, conclusions, interventions, treatment, rehabilitation, or other proceedings of the committee which in any way pertain to a licensee who may be, or who actually is, impaired shall be absolutely privileged and confidential.

5. All records and proceedings of the committee which pertain or refer to a licensee who may be, or who actually is, impaired shall be privileged and confidential and shall be used by the committee and its members only in the exercise of the proper function of the committee and shall not be considered public records under chapter 610 and shall only be subject to discovery or introduction as evidence in any civil, criminal, or administrative proceedings except as provided in subsection 6 of this section.

6. The committee may disclose information relative to an impaired licensee only when:

(1) It is essential to disclose the information to further the intervention, treatment, or rehabilitation needs of the impaired licensee and only to those persons or organization with a need to know;

(2) Its release is authorized in writing by the impaired licensee;

(3) The committee is required to make a report to the board; or

(4) The information is subject to a court order.

7. In lieu of the pursuing discipline against a licensee for violating one or more causes stated in subsection 2 of section 338.055, the board may enter into a diversion agreement with a licensee to refer the licensee to the committee under such terms and conditions as are agreed to by the board and licensee. The board shall enter into no more than two diversion agreements with any individual licensee. If the licensee violates a term or condition of a diversion agreement entered into under this section, the board may elect to pursue discipline against the licensee under chapter 621 for the original conduct that resulted in the diversion agreement, or for any subsequent violation of subsection 2 of section 338.055. While the licensee participates in the committee, the time limitations of section 620.154 shall toll under subsection 7 of section 620.154. All records pertaining to diversion agreements are confidential and may only be released under subdivision (7) of subsection 14 of section 620.010.

8. The committee shall report to the board the name of any licensee who fails to enter treatment within forty-eight hours following the provider's determination that the pharmacist needs treatment or any failure by a licensee to comply with the terms of a diversion agreement during inpatient or outpatient treatment or aftercare or report a licensee who resumes the practice of pharmacy before the treatment provider has made a clear determination that the pharmacist is capable of practicing according to acceptable and prevailing standards.

9. The board may disclose information and records to the committee to assist the committee in the identification, intervention, treatment, and rehabilitation of any licensee who may be impaired by reason of illness, substance abuse, or as the result of any physical or mental condition. The committee shall keep all information and records provided by the board confidential to the extent the board is required to treat the information and records as closed to the public under chapter 620.

10. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2007, shall be invalid and void.

(L. 2007 S.B. 195)

Standard of care, definitions, rules.

338.400. 1. As used in this section, the following terms shall mean:

(1) "Ancillary infusion equipment and supplies", the equipment and supplies required to infuse a blood clotting therapy product into a human vein, including syringes, needles, sterile gauze, field pads, gloves, alcohol swabs, numbing creams, tourniquets, medical tape, sharps or equivalent biohazard waste containers, and cold compression packs;

(2) "Assay", the amount of a particular constituent of a mixture or of the biological or pharmacological potency of a drug;

(3) "Bleeding disorder", a medical condition characterized by a deficiency or absence of one or more essential blood-clotting components in the human blood, including all forms of hemophilia, von Willebrand's disease, and other bleeding disorders that result in uncontrollable bleeding or abnormal blood clotting;

(4) "Blood clotting product", a medicine approved for distribution by the federal Food and Drug Administration that is used for the treatment and prevention of symptoms associated with bleeding disorders, including but not limited to recombinant Factor VII, recombinant-activated Factor VIIa, recombinant Factor VIII, plasma-derived Factor VIII, recombinant Factor IX, plasma-derived Factor IX, von Willebrand factor products, bypass products for patients with inhibitors, prothrombin complex concentrates; and activated prothrombin complex concentrates;

(5) "Home nursing services", specialized nursing care provided in the home setting to assist a patient in the reconstitution and administration of blood clotting products;

(6) "Home use", infusion or other use of a blood clotting product in a place other than a hemophilia treatment center, hospital, emergency room, physician's office, outpatient facility, or clinic;

(7) "Pharmacy", an entity engaged in practice of pharmacy as defined in section 338.010 that provides patients with blood clotting products and ancillary infusion equipment and supplies.

2. The Missouri state board of pharmacy shall promulgate rules governing the standard of care for pharmacies dispensing blood clotting therapies. Such rules shall include, when feasible, the standards established by the medical advisory committees of the patient groups representing the hemophilia and von Willebrand diseases, including but not limited to Recommendation 188 of the National Hemophilia Foundation's Medical and Scientific Advisory Council. Such rules shall include safeguards to ensure the pharmacy:

(1) Has the ability to obtain and fill a physician prescription as written of all brands of blood clotting products approved by the federal Food and Drug Administration in multiple assay ranges of low, medium, and high, as applicable, and vial sizes, including products manufactured from human plasma and those manufactured from recombinant technology techniques, provided manufacturer supply exists and payer authorization is obtained;

(2) Provides for the shipment of prescribed blood clotting products to the patient within two business days or less for established patients and three business days or less for new patients in nonemergency situations;

(3) Provides established patients with access to blood clotting products within twelve hours of notification by the physician of the patient's emergent need for blood clotting products;

(4) Provides all ancillary infusion equipment and supplies necessary for established patients for administration of blood clotting products;

(5) Has a pharmacist available twenty-four hours a day, seven days a week, every day of the year, either onsite or on call, to fill prescriptions for blood clotting products;

(6) Provides patients who have received blood clotting products with a designated contact telephone number for reporting problems with a delivery or product;

(7) Provides patients with notification of recalls and withdrawals of blood clotting products and ancillary infusion equipment within twenty-four hours of receipt of the notification; and

(8) Provides containers for the disposal of hazardous waste, and provides* patients with instructions on the proper collection, removal, and disposal of hazardous waste under state and federal law.

3. Notwithstanding the provisions of subsection 2 of this section, pharmacies and pharmacists shall exercise that degree of skill and learning ordinarily exercised by members of their profession in the dispensing and distributing of blood clotting products.

(L. 2011 H.B. 552)

*Word "provide" appears in original rolls.

Gross retail prescriptions, tax imposed, definitions.

338.500. 1. In addition to all other fees and taxes required or paid, a tax is hereby imposed upon licensed retail pharmacies for the privilege of providing outpatient prescription drugs in this state. The tax is imposed upon the Missouri gross retail prescription receipts earned from filling outpatient retail prescriptions.

2. For purposes of sections 338.500 to 338.550: (1) "Gross retail prescription receipts" shall mean all amounts received by a licensed pharmacy for its own account from the sale of outpatient prescription drugs in the state of Missouri but shall not include those sales shipped out of the state of Missouri and shall include the receipts from cost sharing, dispensing fees, and retail prescription drug sales; (2) "Licensed pharmacy" shall have the same meaning as such term is defined in section 338.210; (3) "Retail" means a sale for use or consumption and not for resale.

(L. 2002 S.B. 1248)

Effective 6-19-02

Expires 9-30-18

Formula for tax liability, rulemaking authority, appeals procedure.

338.505. 1. Each licensed retail pharmacy's tax shall be based on a formula set forth in rules promulgated by the department of social services. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2002, shall be invalid and void.

2. The director of the department of social services or the director's designee may prescribe the form and contents of any forms or other documents required by sections 338.500 to 338.550.

3. Notwithstanding any other provision of law to the contrary, appeals regarding the promulgation of rules pursuant to this section shall be made to the circuit court of Cole County. The circuit court of Cole County shall hear the matter as the court of original jurisdiction.

(L. 2002 S.B. 1248)

Effective 6-19-02

Expires 9-30-18

Records to be maintained, form--report of gross receipts,information--confidentiality of information.

338.510. 1. Each licensed retail pharmacy shall keep such records as may be necessary to determine gross retail prescription receipts.

2. The director of revenue may prescribe the form and contents of any forms or other documents required by this section.

3. Each licensed retail pharmacy shall report the gross retail prescription receipts to the department of revenue.

4. The department of revenue shall provide the department of social services with the information that is necessary to implement the provisions of sections 338.500 to 338.550.

5. The information obtained by the department of social services from the department of revenue shall be confidential and any employee of the department of social services who unlawfully discloses any such information for any other purpose, except as authorized by law, shall be subject to the penalties specified in section 32.057.

(L. 2002 S.B. 1248)

Effective 6-19-02

Expires 9-30-18

Effective date of tax.

338.515. The tax imposed by sections 338.500 to 338.550 shall become effective July 1, 2003, or the effective date of sections 338.500 to 338.550, whichever is later.

(L. 2002 S.B. 1248, A.L. 2003 H.B. 286)

Effective 6-26-03

Expires 9-30-18

Calculation of tax liability--notification to pharmacies--quarterlyadjustment authorized.

338.520. 1. The determination of the amount of tax due shall be the monthly gross retail prescription receipts reported to the department of revenue multiplied by the tax rate established by rule by the department of social services. Such tax rate may be a graduated rate based on gross retail prescription receipts and shall not exceed a rate of six percent per annum of gross retail prescription receipts; provided, that such rate shall not exceed one-tenth of one percent per annum in the case of licensed pharmacies of which eighty percent or more of such gross receipts are attributable to prescription drugs that are delivered directly to the patient via common carrier, by mail, or a courier service.

2. The department of social services shall notify each licensed retail pharmacy of the amount of tax due. Such amount may be paid in increments over the balance of the assessment period.

3. The department of social services may adjust the tax rate quarterly on a prospective basis. The department of social services may adjust more frequently for individual providers if there is a substantial and statistically significant change in their pharmacy sales characteristics. The department of social services may define such adjustment criteria by rule.

(L. 2002 S.B. 1248, A.L. 2003 H.B. 286 merged with H.B. 600)

Effective 6-26-03 (H.B. 286)

7-01-03 (H.B. 600)

Expires 9-30-18

Offset against Medicaid payments due by pharmacy permitted, when.

338.530. The director of the department of social services may offset the tax owed by a pharmacy against any Missouri Medicaid payment due such pharmacy, if the pharmacy requests such an offset. The amounts to be offset shall result, so far as practicable, in withholding from the pharmacy an amount substantially equal to the assessment due from the pharmacy. The office of administration and the state treasurer may make any fund transfers necessary to execute the offset.

(L. 2002 S.B. 1248)

Effective 6-19-02

Expires 9-30-18

Remittance to department--pharmacy reimbursement allowance fundcreated.

338.535. 1. The pharmacy tax owed or, if an offset has been made, the balance after such offset, if any, shall be remitted by the pharmacy or the pharmacy's designee to the department of social services. The remittance shall be made payable to the director of the department of revenue and shall be deposited in the state treasury to the credit of the "Pharmacy Reimbursement Allowance Fund" which is hereby created to provide payments for services related to the Medicaid pharmacy program. All investment earnings of the fund shall be credited to the fund.

2. An offset authorized by section 338.530 or a payment to the pharmacy reimbursement allowance fund shall be accepted as payment of the obligation set forth in section 338.500.

3. The state treasurer shall maintain records showing the amount of money in the pharmacy reimbursement allowance fund at any time and the amount of investment earnings on such amount.

4. Notwithstanding the provisions of section 33.080 to the contrary, any unexpended balance in the pharmacy reimbursement allowance fund at the end of the biennium shall not revert to the credit of the general revenue fund.

(L. 2002 S.B. 1248, A.L. 2009 H.B. 395 merged with H.B. 740)

Effective 6-26-09 (H.B. 740)

7-10-09 (H.B. 395)

Expires 9-30-18

Notice requirements--unpaid or delinquent taxes, procedure forcollection--failure to pay taxes, effect of.

338.540. 1. The department of social services shall notify each pharmacy with a tax due of more than ninety days of the amount of such balance. If any pharmacy fails to pay its pharmacy tax within thirty days of such notice, the pharmacy tax shall be delinquent.

2. If any tax imposed pursuant to sections 338.500 to 338.550 is unpaid and delinquent, the department of social services may proceed to enforce the state's lien against the property of the pharmacy and compel the payment of such assessment in the circuit court having jurisdiction in the county where the pharmacy is located. In addition, the department of social services may cancel or refuse to issue, extend, or reinstate a Medicaid provider agreement to any pharmacy that fails to pay the tax imposed by section 338.500.

3. Failure to pay the tax imposed by section 338.500 shall be grounds for denial, suspension, or revocation of a license granted pursuant to this chapter. The department of social services may request the board of pharmacy to deny, suspend, or revoke the license of any pharmacy that fails to pay such tax.

(L. 2002 S.B. 1248)

Effective 6-19-02

Expires 9-30-18

Expiration date of tax, when.

338.550. 1. The pharmacy tax required by sections 338.500 to 338.550 shall expire ninety days after any one or more of the following conditions are met:

(1) The aggregate dispensing fee as appropriated by the general assembly paid to pharmacists per prescription is less than the fiscal year 2003 dispensing fees reimbursement amount; or

(2) The formula used to calculate the reimbursement as appropriated by the general assembly for products dispensed by pharmacies is changed resulting in lower reimbursement to the pharmacist in the aggregate than provided in fiscal year 2003; or

(3) September 30, 2018.

The director of the department of social services shall notify the revisor of statutes of the expiration date as provided in this subsection. The provisions of sections 338.500 to 338.550 shall not apply to pharmacies domiciled or headquartered outside this state which are engaged in prescription drug sales that are delivered directly to patients within this state via common carrier, mail or a carrier service.

2. Sections 338.500 to 338.550 shall expire on September 30, 2018.

(L. 2002 S.B. 1248, A.L. 2003 H.B. 286 merged with H.B. 600, A.L. 2005 S.B. 189, A.L. 2006 S.B. 822, A.L. 2007 S.B. 4, A.L. 2009 H.B. 395 merged with H.B. 740, A.L. 2011 S.B. 62, A.L. 2015 S.B. 210, A.L. 2016 H.B. 1534)

Expires 9-30-18

CROSS REFERENCE:

Nonseverability clause, 190.840

Criteria for audit--appeals process to be established--report to beprovided--applicability exceptions.

338.600. 1. Notwithstanding any other provision of law to the contrary, when an audit of the records of a pharmacy licensed in this state is conducted by a managed care company, insurance company, third-party payor, or any entity that represents such companies or groups, such audit shall be conducted in accordance with the following:

(1) The entity conducting the initial on-site audit shall provide the pharmacy with notice at least one week prior to conducting the initial on-site audit for each audit cycle;

(2) Any audit which involves clinical judgment shall be conducted by or in consultation with a licensed pharmacist;

(3) Any clerical error, record-keeping error, typographical error, or scrivener's error regarding a required document or record shall not constitute fraud or grounds for recoupment, so long as the prescription was otherwise legally dispensed and the claim was otherwise materially correct; except that, such claims may be otherwise subject to recoupment of overpayments or payment of any discovered underpayment. No claim arising under this subdivision shall be subject to criminal penalties without proof of intent to commit fraud;

(4) A pharmacy may use the records of a hospital, physician, or other authorized practitioner of the healing arts involving drugs or medicinal supplies written or transmitted by any means of communication for purposes of validating the pharmacy record with respect to orders or refills of a legend or narcotic drug. Electronically stored images of prescriptions, electronically created annotations and other related supporting documentation shall be considered valid prescription records. Hard copy and electronic signature logs that indicate the delivery of pharmacy services shall be considered valid proof of receipt of such services by a program enrollee;

(5) A finding of an overpayment or underpayment may be a projection based on the number of patients served and having a similar diagnosis or on the number of similar orders or refills for similar drugs; except that, recoupment of claims shall be based on the actual overpayment or underpayment unless the projection for overpayment or underpayment is part of a settlement as agreed to by the pharmacy;

(6) Each pharmacy shall be audited under the same standards and parameters as other pharmacies audited by the entity;

(7) A pharmacy shall be allowed at least thirty days following receipt of the preliminary audit report in which to produce documentation to address any discrepancy found during an audit;

(8) The period covered by the audit shall not exceed a two-year period beginning two years prior to the initial date of the on-site portion of the audit unless otherwise provided by contractual agreement or if there has been a previous finding of fraud or as otherwise provided by state or federal law;

(9) An audit shall not be initiated or scheduled during the first three business days of any month due to the high volume of prescriptions filled during such time unless otherwise consented to by the pharmacy;

(10) The preliminary audit report shall be delivered to the pharmacy within one hundred twenty days after conclusion of the audit, with reasonable extensions permitted. A final audit report shall be delivered to the pharmacy within six months of receipt by the pharmacy of the preliminary audit report or final appeal, as provided for in subsection 3 of this section, whichever is later;

(11) Notwithstanding any other provision in this subsection, the entity conducting the audit shall not use the accounting practice of extrapolation in calculating recoupments or penalties for audits, except as otherwise authorized under subdivision (5) of this subsection.

2. Recoupments of any disputed moneys shall only occur after final internal disposition of the audit, including the appeals process set forth in subsection 3 of this section. Should the identified discrepancy for an individual audit exceed twenty-five thousand dollars, future payments to the pharmacy in excess of twenty-five thousand dollars may be withheld pending finalization of the audit.

3. Each entity conducting an audit shall establish an appeals process, lasting no longer than six months, under which a licensed pharmacy may appeal an unfavorable preliminary audit report to the entity. If, following such appeal, the entity finds that an unfavorable audit report or any portion thereof is unsubstantiated, the entity shall dismiss the audit report or such portion without the necessity of any further proceedings.

4. Each entity conducting an audit shall provide a copy of the final audit report, after completion of any appeal process, to the plan sponsor.

5. This section shall not apply to any investigative audit that involves probable fraud, willful misrepresentation, or abuse.

6. This section shall not apply to any audit conducted as part of any inspection or investigation conducted by any governmental entity or law enforcement agency.

(L. 2008 S.B. 1068)

Fund established, use of moneys.

338.650. There is hereby established in the state treasury the "Pharmacy Rebates Fund". Any revenues received by the state, either directly or indirectly, from pharmaceutical manufacturer rebates as required by federal law, except where federal law requires rebates to be accounted for otherwise, or state supplemental rebates as defined in state plan amendments shall be deposited into the pharmacy rebates fund and shall be used only in the MO HealthNet pharmacy program or its successor programs authorized under Title XIX, Public Law 89-97, 1965 amendments to the federal Social Security Act, 42 U.S.C. Section 301, et seq.

(L. 2008 S.B. 1068)


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