MISSOURI BOARD OF PHARMACY RIGHT STATUTES & RULES (January 2010) Issued By: Missouri Board of Pharmacy 3605 Missouri Boulevard P.O. Box 625 Jefferson City, Missouri 65109 (573) 751-0091 Fax: (573) 526-3464 http://pr.mo.gov/pharmacists.asp BOP STATUTES CHAPTER 338 RIGHT PHARMACISTS & PHARMACIES CHAPTER 338 PHARMACISTS AND PHARMACIES 338.010. Practice of pharmacy defined--auxiliary personnel--written protocol required, when--nonprescription drugs--rulemaking authority--therapeutic plan requirements. Pg. 1-2 338.013. Pharmacy technician to register with board of pharmacy, fees, application, renewal--refusal to issue, when--employee disqualification list maintained, use. Pg. 2-3 338.015. Patient's freedom of choice to obtain prescription services, waiver--consultation and advice. Pg. 3 338.020. Application for license--requirements--examination--oath--penalty. Pg. 3 338.030. Applicant--requirements for qualification. Pg. 3-4 338.035. Application, contents--intern pharmacist--board shall promulgate rules, procedure. Pg. 4 338.040. License issued without examination, when--reciprocity--equivalency examination--fees. Pg. 4 338.043. Temporary license--eligibility--renewal. Pg. 4-5 338.050. Pharmacist license, issued when, period covered. Pg. 5 338.055. Denial, revocation or suspension of license, grounds for--expedited procedure--additional discipline authorized, when. Pg. 5-6 338.056. Generic substitutions may be made, when, form required for prescription blanks, exception--penalty. Pg. 7 338.057. (Repealed L. 2009 S.B. 296 § A) 338.059. Prescriptions, how labeled. Pg. 7-9 338.060. Renewal of license or permit--late renewal or failure to renew, effect--continuing education require- ments--inactive license issued when--changed to active, procedure. Pg. 8 338.065. Disciplinary hearings--grounds for discipline. Pg. 8-9 338.067. Revocation and restoration of license--conditions. Pg. 9 338.070. Fees, amount, how set, collection, disposition--fund, created, use, funds transferred to general revenue, when. Pg. 10 338.080. Display of license or renewal required. Pg. 9 338.090. Sale of poisons--regulations. Pg. 9-10 338.095. Prescription, drug order, defined--telephone prescription, defined--prescription and medical information may be provided, when. Pg. 10 338.100. Records required to be kept--requirements. Pg. 10-11 338.110. Board of pharmacy, members, qualifications, terms. Pg. 11 338.120. Board of pharmacy--organization. Pg. 11 338.130. Compensation of board members, personnel. Pg. 11-12 338.132. Board of pharmacy, salary schedule for employees to be established. Pg. 12 338.140. Board of pharmacy, powers, duties--advisory committee, appointment, duties--letters of reprimand, censure or warning. Pg. 12 338.145. Board president may administer oaths and issue subpoenas--enforcement of subpoenas. Pg. 12-13 338.150. Inspections by authorized representatives of board, where. Pg. 13 338.155. Immunity from civil liability, when. Pg. 13 338.170. Title of pharmacist--used by whom. Pg. 13 338.180. Prosecution of offenders. Pg. 13 338.185. Board has access to certain court records. Pg. 13 338.190. Violation of law by licensee--penalty. Pg. 13-14 338.195. Violation of law by person not licensed--penalty. Pg. 14 338.196. Prescription by practitioner licensed in another state, may be filled, requirement. Pg. 14 338.198. Pharmacist may fill prescription forwarded by authorized agent. Pg. 14 338.210. Pharmacy defined--practice of pharmacy to be conducted at pharmacy location--rulemaking authority. Pg. 14-15 338.220. Operation of pharmacy without permit or license unlawful--application for permit, classifications, fee-- duration of permit. Pg. 15 338.230. Disposition of fees. Pg. 16 338.240. Evidence required for issuance of permit. Pg. 16 338.250. Equipment required--manner of operation of pharmacy--compliance with state and federal laws re- quired. Pg. 16 338.260. Business name not to include certain words unless supervised by pharmacist--historical names permit- ted--board of pharmacy may enforce. Pg. 16-17 338.270. Renewal applications to be made, when. Pg. 17 338.280. Board of pharmacy, rules and regulations. Pg. 17 338.285. Board may file complaint, when, where filed. Pg. 17 338.290. Appeals from decision of board, notice of right. Pg. 17 338.300. Permit to be posted--not transferable. Pg. 17 338.310. Violation, a misdemeanor. Pg. 17 338.314. Inspection of pharmacy within certain facilities authorized--applicability of law. Pg. 17 338.315. Receipt of drugs from unlicensed distributor or pharmacy, unlawful--penalty. Pg. 17 338.330. Definitions. Pg. 18 338.333. License required, temporary licenses may be granted--out-of-state distributors, reciprocity allowed, when. Pg. 18 338.335. Separate licenses required, when. Pg. 18 338.337. Out-of-state distributors, licenses required, exception. Pg. 18-19 338.340. Sale of drugs, out-of-state distributor, license required. Pg. 19 338.343. Records to be maintained and be available for board inspection. Pg. 19 338.347. Renewal of license, application. Pg. 19 338.350. Board of pharmacy to promulgate rules and regulations--procedure. Pg. 19 338.353. Discipline of licensee, grounds--procedure--administrative hearing commission to conduct hearing. Pg. 19-20 338.357. Sanction imposed by board, when. Pg. 20 338.360. Inspection of premises allowed, when. Pg. 20 338.365. Injunction may be issued, when, procedure. Pg. 20 338.370. Penalties. Pg. 21 338.380. Refusal to issue a certificate, when--impaired license committee authorized, duties, procedures. Pg. 21-22 338.500. Gross retail prescriptions, tax imposed, definitions. Pg. 22 338.501. (Repealed L. 2003 H.B. 286 § A merged with H.B. 600 § A) 338.505. Formula for tax liability, rulemaking authority, appeals procedure. Pg. 22-23 338.510. Records to be maintained, form--report of gross receipts, information--confidentiality of information. Pg. 23 338.515. Effective date of tax. Pg. 23 338.520. Calculation of tax liability--notification to pharmacies--quarterly adjustment authorized. Pg. 23 338.525. (Repealed L. 2003 H.B. 286 § A) 338.530. Offset against Medicaid payments due by pharmacy permitted, when. Pg. 23-24 338.535. Remittance to department--pharmacy reimbursement allowance fund created. Pg. 24 338.540. Notice requirements--unpaid or delinquent taxes, procedure for collection--failure to pay taxes, effect of. Pg. 24 338.545. (Repealed L. 2003 H.B. 286 § A merged with H.B. 600 § A) 338.550. Expiration date of tax, when. Pg. 24-25 338.600. Criteria for audit--appeals process to be established--report to be provided--applicability exceptions. Pg. 25-26 338.650. Fund established, use of moneys. Pg. 26 338.010. Practice of pharmacy defined--auxiliary personnel--written protocol required, when--nonprescrip- tion drugs--rulemaking authority--therapeutic plan requirements. 1. The "practice of pharmacy" means the interpretation, implementation, and evaluation of medical prescription orders, including 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, dis- pensing, labeling, and administration of drugs and devices pursuant to medical prescription orders and administra- tion of viral influenza, pneumonia, shingles 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, 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 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 duties. This assistance in no way is intended to relieve the pharmacist from his responsibilities for compliance with this chapter and he will be responsible for the actions of the auxiliary personnel acting in his assistance. This chapter shall also not be construed to prohibit or interfere with any legally registered practitioner of medicine, dentistry, podiatry, or veterinary medicine, or the practice of optometry in accordance with and as provided in sections 195.070 and 336.220, RSMo, in the compounding or dispensing of his 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 en- gaged in a collaborative practice arrangement under section 334.104, RSMo, or from a physician assistant engaged in a supervision agreement under section 334.735, RSMo. 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, RSMo, 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 pharmaceuti- cals. 7. The state board of registration for the healing arts, under section 334.125, RSMo, and the state board of phar- macy, 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 regulat- ing 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, RSMo, 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 provi- sions of chapter 536, RSMo, and, if applicable, section 536.028, RSMo. This section and chapter 536, RSMo, are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536, RSMo, 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 phar- macist who submits proof of successful completion of a board-approved course of academic clinical study beyond a 1 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 design- ing, 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 pharma- ceutical prescribed by a physician unless authorized by the written protocol or the physician's prescription order. (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) Prior revisions: 1929 § 13140; 1919 § 4712; 1909 § 5764 (2006) Definition of "practice of pharmacy" does not include retail sale of veterinary prescription drugs used for treating animals. United Pharmacal Co. v. Missouri Board of Pharmacy, 208 S.W.3d 907 (Mo.banc). 338.013. Pharmacy technician to register with board of pharmacy, fees, application, renewal--refusal to is- sue, when--employee disqualification list maintained, use. 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 reg- istration 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, RSMo. 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 ap- plicant, 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 busi- ness 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 employ- ment 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. 2 8. After an investigation and a determination has been made to place a person's name on the employment disquali- fication 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, RSMo. 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 hos- pital 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) 338.015. Patient's freedom of choice to obtain prescription services, waiver--consultation and advice. 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 thera- peutic 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) (1992) The use of the word "may" in statute permits pharmacist to provide consultation and advice to customers but does not impose duty on pharmacists to monitor customer's use of prescription drugs. Kampe v. Howard Stark Professional Pharmacy Inc., 841 S.W.2d 223 (Mo.App.W.D.). 338.020. Application for license--requirements--examination--oath--penalty. 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 sci- ence 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 state- ment 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. (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) Prior revisions: 1929 § 13141; 1919 § 4713; 1909 § 5765 338.030. Applicant--requirements for qualification. 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 phar- macist within a licensed pharmacy, or other location approved by the board, and shall be a graduate of a school or 3 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 338.035. Application, contents--intern pharmacist--board shall promulgate rules, procedure. 1. Every person who desires to be licensed as an intern pharmacist shall file with the board of pharmacy an applica- tion, 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, RSMo. (L. 1990 H.B. 1287, A.L. 1993 S.B. 52, A.L. 1995 S.B. 3, A.L. 2007 S.B. 272) 338.040. License issued without examination, when--reciprocity--equivalency examination--fees. 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 (1974) Held that standards to be met by applicant for a reciprocal license are the standards that were in effect in this state at the time he was admitted in the state from which he is applying. Missouri State Board of Pharmacy v. Kennedy (A.), 511 S.W.2d 913. 338.043. Temporary license--eligibility--renewal. 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. 4 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) 338.050. Pharmacist license, issued when, period covered. 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 338.055. Denial, revocation or suspension of license, grounds for--expedited procedure--additional disci- pline authorized, when. 1. The board may refuse to issue any certificate of registration or authority, permit or license required pursuant to this chapter for one or any combination of causes stated in subsection 2 of this section. The board shall notify the applicant in writing of the reasons for the refusal and shall advise the applicant of his or her right to file a complaint with the administrative hearing commission as provided by chapter 621, RSMo. 2. The board may cause a complaint to be filed with the administrative hearing commission as provided by chapter 621, RSMo, against any holder of any certificate of registration or authority, permit or license required by this chap- ter or any person who has failed to renew or has surrendered his or her certificate of registration or authority, permit or license for any one or any combination of the following causes: (1) Use of any controlled substance, as defined in chapter 195, RSMo, or alcoholic beverage to an extent that such use impairs a person's ability to perform the work of any profession licensed or regulated by this chapter; RIGHT (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, per- mit 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 misrep- resentation; (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 coun- try 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 5