Bill Summary – FastDemocracy

This bill makes various changes to the board of pharmacy ("board"), as described below.
APPOINTMENT OF BOARD MEMBERS / BOARD COMPOSITION
     This bill vacates the board as comprised on June 30, 2023, and appoints new members.  Present law provides that the board consists of seven members, one of whom is a consumer.  This bill changes the composition of the board from seven members to nine members, such that there are seven licensed practicing pharmacist members, one qualified practicing pharmacy technician member, and one consumer member.  This bill further provides the following concerning the seven pharmacist members:
     (1)  Three must be independent pharmacists;
     (2)  One must be a hospital pharmacist; and
     (3)  One must have sterile compounding training and be either an independent pharmacist or a hospital pharmacist.
MEMBER ELIGIBILITY
     Under present law, for the consumer member, the person must have been a resident of this state for at least five years, currently reside in this state, and be a nonhealthcare professional by education.  The consumer member must also not own or have any financial interest in any healthcare facility or business.  This bill removes this requirement.
     This bill requires the new pharmacy technician member appointed pursuant to this bill to be a practicing pharmacy technician qualified under rules promulgated by the board.
TERMS
     Present law sets terms of appointment for six years, or until the members' successors have qualified.  This bill staggers the initial terms, which range from two-year terms to six-year terms.  Following the expiration of a member's initial term, each member serves a term of six years.
REMOVAL
     Present law authorizes the governor, upon the recommendation of the remaining members, to remove members that are guilty of misconduct.  This bill widens the scope of the governor's authority to remove members by allowing the governor to remove a member with or without cause.  This bill requires a vacancy created by such removal to be filled by the governor in the same manner as the original appointment.
EXECUTIVE DIRECTOR
     Present law requires the board to consult with the division of health-related boards in appointing a person to serve as executive director of the board.  However, the board is not bound by a recommendation of the division.  The executive director must have been licensed as a pharmacist in this state for at least five consecutive years immediately preceding such appointment.  This bill removes the requirement that the board must consult with the division when appointing an executive director.
     This bill also clarifies that the executive director has the authority to issue subpoenas for witnesses and records and to administer oaths to witnesses, pursuant to the board's power to enforce pharmaceutical laws.
GENERAL COUNSEL
     This bill authorizes the board to employ or retain general counsel to advise the board in matters relating specifically to the board's authority, duties, and function.  The general counsel must be a graduate of an accredited law school and admitted to practice law in this state.  This bill also authorizes the board to hear and make determinations on cases that come before the board.
     ON APRIL 5, 2023, THE SENATE ADOPTED AMENDMENT #4 AND PASSED SENATE BILL 753, AS AMENDED.
     AMENDMENT #4 rewrites this bill to make various changes to the board of pharmacy (“board”), as described below.
APPOINTMENT AND MEMBERSHIP
     This amendment changes the composition of the board from seven members to nine members, which will consist of nine members appointed by the governor that include one consumer member, one registered pharmacy technician, and seven pharmacists who possess the state mandated qualifications. In addition, this amendment clarifies that the six pharmacist members serving on the board on June 30, 2023, must serve as members on July 1, 2023, through the end of the members’ existing six-year terms so long as the members are qualified to serve under state law if reappointed to the board after July 1, 2023.
     This amendment also permits interested pharmacist groups, including, but not limited to, the Tennessee Pharmacists Association, to annually recommend five duly qualified persons for each vacancy from whom the governor may be requested to make appointments.  The governor is required, under this amendment, to consult with such groups to determine qualified persons to fill the positions; however, these provisions do not apply to appointment of the consumer member. 
     A member appointed to the board is required to take oath or affirmation that the member will faithfully and impartially perform their duties within 10 days after the member's appointment to the board.  A member's oath or affirmation taken must be filed with the secretary of state.  In making appointments to the board, the governor must strive to ensure that at least one person serving on the board is 60 or older, one person serving on the board is a member of a racial minority, and the members on the board are representative of a variety of practice settings.
QUALIFICATIONS
     This amendment specifies that each pharmacist member of the board appointed on or after July 1, 2023, must, at the time of their appointment: have been a resident of this state for no less than five years; must be a graduate of a recognized school or college of pharmacy; be licensed and in good standing to engage in the practice of pharmacy in this state; be actively engaged in the practice of pharmacy, as defined in present law, in this state; and have at least five consecutive years of experience in the practice of pharmacy providing patient care services after licensure.
     In addition, this amendment requires that each registered pharmacy technician member of the board must, at the time of their appointment, have been a resident of this state for no less than five years; be currently licensed and in good standing as a glistered pharmacy technician in this state; be actively practicing as a registered pharmacy technician in this state; be certified pharmacy technician as defined by board rules; and have at least five consecutive years of experience as a pharmacy technician after registration.  
     Furthermore, this amendment adds that a consumer member of the board must at the time of their appointment, be a current resident of Tennessee for at least five years and not be a licensed healthcare professional nor should the consumer member have or own a financial interest in any healthcare facility or healthcare business during the consumer’s term on the board.  
     This amendment also permits board members to join professional organizations and associations organized to promote the improvement of the standards of the practice of pharmacy for the protection of the health and welfare of the public.
TERMS OF OFFICE AND REMOVAL
     This amendment alters the board members’ terms to last seven years or until their successors have been qualified. This amendment clarifies that a member of the board is not eligible for reappointment.  However, a member may be reappointed for one full term if the member is appointed to fill a vacancy which occurred prior to the expiration of a former member's term.  The terms of the members of the board are staggered so that the terms of no more than three members expire in one year.
     This amendment also provides that a member of the board who is found to have committed misconduct may be removed by the governor upon the recommendation of the remaining members.  This amendment defines misconduct to mean the refusal or inability of a board member to perform their duties as a member of the board due to inefficiency, irresponsibility, and unprofessional manner; the misuse of office by a member of the board to obtain personal, pecuniary, or material gain or advantage for their self or another through the office; or the violation of a law pertaining to the practice of pharmacy or the distribution of drugs and devices.
ORGANIZATION
     This amendment makes the following revisions regarding the board's organization:
     (1)  The pharmacist members of the board must annually appoint a president and a vice president;
     (2)  The president of the board, and the vice president in the president's absence, must preside at all meetings of the board and is responsible for the performance of all duties and functions of the board;
     (3)  The board president may, if deemed necessary, split the board into panels of three or more to conduct contested case hearings regarding disciplinary matters.  A quorum of at least three panel members is required at such hearings;
     (4)  The board must meet at least annually and at such other times as it deems necessary to perform its duties under this chapter.  A majority of the members of the board constitutes a quorum for the conduct of board meetings and, except where a different number is required by this part or by any board rule, all actions of the board must be by a majority of a quorum; 
     (5)  The members of the board receive a per diem of $100 for each day the member is engaged in performance of the official duties of the board, and must be reimbursed for all reasonable and necessary expenses incurred in connection with the discharge of such official duties.  All reimbursement for travel expenses are in accordance with the comprehensive travel regulations as promulgated by the department of finance and administration and approved by the attorney general and reporter; and 
     (6)  In conjunction, the division of health related boards must employ the necessary administrative and clerical staff and investigators who are pharmacists to carry out the board's duty to enforce pharmaceutical laws. The pharmacist investigators may conduct inspections of pharmacies and other sites where drugs, medicines, chemicals, pharmaceuticals, or poisons are manufactured, stored, sold, dispensed, distributed, or administered and must conduct investigations of a board licensee.  The pharmacist investigators may also assist in inspections and investigations undertaken by other health related boards attached to the division, and investigators assigned to these other health related boards may assist pharmacist investigators as appropriate.
EXECUTIVE DIRECTOR
     This amendment expands the executive director's duties and the administrative functions of the board to include recording and compiling the minutes of the board; supervising employees assigned by the division of health related boards to support the board; performing studies and research as the board or division directs; representing the board at functions as authorized by the board and the division; and serving as a consultant to the division in its enforcement duties on behalf of the board.
     The executive director is also permitted by this amendment to issue subpoenas for witnesses and records and to administer oaths to witnesses. This amendment also adds that the board may dismiss the executive director without consulting with the division.  
PROMULGATION OF RULES AND OTHER RESPONSIBILITES
     This amendment requires the board to promulgate rules:
     (1)  To establish minimum standards and conditions for the operation of a pharmacy;
     (2)  Regarding the practice of pharmacy in this state to protect the health and welfare of the citizens of this state;
     (3)  Regarding professional conduct appropriate to the establishment and maintenance of a high standard of integrity and dignity in the profession of pharmacy;
     (4)  To set minimum standards and conditions for receiving, preparing, maintaining, transferring, and dispensing of prescription orders; 
     (5)  To ensure that persons who are blind, visually impaired, or otherwise print disabled have appropriate access to prescription labels, bag tags, and medical guides; and 
     (6)  Regarding the board’s oversight of facilities that manufacture, warehouse, and distribute medical devices, including the formation of an advisory committee composed of medical device industry representatives and a representative of the department of economic and community development. The rules promulgated pursuant to this (6) must be reviewed by the advisory committee every three years to review the advancement of new medical device technologies.  
     The board is also required, under this amendment, to enforce laws in this state relating to the practice of pharmacy; the manufacture, distribution, and sale of drugs; the medication use process; patient administration; and the education and monitoring of drugs, devices, chemicals, and poisons. 
     This amendment also requires that the board regularly notify licensed pharmacists of changes that are implemented or enforced by the board that affect the licensees resulting from newly promulgated rules, amended statutes, and adopted policies and guidelines; establish and publish on its website the statutes, rules, policies, and guidelines that are implemented or enforced by the board and that affect licensees; and require licensees to maintain a copy of the board of pharmacy statutes, rules, policies, and guidelines at the location in which they practice pharmacy.
     In addition, the board is also tasked with keeping a record of the board’s meetings and other proceedings; issuing and maintaining a register of all persons who have been issued licenses and who have had their licenses renewed; and maintaining a register of pharmacists who have been designated as a pharmacist-in-charge.  In addition, the board may maintain a register of pharmacy technicians as necessary to maintain public welfare.  
     The board may also authorize, subject to the approval of the commissioner, administrative and investigative personnel and board members to attend local, state, regional, and national meetings.  All reimbursement for travel expenses directly incurred as a result of attending such meetings must be in accordance with the comprehensive travel regulations as promulgated by the department of finance and administration and approved by the attorney general. 
     The board is permitted to issue advisory private letter rulings to any affected licensee making a request for a ruling regarding matters within the board's jurisdiction. The private letter ruling affects only the licensee making the inquiry and has no precedential value for any other inquiry or future contested case to come before the board. The board may resolve a dispute regarding a private letter ruling pursuant to declaratory orders. 
POWER TO SUSPEND, REVOKE, OR REFUSE TO ISSUE LICENSES
     This amendment also authorizes the board to deny, restrict, or condition any application for licensure; revoke or suspend any license or certification previously issued; or discipline and assess civil penalties against an applicant, licensee, or holder of a certificate upon a finding that the applicant, licensee, or holder of a certificate has:
     (1)  Been convicted of a criminal offense, including, but not limited to, violating a law of this state or of the United States relating to drugs or to the practice of pharmacy;
     (2)  Been addicted to the use of alcohol, narcotics, or other drugs;
     (3)  Engaged in conduct that is prohibited or unlawful state or federal law relating to drugs or to the practice of pharmacy;
     (4)  Exhibited an incapacity of a nature that prevents a pharmacist from engaging in the practice of pharmacy with reasonable skill, confidence, and safety to the public; 
     (5)  Been guilty of dishonorable, immoral, unethical, or unprofessional conduct;
     (6)  Had the license to practice pharmacy suspended or revoked by another state for disciplinary reasons; or
     (7)  Failed to comply with a lawful order or duly promulgated rule of the board.
LICENSE REQUIREMENTS
     This amendment provides that the board may establish the experience and educational qualifications necessary for admission to the board's licensure or certification examinations.  In addition, the board may use any national certification, licensure examination, or contract with a qualified examination agency to prepare and administer its licensure examination.  The board is required to promulgate rules to establish the minimum score necessary to pass a licensure or certification examination required by the board.  The board is also permitted to promulgate rules regarding the procedures of renewal, administrative fees, and other related issues enumerated in the bill. 
     To apply for a pharmacist license, a person must be at least 21; be a graduate of a school or college of pharmacy recognized by the board; and apply for licensure on forms approved by the board in writing or by online application and pursuant to rules promulgated by the board.  
     The board is permitted to license and register pharmacists, pharmacies, wholesalers, distributors, pharmacy technicians, pharmacy interns, manufacturers, third party logistics providers, and other persons as may be required under federal or state law. In addition, the board may also grant licenses to reciprocal applicants from other states upon deciding that the qualifications of pharmacists licensed in other states are equivalent to or greater than requirements for licensure in this state.  The board may refuse to issue licenses to reciprocal applicants from other states on grounds as determined by the board's rule.  These provisions do not include manufacturers' representatives unless otherwise required by federal or state law. 
INSPECTION OF SITES
     The board or its designated agents are also authorized to regulate the practice of pharmacy and to inspect any site or professional pharmacy practice, other than storage sites utilized by manufacturer's representatives, where drugs, medicines, chemicals, pharmaceuticals, or poisons are manufactured, stored, sold, dispensed, distributed, or administered. This amendment also specifies that the authority over drug dispensing in the office of a physician licensed to practice is vested in the board of medical examiners.
TERMINATION
     This amendment sets the board to terminate in June 30, 2025, pursuant to the Tennessee Governmental Entity Review Law.
Statutes affected: 
Introduced: 63-10-301(a), 63-10-301, 63-10-302, 63-10-303(a), 63-10-303, 63-10-303(c), 63-10-304(f)(3), 63-10-304