3.1 Tennessee Board of Pharmacy Structure, Membership & Powers

3.1 Tennessee Board of Pharmacy Structure, Membership & Powers

Quick Answer: The Tennessee Board of Pharmacy is an administrative regulatory agency within the Division of Health Related Boards of the Tennessee Department of Health. It is comprised of 9 members appointed by the Governor (7 licensed pharmacists, 1 registered pharmacy technician, and 1 consumer member) under T.C.A. § 63-10-302, who each serve a seven-year term under T.C.A. § 63-10-305 with no reappointment except for one full term after filling a vacancy, and whose terms are staggered so that no more than three expire in any one year. The Board exercises comprehensive regulatory authority over personnel and practice sites under T.C.A. Title 63, Chapter 10, including warrantless inspections during normal business hours, emergency summary suspensions under the Uniform Administrative Procedures Act (UAPA), and civil penalties up to $1,000 per violation day under Rule 1140-08.

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1. Statutory Composition and Legislative Modernization

The Tennessee Board of Pharmacy is established under the Tennessee Pharmacy Practice Act of 1996 (codified at Tennessee Code Annotated [T.C.A.] § 63-10-301 et seq.). The Board exists to enforce laws and promulgate rules that safeguard the health, safety, and welfare of the citizens of Tennessee from improper, illegal, or substandard pharmacy practice.

Legislative Evolution: The 2023 Rewrite

Historically, the Board operated with six pharmacist members serving six-year terms. Tennessee Public Chapter 457 (Senate Bill 753), effective July 1, 2023, deleted Title 63, Chapter 10, Part 3 in its entirety and substituted a new Part 3 — which is why so many older MPJE study aids cite the wrong section numbers. Under the rewrite:

1. Expanded Total Membership: Expanded the Board from 7 to 9 members.
2. Dedicated Technician Seat: Statutorily established a voting seat specifically for a registered pharmacy technician.
3. Extended Term Length: Increased board member terms from 6 years to 7 years.
4. Sterile Compounding Expertise Mandate: Codified an explicit requirement that at least one pharmacist member must possess demonstrated expertise in sterile compounding.

Composition Goals — Aspiration, Not Quota

A persistent myth holds that Tennessee reserves a fixed number of pharmacist seats for particular practice settings. It does not. T.C.A. § 63-10-304(c) instead directs that, in making appointments, the governor shall strive to ensure that at least one person serving on the board is sixty (60) years of age or older, at least one is a member of a racial minority, and that the members are representative of a variety of practice settings. This is a directory goal addressed to the appointing authority, not a qualification a candidate must meet, and there is no statutory floor for independent community practice or in sterile compounding (USP <797> standards).

• Hospital / Institutional & Chain Practice: The remaining pharmacist seats represent hospital/health-system practice sites and community chain retail pharmacies.
• Grand Division Representation: Appointments must reflect proportional geographic distribution across Tennessee's three Grand Divisions: East Tennessee, Middle Tennessee, and West Tennessee.

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2. Appointment Process, Terms of Office & Officers

Gubernatorial Appointments and Nominations

All 9 members are appointed directly by the Governor of Tennessee. In making appointments for pharmacist seats, the Governor may receive advisory recommendations submitted by the Tennessee Pharmacists Association (TPA). While TPA recommendations are traditionally submitted after member polling, the Governor retains plenary appointment discretion under the state constitution and statutes.

Term Length and Reappointment Prohibition

• Term Duration: Members serve a term of seven (7) years.
• Term Expiration: Terms are staggered so that seats expire on a predictable annual rotation.
• Reappointment Restriction: A member who has served one full 7-year term is statutorily ineligible for reappointment to a successive full term. A member cannot serve consecutive full terms.
• Vacancy Appointments: If a vacancy occurs before a term naturally expires (due to death, resignation, or removal), the Governor appoints a successor to serve the remainder of the unexpired term only.

Board Officers and Administration

• Officers: The Board annually elects from among its pharmacist members a President and a Vice President.
• Executive Director: Under T.C.A. § 63-10-307, the Board consults with the division of health related boards in appointing an Executive Director but is not bound by the division's recommendation, and the Board may dismiss the executive director without consulting the division. The Executive Director must be a pharmacist licensed in Tennessee. Key functions include:
  • Directing day-to-day administrative operations of the Board.
  • Coordinating with the Division of Health Related Boards within the Tennessee Department of Health.
  • Managing Board staff, licensing analysts, and investigators.
  • Executing administrative documents, subpoenas, and official board notices.
  • Note for the Exam: The Executive Director is an employed executive official, not a voting member of the 9-member Board.

Meetings and Quorum Rules

• Meeting Frequency: The Board must meet at least annually, but routinely convenes bimonthly (six regular meetings per calendar year) for public business meetings and contested case adjudications.
• Quorum Standard: A simple majority of appointed members (e.g., 5 members when all 9 seats are filled) constitutes a quorum authorized to conduct official administrative and disciplinary business.

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3. Scope of Regulatory Authority & Jurisdiction

Under T.C.A. § 63-10-308, the Tennessee Board of Pharmacy possesses comprehensive administrative, supervisory, investigative, and rulemaking powers. (Appointment procedure now sits at § 63-10-304; do not cite § 63-10-304 for the Board's enforcement powers.)

Entities Subject to Board Licensure and Regulation

The Board licenses, registers, and regulates:

1. Individuals: Pharmacists, pharmacy interns, and pharmacy technicians.
2. In-State Practice Sites: Retail community pharmacies, hospital/institutional pharmacies, ambulatory clinics, long-term care pharmacies, home infusion pharmacies, and compounding pharmacies.
3. Out-of-State Facilities: Non-resident pharmacies that ship, mail, or deliver prescription drugs or medical devices into Tennessee.
4. Supply Chain Entities: Prescription drug manufacturers, wholesale distributors, third-party logistics providers (3PLs), and 503B outsourcing facilities.

Rulemaking Power

The Board is empowered to promulgate administrative rules codified in the Rules of the Tennessee Board of Pharmacy, Tenn. Comp. R. & Regs. Chapter 1140. These regulations govern minimum facility physical specifications, sterile and non-sterile compounding standards, automated dispensing systems, telepharmacy, continuous quality improvement (CQI) programs, and collaborative practice frameworks.

Statutory Inspection Authority

Under T.C.A. § 63-10-308(b) and § 63-10-311(a), the division employs investigators who are pharmacists, and those investigators:

• Have the right to enter and inspect any licensed pharmacy practice site, manufacturer, or wholesale distributor during normal business hours.
• May inspect physical facilities, sanitary conditions, security measures, drug inventory, order records, and dispensing logs.
• Do NOT require a criminal search warrant or administrative warrant to conduct routine or for-cause compliance inspections during business hours.
• Possess statutory authority to embargo, quarantine, or seize adulterated, misbranded, expired, or counterfeit drugs or devices that pose a danger to public safety.

[!IMPORTANT] Refusal by a pharmacist, Pharmacist-in-Charge (PIC), or pharmacy owner to permit a Board investigator to conduct a lawful inspection during regular operating hours is an independent ground for disciplinary action and civil penalty assessment under T.C.A. § 63-10-309(7) (failure to comply with a lawful order or duly promulgated rule of the board).

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4. Disciplinary Proceedings, Summary Suspensions & Civil Penalties

Grounds for Disciplinary Action (T.C.A. § 63-10-309)

The Board may initiate disciplinary proceedings against any licensee or registrant on established statutory grounds, including:

• Fraud, misrepresentation, or deceit in procuring a license or registration.
• Conviction of a felony or any violation of federal or state drug or pharmacy laws.
• Dishonorable, unethical, or unprofessional conduct likely to deceive, defraud, or harm the public.
• Dispensing medications without a valid, legally executed prescription.
• Severe substance use disorder or chemical dependency impairing professional competence.
• Aiding or abetting unlicensed persons in the unlawful practice of pharmacy.
• Violating lawful Board rules, formal orders, or consent decrees.

Emergency Summary Suspension (UAPA T.C.A. § 4-5-320(c))

Standard disciplinary action requires advance notice and an opportunity for a formal hearing. However, under the Tennessee Uniform Administrative Procedures Act (UAPA, T.C.A. § 4-5-320(c)) and Board rules:

• If the Board determines that public health, safety, or welfare imperatively requires emergency action, it may execute an emergency summary suspension of a license or permit prior to conducting a full evidentiary hearing.
• Classic triggers: Gross controlled substance diversion, severe compounding contamination posing lethal risk (e.g., fungal contamination in sterile injectables), or a pharmacist practicing while acutely intoxicated or chemically impaired.
• Due Process Requirement: The Board must immediately initiate formal disciplinary proceedings and provide the respondent with an expedited post-suspension contested case hearing.

Contested Case Hearings

Contested cases are governed strictly by the UAPA (T.C.A. Title 4, Chapter 5):

• Proceedings are presided over by an Administrative Law Judge (ALJ) from the Secretary of State's Administrative Procedures Division sitting alongside the Board of Pharmacy.
• The Board functions as the jury and final decision-maker regarding factual guilt and sanction determination, while the ALJ rules on legal motions, objections, and admissibility of evidence.
• Licensees have the right to counsel, cross-examination of state witnesses, subpoena witnesses, and judicial review in the Chancery Court of Davidson County.

Spectrum of Board Sanctions

Upon finding a violation, the Board may impose:

1. Refusal to issue, renew, or reinstate a license or registration.
2. Public Reprimand / Censure: Formal public reprimand on the licensee's permanent record.
3. Probation: Placing a license on probation for a specified duration, subject to conditions (e.g., direct supervision, practice restrictions, periodic auditing, mandatory addiction monitoring via the Tennessee Pharmacy Recovery Network [TPRN]).
4. Suspension: Temporary removal of license authority for a definite term or indefinitely pending satisfaction of rehabilitation requirements.
5. Revocation: Total cancellation of license authority.

Civil Penalties under Tenn. Comp. R. & Regs. 1140-08

In addition to (or in lieu of) professional sanctions, the Board has express statutory authority to assess monetary civil penalties:

$\text{Maximum Statutory Assessment} = \$1,000 \text{ per violation day}$

• Under Rule Chapter 1140-08, the Board may assess civil penalties up to $1,000 per day for each day a violation continues.
• Each calendar day that an unlawful condition or violation persists constitutes a separate and distinct violation.
• Factors considered by the Board when assessing civil penalties:
  • The severity and economic harm of the violation.
  • The risk of physical injury or harm to patients.
  • Whether the violation was willful, intentional, or repeated.
  • The licensee's prior disciplinary history and demonstrated cooperative remedial action.

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5. Practical Exam Scenarios

Scenario 1: Reappointment Eligibility

Case: Dr. Harrison has completed a full 7-year term as an independent pharmacist member on the Tennessee Board of Pharmacy. He has been nominated again by colleagues who petition the Governor to reappoint him to a consecutive 7-year term. Legal Analysis: Under T.C.A. § 63-10-305(a), a member of the board "is not eligible for reappointment" — the single exception is that a member may be reappointed for one full term if the member was appointed to fill a vacancy that occurred before the expiration of a former member's term. Dr. Harrison served a full seven-year term, so no exception applies and the Governor must appoint another qualified pharmacist.

Scenario 2: Warrantless Routine Inspection

Case: A Board investigator arrives at an independent community pharmacy at 2:00 PM on a Tuesday. The PIC refuses entry, stating that the owner is on vacation and that the investigator must return with a search warrant signed by a criminal court judge. Legal Analysis: Under T.C.A. §§ 63-10-308(b) and 63-10-311(a), Board investigators — who must be pharmacists — have statutory authority to inspect any licensed pharmacy practice site and any other site where drugs are manufactured, stored, sold, dispensed, distributed, or administered, without a search warrant. The PIC's refusal constitutes an immediate statutory violation of Tennessee pharmacy law and warrants formal disciplinary charges and civil penalties against both the PIC and the pharmacy permit.