4.2 Pharmacist-in-Charge (PIC) Responsibilities & Operational Governance

4.2 Pharmacist-in-Charge (PIC) Responsibilities & Operational Governance

Quick Answer: Under Tenn. Comp. R. & Regs. 1140-03-.14, every licensed pharmacy practice site must designate a Pharmacist-in-Charge (PIC) who exercises complete operational and legal management of the pharmacy. The PIC must be on duty a minimum of 50% of the hours the pharmacy is open, but is not required to work more than an average of 40 hours per week. A pharmacist may serve as PIC at only one (1) practice site simultaneously, unless granted an express written waiver by the Board. Whenever a change of PIC occurs, a mandatory joint physical inventory of all controlled substances (Schedules II–V) must be executed by outgoing and incoming PICs, signed, dated, maintained for 2 years, and a copy mailed to the Board within 30 days. When permanently closing a practice site, the PIC and permit holder must immediately notify the Board, dispose of or transfer all controlled substances, transfer patient records, and surrender the permit.

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1. Legal Definition & Fiduciary Scope of the PIC

In Tennessee, the Pharmacist-in-Charge (PIC) occupies a foundational statutory role established under the Tennessee Pharmacy Practice Act of 1996 (T.C.A. § 63-10-204) and Tenn. Comp. R. & Regs. 1140-03-.14.

• Definition: The PIC is the licensed pharmacist currently designated on the pharmacy practice site license who accepts legal, ethical, and professional responsibility for the complete operation, management, and regulatory compliance of the pharmacy practice site.
• Joint Liability Principle: Under Tennessee law, both the pharmacy practice site permit holder (the corporate owner, hospital authority, or independent proprietor) and the PIC are jointly responsible for compliance with all state and federal drug laws, Board rules, and administrative orders. Corporate directives do not relieve the PIC of personal administrative or disciplinary liability for regulatory violations occurring under their supervision.

Core Legal Duties of the PIC under Rule 1140-03-.14

The PIC holds direct, non-delegable managerial responsibility for:

1. Personnel Licensure and Credentialing: Verifying that all pharmacists, pharmacy interns, and registered pharmacy technicians working at the practice site hold current, unencumbered Tennessee licenses or registrations in good standing prior to commencing practice.
2. Policy and Procedure Development: Formulating, implementing, and annually reviewing written policies and procedures governing drug procurement, secure storage, compounding, dispensing, medication safety, continuous quality improvement (CQI), and recordkeeping.
3. Controlled Substance Accountability: Maintaining strict perpetual accountability for all Schedule II, III, IV, and V controlled substances, including initial, biennial, and change-of-PIC inventories, DEA Form 222 execution, and CSOS electronic records.
4. Drug Security and Diversion Prevention: Enforcing physical security standards, restricting access keys/codes strictly to authorized pharmacists, and promptly investigating any inventory discrepancies.
5. Mandatory Reporting of Thefts and Losses: Immediately notifying the Tennessee Board of Pharmacy, the DEA (via DEA Form 106), and local law enforcement upon the discovery of any significant theft, embezzlement, burglary, or unexplained loss of controlled substances or prescription drugs.
6. Drug Recall Management: Promptly removing, quarantining, and documenting the return or destruction of any drug subject to manufacturer, FDA, or Board recall actions.
7. Automated Dispensing and Tech-Check-Tech Oversight: Supervising the operation, stocking, and quality assurance auditing of automated dispensing machines and telepharmacy devices.

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2. The On-Duty Standard & Single Practice Site Restriction

To prevent absentee supervision and ensure hands-on operational leadership, Tennessee establishes strict numerical standards regarding PIC working hours and site designations.

The 50% / 40-Hour On-Duty Standard

Under Tenn. Comp. R. & Regs. 1140-03-.14(1):

• General Rule: The PIC must be on duty a minimum of fifty percent (50%) of the total hours the pharmacy practice site is open for business.
• The 40-Hour Weekly Maximum Cap: The rule explicitly contains a ceiling provision: "...but shall not be required to work more than an average of forty (40) hours per week."
• Application Across Practice Settings:
  • Scenario A (Pharmacy open 40 hours/week): The PIC must be on duty at least 20 hours per week (50% of 40 hours).
  • Scenario B (Pharmacy open 60 hours/week): The PIC must be on duty at least 30 hours per week (50% of 60 hours).
  • Scenario C (Pharmacy open 80 hours/week): The PIC must be on duty at least 40 hours per week (50% of 80 hours).
  • Scenario D (24/7 Pharmacy open 168 hours/week): Fifty percent would mathematically equal 84 hours; however, under the 40-hour cap, the PIC is only required to be on duty an average of 40 hours per week.

Strict Single-Site PIC Limitation

• Under Rule 1140-03-.14(2), a pharmacist may be designated as PIC at only one (1) pharmacy practice site at a time.
• Prohibition Against Multiple Sites: A pharmacist cannot act as PIC of two separate retail stores, or a retail store and an institutional pharmacy, or two remote dispensing sites simultaneously.
• Board Waiver Exception: A pharmacist may serve as PIC of more than one site only if the Board of Pharmacy grants an express written authorization or waiver upon formal petition (e.g., in critical access rural hospitals, severe emergency staffing shortages, or temporary disaster response). Serving as dual PIC without prior written Board approval constitutes grounds for immediate disciplinary action against the pharmacist's license and both site permits.

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3. Mandatory Protocols for Change of Pharmacist-in-Charge

A transition in PIC leadership is treated by the Board as a high-risk operational event requiring complete controlled substance accounting.

Step-by-Step Change of PIC Procedure

Under Tenn. Comp. R. & Regs. 1140-03-.14(3):

1. Immediate Written Notice to the Board: The pharmacy permit holder and the outgoing/incoming PIC must immediately notify the Board in writing of the change in PIC designation, specifying the effective date of the transition.
2. Mandatory Joint Controlled Substance Inventory:
   • A complete physical inventory of all controlled substances (Schedules II, III, IV, and V) must be conducted.
   • The inventory must be performed jointly by both the outgoing PIC and the incoming PIC.
   • Counting Precision:
     • Schedule II: Exact, literal count of all units (tablets, capsules, vials, patches).
     • Schedules III, IV, and V: Exact count for containers holding more than 1,000 units; estimated count permitted for open containers holding 1,000 units or fewer.
3. Inventory Record Requirements: The inventory record must include:
   • Pharmacy name, address, and DEA registration number.
   • Date and time the inventory was conducted (specifying explicitly whether taken at the opening of business or the closing of business).
   • Drug names, dosage forms, strengths, and physical quantities counted.
   • The signatures of both the outgoing PIC and incoming PIC.
4. Site Record Retention (2 Years): The original inventory must be retained on file at the pharmacy practice site for at least two (2) years from the date conducted, available for immediate inspection.
5. Mandatory 30-Day Mailing to the Board:
   • A copy of the completed, signed change-of-PIC controlled substance inventory must be mailed (or electronically submitted via approved Board portal) to the Tennessee Board of Pharmacy within thirty (30) days of the effective date of the change!
   • Exam Alert: Missing the 30-day filing deadline is one of the most frequently cited administrative violations on Board compliance audits and MPJE questions.

┌─────────────────────────────────────────────────────────────────────────────┐
│                    CHANGE OF PIC STATUTORY WORKFLOW                         │
├─────────────────────────────────────────────────────────────────────────────┤
│ 1. Immediate Notice  ──► Submit written notice of PIC change to Board       │
│                                                                             │
│ 2. Joint Inventory   ──► Outgoing & Incoming PIC jointly count all CS (II-V)│
│                                                                             │
│ 3. Execute Record    ──► Sign, date, note open/close of business            │
│                                                                             │
│ 4. Site Retention    ──► Retain original inventory at pharmacy for 2 YEARS  │
│                                                                             │
│ 5. Board Submission  ──► Mail certified copy to TN Board within 30 DAYS     │
└─────────────────────────────────────────────────────────────────────────────┘

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4. Emergency Absence, Sudden Resignation, Incapacity, or Death

Unforeseen circumstances may prevent an outgoing PIC from participating in the transition inventory.

• Death or Sudden Total Incapacity: If an outgoing PIC dies, becomes comatose, or is incapacitated by catastrophic illness, the incoming PIC must conduct the complete physical controlled substance inventory alone, noting on the document that the outgoing PIC was unavailable due to death or incapacitation.
• Immediate Board Notification: The permit holder must notify the Board immediately upon learning of the death, disability, or abrupt resignation of the PIC.
• Interim Period and Successor Appointment: The Board allows a temporary transition window (generally up to 30 days) to designate a permanent successor PIC. During any interim gap, the pharmacy must operate under the active supervision of a designated staff pharmacist, and all controlled substance inventories must be finalized within the statutory 30-day timeline.

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5. Permanent Closure and Termination of a Pharmacy Practice Site

When a pharmacy practice site ceases operations permanently, strict public health safeguards apply to prevent controlled substance diversion and safeguard patient confidential health records.

Mandatory Closure Protocols

Under Tennessee law and Board regulations:

1. Immediate Written Notice to the Board: The permit holder and PIC must provide immediate written notice to the Tennessee Board of Pharmacy stating the exact date of permanent closure.
2. Public Notification: The pharmacy must post a conspicuous notice at all entrances and, where practicable, publish notice in a local publication of general circulation informing patients of the closure date and the location where their active prescription files and profiles are being transferred.
3. Disposition of Controlled Substances:
   • Schedule II drugs must be transferred using official DEA Form 222 (or electronic CSOS) to an authorized buyer (such as another licensed pharmacy, wholesale distributor, or registered reverse distributor).
   • Schedules III, IV, and V drugs must be transferred using commercial invoices documenting drug names, dosage forms, strengths, quantities, date of transfer, and names/addresses/DEA numbers of transferor and recipient.
   • Unusable, contaminated, or expired drugs must be transferred to a licensed DEA reverse distributor for destruction via DEA Form 41.
   • Zero Unaccounted Stock: No controlled substances may be left abandoned or discarded in municipal waste.
4. Transfer and Custody of Prescription Records:
   • Patient prescription records, dispensing logs, and profiling histories must be transferred to another licensed pharmacy practice site within reasonable geographic proximity to ensure patient continuity of care.
   • The recipient pharmacy must maintain these records for the full statutory retention period (at least 2 years under Tennessee law; 6 years for HIPAA and Medicare/Medicaid records).
5. Surrender of Licenses and Official Forms:
   • The physical Tennessee pharmacy practice site permit must be returned immediately to the Board office.
   • The federal DEA Certificate of Registration and all unused, blank DEA Form 222 order forms must be marked void and surrendered to the Special Agent in Charge of the local DEA Field Division.

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6. Comparison Table: PIC Governance, Transitions, and Inventories

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7. Practical Exam Scenarios

Scenario 1: Calculating Weekly PIC On-Duty Hour Requirements

Case: Dr. Henderson is appointed PIC of a busy 24-hour retail pharmacy in Memphis that is open 168 hours per week. The corporate district supervisor insists that Dr. Henderson must work 84 hours per week on site because Board Rule 1140-03-.14 mandates that the PIC be on duty 50% of the hours the pharmacy is open. Legal Analysis: The district supervisor is legally incorrect. While Rule 1140-03-.14(1) establishes the general standard that the PIC must be on duty a minimum of 50% of operating hours, the rule contains an explicit statutory maximum ceiling: the PIC "shall not be required to work more than an average of forty (40) hours per week." Therefore, Dr. Henderson fulfills the statutory standard by working an average of 40 hours per week.

Scenario 2: Missed 30-Day Change of PIC Inventory Mailing Deadline

Case: Dr. Vance took over as PIC of a Chattanooga community pharmacy on June 1. On that date, he and the outgoing PIC completed, signed, and dated a thorough physical controlled substance inventory of Schedules II through V and placed the original into the pharmacy's regulatory binder. On August 15, during a routine Board compliance inspection, the investigator discovers that neither pharmacist ever mailed a copy of the inventory to the Board of Pharmacy. Legal Analysis: The pharmacy and the PIC are in direct violation of Tenn. Comp. R. & Regs. 1140-03-.14(3). Although the joint physical inventory was properly executed and maintained on site, Tennessee law strictly mandates that a copy of the inventory must be mailed to the Board within thirty (30) days of the change. Over 75 days have elapsed. Both the pharmacy permit and Dr. Vance's pharmacist license are subject to formal administrative disciplinary citations and monetary civil penalties under Chapter 1140-08.