2.1 Pharmacist-in-Charge (PIC) Responsibilities & Requirements

Pharmacist-in-Charge (PIC) Responsibilities & Requirements

In the Commonwealth of Virginia, the operation of every permitted pharmacy revolves around the legal accountability of a single designated practitioner: the Pharmacist-in-Charge (PIC). Under Code of Virginia § 54.1-3434 and 18VAC110-20-110, the pharmacy permit is granted jointly to the pharmacy owner and the PIC. While corporate owners or health systems own the physical assets and inventory, Virginia law places full and actual charge of the pharmacy's professional operations, security protocols, and statutory compliance squarely on the shoulders of the PIC.

Understanding the precise scope of PIC authority, attendance mandates, multi-facility limitations, and mandatory procedures during a change in leadership is essential for the Virginia MPJE.

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Statutory Definition and Regulatory Role

Under 18VAC110-20-10, "PIC" means the pharmacist-in-charge of a permitted pharmacy, and Va. Code § 54.1-3434 requires every pharmacy permit to name the pharmacist who will be in full and actual charge of the pharmacy. This designation is not merely administrative; it establishes individual administrative and disciplinary liability for regulatory deviations occurring within the prescription department.

Key Legal Principle: The PIC's authority supersedes non-pharmacist corporate management regarding professional pharmacy operations, drug storage integrity, dispensing standards, and physical security. If a conflict arises between corporate directives and Board regulations, the PIC remains personally liable under administrative law for upholding Virginia statutes.

Eligibility and Licensing Criteria

To qualify as a PIC in Virginia, the practitioner must:

1. Hold an active, unrestricted license to practice pharmacy issued by the Virginia Board of Pharmacy.
2. Have obtained a minimum of two years of experience practicing as a pharmacist in Virginia or another United States jurisdiction (18VAC110-20-110 D). The Board may grant an exception to this experience minimum for good cause shown — a frequently tested nuance, because the requirement is waivable but not optional by default.
3. Be in good standing with the Board, without active probationary conditions that explicitly restrict serving in a supervisory capacity.
4. Exercise regular, on-site supervision over pharmacy staff, workflows, and physical drug storage enclosures.

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Working Conditions and the Absence of a Fixed Attendance Quota

A high-yield trap on the Virginia MPJE is the assumption that the Commonwealth imposes a numeric minimum on how many hours per week the PIC must personally stand in the pharmacy. It does not. Unlike several neighboring states, 18VAC110-20-110 contains no minimum weekly personal-attendance quota for the PIC. Candidates who memorize a "20 hours per week" or "half of operating hours" figure are importing another jurisdiction's rule and will miss the question.

What Virginia regulates instead is (i) continuity of the PIC relationship, enforced through the absence rules below, and (ii) working conditions, enforced against the permit holder.

Working-Condition Limits the Permit Holder Must Honor (18VAC110-20-110 B)

Exam framing: These are duties imposed on the permit holder, not privileges the pharmacist must claim. A corporate scheduler who mandates a 13-hour shift violates 18VAC110-20-110 B even if the pharmacist does not complain.

Professional Control Cannot Be Overridden (18VAC110-20-110 C)

The PIC or the pharmacist on duty shall control all aspects of the practice of pharmacy. Any decision overriding that control is itself deemed the practice of pharmacy and may be grounds for disciplinary action against the pharmacy permit. This is the statutory hook that lets the Board sanction a corporate owner, not merely the individual pharmacist, when non-pharmacist management dictates professional judgment.

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Dual PIC Limitation

Under 18VAC110-20-110 A, a pharmacy permit shall not be issued to a pharmacist to be simultaneously in charge of more than two pharmacies. The cap is therefore enforced at the moment of permit issuance, and it is absolute: no volume of hours worked, corporate affiliation, or common ownership authorizes a third concurrent PIC designation.

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PIC Absence, Departure & the 14-Day Permit Clock

Virginia replaces an attendance quota with hard continuity deadlines. These dates are among the most heavily tested items in this competency area.

The 30/15/14 pattern: 30 consecutive days of absence ends the designation automatically; a 15-day unanticipated absence with no return in sight forces the owner to act; and 14 days is the window to name a successor. Note who bears each duty — the exam frequently swaps the PIC and the owner.

The Outgoing PIC's Inventory Opportunity (18VAC110-20-110 F)

Although not required by law or regulation, an outgoing PIC shall have the opportunity to take a complete and accurate inventory of all Schedules II through V controlled substances on hand on the date the pharmacist ceases to be the PIC — unless the owner submits written notice to the Board showing good cause why the opportunity should not be allowed.

Distinguish this carefully from the incoming PIC's duty under Va. Code § 54.1-3434: the succeeding PIC shall cause an inventory to be made of all Schedule I, II, III, IV and V drugs on hand, completed as of the date he becomes PIC and prior to opening for business on that date. The outgoing inventory is an opportunity covering Schedules II–V; the incoming inventory is a mandate covering Schedules I–V.

One Permit Per Prescription Department (18VAC110-20-110 I, J)

Only one pharmacy permit may be issued to conduct a pharmacy occupying the same designated prescription department space, and that space may not simultaneously be used for another board-licensed activity such as manufacturing or wholesale distribution. Before any permit is issued the applicant must attest to compliance with all federal, state, and local laws, and no pharmacy permit may be issued to operate from a private dwelling or residence after September 2, 2009.

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Core Operational Duties of the PIC

The PIC maintains direct responsibility for ensuring compliance across several operational areas defined in 18VAC110-20-110, 18VAC110-20-190 through 210, and 18VAC110-20-240:

1. Physical Security and Prescription Department Key Control

Under Virginia law, the prescription department must be enclosed by a secure floor-to-ceiling barrier whenever a licensed pharmacist is not on duty. Keys and electronic access credentials (alarm disarm codes, keycard access) to the prescription enclosure are strictly restricted to Virginia-licensed pharmacists designated by the PIC.

• No unauthorized possession: No non-pharmacist employee (including store managers, corporate officers, technicians, or janitorial staff) may possess a key or alarm access code to the prescription department.
• Emergency key access: If an emergency access key is stored on-site for emergency entry (such as fire rescue or after-hours security inspection), it must be sealed in a tamper-evident, signed envelope or secure key-box kept outside the pharmacy enclosure, with strict post-entry reporting protocols to the PIC and Board.

2. Controlled Substances Recordkeeping & Biennial Inventories

The PIC is responsible for maintaining all DEA-mandated and state-mandated records of receipt, distribution, and destruction:

• Biennial Inventory: Under 18VAC110-20-240, a complete inventory of all Schedule I through V controlled substances must be conducted at least every two years (biennially) from the date of the previous inventory. The inventory must note whether it was taken prior to opening or after close of business.
• Schedule II Separation: Schedule II physical records (invoices, DEA Form 222 or CSOS records, executed inventory counts) must be maintained separately from all other records.
• Theft and Loss Investigation: The PIC must oversee continuous diversion detection, coordinate internal audits, and ensure required notifications (DEA Form 106 and Board notifications) are executed within statutory deadlines.

3. Environmental Monitoring and Cold-Chain Integrity

The PIC must ensure proper drug storage conditions pursuant to USP and manufacturer specifications:

• Refrigeration: Controlled between 36°F and 46°F (2°C to 8°C).
• Freezer: Maintained between -13°F and 14°F (-25°C to -10°C).
• Continuous Monitoring: Temperature logs must be maintained (manual twice-daily logs or automated electronic data-loggers) and retained on-site for at least two years.

4. Staff Qualifications and Training Documentation

The PIC must ensure that every person practicing in the pharmacy holds active registration or licensure. Furthermore, the PIC must verify that all pharmacy technician trainees are enrolled in Board-approved training programs and maintain documented proof of trainee progress and completed technician site-specific training for two years following termination of employment.

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Change of Pharmacist-in-Charge Procedures

When a PIC resigns, is terminated, or becomes unable to practice, Virginia law enforces a strict regulatory protocol under Code of Virginia § 54.1-3434 and 18VAC110-20-110(D)–(E).

The Change-of-PIC Inventory Rule

The incoming PIC must conduct a complete physical inventory of all Schedule I, II, III, IV, and V controlled substances. Key parameters for this inventory include:

1. Timing: It must be performed on or before the effective date of assuming PIC responsibility, prior to opening for business or after close of business.
2. Scope: All Schedule I through V medications on the premises (including stock in automated dispensing cabinets, will-call bins, return bins, and compounding areas) must be tallied.
3. Counts: Schedule I and II drugs require an exact physical count. For Schedules III through V, an estimated count is permissible unless the commercial container holds more than 1,000 tablets or capsules and has been opened, in which case an exact count is required.
4. Documentation: The inventory document must specify the date, time taken (open or close), signatures of the incoming PIC and individuals conducting the count, and must be retained on the premises for at least two years.

Exam Watch-Out: If the outgoing PIC is terminated suddenly without notice, the pharmacy owner must immediately notify the Board. The pharmacy cannot operate indefinitely without an active PIC. Under Virginia law, if a new permit application naming a qualified PIC is not filed within 14 days, the permit must be surrendered to the Board, and all controlled substances must be safeguarded or transferred under Board supervision.