4.4 Manager of Record: Duties, Appointment & Reporting

Manager of Record: Duties, Appointment & Reporting

Every Massachusetts pharmacy must designate a Manager of Record (MOR) — the state's term for the pharmacist in charge. 247 CMR 2.00 defines the MOR as a pharmacist currently registered by the Board who is responsible for the operation of a pharmacy or pharmacy department in conformance with all laws and regulations pertinent to the practice of pharmacy and the distribution of drugs.

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Qualification and Commitment

A pharmacy shall designate a Manager of Record who is registered as a pharmacist in Massachusetts. Under 247 CMR 9.23, the MOR:

• is responsible for operation of the pharmacy in compliance with M.G.L. c. 112, §§ 24–42D, M.G.L. c. 94C and 247 CMR;
• is responsible for the proper maintenance of records required by those laws;
• must plan and maintain adequate staffing that promotes patient safety;
• must establish, monitor and enforce policies and procedures that maintain the standards of professional practice; and
• must ensure that all licensees working in the pharmacy have completed their continuing education requirements.

[!IMPORTANT] The hours figure is 30, not 35 or 40. 247 CMR 9.23 requires a Manager of Record to work at least 30 hours per week at the pharmacy he or she manages. Numbers around this rule are prime MPJE material, and 30 is the one that is in the regulation.

The duty to plan adequate staffing is not decorative. Read together with the ratio rule in 247 CMR 8.06(3) and the pharmacist's non-delegable acts, it makes chronic understaffing an MOR compliance problem, not merely an operational one.

Extended absence

Board policy on the extended absence of a Manager of Record expects a pharmacy to have written procedures for appointing an interim manager within 5 calendar days when an MOR will be away from the position.

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Changing the Manager of Record — 247 CMR 6.10

A pharmacy shall submit a change of Manager of Record application to the Board for approval whenever there is a change of MOR. The Board may require the proposed MOR to appear before it before approving or denying the application.

The application is signed by the licensee (or a duly authorised representative) and by the proposed new MOR, and must include:

1. an attestation confirming that the pharmacy performed an inventory of:
   • all controlled substances in Schedules II through V; and
   • the controlled substances in Schedule VI that are required to be reported to the prescription monitoring programme (in practice, gabapentin), and that the inventory report has been filed with the pharmacy's controlled substance records. The attestation is signed by both the outgoing and the proposed incoming MOR;
2. the original Drug Store Pharmacy licence;
3. the required fee(s); and
4. any additional information the Board requires.

[!WARNING] Two details are routinely missed. First, the change-of-MOR inventory is not limited to federally controlled substances — it reaches the Schedule VI substances that must be reported to the PMP. Second, the inventory is documented by an attestation on the application and filed with the pharmacy's controlled substance records; it is not sent to the Board as a stand-alone count.

When the outgoing MOR cannot sign. If the outgoing Manager of Record is unavailable due to death, serious illness, or termination, a staff pharmacist may be authorised to sign the inventory report, provided the Board is notified at the time the application is submitted of the reason the staff pharmacist is signing.

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Notification Deadlines — 247 CMR 20.05

The MOR's personal duty is independent of the pharmacy's. A departing manager who assumes the employer will file the paperwork remains individually exposed.

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The MOR's Reporting Calendar

Massachusetts places several distinct reporting deadlines on the Manager of Record, and telling them apart is worth real points.

[!CAUTION] Federal and state clocks run separately. The DEA requires written notice to the local DEA Field Division within one business day of discovering a significant theft or loss (21 CFR 1301.76(b)), followed by DEA Form 106. Massachusetts then requires the Board copy within seven days. Missing either is an independent violation.

Record retention for the serious events. Records relating to improper dispensing that results in serious injury or death, and records relating to serious adverse drug events, must be retained for a minimum of five years from the date the report is filed with the Board and be readily retrievable (247 CMR 20.02(4)). This is a materially longer period than the ordinary two-year pharmacy record retention in 247 CMR 9.05.

The duty to report under 247 CMR 20.02 is in addition to the Continuous Quality Improvement obligations of 247 CMR 15.00 — the two regimes stack rather than substitute (247 CMR 20.02(3)). Note also that the 20.02 reporting requirements do not apply to non-resident pharmacies, although a non-resident pharmacy must separately report improper dispensing into Massachusetts that results in serious injury or death within seven business days (247 CMR 20.07(3)).

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Day-to-day Compliance the MOR Owns

• Licence verification and display. All employees performing pharmacy technician duties must hold a licence, and employee and pharmacy licences must be valid, current and properly displayed (247 CMR 6.02(3)).
• Self-inspection. Board guidance expects a self-inspection at least once per year, and review of the most recent Board inspection report and plan of correction.
• Equipment. Balances and scales must be sealed each calendar year, and new balances must be designated "legal for trade" (247 CMR 6.01(5), 6.02(1)).
• Records. Pharmacy records must be maintained for at least two years (247 CMR 9.05; 105 CMR 700.006; 21 CFR 1304.21) — longer where a third-party payer or another agency requires it.

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Worked Traps

• A chain asks a pharmacist working 24 hours a week to be listed as MOR. Violation — 247 CMR 9.23 requires at least 30 hours per week at the managed pharmacy.
• A new MOR counts only the Schedule II–V stock on taking over. Incomplete — the attestation in 247 CMR 6.10(2)(a) also covers Schedule VI substances reportable to the PMP.
• An MOR resigns; the employer files the change application, so the MOR files nothing. Violation — 247 CMR 20.05(3) imposes a personal duty on the MOR to notify the Board within 14 calendar days.
• A dispensing error causes a hospitalisation; the MOR logs it in the CQI file and stops there. Violation — 247 CMR 15.00 documentation does not discharge the separate 247 CMR 20.02(1) duty to report to the Board within seven business days.