02-392-3 Me. Code R. § 13-3

Current through 2024-51, December 18, 2024

Section 392-3-13-3 - Pharmacist in Charge

1. Generally

The business of a retail pharmacy shall be conducted under the direct supervision of a licensed pharmacist who has registered as the pharmacist in charge of that pharmacy with the board. No retail pharmacy may operate without a pharmacist in charge.

2. Responsibilities

The pharmacist in charge is responsible legally and professionally for all activities related to the practice of pharmacy within the retail pharmacy for which the licensee is registered as pharmacist in charge, and for the pharmacy's compliance with the provisions of the Maine Pharmacy Act, the rules of the board, and the federal laws and rules specified in Chapter 29, Section 1 of the board's rules. The responsibilities of the pharmacist in charge include, but are not limited to:

A. The pharmacy's procedures for the procurement, storage, compounding and dispensing of drugs;

B. The recordkeeping systems required in the practice of pharmacy for the purchase, sale, possession, storage and repackaging of drugs;

C. The security of the prescription filling area and its contents;

D. Ensuring that the prescription filling area is operated in conformance with good pharmaceutical practices;

E. Notifying the board of termination of status as pharmacist in charge via letter, fax or email within 7 days of the termination;

F. The supervision of pharmacy technicians and performance of administrative responsibilities relating to pharmacy technicians as required by Chapter 7 of the board's rules; and

G. Ensuring that each pharmacist employed at the pharmacy for which the pharmacist in charge is responsible is licensed with the board.

3. Presence at Retail Drug Outlet

Except as set forth in Section 3(4) of this chapter, or unless waived by the board for good cause shown, a pharmacist in charge of a retail pharmacy shall practice at that pharmacy for a minimum of 30 hours per week or 50% of the hours the pharmacy is open, whichever is less.

4. Registration as Pharmacist in Charge for More Than One Retail Pharmacy

Except as set forth in Section 3(5)(B) of this chapter, no pharmacist may register or serve as pharmacist in charge for more than one retail pharmacy prior to receiving approval from the board. All requests for approval, including requests for emergency approval made pursuant to Section 3(5) of this chapter, must be made via letter, email or fax. A request to serve as pharmacist in charge of an opioid treatment program and one other type of non-opioid pharmacy, or two opioid treatment programs and no other non-opioid pharmacy, will be approved automatically, subject to disciplinary review. A request to serve as pharmacist in charge of a retail pharmacy, closed-shop pharmacy and/or sterile compounding pharmacy at the same location will be approved automatically, subject to disciplinary review. For all other requests, the board may grant approval only in the following circumstances upon a consideration of the nature and extent of the risk posed to the public:

A. Death, incapacity, emergency medical leave or unexpected resignation or discharge of a pharmacist in charge;

B. Specialty practice setting which does not require a 30 hour/50% pharmacist in charge for reasonable protection of the population served; or

C. Other situations where exigent circumstances warrant the registration of a sole pharmacist in charge of more than one retail pharmacy.

The board's order of approval may be of fixed or of indeterminate duration and shall contain such coverage requirements and other provisions as may be necessary to protect the public health and safety at all locations to be served by a sole pharmacist in charge.

5. Emergency Requests

A request for approval pursuant to Section 3(4)(A) of this chapter must be made within 7 days after the death, incapacity, commencement of emergency medical leave or unexpected resignation or discharge of a pharmacist in charge. Providing that the request was made within this time period,

A. The board administrator or the administrator's designee may rule on the request on an interim basis until the board is able to address it; and

B. The retail pharmacy may operate under the supervision of a pharmacist pending the interim ruling of the board administrator or the administrator's designee.

02-392 C.M.R. ch. 3, § 13-3