This chapter establishes standards of practice and the responsibilities of licensed pharmacists and pharmacy permit holders when using unlicensed personnel in the prescription area of a pharmacy.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Board" means the State Board of Pharmacy.

(2) "Modification in prescription orders" means any alteration in the prescription order other than changing the number of refills that are authorized by the prescriber.

(3) "Permit holder" means a person or corporation or other legal entity holding a permit issued by the Board to establish and operate a pharmacy.

(4) "Pharmacy" means an establishment holding a permit under Health Occupations Article,

§12-401, Annotated Code of Maryland.

(5) "Prescription area" means that portion of an establishment to which a pharmacy permit has

been issued, which contains:

(a) Prescription drugs;

(b) Prescription devices; and

(c) Patient records.

(6) "Prescription process" means the sequence of activities necessary to dispense or distribute

prescription drugs or devices.

(7) "Supervision" means the on-site provision of management, direction, oversight, and review of tasks assigned to personnel.

(8) "Unlicensed personnel" means individuals employed by the permit holder who perform tasks in the prescription area under the supervision of a licensed pharmacist.

The permit holder shall:

A. Determine which tasks the pharmacist may assign unlicensed personnel to perform in the

prescription process or in the prescription area;

B. Ensure that unlicensed personnel:

(1) Receive appropriate training for the tasks that the pharmacist assigns unlicensed personnel to

perform as part of the prescription process;

(2) Maintain the levels of competency necessary to safely complete the tasks that unlicensed

personnel are assigned to perform; and

(3) Receive training that will enable unlicensed personnel to understand how the provisions of

Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland, apply to:

(a) Prescription records, and

(b) The requirements for confidentiality of patient specific information;

C. Establish written policies and procedures to ensure:

(1) The safety and accuracy of the prescription process; and

(2) Compliance with §B(3) of this regulation;

D. Document that unlicensed personnel have achieved the levels of competency necessary to

safely complete the tasks which the unlicensed personnel are assigned to perform;

E. Establish a quality assurance program to ensure that unlicensed personnel maintain safe and

acceptable levels of:

(1) Competency in the unlicensed personnel's performance of assigned tasks; and

(2) Accuracy in the unlicensed personnel's performance of assigned tasks;

F. Document the training required to allow unlicensed personnel to perform functions in that

segment of the prescription process in which unlicensed personnel will participate;

G. Ensure that unlicensed personnel are clearly identified to the consumer; and

H. Provide unlicensed personnel with written job descriptions.

A. The pharmacist shall:

(1) Ensure that unlicensed personnel:

(a) Are adequately trained for the tasks which the pharmacist assigns the unlicensed personnel to

perform, and

(b) Competently perform the tasks which the pharmacist assigns unlicensed personnel to perform; and

(2) Provide supervision to unlicensed personnel.

B. The pharmacist may delegate any pharmaceutical task to trained, competent, unlicensed

personnel, except for:

(1) Ensuring the:

(a) Appropriateness of the prescription or prescriber order, and

(b) Accurate compounding and preparation of the prescription or prescriber order;

(2) Receiving prescription or prescriber orders that are transmitted orally for:

(a) Original prescriptions,

(b) Modifications in prescription orders,

(c) Refill authorizations for prescriptions containing controlled dangerous substances, or

(d) Prescription transfers between pharmacies;

(3) Providing pharmaceutical care as defined in Health Occupations Article, §12-101(l),

Annotated Code of Maryland;

(4) Monitoring drug therapy; and

(5) Providing information to the public or a health care professional concerning prescription or

non-prescription drugs or devices.

A. Unlicensed personnel under the supervision of a pharmacist may perform pharmaceutical tasks in the prescription process which:

(1) A pharmacist has delegated;

(2) The unlicensed personnel have been trained to adequately perform; and

(3) The unlicensed personnel are able to competently perform.

B. Unlicensed personnel involved in the prescription process may not perform any task set forth in Regulation .04B of this chapter.

C. Unlicensed personnel who perform duties in the prescription process or in the prescription area shall maintain the confidentiality of patient specific data in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. 

.06 Grounds for Discipline.

A. A pharmacist licensee may be subject to discipline if the pharmacist licensee:

(1) Delegates unlicensed acts which the delegating pharmacist knows or should have known are to be performed only by a licensed pharmacist;

(2) Delegates unlicensed acts that the delegating pharmacist knows or should have known that the unlicensed lacks the ability to perform;

(3) Fails to properly supervise an unlicensed individual to whom pharmacy acts have been delegated; or

(4) Otherwise violates any provision of Regulation .04 of this chapter.

B. A permit holder may be subject to disciplinary action if:

(1) A pharmacist in the employ of the permit holder is responsible for any of the acts in §A of this regulation and the permit holder knows or should have known that the illegal acts are taking place;

(2) The permit holder fails to take reasonable safeguards to ensure compliance with the regulations of the Board; or

(3) The permit holder otherwise violates any of the provisions of Regulation .03 of this chapter.