# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 21 — Standard of Practice for Unlicensed Personnel

**Authority:** Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland

**Administrative History:** Effective date: March 5, 2001 (28:4 Md. R. 419)

**Administrative History:** Regulation .02B amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .03 amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .03B amended effective December 10, 2001 (28:24 Md. R. 2128)

**Administrative History:** Regulation .03E amended effective November 25, 2002 (29:23 Md. R. 1811)

**Administrative History:** Regulation .04 amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .06 amended effective January 28, 2008 (35:2 Md. R. 127)

#### Regulation .01 Scope.

*COMAR 10.34.21.01*

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.

#### Regulation .02 Definitions.

*COMAR 10.34.21.02*

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

B. Terms Defined.

  (1) “Board” means the State Board of Pharmacy.

  (2) “Operational support” means tasks performed by:

    (a) An administrative clerk;

    (b) A billing clerk;

    (c) A cashier;

    (d) Delivery personnel;

    (e) A file clerk;

    (f) An inventory control clerk; or

    (g) An individual engaged in janitorial services.

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

  (7) “Unlicensed personnel” means individuals employed by the permit holder who provide operational support in the prescription area under the supervision of a licensed pharmacist.

#### Regulation .03 Duties of the Permit Holder.

*COMAR 10.34.21.03*

The permit holder shall:

A. Determine which operational support tasks the pharmacist may assign unlicensed personnel to perform in the prescription area;

B. Ensure that unlicensed personnel:

  (1) Receive appropriate training for the tasks that the pharmacist assigns unlicensed personnel to perform in the prescription area;

  (2) 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; and

  (3) When performing tasks in the prescription area, maintain proper:

    (a) Sanitation;

    (b) Hygiene;

    (c) Biohazard precautions; and

    (d) Infection control; and

C. Ensure that unlicensed personnel are clearly identified to the consumer.

#### Regulation .04 Duties of the Pharmacist.

*COMAR 10.34.21.04*

A. The pharmacist shall provide supervision to unlicensed personnel.

B. The pharmacist may not delegate any pharmacy acts to unlicensed personnel.

#### Regulation .05 Duties of Unlicensed Personnel.

*COMAR 10.34.21.05*

A. Unlicensed personnel under the supervision of a pharmacist may perform operational support which the unlicensed personnel have been trained to adequately perform in the prescription area.

B. Unlicensed personnel who perform duties 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.

#### Regulation .06 Grounds for Discipline.

*COMAR 10.34.21.06*

A. A pharmacist licensee may be subject to discipline if the pharmacist licensee violates any provision of Regulation .04 of this chapter.

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

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

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