10.34.03.17

.17 Requirements for a Decentralized Pharmacy.

A. A decentralized pharmacy is subject to:

(1) Health Occupations Article, Title 12, Annotated Code of Maryland;

(2) This subtitle; and

(3) Other applicable State and federal laws and regulations.

B. A decentralized pharmacy shall ensure that a licensed pharmacist is immediately available on the premises of the decentralized pharmacy to:

(1) Supervise pharmacy operations; and

(2) Provide the final check for preparing medication orders for administration in the institutional facility.

C. Notwithstanding §B of this regulation, a pharmacist assigned to a decentralized pharmacy may leave the decentralized pharmacy for a short period of time to perform pharmaceutical care functions in the institutional facility.

D. A director of pharmacy of the institutional pharmacy shall be responsible for pharmacy operations involving a decentralized pharmacy, including direct supervision of decentralized pharmacy personnel by a pharmacist and compliance with this chapter.

E. A pharmacy department may store prescription medications and over the counter medications that are approved for use by the institutional pharmacy as required for the treatment of patients in the nursing unit served by the decentralized pharmacy.

F. An institutional pharmacy and the decentralized pharmacy shall have shared common electronic files or appropriate technology to allow access to sufficient information necessary or required to process functions required for the care of patients within the service area of the decentralized pharmacy.

G. A decentralized pharmacy shall have a pharmacist physically located at the decentralized pharmacy to directly supervise pharmacy technicians and pharmacy technician trainees during hours of operation.

H. An institutional pharmacy shall notify the Board in writing within 14 days of a change of location, discontinuance of service, or closure of a decentralized pharmacy.

I. Security.

(1) In addition to the security requirements outlined in COMAR 10.34.05, a decentralized pharmacy shall have adequate security and procedures to:

(a) Prohibit unauthorized access;

(b) Comply with federal and State regulations; and

(c) Maintain patient confidentiality.

(2) Access to the decentralized pharmacy shall be limited to pharmacists, pharmacy technicians, and pharmacy technician trainees employed by the institutional pharmacy, and other personnel authorized by the director of pharmacy.