# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 35 — Infusion Pharmacy Services in an Alternate Site Care Environment

#### Regulation .02 Permit Holder Responsibilities.

*COMAR 10.34.35.02*

The permit holder shall:

A. Develop and maintain a policy and procedure manual which establishes the pharmacy’s policies and standard operating procedures related to the provision of infusion therapy services;

B. Ensure that an annual review of the policy and procedure manual is performed by a qualified clinician or clinicians to assure that the policies and procedures meet the current standards of practice and regulatory requirements;

C. Ensure that there is a process to verify the name, address, and contact information of the licensed authorized prescriber of record before initiation of therapy;

D. Establish and maintain a training program which includes, but is not limited to, the requirements set forth in Regulation .07 of this chapter;

E. If the infusion pharmacy is performing sterile compounding, ensure compliance with COMAR 10.34.19;

F. If the infusion pharmacy outsources sterile compounding to another pharmacy, confirm that the secondary pharmacy is appropriately licensed and in compliance with COMAR 10.34.04 and COMAR 10.34.19;

G. Assign a supervising pharmacist to provide oversight of the facility and operations as specified in Regulation .03 of this chapter;

H. Ensure adequate supervision to unlicensed personnel;

I. Limit access to the infusion pharmacy area to authorized personnel;

J. Secure the facility and patient records in compliance with federal and State laws and regulations; and

K. Develop and implement a written performance improvement program as set forth in Regulation .08 of this chapter.