Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment
Section 10.34.35.02 - Permit Holder Responsibilities

Universal Citation: MD Code Reg 10.34.35.02

Current through Register Vol. 51, No. 19, September 20, 2024

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.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.