The permit holder shall:

1. 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;
2. 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;
3. 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;
4. D. Establish and maintain a training program which includes, but is not limited to, the requirements set forth in Regulation .07 of this chapter;
5. E. If the infusion pharmacy is performing sterile compounding, ensure compliance with COMAR 10.34.19;
6. 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;
7. G. Assign a supervising pharmacist to provide oversight of the facility and operations as specified in Regulation .03 of this chapter;
8. H. Ensure adequate supervision to unlicensed personnel;
9. I. Limit access to the infusion pharmacy area to authorized personnel;
10. J. Secure the facility and patient records in compliance with federal and State laws and regulations; and
11. K. Develop and implement a written performance improvement program as set forth in Regulation .08 of this chapter.

Authority: Health-Occupations Article, §12-205, Annotated Code of Maryland

Effective date: March 1, 2012 (38:23 Md. R. 1421)