Sec. 10.34.04.09. Permit and Quality Assurance

A. The permit holder of a pharmacy which prepares patient specific prescriptions as a secondary pharmacy such that these prescriptions account for 5 percent or more of the pharmacy's total number of prescriptions filled shall submit to the Board of Pharmacy, for approval by the Board or a designee of the Board, a plan detailing the steps it has taken to ensure the safety and quality of prescriptions filled as a secondary pharmacy.

B. The plan under §A of this regulation shall include:

(1) Measures to be taken to comply with State and federal laws;

(2) The method by which each pharmacist responsible for each prescription is identified in the records;

(3) Measures taken to maintain the security, integrity, and confidentiality of patient records; and

(4) The establishment and maintenance of a quality assurance program.

C. Except as provided in Regulation .06 of this chapter, a permit holder of a pharmacy shall obtain manufacturing and distribution permits in order to compound or package medication that is not prepared as a prescription destined for a specific patient, but is forwarded to another pharmacy, authorized prescriber, licensed distributor, or other person or entity.