Md. Code Regs. 10.34.04.09

Current through Register Vol. 51, No. 24, December 2, 2024

Section 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.

Md. Code Regs. 10.34.04.09

Regulation .09 Transfer and Outsourcing of Prescriptions and Prescription Orders adopted effective June 25, 2001 (28:12 Md. R. 1110)