Md. Code Regs. 10.34.19.12

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

Section 10.34.19.12 - Minimum Requirements for Policies and Procedures

A. The permit holder shall ensure that the pharmacist or the pharmacist's designee shall maintain a policy and procedure manual, reviewed annually, that sets forth in detail the permit holder's standard operating procedures with regard to compounding sterile preparations.

B. The permit holder shall insure that the policy and procedure manual that sets forth the standard operating procedures with regard to compounding sterile preparations is implemented and adhered to.

C. The policy and procedure manual shall include policies and procedures governing the following:

(1) A risk-management program which includes documentation of outcomes including, but not limited to:

(a) An incident reporting system;

(b) An adverse drug reaction reporting system; and

(c) A preparation contamination reporting system;

(2) Security measures ensuring that the premises where sterile compounded preparations are stored and prepared are secured, to prevent access by unauthorized personnel;

(3) Equipment including, but not limited to:

(a) Procedures for use;

(b) Documentation of appropriate certifications; and

(c) Documentation of appropriate calibration and preventive maintenance if applicable;

(4) Sanitation standards and procedures including monitoring for bacterial microorganisms to demonstrate effectiveness of cleaning activities;

(5) Reference materials as set forth in Regulation .16 of this chapter;

(6) Information concerning drug:

(a) Preparation;

(b) Storage and handling;

(c) Dispensing;

(d) Labeling;

(e) Beyond-use/expiration dating;

(f) Delivery;

(g) Destruction;

(h) Recalls; and

(i) Returns;

(7) Patient record keeping as set forth in Regulation .07 of this chapter;

(8) Handling, dispensing, and documentation of investigational drugs;

(9) A quality assurance program;

(10) Verification of training and competency guidelines;

(11) Compounding process media fill verification procedures;

(12) Description of appropriate garb;

(13) Conduct guidelines for personnel in the controlled areas;

(14) Personnel responsibilities;

(15) Patient education, if appropriate;

(16) Protocol and procedures to maintain the integrity of the interior work area of the laminar air flow workstations;

(17) Written procedures as applicable for handling antineoplastic agents and other hazardous substances including:

(a) Utilizing the proper equipment and supplies;

(b) A statement that compounding shall be conducted within a properly certified biological safety cabinet or negative pressure compounding aseptic isolator;

(c) Proper use of protective attire; and

(d) Proper techniques to prevent both contamination of the preparation and chemical exposure of the individual preparing the prescription;

(18) Written procedures as applicable for the disposal of infectious materials or materials containing cytotoxic residues, or hazardous waste;

(19) Written documentation of policy and procedure changes based on data gathered from quality assurance evaluations; and

(20) Written documentation of policies and procedures assuring the sterility and stability of compounded sterile preparations.

Md. Code Regs. 10.34.19.12

Regulations .12 adopted effective September 10, 2007 (34:18 Md. R. 1580)