059-17 Wyo. Code R. § 17-9

Current through April 27, 2019

Section 17-9 - Policy and Procedure

(a) Pharmacies that engage in the practice of sterile compounding shall have a Policies and Procedures (P&P) manual that describes the common practices of the pharmacy. The P&P manual will be reviewed and updated as necessary, at least annually. The Pharmacist-in-Charge (PIC) is responsible for the completeness, accuracy, and enforcement of compliance with the procedures by all pharmacy personnel. This P&P manual will be available at all times to staff and at the request of a Board of Pharmacy Inspector. All staff will review the P&P manual before engaging in sterile compounding and annually thereafter. If the PIC changes, the new PIC must review, date, and initial the P&P manual within thirty (30) days.

(b) The Policies and Procedures manual will contain procedures detailing at least the following:

(i) Responsibilities of compounding personnel;

(ii) Personnel training and testing;

(iii) Competency practices and assessment of compounding personnel;

(iv) Quality Assessment and Quality Improvement activities;

(v) Proper use and deployment of environmental controls;

(vi) Gowning and garbing practices;

(vii) Inspection of finished products, labeling, storage, and transfer to final use areas for storage or use;

(viii) Introduction of supplies and products into the compounding area;

(ix) The formulation, process for compounding, BUD, and storage requirements of each routinely compounded CSP.

059-17 Wyo. Code R. § 17-9