A suggested step-by-step methodology for USP 797 compliance is as follows:

• JCAHO began surveying for compliance with USP 797 on July 1, 2004, so efforts to comply with USP 797 should have begun and/or must begin immediately
• To begin with, assemble a team within your healthcare institution consisting of : Chief Pharmacist, Director of Facilities, Director of Engineering, and Appropriate Administrator
• Identify, with the guidance of the Chief Pharmacist, those pharmacies within the health care institution where sterile compounding is done
• Create a Gap Analysis document, either in-house, or by hiring a consultant that specializes in Gap Analysis documents, such as Clinical IQ (www.clinicaliq.com)
• Create a Compliance Action Plan, either in-house, or by hiring an architect that specializes in Compliance Action Plans, such as Bernstein & Assoc. (www.bernarch.com)
• Have the architect create construction documents and specifications, indicating the detailed scope required for the project
• Send out the drawings and specifications to 3-5 qualified general contractors who specialize in health care and laboratory space
• Award the project to the selected contractor Work with architect and contractor to complete work in a thorough manner, meeting all project specifications