California State Board of Pharmacy STATE AND CONSUMER SERVICES AGENCY 1625 N. Market Blvd, N219, Sacramento, CA 95834 Phone: (916) 574-7900 Fax: (916) 574-8618 www.pharmacy.ca.gov DEPARTMENT OF CONSUMER AFFAIRS GOVERNOR EDMUND G. BROWN JR. REQUIREMENTS FOR FILING AN APPLICATION FOR STERILE COMPOUNDING PHARMACY LICENSE (Business & Professions Code Sections 4127 and 4127.1) The following may compound injectable sterile drug products in California: A pharmacy that is specially licensed with the board as a sterile compounding pharmacy, or a pharmacy that is operated by an entity that is licensed by the board or the State Department of Health Services and has a current accreditation from the Joint Commission on Accreditation of Healthcare Organizations or another accreditation agency approved by the board. The following private accreditation agencies have been approved by the board: ¾ Accreditation Commission for Health Care, Inc. (ACHC) through February 2014, ¾ Community Health Accreditation Program (CHAP) through February 2014, or ¾ Det Norske Veritas (DNV) through July 2013. x x A license to compound injectable sterile drug products may not be issued until the location is inspected by the board and found to be in compliance with Article 7.5 of Chapter 9, of Division 2 of the Business and Professions Code and regulations adopted by the board. All pharmacies that compound injectable sterile drug products must follow board regulations for sterile compounding. These regulations are found in Title 16 of the California Code of Regulations as Article 8, beginning with section 1751. For a complete application, the following items must be submitted: 1. A completed and signed Application for Sterile Compounding Pharmacy License (17A48). 2. Fee of $600, made payable to “Board of Pharmacy”. Note: This application may be used to apply for a temporary permit when the ownership of a pharmacy that is licensed to compound injectable sterile drug products is transferred from one person to another. Whenever a change of ownership occurs, either a temporary permit must be sought and obtained by the new owners or operation must stop until a license to compound injectable sterile drug products is obtained. In addition to the regular items required for this application, a $550 temporary permit fee must also be submitted. 3. A copy of the pharmacy's proposed policies and procedures for sterile compounding on disk, CD or hard copy. If emailing the policies and procedures, please send to CompoundingPharmacy@dca.ca.gov. 4. Corporate officer, owner, or partner who signed the application will need to complete the enclosed “Request for Live Scan Service” form. ** Effective January 1, 2001, the Board of Pharmacy requires all applicants for a new license to have not only a California Department of Justice (DOJ) criminal record check but also a federal background check. No license will be issued without background clearances from both agencies. Note to Applicants Submitting Fingerprints Via Live Scan: While the Live Scan forms contained in the board’s application package are pre-slugged to indicate level of service at the DOJ and FBI level, please ensure at the time of Live Scan transmission that the Live Scan operator selects both the DOJ and FBI levels of service. If FBI is not selected at the time of original transmission, you may be required to have your Live Scan redone at another time and have to repay for the DOJ and FBI levels of services again. The board has been notified by the DOJ that effective 9/1/07, if the FBI level of service is not requested at the time of original transmission both DOJ and FBI levels of service will have to be redone. Any issue of cost for resubmission should be handled at the Live Scan Site level. 17A-47 (REV. 02/11) American LegalNet, Inc. www.FormsWorkFlow.com