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 NONRESIDENT PHARMACY STERILE COMPOUNDING LICENSE (Business & Professions Code Sections 4127 et. seq.) Effective July 1, 2003, a nonresident pharmacy may not compound injectable sterile drug products for shipment into California unless: 1. The nonresident pharmacy is licensed with the board as an injectable sterile drug compounding nonresident pharmacy, OR: 2. The nonresident pharmacy is operated by an entity that is licensed as a hospital, home health agency, or a skilled nursing facility, 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. Nevertheless all nonresident pharmacies that compound injectable sterile drug products and ship these products into California must follow board regulations for injectable sterile drug compounding. These regulations are found in Title 16 California Code of Regulations at Article 7, beginning with section 1751. A license for a nonresident pharmacy to compound injectable sterile drug products may only be issued for a location that is separately licensed as a nonresident pharmacy, and may only be issued to the owner of the nonresident pharmacy license at that location. To begin the application process, the following items must be submitted: 1. A completed and signed Application for Nonresident Sterile Compounding Pharmacy License (Form 17A-50). 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 an inspection report issued by the pharmacy's licensing agency within the prior 12 months, documenting the pharmacy's compliance with board regulations regarding the compounding of injectable sterile drug products. 4. A copy of the nonresident pharmacy's proposed policies and procedures for sterile compounding on disk, CD, or via email. If emailing the policies and procedures, please send to CompoundingPharmacy@dca.ca.gov. 5. Corporate officer, owner, or partner who signed the application will need to complete the enclosed fingerprint cards. Failure to submit all of the information requested or required by the board may result in the board considering your application incomplete. American LegalNet, Inc. www.FormsWorkFlow.com ** 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 through the Federal Bureau of Investigation (FBI). 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. Fingerprint Requirements California Residents The board will only accept Live Scan Service Forms from California residents. Complete a Live Scan Request form and take all 3 copies to a Live Scan site for fingerprint scanning. Please refer to the Instructions for completing a "Request for Live Scan Service" form. Live Scan sites are located throughout California. For more information about locating a Live Scan site near you, visit the Department of Justice website at http://ag.ca.gov/fingerprints/publications/contact.htm or the sources listed on the bottom of the instructions for completing a "Request for Live Scan Service" form. The lower portion of the Live Scan Request form must be completed by the Live Scan operator verifying that your prints have been scanned and all applicable fees have been paid. Attach the second copy of the form to your application and submit it to the board. Non California Residents If an owner, partner, corporate officer, major shareholder or director reside out of state they must submit rolled fingerprints on cards provided by the board and include a separate fee of $51 ($32 California Department of Justice (DOJ) fee, $19 FBI fingerprint processing fee). (Live Scan processing fees are paid directly at the Live Scan site.) You may contact the board to request fingerprint cards at (916) 574-7900. You may also request cards on our website at www.pharmacy.ca.gov. Fingerprints submitted on cards should be taken by a person professionally trained in the rolling of prints. Fingerprint clearances from cards take approximately six weeks (live scan is faster). Poor quality prints may result in rejection and will substantially delay licensing as additional fingerprint cards will be required from you for processing. The board will only accept fingerprint cards from residents outside of California. 17A-49 (REV. 02/11) American LegalNet, Inc. www.FormsWorkFlow.com