Thursday, July 19, 2012

Instruction and Form for Filing for Application for Sterile Compounding Pharmacy Licence in Califorinia

The form for filing for application to compound injectable sterile drug in California is found here.  The form details who 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:

Accreditation Commission for Health Care, Inc. (ACHC) through February 2014,
Community Health Accreditation Program (CHAP) through February 2014,
Det Norske Veritas (DNV) through July 2013,
Pharmacy Compounding Accreditation Board (PCAB) through February 2014, or
American Osteopathic Association Healthcare Facilities Accreditation Program
(HFAP) through February 2014.
The form explains that "[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."  The form also contains the following warning:  "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."  A $600 fee is required with the application.  Both a state and federal background check are required.  

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