The 15-day comment period for the proposed changes to compounding regulations in California expires July 30, 2012. The notice of proposed action can be found here. The proposed Compounding Self-Assessment Form can be find here. The Initial Statement of Reasons for the Changes can be found here. The notice of modified text can be found here. The modified proposed language can be found here.
Prior post on changes to California regulations relating to compounding can be viewed here.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, July 19, 2012
Mississippi State Board of Pharmacy In Process of Revising Regulations
The Mississippi State Board of Pharmacy website indicates that the board is in the process of updating its current regulations. This appears to include the regulations relating to compounding in Mississippi. Notice of future changes can be viewed here. Check back to this blog for future changes in Mississippi Pharmacy Law.
Also note that changes in the Pharmacy Practice Act and Regulations (effective January 1, 2012) require the pharmacist-in-charge of all non-resident pharmacies be licensed as a pharmacist in the State of Mississippi. In addition, all non-resident pharmacies and wholesalers are required to obtain a Mississippi Controlled Substance Registration issued by the Board. See MS Senate Bill 2455 .
Also note that changes in the Pharmacy Practice Act and Regulations (effective January 1, 2012) require the pharmacist-in-charge of all non-resident pharmacies be licensed as a pharmacist in the State of Mississippi. In addition, all non-resident pharmacies and wholesalers are required to obtain a Mississippi Controlled Substance Registration issued by the Board. See MS Senate Bill 2455 .
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:
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.
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:
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 ofAccreditation 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.
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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