Saturday, April 16, 2016

California Legislation SB 1185 Relating to animal drug compounding

SB 1195 Senate Bill - Bill Analysis

c) Issues : Drug Compounding.
                Background  :  During hospital inspections, Board inspectors  
               routinely encounter bulk form drugs used for compounding  
               medications stored at veterinary hospitals. If the drugs  
               are not properly stored, labeled, or are expired, the  
               inspector will advise the Licensing Manager of the  
               compliance issue. However, there are no specific provisions  
               in the Practice Act to provide oversight of a veterinarian  
               compounding drugs for use in day-to-day veterinary  
               practices and for dispensing to clients. Instead, the Board  
               has looked to laws and regulations governing pharmacies  
               (BPC Sections 4051, 4052, and 4127 & Title 16 CCR Sections  
               1735-1735.8 and 1751 et. seq.) since veterinarians are  
               authorized prescribers under BPC Section 4170. Pharmacy  
               regulations not only include specific requirements for  
               pharmacies that compound and dispense medications, but also  
               define the "reasonable quantity" of a compounded medication  
               that may be furnished to a prescriber (in this case,  
               veterinarian) by the pharmacy to administer to the  
               prescriber's patients within their facility, or to dispense  
               to their patient/client. It should be noted that the Board  
               of Pharmacy is currently pursuing a regulatory amendment to  
               its Compounding Drug Preparation regulations that includes  
               amendments to the "reasonable quantity" definition of  
               compounded drugs that may be supplied to veterinarians for  
               the purposes of dispensing. In addition to pharmacy  
               provisions, federal law provides for Extralabel Drug Use in  
               Animals, CFR Title 21 Part 530.13, which authorizes  
               veterinarians to compound medications in following  

                           There is no approved animal or human drug  
                    available that is labeled for, and in a concentration  
                    or form appropriate for, treating the condition  

                           The compounding is performed by a licensed  
                    veterinarian within the scope of a professional  

                           Adequate measures are followed to ensure the  
                    safety and effectiveness of the compounded product.


          SB 1195 (Hill)                                          Page 19  
          of ?

                           The quantity of compounding is commensurate  
                    with the established need of the identified patient.

               The Board has been actively engaged in discussions  
               regarding the regulation of veterinarians compounding drugs  
               since October 2014 when the US Government Accountability  
               Office contacted the Board to obtain information on  
               California's regulation of animal drug compounding. At that  
               time, the federal Food and Drug Administration (FDA) was  
               considering changes to its guidance on Compounding Animal  
               Drugs from Bulk Drug Substances. Ultimately, the FDA  
               released Draft Guidance #230 in May 2015, which was  
               intended to provide parameters for compounding animal  

               At its October 20, 2014 meeting, the MDC reviewed the issue  
               of drug compounding by veterinarians for their animal  
               patients. The issue, as raised by Board legal counsel, was  
               that there is no explicit grant of authority in the  
               Practice Act authorizing licensed veterinarians to compound  
               drugs pursuant to federal law. Board counsel advised that  
               provisions for veterinarians to compound drugs for animal  
               patients would need to be added to the veterinary medicine  
               scope of practice. The MDC examined the lack of statutory  
               guidance for veterinarians and ultimately recommended that  
               the Board consider a legislative proposal to grant  
               veterinarians the authority to compound drugs for their  
               animal patients under the existing limitations of CFR Title  
               21 Part 530.13.

                Recommendation and Proposed Statutory Change  :  The  
               Committees may wish to amend Business and Professions Code  
               to grant limited state authority for veterinarians to  
               compound drugs. 

               This bill establishes authority for drug compounding in the  
               practice of veterinary medicine.

                Note  : The exact language for this section is still under   
               revision and will likely be amended at a later date. lifornia

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