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 situations: There is no approved animal or human drug available that is labeled for, and in a concentration or form appropriate for, treating the condition diagnosed. The compounding is performed by a licensed veterinarian within the scope of a professional practice. 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 drugs. 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
Saturday, April 16, 2016
California Legislation SB 1185 Relating to animal drug compounding
c) Issues : Drug Compounding.
revision and will likely be amended at a later date. lifornia