SB 1195 Senate Bill - Bill Analysis
www.leginfo.ca.gov/.../sb_1195_cfa_20160414_145810_sen_...
Ca
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
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
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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
revision and will likely be amended at a later date. lifornia
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