On April 18th, the Board of Pharmacy Enforcement and Compounding Sub-Committee met. On the agenda was a discussion of how the new compounding laws have been affecting veterinary practice. Primarily at issue was the Beyond Use Date updates that require cGMP level testing in order to extend Beyond Use Dates beyond 14 days for most water based suspensions. The Golden Gate team worked closely with the team from UC Davis to develop and present a well thought out and comprehensive statement. Our position is that the Board’s enactment and enforcement of these regulations went well beyond any currently recognized standard of practice and is detrimental to veterinary patient care.
At Golden Gate VCP our primary concern is the care of our patients. Our goal is to ensure that our compounds are clinically efficacious, safe for both pet and owner, and that our formulations promote pet medication compliance. We have put in a lot of time, effort, and testing to ensure our formulations will be effective and acceptable to our even most finicky pet patients. We feel that ultimately the Boards’ enactment and enforcement of these regulations is going to force pet owners to make tough decisions on whether or not to medicate their pets. The tests required by the board are extremely expensive and quite frankly, unnecessary. They can easily run into the tens of thousands of dollars. Compounders that take on this extra testing burden will be forced to pass these costs along to pet owners significantly increasing the cost of many maintenance medications. Those compounders that decide not to pay for testing will be limited to a 14-day shelf life for many of their common water based suspensions. It is also unrealistic to expect a pet owner to refill a maintenance medication like methimazole oral suspension every 2 weeks.
Some compounders have resorted to switching all of their formulations to oil bases as a way to get around the regulations. Currently the law allows 6 month dating when compounding with oil. We do not support this practice and find it to be both a clinically and ethically questionable practice. In general, many pets do not tolerate oil based preparations, especially our cat and exotic patients. Compounding everything in oil will likely lead to a decline in compliance for many of our pet patients. In addition to the tolerability issue, the bioavailability of many common drugs in oil is unknown and can therefore lead to a decline in clinical outcomes. As a rule of thumb, we only compound in oil when clinically or chemically necessary. Therefore, we continue to support and defend the practice of compounding in a water base for our pet patients. We reference our formulations whenever possible to either USP monographs or published literature to support the extension of the Beyond Use Date. For those drugs that do not have a monograph or published study, we hope and encourage the Board to rethink their approach and continue to allow compounders to base Beyond Use Dates on HPLC potency tests when appropriate.
We know many of you share our concerns. The Committee has agreed to further discuss this subject at their June meeting. We highly encourage you to write to the Board of Pharmacy and let them know how the changes they have enacted are affecting the treatment of your patients. We know many of you fully support compounding and utilize it daily in your practice. We suggest that any correspondence with the Board focus on the impact to patient care. If you are interested in the Board hearing your concerns, you may send any correspondence to the address below and address it to the attention of the Enforcement and Compounding Sub-Committee Chair Person:
California Board of Pharmacy
1625 N. Market Blvd., Suite N219
Sacramento, CA 95834