The following blog is written by Epicur Pharma’s Advisory Council member Jan Woods, a veterinary hospital consultant, and national speaker with expertise in DEA compliance, state and federal regulations, and clinic and hospital practice management.
Below, Jan outlines how to properly manage a spilled or broken bottle.
Have you ever broken or spilled a bottle of a controlled substance? If so, did you document it? Correctly, according to the Drug Enforcement Administration (DEA) regulations?
Answering no to either of those documentation questions could mean your practice is at risk. The stocking of controlled substances in veterinary practices offers several benefits to patient care, but it also means veterinarians and staff must stay up to date on proper documentation, handling, storage, and disposal methods to ensure the practice remains compliant.
Mistakes happen – bottles spill or break. Keep these small messes from turning into larger ones by improving your compliance with DEA regulations!
5 Reminders for Properly Documenting a Spilled or Broken Bottle of a Controlled Substance
- A spill or breakage does not constitute a loss because the registrant can account for the controlled substance.
- A spill or break does not require notification to the DEA, per 70 FR 47096and 68 FR 40578. However, the DEA specifically states that the registrant “should continue to employ common sense, good faith approaches to their reporting, and recordkeeping obligations in the case of breakage and spillage.”
- The person who spilled or broke the bottle and a witness (2 people total) must immediately date and log the spill or break in your controlled substance reconciliation log, by schedule and list the reason for the break or spill. For example a bottle accidentally broke or spilled/unintentional loss.
- Dispose of the controlled substance spill or break according to controlled substance medical waste regulations.
- Fill out a DEA Form 41 completely, using the same reason for the break or spill as written in your controlled substance reconciliation log. For example, a bottle accidentally broke or spilled/unintentional loss. Keep the break or spill on file with your controlled substance recordkeeping. *Reminder* your state regulations may differ from the DEA’s
If you need any type of controlled substance guidance, logs, forms, pre or post-audit, or a controlled substance policy, you can find more at askjanforhelp.com.
Thanks for the insights, Jan! Want to hear more from Jan? Check out our previous blog from her about helping veterinary practices better understand the value of 503B manufacturers.
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The Stokes & Bova Partnership: Transforming Veterinary Medicine
Our sister division, Stokes Pharmacy, and the Bova Group have almost parallel stories—pharmacies with retail roots that expanded into compounding to better serve a larger audience with the highest quality medications possible. Both organizations have made a significant impact in the countries they serve—Stokes in the US and Bova in Australia and the United Kingdom—and they’ve both raised the bar for quality of care in veterinary medicine. In the Spring of 2024, the two organizations announced they were partnering to bring life-saving treatment for cats with feline infectious peritonitis (FIP) to the United States. Since the announcement and the availability of the treatment, GS-441524, Stokes Pharmacy has successfully treated thousands of patients. The partnership didn’t end with the rollout of GS-441524. Soon, we will be announcing the availability of Omeprazole Injection for horses—a first in the United States and made possible through our collaboration with Bova Group. Together, our groups are changing the lives of pet owners and veterinarians alike. We are excited to work hand-in-hand with a group that is as dedicated to transforming veterinary care as Stokes Healthcare is. Brett Davidson, former Bova National Sales Manager in Australia and new Stokes Healthcare (Stokes and Epicur) National Equine Sales Manager, shares his unique insider’s perspective on how the two organizations are changing the landscape of veterinary medicine. Brett, tell us about your previous work at Bova and a brief background about the company. So, I worked at Bova for 16 years in Australia. I launched the expansion of the company with Nick Bova, the owner, so you could say I was employee number one, I suppose. Nick took over in 2008 after finishing his pharmacy degree. I started the same year, and we built the business in Australia from there. And then in 2017, Nick went to the UK and started that office, focusing on specialty medications for UK veterinarians. Emma Jones, Sales Director for Bova UK, was one of the first ones to help him there. And now, Bova has grown to what it is today. Because I knew the company so well, I was a jack of all trades, but my main role was organizing my sales team and our customer relationships. I worked with a lot of corporate accounts, buying groups, larger hospitals, and specialty centers. I supported my team however was most valuable to make sure we keep our clients. And now you’ve joined the Stokes Healthcare team! Tell us how that move came about and your new role. It’s great here, and I’m thrilled to be part of the team. The story of how it all happened isn’t particularly exciting, ha! I noticed that Stokes Healthcare was advertising for an Equine Sales Account Manager, so I reached out to Michael Tursi to discuss the role and his vision for it. True to form, Michael was very open and accommodating, making it easy to have an honest conversation about the opportunity. Given my experience with some of the equine products that Epicur and Stokes are launching, I’m hopeful that I can help the team break into the equine market here in the U.S. I’m really enjoying this new challenge, learning a lot, and having a great time working alongside such a dedicated team. Back to your start at Bova and the expansion – what was the vision for expanding Bova into compounding and the veterinary market? Bova chemists had been around for years, with Nick’s dad starting the business in 1968. In Australia, a pharmacy can only be owned by a pharmacist, it can’t be owned by a group or corporate, so Nick took over the retail pharmacy after graduating from university and Bova started compounding at the same time. At first, it wasn’t specifically for veterinary medicine, we were just doing compounding for human medicine, but we had a lot of the big box retail pharmacies starting to take over. They would buy a number of pharmacies in different locations, and then reduce their margins considerably. Being that Bova was an independent, we would have had to compete with these larger corporate types of pharmacies that are known for cutting prices. So, instead of trying to compete on a retail pharmacy level, Nick explored what else might be available. That’s when he came across compounding and decided that would be the direction he’d prefer to go in rather than trying to compete on price. What sets Bova apart from other compounders? In Australia, Bova built its foundations on the quality of what they do and innovation. To be honest, they are the only compounder in Australia that has continued to release new products for the veterinary industry. So, whether it’s a long-acting injection or a combination of medications for behavior or anxiety, Bova has always been first to the market with a new product. Competitors will usually follow after a year or two and release the same products. Bova is always trying to find new ways to help treat veterinary patients, that’s how they’ve really built a reputation for innovation. I think the GS tablets are a perfect example of that. We were the only ones in the world, for a long time, that had that product, and we worked with a lot of international KOLs (Key Opinion Leaders) to get it right and release it. It was amazing to be a part of. And then, in Australia, it’s a differentiator how we focus a lot on quality. There are no kind of regulatory agencies actively monitoring pharmacies with compounding as much as they do in the US or the UK. Obviously, you still have the pharmacy councils and boards, but there’s no system in place where pharmacies or pharmacists can acquire certain licenses or approvals, like 503A or 503B in the US, to make certain products their facilities don’t have. At Bova, we implemented our own kind of quality assurance program based on GMP guidelines, or good manufacturing practices, which is the same as the pharmaceutical standard that Epicur has to reach.
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Advancements in Compounding – A Commitment to Integrity and Quality
The following blog is written by Epicur Pharma’s Advisory Council member Jamie Rauscher, LVT. Jamie is the current president of the National Association of Veterinary Technicians in America, vice president of the Georgia Veterinary Technician & Assistant Association, and part owner and medical manager of the Animal Hospital of Towne Lake. Below, Jamie shares her perspective on the advancements in compounding based on her visit to the Stokes Healthcare facility. From Jamie Recently, I had the opportunity to visit Stokes Healthcare, the parent company of Stokes Pharmacy and Epicur Pharma in Mt. Laurel, New Jersey. My tour of their facility was not what I had expected. I was blown away by what I saw. As a new member of the Stokes/Epicur Advisory Council, I initially sat down and had a get-to-know-you and update session with the Director of Marketing and one of the owners of the company. We talked about new things to come into their world from a pharmacy point of view and the things that they had worked on that they had been successful with in the past. The Complexities of Laws and Regulations around Compounding We also discussed updated pharmacy regulations regarding compounding laws. Part of our conversation centered around new compounded medications, like the FIP treatment, Bova GS-441524, and the impact they will have on our profession. There is a lot of misinformation out there, especially because the black market has made those desperate for a solution compromise their best judgment and purchase medications from companies with NO regulations. There finally is a viable treatment in the United States and Stokes’ partnership with BOVA made it happen. Treatment for FIP is now Available! Learn more about the life-saving medication and order today! Bova GS-441524 A Seat at the Table as a Technician Being asked for my input along with being recognized for my knowledge base and expertise as a technician was refreshing and appreciated. Technicians spend a large portion of their time communicating with owners about the medications that have been prescribed and the best way to obtain and administer them. Creativity is the key more often than not. When touring their compounding facilities, being able to see the behind-the-scenes part of their process was eye-opening. The protocols that are put in place for sterility and quality control are amazing. Being able to see these things in person gave me a whole new respect for their compounding pharmacies. The size of their businesses, their growth history, and their continued focus on integrity and quality make me hopeful for our profession. Explore our 503B Facility! Training Equipment Facility Testing Quality Control And More! Witnessing these things in person also allowed me to get a better sense of how the company works and will let me continue to grow in my partnership with the Epicur/Stokes family. I am a proud supporter! Thank you for sharing these insights, Jamie! More Resources New USP Guidelines: What Changes Impact My Veterinarian Practice? 3 Reasons You Should Make the Switch to a 503B Pharmacy Partner 503A or 503B—Knowing When to Order from Each One