FDA Registered 503B Outsourcing Facility

Meet Epicur’s Advisory Council: Jan Woods Shares How She Helps Veterinary Practices Better Understand the Value of 503B Manufacturers

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Controlled substances compliance and 503B manufactured products are two areas that create a lot of questions for DVMs. Jan Woods, a veterinary hospital consultant and national speaker with expertise in DEA compliance, state and federal regulations, and clinic and hospital practice management, advises DVMs on how to navigate regulations in their practices. With over 30 years in human and veterinary medicine, Jan understands the challenges facing the veterinary industry. She brings an important perspective to Epicur Pharma’s Advisory Council.

We sat down with Jan to learn more about what she commonly advises a veterinary practice on when helping them better understand such important regulations.

Hi, Jan; thank you for taking some time with us. What are the principal benefits you advise veterinary practices on when comparing the use of a 503B outsourcing facility versus a regular compounding pharmacy?  

Having a good 503B outsourcing facility that you can trust and depend on is an incredible convenience for the veterinarian, their patients, and their patients’ owners. I think the biggest time- and cost-saving benefit is when buying compounded controlled substances or legend drugs from a 503B manufacturer, such as Epicur Pharma, a practice can use those drugs for all their patients any time they are needed. When controlled substances and legend drugs are ordered from a regular compounding pharmacy, as veterinarians already know, those drugs can only be administered in-house to the specific patients for whom they were ordered.

Another great benefit of a 503B manufacturing partner is the veterinarian’s ability to dispense the compounded controlled substance or legend drug directly to the patient or pet owner at discharge. This supports better treatment compliance even after the patient leaves the practice.

Both benefits can help the veterinarian stay compliant with the tricky state and federal compounding regulations that impact a regular compounding pharmacy but don’t impact a 503B manufacturing facility. Not only can a veterinarian reduce their risk, but they can also increase their revenue through several of these time- and cost-saving benefits.

What are some of those time and cost savers?
  1. The veterinarian does not have to call in a prescription to a compounding pharmacy or write a prescription because it’s available at the practice ready for administration or dispensing to any patient.
  2. The client does not have to stand in line at a compounding pharmacy (if one is available in their community) or wait for the USPS to deliver their pet’s compounded prescription, which can cause a delay in treatment or healing.
  3. The veterinarian can dispense a 503B controlled substance or legend drug directly to any patient that needs the drug. This improves owner compliance and helps to assure that the pet will not miss an important dose.
  4. Traditional compounding pharmacies are regulated differently by both state and federal regulations than 503B outsourcing facilities. That means a veterinarian’s risk is increased if he/she orders a compounded drug from a traditional 503A compounding pharmacy for one patient (as required by regulations), but he/she administers or dispenses it to other patients in the practice. As mentioned, a 503B outsourcing facility is immune from this regulation.
  5. Using a controlled substance ordered from a 503B manufacturer reduces the veterinarian’s risk, saves time, and improves patient compliance. It’s a win-win for the veterinarian, patient, and client!
With the influx of internet medications manufactured overseas, product integrity is something else that many veterinarians are concerned about when ordering from a new supplier. How do you reassure veterinarians and practices of the safety that comes with partnering with a 503B?

503B outsourcing facilities manufacture drugs according to cGMP, or current Good Manufacturing Practices, that are overseen by the FDA to ensure high quality drugs; 503Bs, like Epicur Pharma, manufacture products with consistent potency, sterility, and purity in every batch. In working with Epicur Pharma, I have become very familiar with their facility, as well as their team, and I trust them implicitly. 

Are there any other nuggets or interesting facts that you tell your clients about or that you feel readers should know?

Absolutely! After all, it’s the little things in life that make the difference, isn’t it? This may seem trivial, but it’s not. If you are trying to administer and log Buprenorphine from those tiny 1 ml vials or those glass pop top vials, it can be frustrating and time consuming. Luckily, Epicur Pharma has come to our rescue with Buprenorphine available for purchase from their 503B facility in 10 ml and 50 ml vials! From a daily workflow and DEA logging standpoint, this makes a surprising difference as it’s just so many fewer containers to track!

Additionally, Epicur Pharma now makes chemotherapeutic drugs in individual blister packs. That’s amazing since chemotherapeutic state and federal regulations have tightened over the years and rightly so to protect the patient, veterinarian, and the nurse. An individual blister pack helps prevent unneeded chemotherapeutic agent exposure to the veterinarian and the nurse and helps to assure a more accurate dose for the patient.

So, after reviewing all the benefits provided to veterinarians and their staff, from my point of view, there is just no reason not to purchase from Epicur Pharma.

Thanks for sharing your insights, Jan! 

Dive deeper into the differences Jan highlighted between 503As and 503Bs with these resources:

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