Traditional 503A compounding pharmacies and 503B outsourcing manufacturers both serve as important partners for veterinary practices, providing patient-specific prescriptions and manufacturing bulk drugs for in-practice use and dispensing when allowed by state regulations. Having a trusted partner is important to practice success and quality patient care.
So, how do you know which 503A and 503B partners are best for your practice? Different guidelines regulate each type of provider, but there are standards of quality you can look for regardless of regulations to know you’re getting the best products to provide the best patient care. Use the following five marks of quality to find your right-fit veterinary pharmacy partner.
1. High Standards for Safety
Safe, clean facilities are vital when it comes to preventing drug contamination.
503A compounding pharmacies follow USP <795>, <797>, <800>, and SBOP regulations with the State Board of Pharmacy primarily overseeing them. Because these traditional compounding pharmacies provide individual formulations per patient, their testing protocols are different and less regulated. As a result, the testing requirements for 503A compounding pharmacies are not as stringent as they are for 503B outsourcing manufacturers, potentially increasing potency and consistency variations between preparations.
503B outsourcing manufacturers are overseen by the FDA, meaning they follow cGMP standards – the same standards as human drug manufacturers. These higher safety and testing requirements mean drugs from a 503B partner go through strict stability, sterility, and potency testing per batch.
Want to verify the quality of the preparations and drugs your patients and office are receiving? Order from a 503B manufacturer like Epicur Pharma. Every batch of Epicur products has a certificate of analysis backed by a proven FDA process. The certificate of analysis includes the results of any pertinent testing (potency, sterility, endotoxin, bioburden, etc.) performed on the batch. Ask to see those test results. Any valuable and trusted partner will have the results on-hand to share and will take the time to help you understand the testing process. Prefer to script out? Epicur Pharma’s manufactured products are conveniently available through its sister division, Stokes Pharmacy, for individual patient prescriptions.
2. Proven Record of Consistent, Quality Products
In veterinary pharmaceuticals, small inconsistencies in drug composition can be devastating for pets. Because the 503A compounding process is less precise than manufacturing, there is a greater risk for batch-to-batch variances. In many cases, those variances have led to compounding tragedies. Further research confirmed these wide variances in medications from compounding pharmacies, ultimately leading the FDA to establish the veterinary 503B category. Large batch production in 503B manufacturing leaves less room for human error and is highly tested, meaning consistent outcomes are more likely.
Need a refresher on the difference between 503A compounding pharmacies and 503B outsourcing facilities? Our blog gives you a comprehensive look at the two.
3. Accurate Ingredient Labeling
Accurate labeling also applies more in 503A pharmacies than 503B outsourcing facilities due to stricter regulations on 503B manufacturers. 503A pharmacies have less testing, or sometimes no testing, to verify their label claims. Due to the lack of testing, particular batches may not contain the exact requested dosage needed. In contrast, what is stated on a 503B label is what the patient actually gets due to the strict and reliable quality, potency, and sterility testing for each batch.
4. Inventory Availability
Drug shortages can have a ripple effect – your practice could run into a critical patient case that needs a specific drug immediately, and care and recovery can be delayed due to low or unavailable stock or delay in availability.
Download our digital or printable product lists to see all of the drugs we offer, available dosages, and the forms they’re manufactured in.
503B manufacturing facilities’ ability to dispense large quantities of traditionally compounded veterinary medications provides your practice with cost savings and helps you speed up patient treatment when you can dispense in-house. Unfortunately, a partner who is unable to keep your inventory stocked creates risk for your practice.
Monitor your 503B manufacturing partners’ inventory list regularly so you can stay stocked for critical moments. Look for a partner who has a large portfolio, is growing their portfolio, and communicates early and effectively when there is a shortage or delay.
5. Additional Services and Ordering Options
Even if a company has excellent safety, quality, ingredient integrity, and inventory, it still may not be the best company to work with. Do they provide options for easy ordering and fast delivery? Are their reps helpful? Does their team answer your questions and offer guidance on the best ordering options?
A partner that goes the extra mile to provide easy ordering systems with options that fit your practice’s needs can make a big difference in workload for you and your staff. If you have a dedicated inventory manager, get their input on what would make stocking processes easier. A seamless ordering and stocking process gives you more time to focus on your patients or life outside of work.
Choosing a 503A or 503B veterinary pharmaceutical partner is a highly personal decision and depends on the individual practice and its needs. If you have a trusted partner of one type, 503A or 503B, but are looking to find someone you trust to fill the other types of orders, explore if that trusted partner has a sister company.
As Epicur and Stokes Pharmacy partners know, our sister companies provide veterinary practices with both patient-specific scripts and bulk orders of the highest degree.