With a busy schedule and an increasing number of regulations to comply with, it can be hard for veterinarians and their staff to keep up on all aspects of veterinary pharmacy and dispensing. You may have heard the terms 503B, outsourcing, or cGMP used when referring to veterinary pharmaceuticals, but were unsure of what they meant. Knowing terms like these can impact patient care and practice profitability, making it important to understand them.
Below we take a closer look at these terms and offer more clarification on how they impact your practice.
cGMP – Current Good Manufacturing Practice
What It Means:
This term refers to the regulations enforced by the FDA to ensure there is a minimum standard requirement for methods, facilities, and controls in the drug manufacturing process. This is used in both human and veterinary pharmaceutical manufacturing; its purpose is to ensure the safety of the drug for consumption and prove the drug’s effectiveness. cGMP provides pharmaceutical manufactures with a fundamental structure to ensure quality standards are controlled and maintained for, but not limited to:
- Facility design and function
- Procurement from qualified suppliers
- Tracking and traceability of product and components
One significant requirement of cGMP is finished product specifications which require results, obtained through validated testing, that ensure each batch of product meets all quality standards prior to release. If a company follows cGMPs, then quality is built into the process and verified by an independent quality department. Every single step in their manufacturing process is controlled through these practices which is why the quality of products is superior when they are required to follow cGMPs.
Why It’s Important:
Traditional compounding pharmacies, known as 503As, are not held to cGMP standards. This means the medications your patients receive from a 503A can vary in qualities such as potency and sterility from batch to batch. Adulterated or expired medications can potentially lead to adverse effects such as illness and/or death. Partnering with a 503B manufacturing facility or a pharmacy that dispenses drugs manufactured under cGMPs means you receive reliable medications and your patients receive the best treatment.
503B Compounded Drugs
What It Means:
503B manufacturers are referred to as outsourcing facilities by the FDA, but this terminology can be misleading. In simplest terms, a 503B outsourcing facility is regulated by the FDA and manufactures drugs in accordance with cGMP. Because of this, every process in a 503B facility must be validated and traceable. Products manufactured by 503Bs are trusted for stability, purity, and sterility in every batch, so you know exactly what product you are getting every time.
Why It’s Important:
The use of 503B medications can improve patient outcomes and reduce practice liability because correct dosages are required and monitored in every batch, unlike traditional 503A veterinary pharmaceuticals.
Additionally, in 503B facilities, the FDA completes on-site inspections and requires these outsourcing facilities to have a quality control department. Stability is important for veterinary practices because it directly impacts shelf-life. With 503B medications, rigorous testing is performed to determine an accurate product expiration which makes it more reliable for office use. cGMP requires stability testing for all products which allows 503B to extend shelf-life with supporting data. This can help save your practice money because you’re purchasing medications less often.
Although terms like 503B and cGMP can seem confusing or irrelevant to your practice, they can have notable impacts and are important to patient outcomes.