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We understand that many individuals are concerned about what they put into their bodies. When it comes to taking supplements, it’s important to use quality ingredients that render healthful and effective results. It’s also important to know where and how these supplements are manufactured. Our goal is to provide our patients with quality supplements that are trustworthy and effective. To ensure this, we attain all of our IV supplements from a 503B pharmaceutical manufacturing facility.
What is a 503B Facility and why do we use one?
Since we use a number of supplements to treat our patients, it’s important to know that they are being produced in a facility known for its high standards. That is why we use a 503B facility to produce our products. A 503B facility is a pharmaceutical manufacturing center that follows a high standard of manufacturing practices. This is very important when you are dealing with drugs or supplements that are being injected directly into the bloodstream. Why? Well in 2012 a number of patients around the country began to fall ill after receiving a common steroid that was injected into the spine. After the CDC and FDA conducted an investigation, it was found that the source of the multi-state outbreak stemmed from infected vials produced by a pharmaceutical compounding company that provided drugs to a number of medical institutions around the country. That incident made headlines and inspired the Drug Quality and Security Act in 2013.
Since that point, pharmaceutical manufacturing facilities have been required to raise their standards. This is where a 503B facility comes into the picture. These facilities have an increased standard of quality control standards that ensure the sterility, potency, and efficacy of each drug or supplement manufactured there. These facilities operate under a standard known as Current Good Manufacturing Practice or cGMP. cGMP is a set of regulations enforced by the FDA. Under these standards, each facility is required to test each supply or batch before releasing it for public use. The cGMP standard also requires each pharmaceutical manufacturing facility to procure raw materials from FDA-approved suppliers to ensure that the materials and chemicals are up to standard.
Additionally, each facility is also required to submit every batch of sterile medications to a third party analytical lab to test potency, sterility, and endotoxin content prior to dispensing. Completing these tests prior to releasing the product ensures clinicians that they are administering a sterile medication with accurate potency.
This standard not only gives us peace of mind, but it also helps us to continue providing our patients with quality supplements.
Why We Use a 503B Pharmaceutical Manufacturing Facility:
We carry those same standards into our medical facility. It’s important to know how to properly mix each cocktail. It is also important to know what vitamins and supplements can be mixed together. If the solution is stored too long after it is initially mixed at our facility, the product’s potency could be minimized or nullified. In other cases, certain vitamins, when mixed with other vitamins or minerals, could oxidize and be rendered useless for patient use.
The members of our medical staff are aware of the unique characteristics of certain chemicals and understand that not all cocktail ingredients are treated equally. For example, it’s important to know that methylcobalamin (B12) and ascorbic acid (Vitamin C) are both sensitive to light. In most cases, other clinics may mix these ingredients in a well-lit room and then let them sit out only to lose their effective qualities. All cocktails are created in a sterile room at our facility known as the clean room. This allows us to blend ingredients in a controlled sterile environment. By practicing these high standards, we are able to effectively treat each patient and promote their overall health