Why IV Therapy?

Injectable Nutrition: A Different Approach to Nutritional Supplementation

Micronutrients are found in small amounts within the foods that we eat and have important functions in the body. They include vitamins, minerals and amino acids. Administering nutrients via injection or intravenously (IV) allows for much higher concentrations to be infused directly into the body for various uses.

There are many reasons a person may require nutrient supplementation. Here are a few of the common conditions that may result in nutrient deficiencies or the need for higher concentrations:

• Malabsorption secondary to chronic inflammation caused by food intolerances, gastrointestinal issues or chronic NSAID usage
• Chelation, chemical toxicity
• Immune disorders
• Hypertension
• Chronic obstructive pulmonary disease (COPD), asthma
• Elevated liver enzymes
• Acute and chronic viral infections
• Drug/alcohol withdrawal
• Dehydration
• Esophageal spasm
• Pain-management medication
• Adjunctive cancer treatment

Medical clinics across the U.S. with different specialties offer customized nutrient combinations for a multitude of conditions using IV drips or injections that are usually designed by the physician and a compounding pharmacist who specializes in sterile formulations.

Common Reasons Patients Seek IV Therapies

IV therapy is an increasingly popular service that patients are requesting for various reasons:

• Anxiety and mood issues
• Athletic performance
• Muscular endurance and pain reduction
• Acute alcohol “hangover” symptoms
• Alcohol/drug withdrawal
• Acute viral infection
• Fatigue
• Hydration and nutritional supplementation

What Are the Results of IV Therapy?

Depending on the combination administered, patients and healthcare providers consistently report these effects and more:

• More energy
• More relaxed
• More focused
• More hydrated
• Less pain
• Less anxiety
• Improved sleep
• Improved mood
• Improvement in acute symptoms (e.g., body aches from the flu)
• Improved breathing (e.g., reduced asthma symptoms)
• Faster recovery from illness or injury
• Increase in performance and muscular endurance

In most cases, patients leave feeling better after receiving an IV.

Choosing the Right Vendor for Injectable and IV Nutrition Products

Finding a vendor that is an FDA-registered 503B outsourcing facility is important. They should carry a comprehensive catalog of injectable nutrients and strictly follow the FDA’s current good manufacturing practices (CGMPs). Every batch should be tested for stability, sterility, endotoxins, potency, pH and osmolarity. If they are not in the state where your clinic is located, they will also need to be licensed to ship preparations into that state.

503B outsourcing facilities, sometimes called 503B pharmacies, are registered with the FDA and qualified to manufacture custom medications meant for treatments performed by a licensed healthcare provider at the clinic. 503B outsourcing facilities are required to follow a higher standard of quality controls than traditional compounding pharmacies that make custom medications, including CGMPs.

Partnering with the right 503B facility is especially important for sterile formulations prescribed for IV use. The facility will confirm the stability of each custom formulation to ensure product potency and sterility for its entire shelf life (beyond-use date). Some common ingredients are not stable in certain combinations, so the higher level of quality controls will offer the provider assurance in each formulation. Additionally, since IV therapy is performed in the office and can involve walk-in patients, it is important to be able to maintain inventory by ordering products in bulk without a prescription, something only a 503B facility can offer in most states.

The FDA maintains an updated list of registered 503B outsourcing facilities. Not all facilities specialize in the same products, so it is important to find one that offers IV nutrition, including the formulas needed for treatment protocols.

Product Stability Studies

CGMPs require sterile drug manufacturers to perform stability studies to ensure that a drug product will retain its quality (e.g., strength) and remain sterile through the labeled beyond-use date.

The testing involved with these studies includes pH, particulate, appearance, preservative effectiveness, preservative content, method suitability, container-closure integrity, potency, endotoxin and sterility, all of which are detailed in the United States Pharmacopeia (USP).

It is important to confirm that any final product used for IV nutrient supplementation has undergone stability studies. According to federal and state laws, all office-use medications must be sourced from either a 503B outsourcing facility or commercial drug manufacturer. Choosing high-quality sterile ingredients to infuse is the most effective step to minimize risk.

Why Compounding Is Important to Your IV Practice

Modern IV nutrition clinics require a source of the ingredients used in IV treatments. Identifying a compounding pharmacy to build a relationship with is important since many of the formulas used are not available through commercial suppliers due to shortages or because there is no commercially manufactured product available on the market. Compounding pharmacies that specialize in sterile formulations can produce unique products used in IV treatments in addition to offering commercially manufactured products when they are available.

It may take more than one pharmacy to supply all of the ingredients, however, depending on what the provider needs for each IV cocktail. The number of available commercial nutrients on the market is limited; therefore, a compounding pharmacy is necessary to have access to all the common vitamins, minerals, amino acids, chelating agents and specialty nutrients used in modern therapies. Not all compounding pharmacies are the same, though.

Traditional 503A compounding pharmacies can produce smaller, patient-specific batches of custom medications, but they are usually not able to ship larger quantities of compounded product directly to the clinic without a patient-specific prescription. In addition, to allow 503A pharmacies to reduce cost and turnaround time for single patient-specific prescriptions, they are not required to follow CGMPs or register with the FDA.

A 503B outsourcing facility is basically a compounding pharmacy that has registered with the FDA to manufacture larger batches of custom pharmaceutical products that are administered to patients by a practitioner as part of a treatment or procedure. 503B outsourcing facilities have stricter quality controls as well, including the requirement to prove the stability of custom IV formulations, which is a very important aspect of quality assurance for the provider and patient.

Sometimes, it may benefit an IV therapy practice to have a 503A and 503B source to cover all custom pharmaceutical needs, including both patient-specific and office-use formulations. As a result of growing demand for these treatments, however, there are now a few multi-facility pharmacies who offer both 503A and 503B product lines with focus on hormone and nutritional therapies.

All compounding pharmacies are unique and specialize in different areas depending on the communities they serve. It is therefore important to identify a compounding pharmacy that offers what your practice needs and can support you in treating patients.