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What’s the deal? Do I need a sterile hood for my IV clinic?

With the growth of IV hydration therapy, many clinic owners wonder, do I need a sterile hood if I’m mixing bags in the clinic? Well, that depends. It depends on whether you are a physician, mixing outside of a manufacturing instructions, and more.

The FDA and state Boards of Pharmacy govern “compounding” facilities. When a facility is mixing, adulterating, or diluting, they’re considered to be “compounding”. This is not the case if you do so in accordance with directions on approved labeling provided by the product manufacturer.

Physicians fall under an exception, however. The FDA says that licensed physicians are exempt from 503A pharmacy laws and the FD&C Act if they are done in a clean and sterile environment, compounded based on a valid prescription, and compounded by the physician. So, it has to be compounded for a patient who presents with an immediate need for the product or because “it would not be safe for the patient to take the drug home for self-administration, and it would be more convenient for the physician to have the drug in his or her office to administer immediately upon diagnosis, rather than asking the physician to order the drug and have the patient return to the health care practitioner for administration.”

This guidance would exempt licensed physicians from requirements to utilize a hood for compounding.

If you’re not a physician, then you should follow FDA guidance on safe practices for compounding.