Frequently Asked Questions

Medical Food Support
Consuming VSL#3
VSL#3 Ingredients
Safety Information

Do I need a prescription to buy VSL#3?

Although the FDA does not mandate that patients obtain a prescription for medical foods, Sigma-Tau requires  a prescription for VSL#3 DS. We are dedicated to the safety, health and wellness of our patients. As a high potency probiotic medical food, VSL#3 manages the serious digestive disorders of IBS, ulcerative colitis and an ileal pouch and is intended to be used under medical supervision as per the FDA’s criteria.

Sigma-Tau believes that obtaining a prescription and complying with their physician’s instructions will ensure that patients achieve the best possible outcome from therapy, and will help to prevent any self-diagnosis, self-medicating, confusion in consumption and dosage, and infrequent follow up with a medical professional.

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Do I need a prescription to buy VSL#3-DS Sachets?

Although the FDA does not mandate that patients obtain a prescription for medical foods, Sigma-Tau requires  a prescription for VSL#3. We are dedicated to the safety, health and wellness of our patients. As a high potency probiotic medical food, VSL#3 manages the serious digestive disorders of IBS, ulcerative colitis and an ileal pouch and is intended to be used under medical supervision as per the FDA’s criteria.

Sigma-Tau believes that obtaining a prescription and complying with their physician’s instructions will ensure that patients achieve the best possible outcome from therapy, and will help to prevent any self-diagnosis, self-medicating, confusion in consumption and dosage, and infrequent follow up with a medical professional.

What is a medical food?

The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” If you wish to learn more, please go to the FDA website link below.
http://www.fda.gov

What does “Under Medical Supervision” mean?

Under Medical Supervision means that the consumption of the product (in this case VSL#3) can only be by a patient receiving ongoing medical care for the dietary management of the product-designated diseases under the supervision of a physician who has determined that VSL#3 is necessary to the patient’s overall medical care.

Are VSL#3 and VSL#3-DS FDA approved drugs?

No. VSL#3 and VSL#3-DS are high potency probiotic medical foods that should only be used under medical supervision. They are for the dietary management of IBS, UC and an ileal pouch. .

Is VSL#3 covered by insurance?

VSL#3 may be covered by some insurance providers and managed care organizations. For more information please refer to your insurance provider or managed care organization.

This site is intended to use by U.S. healthcare professionals only

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