FAQ

Medical Food Support
Safety Information
Recommending VSL#3
The Difference

Do I need to prescribe VSL#3 DS for my patients?

Although VSL#3 DS is not a drug (it is a medical food) and the FDA does not mandate that patients obtain a prescription for it or any other medical foods, Sigma-Tau Healthscience requires  a prescription for VSL#3 DS. We are dedicated to the safety, health and wellness of your 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 and will help to prevent any self-diagnosis, self-medicating, confusion in consumption and dosage, and infrequent follow up with a medical professional.

Do I need to prescribe VSL#3 for my patients?

VSL#3 capsules and unflavored packets do not need a prescription but VSL#3 DS does. Although VSL#3 DS is not a drug (it is a medical food) and  the FDA does not mandate that patients obtain a prescription for it or any other medical foods, Sigma-Tau Healthscience requires a prescription for VSL#3 DS. We are dedicated to the safety, health and wellness of your 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 Healthscience believes that obtaining a prescription and complying with their physician’s instructions will ensure that patients achieve the best possible outcome 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?

A physician’s supervision of patients taking medical foods (MF) is required by both the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA regulations (See 21 U.S.C. § 360ee(b)(3); 21 C.F.R. § 101.9(j)(8)(iv)-(v)). Specifically, the administration and consumption of medical foods are similar to prescription drug products, in that patients must obtain instructions from their physician on the use of MF on a recurring basis and should also be under frequent and continual medical supervision with regard to their use of the MF.

VSL#3 can only be given to a patient receiving active medical care on a recurring basis for dietary management of ulcerative colitis, an ileal pouch or irritable bowel syndrome (IBS) and for instructions on the use of the medical food.

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

 

No. VSL#3 and VSL#3 DS are high potency probiotic medical foods that must be used under medical supervision.

Does the FDA have a Compliance Program specifically for medical foods?

Yes. You can find a copy of the agency’s compliance program at “MEDICAL FOODS PROGRAM – IMPORT AND DOMESTIC (FY 06/07/08)” . Please go to the FDA website link below.
http://www.fda.gov

What is the purpose of FDA’s compliance program for medical foods?

The Compliance Program enables FDA inspectors to (1) obtain information regarding the manufacturing/control processes and quality assurance programs employed by domestic manufacturers of medical foods through establishment inspections, (2) collect domestic and import surveillance samples of medical foods for nutrient and microbiological analyses, and (3) take action when significant violations of the Federal Food, Drug and Cosmetic Act (or related regulations) are found.

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

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