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FDA and National Drug Code NumbersProBLEN products are committed to superior quality from the individual ingredients to the time your ProBLEN products arrive at your door. After 12 years, we have come to work with some of the best Homeopathic and Nutritional formulators and facilities so we can guarantee that each ProBLEN product that arrives at your door meets or exceeds all FDA and GMP guidelines. Q: Are ProBLEN Homeopathic and Nutritional Supplements Manufactured in a FDA Registered Facility?A: Yes, ProBLEN Homeopathic and Nutritional Supplements are manufactured, bottled, labeled, and packaged all in a State and FDA regulated facility. Q: Are ProBLEN Homeopathic and Nutritional Supplements FDA Registered?A: Yes, ProBLEN homeopathic products are registered with the FDA and each received a National Drug Code (NDC) number. FDA regulates ProBLEN’s Nutritional Supplements under a different set of regulations than ProBLEN Homeopathic Supplements because they are considered to be Over-the-Counter medication. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. Q: Why are ProBLEN Homeopathic products subject to regulation by the FDA?The FDA recognizes ProBLEN Homeopathic products as medicines able to treat symptoms and relieve health conditions. Because ProBLEN products are medicines, the FDA maintains full oversight over formulations, manufacturing procedures, product claims and labeling. ProBLEN has received a National Drug Code Number from the FDA for each of its homeopathic products. Note: You can find evidence that the FDA considers homeopathic products to be OTS Drugs in FDA Compliance Policy Guide #7132.15. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm Q: What are National Drug Code Numbers?The NDC is a unique 11-digit, 3-segment number that identifies the Labeler/Vendor, Product, and Packaging. This number is assigned to each medication listed under Section 510 of the U.S. Federal Food, Drug, and Cosmetic Act. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm109201.htm
Q: Can I verify ProBLEN’s NDC numbers online?Unfortunately, the FDA does not include NDC numbers in their online NDC database. The online NDC Directory is not a cumulative director of all products with NDC codes. It is limited to prescription drugs and insulin products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution. |
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