Unit of Measure for the Denominator Ingredient Strength (taken from the product label)
Where a product was distributed
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes..
The U.S. Department of Health and Human Services
A dietary supplement is considered to be a \"food\" under the meaning of the Federal Food, Drug and Cosmetic Act [21 USC 321]. A dietary supplement is a product (other than tobacco) that is intended to supplement the diet, and that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, herb or other botanical, amino acid—or a substance that is intended to raise a person’s dietary intake; or else, a concentrate, metabolite, constituent, extract, or combination of any ingredient listed here. Additionally, a \"dietary supplement\" is not represented for use as a conventional food or as a sole item of a meal or the diet; and must be labeled as a \"dietary supplement.\"
A substantial disruption of a person’s ability to conduct normal life functions. [Refer to: 21CFR600.80; Subpart D]
One or more reports received together (if a single submission) on a floppy disk, a compact disk, or a DVD.
Can include: destroyed, reconditioned, diverted to animal food, other, or unknown
All records, in any form (including, but not limited to, written and electronic records) that describe or record capabilities, methods, conduct, and/or results of actions taken.
not yet completed and submitted (For registered users, the report will appear in the list of Draft Reports, under \"My Reports.\" Compare to \"Submitted Safety Report.\")
(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement. [Refer to: Sec. 201. [21 U.S.C. 321], Chapter Ii—Definitions 1]
A finished dosage form—for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. [Ref: 21CFR314.3]
An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient. [Ref: 21CFR314.3]
Dun & Bradstreet (D&B) provides a D-U-N-S® Number, a unique nine digit identification number, for each physical location of a business. The number/identifier is free to any business that is required to register with the US Federal government for contracts or grants.