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The substance must be shown to be "generally recognized" as safe under the conditions of its intended use. [2] For new proposals, the proponent of the exemption – usually a food manufacturer or ingredient supplier wishing to highlight a food ingredient in its manufactured product – has the burden of providing rigorous scientific evidence ...
The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...
This list of pharmaceutical compound number prefixes provides codes used by individual pharmaceutical companies when naming their pharmaceutical drug candidates. . Pharmaceutical companies generally produce large numbers of compounds in the research phase for which it is impractical to use often long and cumbersome systematic chemical names, and for which the effort to generate nonproprietary ...
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or ...
The United States Food and Drug Administration (FDA) lists these items as "generally recognized as safe" (GRAS); [4] they are listed under both their Chemical Abstracts Service number and FDA regulation under the United States Code of Federal Regulations. See list of food additives for a complete list of all the names. [citation needed]
The Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA).
A drug reference standard or pharmaceutical reference standard is a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.