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It is one of 26 published standards that are devoted to the cosmetic industry sector. [1] ISO 22715 does not regulate what products are to be considered cosmetic. This determination is left to the national regulations of those countries that follow the ISO 22715 and use it as a guide to best practices for packaging and labeling cosmetic ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
The 600 series covers biological products (e.g. vaccines, blood): 601 Licensing under section 351 of the Public Health Service Act; 606 et seq. cGMPs for human blood and blood products; The 700 series includes the limited regulations on cosmetics: 701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
In the United States, companies must comply with the Federal Food, Drug and Cosmetic Act. Although the FDA does exercise authority over the cosmetic industry, it does not allocate sufficient resources to constantly monitor the industry. ISO defines an ingredient as a material that makes up the final product and not necessarily raw materials ...
A guidance document of the FDA states: [5] An imported product, such as shrimp, is peeled, deveined and incorporated into a shrimp dish, such as "shrimp quiche." The product is no longer identifiable as shrimp but as "quiche." The quiche is a product of the US. So labeling it as "product of the USA" would not be a violation of the FFD&C Act.
In the U.S., under the Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, certain accurate information is a requirement to appear on labels of cosmetic products. [6] In Canada, the regulatory guideline is the Cosmetic Regulations. [7] Ingredient names must comply by law with EU requirements by using INCI names. [8]