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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]
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.
ISO 22715 is not legally binding, but it is the common denominator used for developing national regulations that address the labeling and packaging of cosmetic products. Regulators in individual countries often look to ISO standards as the benchmark for best practices for the different industry sectors in which they apply.
Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary. Instructions and procedures must be written in clear and unambiguous language using good documentation practices. Operators must be trained to carry out and document procedures.
It also talks about the FDA citizen petition. The 1100 series includes updated rules deeming items that statutorily come under the definition of "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco. [5]
The Fair Packaging and Labeling Act required all "consumer commodities" to have a label. Under the act, consumer commodities were defined as any food, drug, device, or cosmetic, that is produced or distributed for sale through retails sales/agencies for consumption by individuals or used by individuals for the purpose of personal care.
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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.