What are the legal requirements for the labeling of pharmaceuticals?

In California, pharmaceuticals must meet certain legal requirements when it comes to labeling. According to the California State Board of Pharmacy, pharmaceutical labels must have the following information: the name of the product, its expiration date, the formulation, the dosage form, the quantity of the drug, the manufacturer’s name and address, the lot number, directions for use, warnings for use, the name and address of the dispensing pharmacy, a list of the ingredients, and the National Drug Code (NDC) number. Labels must also be written in English and it is recommended to include other languages if a majority of the population speaks those languages. The label must also include a symbol or warning if the drug should be kept out of the reach of children. Additionally, the labels of injectable medications must include a notation if the product is sterile or non-sterile. Labels must also be legible and printed in a durable fashion, as well as be resistant to wear and tear. Furthermore, the labels must be resistant to fading due to light and heat. Finally, The Federal Food, Drug, and Cosmetic Act requires all medicines, ointments, or other treatments to be labeled with warnings and precautions. This includes risks that could occur from using the product, such as allergies or adverse side effects. It is important for all consumers to read the labels before using any pharmaceuticals, as failure to follow directions and warnings can have dangerous consequences.

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What are the legal requirements for the labeling of pharmaceuticals?

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