What are the legal requirements for the labeling of pharmaceuticals?

In Nebraska, the labeling requirements for pharmaceutical drugs are strictly regulated by both federal and state law. All drug manufacturers must follow the Food and Drug Administration (FDA) labeling regulations, which are detailed in the US Code of Federal Regulations. At a minimum, a pharmaceutical drug label must include the drug’s active ingredients, dosage form and potency, an expiration date, cautionary statements, and the name and address of the drug’s manufacturer. The label also must include the warning statement “Federal law prohibits dispensing without a prescription.” In addition, some drugs may require additional labeling information, such as labeling for pediatric use or special instructions for safe use. Nebraska also has its own state standards for labeling pharmaceutical products. All drug labels must be kept up-to-date and be accessible to pharmacists at all times. Pharmacists must ensure that the label meets the requirements of both the FDA and the state of Nebraska. In addition, Nebraska requires that drug labels in the state include a statement informing consumers that they may be eligible for co-pay assistance if they have a prescription from a health care provider. This statement encourages consumers to ask their health care provider about any available assistance that might help them cover the cost of their prescription drugs. The labeling of pharmaceuticals is an important component of providing safe, effective products to Nebraskans who rely on these medications to maintain their health and well-being. It is important for drug manufacturers, pharmacists, and health care providers to understand and comply with the laws and regulations in this state.

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