What are the regulations governing the production of generic drugs?

In North Dakota, the regulations surrounding the production of generic drugs are outlined within the North Dakota Century Code (NDCC) Chapter 19-03, which enforces the state’s Pharmaceutical Law. This law ensures that only products demonstrating both adequate quality and safety standards are produced. Generic drugs produced in North Dakota must meet high manufacturing standards set forth in the NDCC, the same standards necessary for other drugs. This ensures that generic drugs are both safe and effective for patients. Additionally, all generic drugs must use the same active ingredient, at the same strength, and in the same dosage form. The NDCC also requires that generic drug labels include the brand name, a description of the drug, the strength, the expiration date, and directions for use. The labels also include a disclaimer stating that the product is a generic form of the original, branded product. North Dakota also requires that all generic drugs be manufactured in accordance with the current Good Manufacturing Practices (GMPs). These GMPs are standards that all manufacturers must adhere to in order to ensure the safe production of drugs. All generic drugs must meet these standards to be approved by the North Dakota Board of Pharmacy. By following these regulations, North Dakota is able to ensure that all generic drugs produced in the state are of a high quality and safe to use. This helps to protect patients and ensure that they receive effective treatments.

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What are the regulations governing the production of generic drugs?

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