FDA Labeling Requirements for Drugs
The Food and Drug Administration of United States requires that all drugs and foods are labeled with the information about that food or drug. This is done for the safety of the general public. This information can prevent the ingestion of an allergen and the toxic interaction between drugs. There are special rules for those companies that package drugs that help to ensure public safety.
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Bar Codes
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Most bar codes are associated with check-out information at the grocery store. The FDA requires that the drug labels include a bar code. This bar code is encrypted with information about that drug. These bar codes help to protect the population from medical error and drug interactions. This information can include the dosage amount and the drug interaction information. The minimum amount of information required on these bar codes is the National Drug Code number.
Manufacturing Information
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The drug label must include information about the manufacturing of the drug. This includes the company that has manufactured the product, the location of the factory and the distributor. The batch number is often printed. This can help to narrow down the source of a problem with the medication. If a medicine appears to be contaminated, the FDA can then use this information to determine where the problem originated and remove the product from the store shelves and allow customers to return the product.
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Product Contents
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The FDA requires that the drug company provides the dosage amount and the amount of the medication in the bottle. This can be determined in either the weight or numeric count of the product. This is to ensure that the dosage is correct and that there is enough medicine for the prescribed amount. This also helps to limit the chances of purchasing additional medications for resale.
Directions for Use
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The drug label is required by the FDA to provide information about the use and misuse of the drug. This includes the potential drug interactions and overdose information. This is done to protect the public by informing them or reminding them about how to use the medication and the potential harm of misuse. There will also be specific information regarding the dangers of overdose to children under a certain age or size.
Additives
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Additives to the medication for the use of color or flavor only are required to be noted on the drug label. This is done to help prevent confusion between non-colored or flavored medication and colored or flavored mediation. This is also done to prevent people with allergies to some colors and flavor agents from using the medication.
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References
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