How to Label an Investigational Drug

The FDA and other regulatory agencies require that investigational drug products be maintained and tracked. It is also a requirement that they be properly labeled to ensure the recipient is aware that it is not an approved medication. To ensure you meet those requirements, follow the steps outlined in this article.

Things You'll Need

• An investigational drug product
• Labels

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Instructions

• 1

  Hire a professional.

  Depending on the number of labels you need, it might be best to hire a clinical packaging and labeling company to create the labels for you. Several are listed on the internet and professional periodicals.

• 2

  Create a draft.

  If you only need a manageable amount, create a draft of the investigational product label to ensure that all information is present and work from it.

• 3

  Add disclaimer.

  A major requirement is that the label must have the statement "Caution: New Drug--Limited by Federal (or United States) law to investigational use."

• 4

  Include basic information about the investigational drug.

  The label must identify the following: 1) name of the drug product, 2) storage conditions (such as temperature and humidity), 3) name of manufacturer, 4) strength or dosage, and 5) name of person to contact in case of an emergency.

• 5

  Include protocol information.

  For tracking purposes, most sponsors will include the name and protocol number on the investigational drug label.