The Food, Drug, and Cosmetic Act of 1938 is one of the most important pieces of legislation in pharmaceutical history. You learned (or will learn) in Pharmacy Law that the act created the Food and Drug Administration (FDA) in order to regulate newly manufactured drugs to ensure they are safe.
Once a drug has been approved, the FDA also oversees the side effects and adverse reactions of the product. They have the authority to recall any drug that is contaminated, of poor quality, or that causes serious adverse reactions. In some cases the FDA may even withdraw the drug from the market if the manufacturer doesn’t voluntarily do so.
The FDA has come up with 3 classes of recalls:
A reasonable probability exists that the use of the product will cause or lead to serious adverse health events or death. An example of a product that could fall into this category is a label mix-up on a lifesaving drug.
The probability exists that use of the product will cause adverse health events that are temporary or medically reversible. This is the drug recall you will deal with the most. One example would be if there were an interaction between the drug solution and the glass vial that may lead to tiny flakes of glass inside the vial.
The use of the product will probably not cause an adverse health event. Examples might be a container defect, off taste, or color in a liquid.
In order for you to “protect your patient” as a pharmacy technician, it will be important for you to know your pharmacy’s guidelines for removing recalled products from the shelf and notifying the patients who may be affected by a drug recall.