ABSTRACT

Drug product tampering is the deliberate alteration of products after they have been produced or manufactured. This applies to the product itself as well as the containers or labeling. The majority of over-the-counter drugs are required to have at least one indicator or barrier to entry that is capable of providing visible evidence of tampering. Tampering is distinct from other illegal practices involving commercial products such as counterfeiting, violation of manufacturing standards, and diversion of products from intended markets. Tampering and threats of tampering of drug products are federal crimes, and the Federal Bureau of Investigation and the Food and Drug Administration should be consulted when product tampering is encountered or suspected. Both of these agencies have specialized resources dedicated to tampering investigation. Distinct from over-the-counter drugs, dietary supplements and prescription drugs continue to be available in capsule form.