What does tamper-evident mean?

The packages of most over-the-counter (OTC) drug products have at least one thing in common: They must be tamper-evident. A tamper-evident package, according to the regulations of the Food and Drug Administration (21 CFR § 211.132), "is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred." In addition, the indicator or barrier must be "distinctive by design," which means the tamper-evident feature is designed from material not readily available to the public. Therefore, it can't be easily duplicated. The labeling must also include a description of the safety feature. For blister packaging, each tablet or capsule is individually sealed, so any form of tampering is immediately visible. The product label needs to include a statement similar to the following: "Do not use if blister is cut or broken."

May 10th, 2005

A bottled product could utilize an induction seal, glue seal, or shrink band to meet the tamper-evident requirement. The use of any of these options will show the consumer that if absent or damaged, tampering has likely occurred. The product label would include a statement such as "Do not use if seal on bottle printed 'sealed for you protection' is broken or missing," or "Do not use if neck wrap imprinted safety seal is broken or missing."

--By Linda McBride, registered pharmacist

Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread, and Novartis Consumer Health. She holds a B.S. in Pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.