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.