Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products

The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging to require that all over-the- counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed using a tamper-evident technology; to change the term ``tamper-resistant'' in the labeling of all OTC drug products to ``tamper-evident;'' and to specify that the required OTC drug product labeling statement must refer to all packaging features used to comply with the tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure, and any capsule sealing technologies used. FDA is taking this action as a result of its continuing review of the potential public health threat posed by product tampering and to improve consumer protection by addressing specific vulnerabilities in the OTC drug market.