FDA Amends Regs on 'Tamper-Resistant' Packaging

The Food and Drug Administration (FDA) is amending its regulations on tamper-resistant packaging (21 CFR 211) 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. The effective date is December 4, 1998.

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.