US FDA Amends Anti-Tampering Rule For OTCs

The US Food and Drug Administration is amending its tamper-resistantpackaging regulations to require all over-the-counter human-use drugs to be marketed in two-piece, hard gelatin capsules, sealed using tamper-evident technology. A final rule, taking effect December 4, 1998, requires companies to change the term "tamper-resistant" in all OTC drug labeling to "tamper-evident;" labeling cannot imply that the product is tamper-resistant or tamper-proof.

The FDA said it is taking this action under 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. It puts total one-time compliance costs at $15.5 million.

The rule says that the labeling statement must refer to all features used to comply with tamper-evident packaging requirements, including those on the secondary package, the immediate container or closure and any capsule-sealing technologies. All two-piece, hard gelatin capsules subject to it that are initially introduced or delivered for introduction into interstate commerce by November 4, 1999, must be sealed in compliance. "Tamper-resistant" labeling must be changed to "tamper-evident" by November 6, 2000.