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

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The Food and Drug Administration (FDA) is proposing to amend its tamper-resistant packaging requirements to require that all over- the-counter (OTC) human drug products marketed in two-piece, hard gelatin capsules be sealed. This proposal follows continuing tampering incidents involving two-piece, hard gelatin capsules. The agency is also proposing a change in terminology throughout its regulatory program from ``tamper-resistant`` to ``tamper-evident.`` In addition, FDA is soliciting comments on whether additional regulatory changes, such as packaging performance standards, may be necessary. These proposed amendments are part of the agency's continuing review of the potential public health threat posed by product tampering and are meant to address specific vulnerabilities in the OTC drug market and to improve consumer protection.