FDA "TAMPER-EVIDENT" OTC PACKAGING PROPOSAL WOULD REQUIRE ALL HARD-SHELL CAPS
This article was originally published in The Tan Sheet
Executive Summary
FDA "TAMPER-EVIDENT" OTC PACKAGING PROPOSAL WOULD REQUIRE ALL HARD-SHELL CAPS to be sealed "using a technology that would provide evidence that the capsule has been tampered with after filling." Under the proposal published in the Jan. 18 Federal Register, FDA's existing regs, which allow the use of unsealed capsules as long as packaging contains at least two tamper- resistant features, would be amended to require that all two-piece hard gelatin capsules feature a tamper-evident seal.