This article was originally published in The Tan Sheet
Firm requests temporary exemption from FDA's final rule requiring use of "tamper-evident" instead of "tamper-resistant" language on OTC packaging. Alcon states in an Oct. 9 citizen petition that it has depleted inventory for 121 packaging components impacted by the reg, which is effective Nov. 6. However, the firm is unable to deplete its inventory of Tears Naturale P.M. Lubricant Eye Ointment "due to the closure of a manufacturing plant and issues related to the timing of transfer of product manufacturing." "Tamper-evident" language will begin appearing on the product tube after February, Alcon says
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