Executive Summary

NDMA objects to comments from the American Society of Hospital Pharmacists, which asked that FDA extend tamper-resistant packaging requirements to OTCs including dermatologicals in the final rule ("The Tan Sheet" April 11, p. 20). NDMA claimed that "a final rule could not properly extend the TRP requirements to other categories of OTCs without publication of a new proposal." NDMA also stated that an expansion of the TRP scope to cover dermatologics, dentifrices, insulin and throat lozenges would have an "immense" economic impact on industry "without demonstrable public health and safety benefit"