Food and Drug Administration Drug Safety and Risk Management Advisory Committee May 5, 2004 Low Density Polyethylene Vials (LDPE) Paul Seligman, M.D., M.P.H. Director Office of Pharmacoepidemiology & Statistical Science

Food and Drug Administration 2 LDPE Current Labeling Techniques  Emboss/deboss LDPE containers  Printed and elongated bottom tabs to LDPE container  Paper label  Shrink wrap labels

Food and Drug Administration 3 LDPE Current Labeling Techniques  Tactile recognition (use of textures on LDPE vial)  Glass vials  Unit package overwrap (printed foil pouch containing one embossed LDPE vial)

Food and Drug Administration 4 LDPE: Issues for Discussion  Please identify creative solutions or alternative packaging designs that improve legibility and address the problem of ingress of chemical contaminants and at the same time, do not create additional problems.

Food and Drug Administration 5 LDPE: Issues for Discussion  Please consider which stakeholder groups manufacturers, practitioners, consumers, etc., can best advise the FDA about possible new packaging configurations that may resolve these issues.

Food and Drug Administration 6 LDPE: Issues for Discussion  Given what you have heard today, please describe an appropriate course of action to address the problem of ingress and medication errors due to legibility and similar packaging.