Docket Management
Docket: 02D-0254 - Draft Guidance on Inhalation Drug Products Packaged in Semipermeable Container Closure Systems
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Ms. Cheryl Olson Date/Time 2002-10-23 14:46:10
Organization Mayo Clinic Rochester - Hospital Pharmacy Services
Category Health Professional

Comments for FDA General
1. General Comments The new recommendations for the labeling of nebulization products in semipermeable container closure systems is problematic. The embossed label is very difficult to read, and the appearance of all the nebulizer solutions will be similar creating look alike problems and compromising patient safety. At Mayo Clinic Rochester, our Hospital Pharmacy Services Patient Safety Committee discussed the following concerns/alternatives: Has consideration been given to using a non-permeable container instead of a semipermeable container so the readable adhesive label can still be attached? Could a large flange be created as part of the container? The paper medication label could be attached to the large flange. If the medication did not go into the flange portion it would eliminate the concern of adhesive contaminating the medication. It would also make the lot # and expiration date legible. A point of concern is continued use of the embossed clear containers will only necessitate pharmcy department relabeling the nebulizer contianers. This is problematic because any manipulation of the product introduces the opportunity for errors. Thank you, Cheryl Olson, Pharm.D. Pharmacy Specialist - Medication Safety Mayo Clinic Rochester, Hospital Pharmacy Services

EC -3