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Press Release 07/30/01 |
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Monday, July, 30, 2001, 8:30 am Eastern Time Company Press Release SOURCE: Citation Clinical Labeling Systems
Citation Clinical Labeling Systems Announces the Certification and Patent for their NEW Child Resistant and Senior Effective Blister Labels for Immediate Packages A leading international testing service recently certified that Citation's New Blister labels were both child resistant and senior effective*. Mr. Bolnick, President of Citation, pointed out that, "Now, pharmaceutical executives and their Clinical Trial Managers can, as always, turn to the industry leader to meet this important new regulation. We're glad to see the change in the regulations by the CPSC. No one can argue against the keeping these toxic drugs out of children's hands. We were glad to apply our patented technology to offer the industry a cost-effective solution." The U.S. Consumer Product Safety Commission recently mandated the end the Clinical Trial exemption for Child Resistant labels on primary or immediate packages. The operative document that the CPSC used for this decision is a June 22, 2000 letter from Geri Niebauer, Compliance Officer, Recalls and Compliance Division, Office of Compliance U.S. Consumer Product Safety Commission, (click here for a PDF file of this important document.) Every pharmaceutical company conducting clinical trials in the United States is impacted and must ensure that their clinical trial drugs are in child resistant immediate primary packages. Specifically the letter states: "Finally, the immediate packages of all toxic oral drugs intended for human use that are dispensed for household use in Phase II, III or IV clinical trials initiated after twenty-four (24) months from our May 23, 2000 statement, must be child resistant. This means that, after this date (May 23, 2002), firms conducting new clinical trials can no longer use a CR outer container to satisfy the CR requirement." The Citation Blister Label consists of a specially designed label with a combination of permanent and peelable adhesive that is applied to the back of your clinical trial blister pak. The peelable areas are perforated and designed to coincide with the pockets in the blister. To gain access simply peel back the section over the pocket and push through the tablet. In an effort to get the word out to the industry, Citation is embarking on a multi media advertising campaign. It includes placements in such trade magazines as Applied Clinical Trials and R & D Directions, as well as several European publications, such as Pharmaceutical Visions. Almost simultaneously with the certification,
Citation was also awarded a patent on their NEW Child Resistant and Senior
Effective Blister Labels.
*”Standard Classification of Child Resistant Packages ASTM-Designation D3475-95- Type VIII Non-reclosable Packages (Semi-rigid) (Blister), Version D, Peel back and push out”. ==============================
About Citation Clinical Labeling Systems Citation Clinical Labeling Systems is the technological leader in the development and distribution of specialty labels for the clinical trial industry. The labeling of clinical trial materials is a specialty branch of the drug and medical labeling business. The company currently holds two patents for, “Label Form for use in Drug Testing” and has an application for a third pending. Founded over thirty seven years ago, their client list includes more then half of the top ten pharmaceutical firms in the United States. About Richard Bolnick
####### SOURCE: Citation Clinical Labeling Systems For more information and samples contact:
Return to Citation's Marketing Profile ###
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