Carl Gumper calls ASHP Members to Provide Input for Shaping Society’s Comments to FDA on the Barcode Rule

October 26, 2011 | In: POC Headlines

Dear AHSP Members:

We will be submitting comments to the FDA on the Barcode Final Rule. The 2004 rule is open for review at this time. Attached is the notice from the Federal Register. I have attached a word document with 13 specific questions that the Agency would like to have answered during this public comment period.

Initial comments are due on January 9, 2012. With this deadline in light of the Holidays and the Midyear Clinical Meeting, we should aim getting our final comments together by the middle of December.

If you are interested in helping ASHP provide comments, please record your comments on the attached word document under each question. Obviously, you may not have a response for all the questions.

ASHP has the following policies that include barcoding:

ASHP Statement on Bar-Code-Enabled Medication Administration Technology: http://www.ashp.org/DocLibrary/BestPractices/AutoITStBCMA.aspx

ASHP Statement on Bar-Code Verification during Inventory, Preparation, and Dispensing of Medications: http://www.ashp.org/DocLibrary/BestPractices/AutoITStBCVerif.aspx

1003        FDA AUTHORITY ON RECALLS – http://www.ashp.org/DocLibrary/BestPractices/policypositions2011.aspx#pos1003

0920        STANDARDIZED CLINICAL DRUG NOMENCLATURE – http://www.ashp.org/DocLibrary/BestPractices/policypositions2011.aspx#pos0920

9919        MANAGEMENT OF BLOOD PRODUCTS AND DERIVATIVES – http://www.ashp.org/DocLibrary/BestPractices/policypositions2011.aspx#pos9919

Please respond by November 11, 2011with any comments. If we need to discuss further, we can schedule a follow-up conference call. You may be receiving this e-mail for a variety of reasons: SAG member, frequent poster on ASHP Connect/old Listserv, or a reviewer of one of the above statements. If you are not interested or do not have time to provide comments, that is fine. If there is someone within your institution better able to provide comments, please feel free to forward this e-mail to him/her.

Thanks for your continued support of ASHP and the Section.

Karl

Karl F. Gumpper, RPh, BCPS, FASHP
Director, Section of Pharmacy Informatics & Technology
American Society of Health-System Pharmacists®
7272 Wisconsin Avenue
Bethesda, MD 20814
Tel: 301-664-8723
Fax: 301-634-5823
kgumpper@ashp.org

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