H-1711.1          _______________________________________________

 

                                  HOUSE BILL 2017

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State of Washington              52nd Legislature             1991 Regular Session

 

By Representatives Cole, Mielke, Sprenkle, Moyer, Morris, Scott and Paris.

 

Read first time February 19, 1991.  Referred to Committee on Health Care.Creating an identification and labeling system for legend drugs.


     AN ACT Relating to the board of pharmacy; and adding new sections to chapter 18.64 RCW.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

 

     NEW SECTION.  Sec. 1.      The legislature finds that significant errors continue to occur in our state's hospitals as well as in physician's and dentist's offices with the use of medications packaged in ampules, vials, or prefilled syringes.  These errors pose serious health hazards to the public and subject manufacturers, dispensers, and prescribers of legend drugs to potential legal liability.  These misidentification errors result in large part as a consequence of human error in failing to adequately distinguish between and among the multitude of options available because of the lack of consistent and systematic markings and colorings on the container.

     In order to minimize the occurrence of these errors, the legislature declares the need for adopting a rational identification and labeling system for all legend drugs that are furnished in ampules, vials, and prefilled syringes.

 

     NEW SECTION.  Sec. 2.      By June 30, 1992, the board of pharmacy is directed to develop and adopt by rule requirements for an identification and labeling system for all legend drugs that are furnished in ampules, vials, and prefilled syringes.  The board shall consider the standards and recommendations of the American society for testing and materials, and consult with appropriate federal and state agencies, and professional and pharmaceutical associations in the development of the rules.

 

     NEW SECTION.  Sec. 3.      The rules shall not be in full force and effect until January 1, 1994, unless the board makes a finding that an identification and labeling system that is substantively equivalent to that established by the rules of the board has been adopted by the federal food and drug administration or other competent federal authority before the effective date of the rules.

 

     NEW SECTION.  Sec. 4.      The board shall consider in the identification system the necessity for the imprinting of the trade or generic name of the legend drug that is recognizable under appropriate lighting conditions; the color coding of tips of ampules, the caps of vials, as well as the labels of prefilled syringes to enhance rapid and accurate identity; and warnings for the dilution of legend drugs prior to use, as well as other requirements the board finds necessary to protect the public health.

 

     NEW SECTION.  Sec. 5.      Sections 1 through 4 of this act are each added to chapter 18.64 RCW.