Title: New York ePedigree Bill A06546 Update
Date Posted: 03/06/09
Tags: REGULATORY UPDATE, NORTH AMERICA, NEW YORK
On March 6, 2009, New York Board of Pharmacy came out with a bill A06546 that amends the education law by adding a new section 6810-b to it. Part of the bill states:
Every manufacturer shall establish and maintain a pedigree for each prescription drug, and every wholesaler, pharmacy or other person who furnishes or dispenses a prescription drug shall maintain a pedigree for each prescription drug. A pedigree shall be in a form and contain information as determined by the department of education (SED). Minimal information that shall be included is outlined. Every pedigree shall be maintained for a period of three years, or a reasonable period of time as determined by the commissioner of education and shall be made available for inspection by SED. A pedigree shall be maintained in an electronic pedigree tracking system or other acceptable format beginning January 1, 2011. One year extensions may be issued by SED in order to comply. Feasibility of a format shall be determined by SED. Certain outlined criteria shall be considered in determining the feasibility of any format used. Any person who violates any provision of this Section shall be subject to a fine.
This bill clearly mandates all pharmaceutical outfits operating in the state of New York to gain compliance by incorporating the generation and maintenance of electronic pedigrees by the beginning of 2011.