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News & Press: Legislative & Regulatory

Notice of Rulemaking Activity: Projects 2014-3 + 2014-4 + 2014-5 + 2014-6

Tuesday, September 16, 2014   (0 Comments)
Posted by: Tijonne Edmond
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The following information has been released by the Louisiana Board of Pharmacy.

 

The Board has initiated several rulemaking projects and they are in various stages of completion.  All four of the active projects are described below.  You can follow the progress of the Board's rulemaking activities by visiting the Board's website at www.pharmacy.la.gov and visiting the Public Notices section of the Public Library.

 

  • Regulatory Project 2014-3 ~ Pharmacy Records
    The Board published its Notice of Intent to revise its rules for pharmacy recordkeeping on March 20, 2014.  As indicated in that notice, the Board conducted a public hearing on April 29 to receive comments and testimony on the proposed rule changes.  During their subsequent May 7 meeting, the Board agreed with some of the comments suggesting a revision of portions of the original proposal.  The Board published its Potpourri Notice to revise its original proposal on August 20.  As indicated in that notice, the Board will conduct a public hearing on September 30 to receive comments and testimony on those proposed revisions.  The Board is scheduled to evaluate those comments and testimony during their next meeting on November 13.

 

  • Regulatory Project 2014-4 ~ Pharmacy Compounding
              As you know, the Board adopted an Emergency Rule in January 2013 placing limits on pharmacies that compound preparations for practitioner administration (sometimes referred to as 'office use') such that the total amount of compounding for office use could not exceed ten percent of the compounding pharmacies total business for a calendar year.  The Board continued to re-publish that Emergency Rule as needed to give the Board's Regulation Revision Committee time to develop and promulgate a permanent rule.
              During the Board's August 6, 2014 meeting, the Board received a recommendation from that committee taking note of the recently-enacted federal legislation (Drug Quality & Security Act of 2013) that limits state-licensed pharmacies to compounding activities in response to patient-specific prescriptions with no authority for compounding preparations for office use in response to purchase orders from practitioners.  The Board voted to allow the previous Emergency Rule to expire on August 4, and further, voted to issue a new Emergency Rule that became effective on August 8.  The new Emergency Rule seeks to harmonize the Board's existing compounding rules with the recently-enacted federal legislation.  The Board intends to re-publish the new Emergency Rule as necessary while pursuing the development and promulgation of a permanent rule.
              Toward that end, the Board will publish its Notice of Intent to amend its compounding rules in the September 20, 2014 edition of the Louisiana Register.  As indicated in that notice, the Board will conduct a public hearing on October 30 to receive comments and testimony on the proposed rule changes.  The Board is scheduled to evaluate those comments and testimony during their next meeting on November 13.

 

  • Regulatory Project 2014-5 ~ Prescriptions
    The Board published its Notice of Intent to update its requirements for written and electronic prescriptions on June 20, 2014.  As indicated in that notice, the Board conducted a public hearing on July 28 to receive comments and testimony on the proposed rule changes.  During their subsequent meeting on August 6, the Board agreed with one of the comments suggesting a revision of a portion of the original proposal.  The Board will publish its Potpourri Notice to revise its original proposal in the September 20, 2014 edition of the Louisiana Register.  As indicated in that notice, the Board will conduct a public hearing on October 30 to receive comments and testimony on those proposed revisions.  The Board is scheduled to evaluate those comments and testimony during their next meeting on November 13.

 

  • Regulatory Project 2014-6 ~ Special Event Pharmacy Permit
    The Board is preparing to publish its Notice of Intent to develop a new classification of pharmacy permit intended for use by certain organizations, e.g., medical missions, for limited periods of time.  The notice has been accepted for publication in the September 20, 2014 edition of the Louisiana Register.  As indicated in the notice, the Board will conduct a public hearing on October 30 to receive comments and testimony on the proposed new rule.  The Board is scheduled to evaluate those comments and testimony during their next meeting on November 13.

 


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