Thursday, May 12, 2016

Update on Louisiana Board of Pharmacy Compounding for Office Use for Veterinarians 5/10/2016 2nd report



2015-4 ~ Compounding for Office Use for Veterinarians [Source: Regulatory Proposal 2015-D]
               05-27-2015     Board adopted Declaration of Emergency and Emergency Rule, to become effective on 06-01-2015.
               06-01-2015     Posted as an Emergency Rule with an immediate effective date.
               06-01-2015     Distributed required notices to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
               06-01-2015     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and technician candidates.
               07-01-2015     Notified all pharmacy licensees in July 2015 Newsletter.
               07-09-2015     1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare.
               07-10-2015     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and technician candidates.
               07-20-2015     Notice of Intent published in Louisiana Register
               08-26-2015     Public Hearing
               09-21-2015     Board re-issued Emergency Rule, effective today
               09-21-2015     Distributed required notices to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
               09-21-2015     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and technician candidates.
               10-01-2015     Notified all pharmacy licensees in October 2015 Newsletter.
               11-18-2015     Board considered comments and testimony offered during public hearing, and determined that, although there appears to be clear federal authority for the compounding of veterinary products pursuant to patient-specific prescriptions, there does not appear to be clear federal authority for the compounding of veterinary products for office use by veterinarians.  Given the current absence of clear federal authority for compounding for office use for veterinarians, any rule promulgated by the Board allowing that practice should include a warning that state permission does not provide immunity from federal enforcement action.  The members voted to return the proposed rule to the Board's Regulation Revision Committee for development of some type of warning language placing its pharmacies and pharmacists on notice.  In the interim, they directed staff to re-publish the Emergency Rule in its original form while the rulemaking process continues.
               01-15-2016     Board re-issued Emergency Rule, effective today.
               01-15-2016     Distributed required notices to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
               01-15-2016     Distributed electronic Notice of Ruelmaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and technician candidates.
               01-19-2016     Regulation Revision Committee voted to recommend the approval of Regulatory Proposal 2015-D ~ Compounding for Office Use for Veterinarians - Draft # 3.

               02-24-2016     Board voted to approve Draft #3 for promulgation, upon the instruction of the President.
               02-24-2016     Board also voted to cancel the originally issued and re-published emergency rule, and further, voted to approve a revised Declaration of Emergency as well as Draft #3 as a revised Emergency Rule, with an immediate effective date.
               02-27-2016     Distributed required Notice of Issuance of Revised Emergency Rule to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, Chair of the Senate Health & Welfare Committee, Chair of the House Health & Welfare Committee, and Director of the Louisiana Register.
               02-27-2016     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and technician candidates.
               03-09-2016     Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and technician candidates with advance notice of the publication of the Potpourri Notice in the March 20, 2016 edition of the Louisiana Register as well as advance notice of the public hearing scheduled for April 19, 2016.
               03-20-2016     Potpourri Notice published in Louisiana Register.
               04-19-2016     Public Hearing
               05-04-2016     Board evaluated all comments and tesimony, then determined no more revisions were necessary.  They directed formal replies to all commentators, and the submission of the required report to the legislative oversight committee.
               05-10-2016     2nd Report Hearing Records to Joint Legislative Oversight Committee on Health & Welfare.

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