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Louisiana

 


Notice of Rulemaking Activity

Declaration of Emergency & Emergency Rule
 

During their January 18, 2013 oversight hearing, the Louisiana Senate Health & Welfare Committee directed the Board of Pharmacy to develop a replacement emergency rule for the Board's December 13, 2012 emergency rule the committee rejected that day.  During their January 29, 2013 meeting, the Board of Pharmacy adopted a replacement emergency rule with a stipulated effective date of January 31, 2013.

As required by the Administrative Procedure Act, the Board has filed notice of this Declaration of Emergency & Emergency Rule with the Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.  The Editor of the Louisiana Register has posted the document on their website at www.doa.la.gov/osr. Click here to review this document on our website.

Malcolm J. Broussard, Executive Director, Louisiana Board of Pharmacy
 

Posted 1/31/2013


Correction to Notice of Rulemaking Activity

As we notified you on January 18, 2013, the Louisiana Senate Committee on Health and Welfare rejected the Board's December 13, 2012, Emergency Rule relative to Compounding for Prescriber's Use. The effect of that legislative decision was to void the emergency rule, effective immediately. The legislative committee also directed the Board to develop a replacement emergency rule within two weeks.

The Board's Regulation Revision Committee met on January 23rd to develop a proposal for a replacement emergency rule. In our Notice of Rulemaking Activity distributed late on January 23rd, I provided a link to an incorrect version of the document approved by the committee; in particular, the final amendment in Sub-Paragraph D.4 was inadvertently omitted. With my apologies for any confusion caused by the error, the corrected version of Draft #1 of Regulatory Proposal 2013-E-C ~ Compounding for Prescriber's Use is available here. The full Board is scheduled to meet on Tuesday, January 29, 2013, and will consider this proposal for a replacement emergency rule. A copy of the corrected proposal can be accessed on the Board's website at www.pharmacy.la.gov.

Malcolm J. Broussard, Executive Director, Louisiana Board of Pharmacy

Posted 1/28/2013
 


  

The Louisiana Board of Pharmacy met on January 23, 2013, to address concerns about the Board's December 2012 statement prohibiting compounding for office-use. The Board drafted an emergency rule that would permit office-use prescription dispensing up to a quantity not to exceed 10% of the number of prescriptions dispensed and products distributed by a pharmacy annually. Additionally, the emergency rule clarifies what constitutes a drug shortage - click here to review. The Board will meet again on January 29, 2013, to finalize the emergency rule.

Posted 1/25/2013


 

Notice of Rulemaking Activity

The Board adopted an Emergency Rule on December 13, 2012, that repealed certain provisions of the Board's rule permitting pharmacies to compound medications for prescriber's use without a patient-specific prescription. Earlier today, the Louisiana Senate Committee on Health and Welfare held an oversight hearing on that emergency rule. The committee determined the unintended consequences were more signficant than the potential risk avoided, and rejected the rule. The effect of that committee decision is to void the Board's December 13, 2012, emergency rule, effective immediately.

However, in recognition of the continuing potential risk, the legislative committee also directed the Board to develop a replacement emergency rule that provided a better balance of risk versus benefit and then adopt that replacement emergency rule within two weeks.

The Board's Regulation Revision Committee will convene at 8:30 a.m., on Wednesday, January 23, 2013, at the Board office for the single purpose of developing a proposal for a replacement emergency rule. The full Board will convene at 8:30 a.m., on Tuesday, January 29, 2013, at the Board office for the single purpose of considering that proposal for a replacement emergency rule.

 Posted 1/23/2013


 

On December 13, 2012 the LA of Pharmacy issued a clarification and set of emergency regulations pertaining to compounding for “office-use” by resident and non-resident permit holders.  The Board clearly stated that “The preparation of compounds in the absence of a patient-specific prescription is construed as manufacturing as opposed to compounding, which is defined in Louisiana pharmacy law as the preparation of medications pursuant to a patient-specific prescription.” Enforcement of the new regulations is effective January 14, 2013. Click here for more information.

Posted 1/4/2013


 

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