Louisiana Board of Pharmacy Agenda for Meeting on August 15, 2013

AGENDA
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 08-12-2013

1. Call to Order
   
2. Invocation & Pledge of Allegiance
   
3. Quorum Call
   
4. Call for Additional Agenda Items
   
5. Opportunity for Public Comment
   
6. Formal Hearings
   

01. PST.014998 - Nick Christopher Tran Case No. 10-0057

G. Report

2. CPT.008886 – LaShanda Toural Miles
   
3. PHY.006113 – Custom Pharmacy Solutions
   
4. PHY.006168 – Wellcare Pharmacy & Medical Supply
   
5. PHY.006235 – Pharmacy Alternatives of Texas
   
6. PHY.006650 – Post Haste Pharmacy
   
7. PST.011492 – Jeffery Paul Bolotte
   

H. Report

of General Counsel
Consideration of Voluntary Consent Agreements

Case Nos. 13-0129 & 13-013
Case No. 13-0137
Case No. 13-0183 Case No. 13-0241 Case No. 13-0240
Case No. 13-0238

of Violations Committee – Consideration of Voluntary Consent Agreements Case No. 12-0354 Case No. 13-0122 Case No. 13-0125 Case No. 13-0059

8. PHY.006694 – Belmar Pharmacy
   
9. CPT.008541 – Ilyssa Monique Johnson
   
10. PHY.006390 – Greer Pharmacy
    Consideration of Voluntary Surrenders
    
11. PST.014543 – Christian Allen Reuter, Jr. 
    
    
    12. PTC.018464 – Cynthia Perkins Little Case No. 13-0248
        
    13. PST.011145 – Louis Charles Gambina Case No. 13-0285
        Consideration of CDS Licenses for Disciplined Practitioners
        

    14. CDS.035358-MD – Andre’ Stephen Viator
        
    15. CDS.017125-MD – Ronald Dane Sylvest
        
    16. CDS.021107-DDS – David L. Ruegsegger
        
    17. CDS.006972-MD – Jerry Dwayne Helms
        
    18. CDS.025779-MD – Brian Allen Heise
        
    19. CDS.027772-MD – Howard Eugene Gidden
        

    I. Adjourn
    

    Case No. 13-0168 Case No. 13-0169 Case No. 13-0186 Case No. 13-0244 Case No. 13-0245 Case No. 13-0255 
    
    
    

Lousiana Regulation Revision Committee to Meet April 9, 2013

Tuesday | April 09, 2013 Regulation Revision Committee

Time: 8:00 am - 5:00 pm
Location: Board Office
For more information, contact: Ms. Judy Dinecola, Secretary 

Louisiana has proposed a law in its Pharmacy Practice Act that Uses the Term "Pharrmacy-Generated Product"

2013-A ~ Defines a new term 'Pharmacy-generated product' in the Pharmacy Practice Act.
               03-06-2013 - Amended, and then Draft #2 approved for filing by the Board.


Legislative Proposal 2013-A ~ PGP Draft #2
1 Louisiana Revised Statutes of 1950
2 Title 37 – Professions and Occupations
3 Chapter 14 – Pharmacy Practice Act
4 Part A. General Provisions
5 …
6 §1164. Definitions
7 As used in this Chapter, the following terms have the meaning ascribed to them by this Section:
8 …
9 (4.9) “Compounded pharmacy-generated product” means a drug product prepared by a pharmacy for
10 distribution as defined by rule.

Source found here




 

Louisiana Board of Pharmacy Meeting Today, March 6, 2013

Revised 03-01-2013
1. Call to Order
2. Invocation & Pledge of Allegiance
3. Quorum Call
4. Call for Additional Agenda Items
5. Consideration of Minutes from Previous Meetings – December 12-13, 2012 & January 29, 2013
6. Report on Action Items
7. Confirmation of Acts
8. Opportunity for Public Comment
9. Committee Reports
A. Finance – Mr. Pitre
• Consideration of Interim Report for Fiscal Year 2012-2013
B. Application Review – Ms. Melancon
• Consideration of Committee Recommendations re Applications
C. Reciprocity – Ms. Hall
• Consideration of Committee Recommendations re Applications
D. Violations – Mr. Bond
E. Impairment – Mr. Rabb
• Consideration of Committee Recommendations re Applications
F. Reinstatement – Mr. Adams
• Consideration of Committee Recommendations re Applications
G. Tripartite – Mr. Burch
H. Regulation Revision – Mr. McKay
• Consideration of Comments & Testimony at February 27, 2013 Public Hearing
• Consideration of Regulatory Proposal 2013-A ~ Pharmacy Recordkeeping (Draft #4)
• Consideration of Regulatory Proposal 2013-C ~ Pharmacy Technician Training
Programs (Draft #2)
• Consideration of Legislative Proposal 2013-A ~ Pharmacy-generated Product
• Consideration of Legislative Proposal 2013-B ~ Non-resident Pharmacies
• Consideration of Legislative Proposal 2013-C ~ Pharmacy Schools
• Consideration of Legislative Proposal 2013-D ~ PMP Delegates
I. Executive – Mr. Aron
• Consideration of Committee Recommendations re Contracts & Agreements
10. Staff Reports
J. Prescription Monitoring Program – Mr. Fontenot
• Consideration of Requests from Pharmacies for Waivers from Reporting to PMP
• Consideration of Memorandum of Understanding with Indian Health Service
K. General Counsel – Mr. Finalet
L. Executive Director – Mr. Broussard
11. Request for Opinion: Disposition of Dispensed (but not retrieved by patient) Prescription
Medications from Central Fill Pharmacy [LAC 46:LIII.1141] – Timothy Koch, Wal-Mart Pharmacies
12. Request for Review of Penal Pharmacy Rule [LAC 46:LIII.Chapter 18] – Joseph Wiley
13. Announcements
14. Recess

Source found here

Repost:Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

WEDNESDAY, JANUARY 30, 2013

Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

2013-1 ~ Compounding for Prescriber's Use (aka compounding for office use)               12-13-2012     Board issued Declaration of Emergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing

Reminder of Public Hearing on Issue of Compounding for Prescriber's Use (Office Use) in Louisiana on Feb. 27, 2013

2013-1.1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]
               12-13-2012     Board issued Declaration of Emgergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to all pharmacies, all pharmacists, and List of Interested Parties.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the emergency rule.  The effect of that decision was to void the December 13, 2012 emergency rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.

2013-1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing

Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

2013-1 ~ Compounding for Prescriber's Use (aka compounding for office use)               12-13-2012     Board issued Declaration of Emergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing

source found here

Reminder of Louisiana Board of Pharmacy Meeting 1/29/13 at 8:30

Louisiana Board of Pharmacy
3388 Brentwood Drive
Baton Rouge, Louisiana 70809-1700
www.pharmacy.la.gov
NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and called for 8:30 a.m. on Tuesday, January 29, 2013 at the Board office, for the purpose to wit:
A G E N D A
NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 01-16-2013
1. Call to Order
2. Invocation & Pledge of Allegiance
3. Quorum Call
4. Consideration of Replacement Emergency Rule re Compounding for Prescriber’s Use
5. Opportunity for Public Comment
6. Announcements
7. Adjourn

Assessment by Compliance Officers of Compounding Pharmacies of Emegency Rule in Louisiana Begins on January 14, 2013

Board Adopts Emergency Rule re Compounding for Prescriber's Use

Sunday, December 16, 2012

The Board has taken note of the recent tragedies associated with fungal meningitis traced to medications dispensed by a compounding pharmacy in Massachusetts.  That pharmacy was licensed to do business in Louisiana, although none of the cases - to date - have been located within the state.  Further, the Board has learned there are other similar types of pharmacies operating across the country that are also licensed to do business in Louisiana.  Some of these pharmacies specialize in the large-scale preparation of practitioner-administered compounds without a prescription as opposed to compounding medications pursuant to patient-specific prescriptions.  Further, the Board has recently learned that other state boards of pharmacy may have resource limitations that restrict their ability to inspect such facilities on a sufficiently regular basis.

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.  Compounding by pharmacies is regulated by the Board of Pharmacy, and manufacturing is regulated by the federal Food & Drug Administration (FDA).  In an abundance of caution for the health, safety and welfare of Louisiana citizens, the Board seeks to repeal the rules which allows pharmacies to compound preparations without the necessity of a patient-specific prescription.  The business entity that wishes to continue the preparation of such products without a prescription may apply to the federal FDA for a manufacturer's registration.

During their December 13, 2012 meeting, the Board adopted this Declaration of Emegency and Emergency Rule.  In recognition of the necessity for practitioners to develop alternative business procedures to acquire needed medications for their patients, the Board has instructed its compliance officers to delay their assessment of compounding pharmacies for compliance with this emergency rule until January 14, 2013.

 

Source located here

 

Louisiana Adopts Emergency Rule Re: Compounding for Prescriber's Use: Patient-Specific Rule

Board Adopts Emergency Rule re Compounding for Prescriber's Use

Sunday, December 16, 2012

The Board has taken note of the recent tragedies associated with fungal meningitis traced to medications dispensed by a compounding pharmacy in Massachusetts. That pharmacy was licensed to do business in Louisiana, although none of the cases - to date - have been located within the state. Further, the Board has learned there are other similar types of pharmacies operating across the country that are also licensed to do business in Louisiana. Some of these pharmacies specialize in the large-scale preparation of practitioner-administered compounds without a prescription as opposed to compounding medications pursuant to patient-specific prescriptions. Further, the Board has recently learned that other state boards of pharmacy may have resource limitations that restrict their ability to inspect such facilities on a sufficiently regular basis.
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. Compounding by pharmacies is regulated by the Board of Pharmacy, and manufacturing is regulated by the federal Food & Drug Administration (FDA). In an abundance of caution for the health, safety and welfare of Louisiana citizens, the Board seeks to repeal the rules which allows pharmacies to compound preparations without the necessity of a patient-specific prescription. The business entity that wishes to continue the preparation of such products without a prescription may apply to the federal FDA for a manufacturer's registration.
During their December 13, 2012 meeting, the Board adopted this Declaration of Emegency and Emergency Rule. In recognition of the necessity for practitioners to develop alternative business procedures to acquire needed medications for their patients, the Board has instructed its compliance officers to delay their assessment of compounding pharmacies for compliance with this emergency rule until January 14, 2013.

$10,000 fine Imposed Against Intrathecal Compounding Specialists

The Louisana Board of Pharmacy assessed a fine of  $10,000 plus cost against Intrathecal Compounding Specialists.  The fine was for six counts, including accountability for the diversion of 220 pints of promethazine with codeine syrup and over 16,000 tablets of hydrocodone/acetaminophen 10/500 over a six-month period of time. 


Source found here .