Louisiana Board of Pharmacy - State of Louisiana

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Regulatory Proposals


2016-H
~ Amends Chapter 27 - Controlled Dangerous Substances to streamline the reinstatement process for prescribing practitioners whose primary professional licenses were suspended or revoked by their primary professional licensing agency.
               11-16-2016 - Board voted to approve Draft #1 for promulgation, and further, voted to approve the Declaration of Emergency and set the effective date for the Emergency Rule as November 17, 2016.
               01-20-2017 - Incorporated as Regulatory Project 2016-5.


2016-G
~ Amends Chapter 25 - Prescriptions, Drugs and Devices to create a new section §2514 - Standing Orders for the Distribution of Naloxone and Other Opioid Antagonists. Authorized by Act 370 of the 2016 Legislature, the new rule allows pharmacists to distribute naloxone or other opioid antagonists pursuant to nonpatient-specific standing orders issued by licensed medical practitioners.
               08-10-2016 - Board voted to approve Draft #1 for promulgation, and further, voted to approve the Declaration of Emergency and set the effective date for the Emergency Rule as August 10, 2016.
               12-07-2016 - Board re-issued Emergency Rule, effective today
               01-20-2017 - Incorporated as Regulatory Project 2016-4.


2016-F ~ Amends Chapter 25 - Prescriptions, Drugs and Devices to amend §2519 - Prescription Refills with procedures for medication synchronization.
               01-19-2016 - Committee reviewed Draft #1 and requested one revision, then voted to recommend the approval of Draft #2 to the Board.
               02-24-2016 - Board voted to approve Draft #2 for promulgation, upon the instruction of the President.
               04-20-2016 - Incorporated as Regulatory Project 2016-3.
               09-20-2016 - Final Rule published, effective today.


2016-E ~ Amends Chapter 23 - Out-of-State Pharmacy to (a) implement technical changes from Act 282 of the 2013 Legislature, and (b) update the pharmacist-in-charge requirements for nonresident pharmacies to be consistent with the same requirements for pharmacies located within the state.
               01-19-2016 - Committee voted to recommend the approval of Draft #1 to the Board.
               02-24-2016 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               04-20-2016 - Incorporated as Regulatory Project 2016-2.
               01-20-2017 - Final Rule published, effective today.


2016-D ~ Amends Chapter 25 - Prescriptions, Drugs and Devices to implement Act 391 of the 2015 Legislature, which updated the definition of the term 'equivalent drug product' to now include biological products which have been rated as interchangeable biosimilars by the federal Food & Drug Administration.
               01-19-2016 - Committee scheduled to review Draft #1, but ran out of time.
               04-21-2016 - Committee reviewed Draft #1, requested no changes, then voted to recommend the approval of Draft #1 to the Board.
               05-04-2016 - Board approved Draft #1 for promulgation. 


2016-C ~ Amends Chapter 25 - Prescriptions, Drugs and Devices as well as Chapter 27 ~ Controlled Dangerous Substances to (a) update the expiration date of controlled substance prescriptions in §2525, (b) implement Act 453 of the 2015 Legislature, which extended the controlled substance prescriptive authority for physician assistants and optometrists to include Schedule II, and (c) update the prescription format rules for controlled substance prescription forms used by mid-level practitioners to remove the requirement for the supervising physician's information to appear on the form.
               01-19-2016 - Committee voted to recommend the approval of Draft #1 to the Board.
               02-24-2016 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               04-20-2016 - Incorporated as Regulatory Project 2016-1.
               07-20-2016 - Final Rule published, effective today.


2016-B ~ Amends §705 of Chapter 7 - Pharmacy Interns, to change the practical experience requirements for pharmacist licensure, by recognizing all of the hours earned during the professional experience curriculum in an accredited college of pharmacy as full satisfaction of the licensure requirements and eliminating the requirement of additional hours of experience beyond those acquired during a college curriculum.
               08-25-2015 - Committee reviewed Draft #1 and requested several amendments.
               01-19-2016 - Committee reviewed Draft #2 and requested one change, then voted to recommend approval of Draft #3 to the Board.
               01-27-2016 - Proposal referred to Tripartite Committee for further review.
               03-30-2016 - Tripartite Committee reviewed Draft #3 and offered suggested revisions; Regulation Revision Committee met afterwards and requested additional revisions.
               04-21-2016 - Regulation Revision Committee reviwed Draft #4, requested changes incorporated as Draft #5, then voted to recommend the approval of Draft #5 to the Board.
               05-04-2016 - Board approved  Draft #5 (coded / clean) for promulgation.


2016-A ~ Creates a new chapter of rules in response to Act 261 of the 2015 Legislature, which requires the Board to establish a special type of pharmacy permit to enable the dispensing of marijuana for therapeutic purposes, subject to the limitations itemized in the enabling legislation.
               08-25-2015 - Committee reviewed Draft #1 and requested several amendments.
               01-19-2016 - Committee reviewed Draft #2 (Coded / Clean) and requested multiple revisions.
               03-30-2016 - Committee received stakeholder input on Draft #2; will continue its revew at next meeting.
               04-21-2016 - Committee continued its review of Draft #2; requested new draft for next meeting.
               06-28-2016 - Committee reviewed Draft #3 (Coded), and made requested additional revisions, which were completed in Draft #4..
               08-09-2016 - Committee received additional stakeholder input and requested changes to Draft #4; staff recorded those changes in Draft #4 - Coded.  The clean version of the updated document is titled Draft #5.
               08-10-2016 - Board approved Draft #5 to begin the promulgation process, upon the instruction of the President.
               01-20-2017 - Incorporated as Regulatory Project 2016-6.


2015-J ~ Amends Chapter 9 - Pharmacy Technicians to require completion of a pharmacy technician training program that is nationally-accredited and board-approved, and further, delays the implementation of the new requirement until January 1, 2017.
               11-18-2015 - Board adopted Draft #1 as an Emergency Rule, to become effective 11-30-2015.
               01-19-2016 - Regulation Revision Committee reviewed Draft #2 and requested multiple revisions.
               01-27-2016 - Proposal referred to Tripartite Committee for further review.
               03-30-2016 - Tripartite Committee and Regulation Revision Committee reviewed Draft #3 and suggested additional revisions.
               04-21-2016 - Regulation Revision Committee reviewed Draft #4 (coded / clean), requested no changes, then voted to recommend the approval of Draft #4 to the Board.
               05-04-2016 - Board approved Draft #4 for promulgation.
               01-20-2017 - Incorporated as Regulatory Project 2015-9.


2015-H ~ Amends Chapter 15 - Hospital Pharmacy to a new Section §1527 ~ Remote Access to Medical Orders.  This rule will permit a pharmacist employed by or under contract with a hospital pharmacy to have access to that pharmacy's dispensing information system from a location other than a pharmacy in order to process prescription drug orders or medical orders, but only under certain circumstances.
               04-30-2015 - Committee reviewed Draft #1 and then voted to recommend its approval at the next Board meeting.
               05-27-2015 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               07-20-2015 - Incorporated as Regulatory Project 2015-8.
               10-20-2015 - Final Rule published, effective today.


2015-G ~ Amends Chaptaer 24 ~ Limited Service Providers by creating a new Subchapter D ~ Remote Processor Pharmacy.  This rule will develop a new type of pharmacy permit for a remote processor pharmacy that may be established within the state.  This type of pharmacy will not be permitted to procure, possess, or dispense any prescription drugs or controlled substances, but will be permitted to perform remote processing services for other pharmacies.
               04-30-2015 - Committee reviewed Draft #1, requested one amendment, then voted to recommend the approval of Draft #2 at the next Board meeting.
               05-27-2015 - Board voted to approve Draft #2 for promulgation, upon the instruction of the President.
               07-20-2015 - Incorporated as Regulatory Project 2015-7.
               10-20-2015 - Final Rule published, effective today.


2015-F ~ Amends Chapter 24 ~ Limited Service Providers by creating a new Subchapter C ~ Telepharmacy Services.  This rule will develop a new type of pharmacy permit for a telepharmcy dispensing site to be placed in an area without pharmacy services that can be supervised via technology by another pharmacy within the state.
               04-30-2015 - Committee reviewed Draft #1 and requested several amendments.
               05-26-2015 - Committee reviewed Draft #2 and requested one amendment.
               05-27-2015 - Board considered Draft #3 and approved an amendment, then voted to approve Draft #4 for promulgation, upon the instruction of the President.
               07-20-2015 - Incorporated as Regulatory Project 2015-6.
               10-20-2015 - Final Rule published, effective today. 


2015-E ~ Amends Chapter 25 - Prescriptions, Drugs, & Devices, more specifically §2511 - Prescriptions, to reinstate, for a temporary amount of time, the recognition of an electronic signature of the prescriber on a prescription for a drug not listed as a controlled substance that is received by facsimile in a pharmacy.
               04-29-2015 - Committee reviewed Draft #1 and requested one amendment, then voted to recommend the approval of Draft #2 at the next Board meeting.
               05-27-2015 - Board voted to approve Draft #2 for promulgation, upon the instruction of the President.
               06-01-2015 - Incorporated as Regulatory Project 2015-5 and posted as an Emergency Rule with an immediate effective date.
               10-20-2015 - Final Rule published, effective today; Emergency Rule cancelled.              


2015-D ~ Amends Chapter 25 - Prescriptions, Drugs, & Devices, more specifically §2535 - General Compounding Standards, to reinstate a provision that would enable pharmacies to compound medications for office use (sometimes known as compounding for practitioner administration, or pharmacy-generated drugs).  The proposal seeks to limit the reinstated provision to office use for veterinarians only, since the recent federal compounding law prohibits pharmacies from compounding human drugs for office use.
               04-29-2015 - Committee reviewed Draft #1 and requested two amendments, then voted to recommend the approval of Draft #2 at the next Board meeting.
               05-27-2015 - Board voted to approve Draft #2 for promulgation, upon th instruction of the President.
               06-01-2015 - Incorporated as Regulatory Project 2015-4 and posted as an Emergency Rule with an immediate effective date.
               11-18-2015 - On consideration of comments offered during public hearing, Board returned the proposal to the Regulation Revision Committee for additional language, and directed staff to re-publish the existing Emergency Rule in the interim.
               01-19-2016 - Regulation Revision Committee voted to recommend approval of Draft #3 to the Board.
               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.  Further information available at Regulatory Project 2015-4.
               06-20-2016 - Final Rule published, effective today; Emergency Rule cancelled.

2015-C ~ Amends Chapter 27 - Controlled Dangerous Substances (CDS) of the Board's rules, more specifically §2745 - Prescriptions and §2747 - Dispensing Requirements.  Act 865 of the 2014 Legislature amended the CDS Law to shorten the expiration date of prescriptions for medications listed in Schedule II of the state list of  controlled substances.  This rule change will make the same change in the rules, from a six month to ninety day expiration date.
               10-16-2014 - Committee reviewed Draft #1, removed an unrelated section, and then voted to recommend the approval of Draft #2 at the next Board meeting.
               11-13-2014 - Board voted to approve Draft #2 for promulgation, upon the instruction of the President.
               12-20-2014 - Incorporated as Regulatory Project 2015-2.
               04-20-2015 - Final Rule published.
 

2015-B ~ Amends Chapter 29 - Prescription Monitoring Program (PMP) of the Board's rules, more specifically §2901 - Definitions and §2911 - Reporting of Prescription Monitoring Information.  Act 472 of the 2014 Legislature amended the PMP Law to shorten the time frame within which pharmacies and other dispensers of prescriptions for controlled substances are required to report those transactions to the PMP database, from seven days after the date of dispensing to the next business day after the date of dispensing.  In addition, the DEA has placed all tramadol products into Schedule IV of the federal list of controlled substances.  Since tramadol has been defined as a 'drug of concern', this rule change will remove tramadol from the definition of 'drug of concern.
               10-16-2014 - Committee reviewed Draft #1 and voted to recommend its approval at the next Board meeting.
               11-13-2014 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               12-20-2014 - Incorporated as Regulatory Project 2015-1.
               04-20-2015 - Final Rule published.
 

2015-A ~ Amends Chapter 12 - Automated Medication Systems (AMS) and Chapter 15 - Hospital Pharmacy of the Board's rules, more specifically §1217 - Stocking and Restocking as well as §1509 - Drug Distribution Control.  The intent of these amendments is to enable the use of Electronic Product Verification in those pharmacies using automated medication systems, and further, when such bar-coded or other types of verification processes are used, then restocking activities may not require direct pharmacist oversight but can be delegated to technicians.
               10-16-2014 - Committee reviewed Draft #1 and requested changes and further discussion.
               01-22-2015 - Draft #2 reviewed by committee, which voted to recommend its approval at the next Board meeting.
               02-25-2015 - Board voted to approve Draft #2 for promulgation, upon the instruction of the President.
               03-20-2015 - Incorporated as Regulatory Project 2015-3.
               08-20-2015 - Final Rule published.


2014-D ~ Amends Chapter 24 of the Board's rules, more specifically creates a new Subchapter B - Special Event Permits.  This rule establishes a new type of pharmacy permit - Special Event Permit - that is designed for use for a limited period of time.  It is intended for use primarily by organizations desiring to conduct medical messions within the state, although it could be used for other types of events as well.  The proposal establishes the licensing procedures and standards of practice for the special event pharmacy permit.
               07-10-2014 - Committee reviewed Draft #1 and voted to recommend its approval at the next Board meeting.
               08-06-2014 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               09-20-2014 - Incorporated as Regulatory Project 2014-6.
               01-20-2015 - Final Rule published.


2014-C ~ Amends Chapter 25 of the Board's rules, more specifically Subchapter C - Compounding of Drugs. Act 168 of the 2013 Legislature introduced a new term "pharmacy-generated drug" to describe a drug made by a pharmacy in response to a non patient-specific order.  Compounding is used to describe the process whereby a pharmacy makes a drug in response to a patient-specific order.  In addition to incorporating the new legislatively-defined term, the proposal also retains the basic elements of the currently-pending emergency rule and also incorporates suggestions and comments offered during public hearings on the emergency rule.  After the committee's approval of Draft #3, and following the passage of the Drug Quality & Safety Act of 2013 (DQSA) by the US Congress in November 2013, the federal Food & Drug Administration (FDA) issued guidance to compounding pharmacies indicating that compounding in a pharmacy could only occur pursuant to a patient-specific prescription.  The committee then directed staff to prepare a fourth draft that would align the Board's rule with the new federal legislation.
               11-13-2013 - Committee reviewed Draft #1 and requested further changes and discussion.
               02-06-2014 - Committee discussed further changes and requested new draft; Draft #2 prepared.
               02-25-2014 - Draft #2 scheduled for review by the committee; revisions approved and committee approved Draft #3.  Coded and clean versions of Draft #3 are posted here.
               07-10-2014 - Committee reviewed and approved proposed revisions to Draft #3, then voted to recommend the approval of Draft #4 at the next Board meeting.  Coded and clean versions of Drafat #4 are posted here.
               08-06-2014 - Board voted to approve Draft #4 for promulgation, upon the instruction of the President.
               08-07-2014 - Incorporated as Regulatory Project 2014-4.
               01-20-2015 - Final Rule published.


2014-B ~ Amends Chapter 29 of the Board's rules relative to the prescription monitoring program (PMP), as required by Act 27 of the 2013 Legislature.  That legislation amended the PMP law to remove veterinarians from the program's requirements.
               11-13-2013 - Committee voted to recommend the approval of Draft #1 at the next Board meeting.
               02-12-2014 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               03-20-2014 - Incorporated as Regulatory Project 2014-2.
               06-20-2014 - Final Rule published.


2014-A ~ Amends Chapter 29 of the Board's rules relative to the prescription monitoring program (PMP), as required by Act 110 of the 2013 Legislature.  That legislation amended the PMP law to authorize prescribers and dispensers to appoint delegates to assist them in retrieving information from the PMP database.
               11-13-2013 - Committee voted to recommend the approval of Draft #1 at the next Board meeting.
               02-12-2014 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               03-20-2014 - Incorporated as Regulatory Project 2014-1.
               06-20-2014 - Final Rule published.

 
2013-J ~ Amends Chapter 18 of the Board's rules relative to penal pharmacy permits to clarify that permit is required to provides medications and services to offenders in the custody of the state department of corrections, not to offenders in the custody of parish or municipal prison facilities.
               05-09-2013 - Committee voted to recommend the approval of Draft #1 at the May 29 meeting of the Board.
               05-29-2013 - Board voted to approve Draft #1 for promulgation, upon the instruction of the President.
               07-10-2013 - Incorporated as Regulatory Project 2013-6.
               11-20-2013 - Final Rule published.


2013-H ~ Amends §523 of the Board's rules relative to collaborative drug therapy management (CDTM) to reduce the administrative burden of the process.
               05-09-2013 - Committee reviewed Draft #1 and requested further changes.
               05-28-2013 - Committee voted to recommend the approval of Draft #2 by the Board.
               05-29-2013 - Board voted to approve Draft #2 for promulgation, upon the instruction of the President.
               07-10-2013 - Incorporated as Regulatory Project 2013-5.
               12-20-2013 - Final Rule published.


2013-G ~ Creates new rules for pharmacists and technicians to establish preferential licensing procedures for military-trained applicants and their spouses, in compliance with Act 276 of the 2012 Legislature.
               05-09-2013 - Committee reviewed Draft #1 and requested further changes.
               05-28-2013 - Committee voted to recommend the approval of Draft #2 by the Board.
               05-29-2013 - Board voted to approve Draft #2 for promulgation, upon the instruction of the President.
               07-10-2013 - Incorporated as Regulatory Project 2013-4.
               11-20-2013 - Final Rule published.


2013-F ~ Amends §2511 of the Board's rules to establish minimum requirements for prescriptions including specific data elements and signatures.
               02-20-2013 - Committee reviewed Draft #1 and requested further changes.
               02-25-2014 - Committee reviewed Draft #2 and requested further changes.
               04-16-2014 - Committee voted to recommend the approval of Draft #3 by the Board.
               05-07-2014 - Board voted to approve Draft #3 for promulgation, upon the instruction of the President.
               06-10-2014 - Incorporated as Regulatory Project 2014-5.
               01-20-2015 - Final Rule published.


2013-E ~ Amends the section of rules that allows pharmacies to prepare practitioner-administered compounds without a patient-specific prescription; specifically authorizes preparation of copies of commercial products when such products are unavailable; limits the amount of products that may be prepared by a pharmacy without a patient-specific prescription to ten percent of total products dispensed and distributed on an annual basis.
               01-23-2013 - Regulation Revision Committee approved Draft #1 (corrected).
               01-29-2013 - Draft #1 amended further.  Board adopted Declaration of Emergency and Emergency Rule with a stipulated effective date of January 31, 2013.
               01-30-2013 - Incorporated as Regulatory Project 2013-1.2.
               08-06-2014 - Project terminated with approval of new Regulatory Proposal 2014-C (see above)


 2013-D ~ Repeals the sections of the rules that allow pharmacies to prepare practitioner-administered compounds without a patient-specific prescription.
               12-13-2012 - Board adopted Emergency Rule, with an immediate effective date.
               12-14-2012 - Incorporated as Regulatory Project 2013-1.1.
               01-18-2013 - Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision voided the Emergency Rule effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule reflecting a different balance of risk vs benefit within two weeks.
               01-23-2013 - Replacement Emergency Rule via Regulatory Proposal 2013-E (see above).
              

2013-C ~ Revises rules for pharmacy technician training programs, pharmacy technician candidates, pharmacy technicians.
               01-10-2013 - Regulation Revision Committee approved Draft #2; to be considered by the Board during its March 2013 meeting.
               03-06-2013 - Draft #2 authorized for promulgation, upon the instruction of the president.
               04-20-2013 - Incorporated as Regulatory Project 2013-3.
               07-20-2013 - Final Rule published.


2013-B ~ Continues the work of Regulatory Proposal 2012-13 (see below) relative to hospital off-site satellite pharmacies.
               01-20-2013 - Incorporated as Regulatory Project 2013-2.
               07-20-2013 - Final Rule published.


2013-A ~ Continues the work of Regulatory Proposal 2012-4 to revise the recordkeeping requirements for pharmacies, including hospital pharmacies.
               01-10-2013 - Committee requested amendments of second draft; Draft #3 will be considered at next committee meeting.
               02-20-2013 - Committee requested amendments of third draft, then approved Draft #4 for recommendation to the Board.  Will be considered at March 6 Board meeting.
               03-06-2013 - Board declined to approve Draft #4 and returned it to the committee for further consideration.
               05-09-2013 - Committee reviewed Draft #5 and requested further changes.
               05-28-2013 - Committee voted to recommend the approval of Draft #6 by the Board.
               05-29-2013 - Board amended Draft #6, then approved Draft #7 for promulgation, upon the instruction of the President.
               03-20-2014 - Incorporated as Regulatory Project 2014-3.
               11-20-2014 - Final Rule published, with delayed effective date of 01-01-2015.