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. Codedand 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.
2014-4 ~ Pharmacy Compounding [Source: Regulatory Proposal 2014-C]
08-06-2014 Board issued Declaration of Emergency & Emergency Rule, to become effective on 08-08-2014.
08-08-2014 Distributed required Notice of Emergency to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register. 08-08-2014 Distributed electronic Notice of Rulemaking Activity to all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians, as well as the electronic List of Interested Parties.
09-09-2014 1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
09-15-2014 Corrected 1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
09-16-2014 Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and candidates
10-30-2014 Public Hearing
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. Codedand 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.
2014-4 ~ Pharmacy Compounding [Source: Regulatory Proposal 2014-C]
08-06-2014 Board issued Declaration of Emergency & Emergency Rule, to become effective on 08-08-2014.
08-08-2014 Distributed required Notice of Emergency to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register. 08-08-2014 Distributed electronic Notice of Rulemaking Activity to all pharmacies, pharmacists, pharmacy interns, and pharmacy technicians, as well as the electronic List of Interested Parties.
09-09-2014 1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
09-15-2014 Corrected 1st Report submitted to Joint Legislative Oversight Committee on Health & Welfare
09-16-2014 Distributed electronic Notice of Rulemaking Activity to List of Interested Parties, as well as all pharmacies, pharmacists, interns, technicians, and candidates
10-30-2014 Public Hearing
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