More information on Louisiana Board of Pharmacy's Emergency Compounding Rule and the Future Rule of Compounding in that State

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.