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.