Notice is hereby given that the Board of Pharmacy has received a Petition for Declaratory Statement filed by Ruben V. Chavez, Esquire, on behalf of Palm Springs General Hospital on February 19, 2015. The Petitioner seeks a Declaratory Statement from the Board with regard to whether the MIC Isolator purchased by petitioner from Containment Technologies Group, Inc., and described in the petition, is in compliance with USP 797 and asks for clarification from the Board of the following questions:
- Can Palm Springs General Hospital use a compounding aseptic containment isolator device that resides in a high ISO classified environment when the device fails to maintain non-stagnant, non-turbulent unidirectional airflow under dynamic conditions?
- Can Palm Springs General Hospital use the MIC Isolator depicted in the video attached to the petition?
- Based on the Board’s review, does the MIC Isolator seen in the video attached to the petition, reveal a failure to maintain non-stagnant, non-turbulent unidirectional airflow under dynamic conditions?
Except for good cause shown, motions for leave to intervene must be filed within 21 days after the publication of this notice.
A copy of the Petition for Declaratory Statement may be obtained by contacting Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 or by email: info@floridaspharmacy.gov.
