Variance and Waiver (“the Petition”) from Jody E. Okrzesik, Counsel on behalf of Baptist Hospital, Inc. The Petition seeks a variance and waiver of Rule of 61N-1.023(2), Florida Administrative Code, to allow Baptist Hospital, Inc., a permitted ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that on October 31, 2014, the Division of Drugs, Devices and Cosmetics received a petition for Variance and Waiver (“the Petition”) from Jody E. Okrzesik, Counsel on behalf of Baptist Hospital, Inc.

The Petition seeks a variance and waiver of subsection 61N-1.023(2), Florida Administrative Code, to allow Baptist Hospital, Inc., a permitted Restricted Prescription Drug Distributor – Health Care Entity, to distribute prescription drugs to 28 physicians’ office locations that are under common control and/or ownership with Baptist Hospital, Inc.

Subsection 61N-1.023(2), Florida Administrative Code, restricts the Petitioner’s distributions to entities that have pharmacy permits. The Petition asserts that requiring the physician’s offices that are under common control and/or ownership to obtain pharmacy permits would present a financial hardship for the Petitioner and violated the principles of fairness.

A copy of the Petition for Variance or Waiver may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047.

Please refer all comments to: Reggie Dixon, Director, Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, Florida 32399-1047, website http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.