Gabriel F. Warren, General Counsel on behalf of Parallon Business Solutions, LLC; Parallon Business Solutions, LLC is requesting that the Department of Business and Professional Regulation issue a Declaratory statement as to the following. 1. ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that Division of Drugs, Devices and Cosmetics has received the petition for declaratory statement from Gabriel F. Warren, General Counsel on behalf of Parallon Business Solutions, LLC. The petition seeks the agency’s opinion as to the applicability of paragraph 499.01(2)(g), subparagraph 499.03(54)(a)3, subsection 499.003(23), and subsection 61N-1.023(2), Florida Statutes, and related administrative rules, as it applies to the petitioner.

Parallon Business Solutions, LLC is requesting that the Department of Business and Professional Regulation issue a declaratory statement as to the following. 1. Parallon owns and operates 3 prescription drug distribution centers that are licensed by the Department as Restricted Rx Drug Distributors- Health Care Entity in the State of Florida. The distribution centers purchase prescription drugs from authorized suppliers and distribute these drugs to Class II or Modified Class II institutional permits under common ownership. The distribution centers need to be able to accept the transfer of prescription drugs back from these locations in order to appropriately manage drug surpluses and shortages among the recipient pharmacies and provide timely dispensing of needed medication to patients. 2. Parallon distribution centers do not have pharmacy permits or licensed pharmacies onsite. However, the distribution centers are authorized to acquire and possess prescription drugs by their very nature as distribution centers. Parallon believes that Rule 61N-1.023(2), Florida Administrative Code, was developed for an outdated business model that contemplated hospitals with onsite pharmacies as distributors. It has not been updated to account for industry changes that now use warehouses, which lack onsite pharmacies, as distributors. 3. Parallon wishes to avoid administrative and criminal prosecution for violating Chapter 499, Florida Statutes, and request this declaratory statement to clarify its rights under the above statutes and rules. WHEREFORE, Parallon respectfully requests that DBPR issue a Final Order determining that: The transfer of prescription drugs from a recipient pharmacy back to a Parallon distribution center without a pharmacy permit is authorized by the Restricted Rx Drug Distributor-Health Care Entity permit held by the distribution center.

A copy of the Petition for Declaratory Statement may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, Attn: Dinah Greene, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047.

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