Edwin A. Bayo, of Grossman, Furlow & Bayo on behalf of Owens and Minor Distributions, Inc.; A. Resident and non-resident prescription drug wholesale distributors, third party logistics providers, repackagers, and manufacturers distributing in or ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics has issued an order disposing of the petition for declaratory statement filed by Edwin A. Bayo, of Grossman, Furlow & Bayo on behalf of Owens and Minor Distributions, Inc. on October 14, 2014. The following is a summary of the agency’s disposition of the petition:

A. Resident and non-resident prescription drug wholesale distributors, third party logistics providers, repackagers, and manufacturers distributing in or into the State of Florida products that are exempted from the definition of “transaction” under the DQSA, must maintain a license with this Department. The fact that products are exempted from the definition of “transaction” under the DQSA does not mean such products are currently exempted from prescription drug distribution recordkeeping requirements of Section 499.0121(6)(a)1.-5., Florida Statutes or Rule 61N-1.012, Florida Administrative Code. B. Resident and non-resident prescription drug wholesale distributors, third party logistics providers, repackagers, and manufacturers distributing in or into the State of Florida products that are exempted from the definition of “transaction” under the DQSA, must comply with the recordkeeping requirements of Section 499.0121(6)(a)1.-5., Florida Statutes. C. The Department declines to answer this inquiry as it relates solely to an interpretation of the DQSA, and not Chapter 499, Florida Statutes.

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

Please refer all comments to: Reggie Dixon, The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399.