To define terms that are used in Chapter 499, F.S. and Rule 61N, F.A.C. and to adopt and incorporate the division’s permitting application forms into rule.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.0111Application for Nonresident Prescription Drug Manufacturer- Virtual Permit

PURPOSE AND EFFECT: To define terms that are used in Chapter 499, F.S. and Rule 61N, F.A.C. and to adopt and incorporate the division’s permitting application forms into rule.

SUBJECT AREA TO BE ADDRESSED: The proposed rule development: sets the limit on the amount of prescription drugs that may be distributed by a retail pharmacy before that pharmacy is required to be permitted by the division; establishes the criteria for determining when distributions between commonly owned, End-Stage Renal Dialysis pharmacies is such that it requires a license from the department; and revises the application forms that permit applicants for virtual prescription drug manufacturers and repackagers must submit.

RULEMAKING AUTHORITY: 499.01, 499.012, 499.0121, 499.04, 499.041 FS.

LAW IMPLEMENTED: 499.01, 499.012, 499.0121, 499.015, 499.04, 499.041 FS.

IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Dinah Greene, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 N. Monroe St., Suite 26A, Tallahassee, FL 32399-1047, [e-mail], [phone].

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.