The purpose and effect of the proposed rule is to set forth the parameters under which an entity may distribute prescription drugs during a state of emergency declared by the Governor.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.011Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized

PURPOSE AND EFFECT: The purpose and effect of the proposed rule is to set forth the parameters under which an entity may distribute prescription drugs during a state of emergency declared by the Governor.

SUMMARY: The proposed rulemaking amends Rule 61N-1.011, F.A.C., in order to update and revise the rule to clarify existing language, and add or remove existing language.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The economic review conducted by the agency.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.003(48)(b), 499.012, 499.05, FS.

LAW IMPLEMENTED: 499.003(48)(b), 499.012, 499.03, 499.05, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Stephanie Prine, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, FL 32399-1047, [e-mail], [phone].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.011 Wholesale Distribution of Prescription Drugs – Exceptions and Specific Distributions Authorized.

(1) The exemption from the definition of wholesale distribution in section 499.003(48)(53)(b)2., F.S., for “emergency medical reasons” includes:

(a) through (j) No change.

(k) The distribution of a prescription drug during a state of emergency declared by the Governor pursuant to s. 252.36, F.S., by a prescription drug wholesale distributor located outside of this state and not permitted by the Department on behalf of a prescription drug wholesale distributor located in the State of Florida for the purposes of supplying prescription drugs to authorized customers located in Florida, if the out-of-state prescription drug wholesale distributor  meets the following conditions:

1. The out-of-state prescription drug wholesale distributor holds a current and active license as a wholesale distributor in its resident state, or is currently licensed as a prescription drug wholesale distributor pursuant to the federal act;

2. The Florida prescription drug wholesale distributor holds a current and active prescription drug wholesale distributor permit with the Department;

3. Both the in-state and out-of-state prescription drug wholesale distributors are under common ownership. For the purposes of this subsection, “common ownership” means that one prescription drug wholesale distributor owns the other prescription drug wholesale distributor or both prescription drug wholesale distributors share a common owner or ultimate parent company that has the authority to control the management and operations of both entities.

4. The permitted Florida prescription drug wholesale distributor shall be responsible for ensuring the activities of the out-of-state prescription drug wholesale distributor conducted in Florida on its behalf during the state of emergency are in compliance with applicable Florida and federal requirements.

5. The distributions of prescription drugs pursuant to this section shall terminate no more than thirty (30) days after the expiration of the state of emergency.

(2) through (4) No change.

Rulemaking Authority 499.003(48)(53)(b), 499.012, 499.03, 499.05 FS. Law Implemented 499.003(48)(53)(b), 499.012, 499.03, 499.05 FS. History–New 7-1-96, Formerly 10D-45.0525, Amended 1-26-99, 4-17-01, 1-1-04, 10-4-07, 12-13-09, 6-8-10,           , Formerly 64F-12.011.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Stephanie Prine, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, FL 32399-1047, [e-mail], [phone].

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Halsey Beshears, Secretary, Department of Business and Professional Regulations

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 8/6/2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 29, 2019