The Division proposes the rule amendments to clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s rules 61N-1.001, 61N-1.012 and 61N-1.013; set forth the records which must be created and maintained by entities in ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NOS.: RULE TITLES:

61N-1.001General Regulations; Definitions

61N-1.012Records of Drugs, Cosmetics and Devices

61N-1.013Prescription Drugs; Receipt, Storage and Security

The Division of Drugs, Devices and Cosmetics announces a workshop to which all persons are invited.

DATE AND TIME: June 10, 2015, 9:00 a.m. - 10:00 a.m.

PLACE: Department of Business and Professional Regulation, Professions Board Room, 1940 N. Monroe Street, Tallahassee, FL, 32399

GENERAL SUBJECT MATTER TO BE CONSIDERED: The Division proposes the rule amendments to clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s Rules 61N-1.001, 61N-1.012 and 61N-1.013; F.A.C. set forth the records which must be created and maintained by entities in Florida engaging in the possession of limited quantities of prescription drugs, obtained from non-Florida licensed sources, for the purpose of research and development; and set forth the storage requirements for those entities.

 

Limited Quantities: [Paragraph 61N-1.001(2)(n), F.A.C.]

 

(n) “Limited quantities” pursuant to Section 499.01(3) and(4)(b), F.S., means the number of transactions necessary for research and development purposes, the number of transactions necessary for research and development purposes to obtain a final FDA approval, or the number of transactions necessary for research and development purposes to obtain a final approval from a foreign regulatory authority; all transactions must be based on requirements set forth in the acquiring entity’s research and development records created contemporaneously with the research and development activities.

 

Records of Drugs: [Subsection 61N-1.012(17), F.A.C.]

 

(17) For purposes of prescription drugs obtained in “limited quantities” for research and development (“R&D”) purposes under Section 499.01(3) and (4)(b), F.S. and paragraph 61N-1.001(2)(n), F.A.C., the required records must identify the requirements and schedule the acquisition and use of each such drug relative to anticipated and ongoing R&D activities. These records must be created in advance of or within 30 calendar days of the particular R&D activities, and are subject to inspection under Section 499.051, F.S. Non-clinical/pre-clinical R&D quantities must be updated annually, and clinical quantities must be updated semiannually. The researcher must maintain all other records required under Chapter 499, including, without limitations, Section 499.01(3) or (4)(b), F.S. and applicable federal laws.

 

Storage & Security: [Subparagraph 61N-1.013(3)(d)3., F.A.C.]

 

3. Prescription drugs obtained in “limited quantities” for research and development (“R&D”) purposes under Section 499.01(3) and (4)(b), F.S. and paragraph 61N-1.001(2)(n), F.A.C., must be physically segregated from all other products intended for manufacturing, compounding, dispensing, or administration. In a manufacturer’s establishment, these drugs must also be stored and maintained in a separate and clearly designated area.

A copy of the agenda may be obtained by contacting: Dinah Greene at The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, [phone].

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 10 days before the workshop/meeting by contacting: Dinah Greene at The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

If any person decides to appeal any decision made by the Board with respect to any matter considered at this meeting or hearing, he/she will need to ensure that a verbatim record of the proceeding is made, which record includes the testimony and evidence from which the appeal is to be issued.

For more information, you may contact: Dinah Greene at The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, [phone].