13073677, 61N-1.001 - Florida Administrative Rules, Law, Code, Register

Home

Florida Department of State and Division of Library and Information Services

Notice: 13073677

Notice of Proposed Rule

Department:

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division:

Drugs, Devices and Cosmetics

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

61N-1.001	General Regulations; Definitions
61N-1.012	Records of Drugs, Cosmetics and Devices
61N-1.013	Prescription Drugs; Receipt, Storage and Security

PURPOSE:

To clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s rules; 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.

SUMMARY:

The Division proposes the rule amendments to clarify the definitions of terms set forth in Chapter 499, F.S., and the Division’s rules; 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.

RULEMAKING AUTHORITY:

499.003;499.01(3),(4),(6);499.012(12);499.0121;499.0122;499.013;499.014;499.024;499.025(5);499.03(4);499.05;499.052. F.S.

LAW:

499.028 (6), 499.003, 499.004, 499.005, 499.0054, 499.0057, 499.006, 499.007, 499.008, 499.009, 499.01, 499.012, 499.0121, 499.0122, 499.013, 499.014, 499.015, 499.023, 499.024, 499.025, 499.028, 499.03, 499.033, 499.035, 499.039, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067, 499.069, 499.61, 499.62, 499.63, 499.64, 499.65, 499.66, 499.67, 499.71, 499.75 F.S.

PRINT PUBLISH DATE:

6/7/2013 Vol. 39/111

COMMENTS:

From 6/7/2013 To 6/28/2013 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

Under Florida law, E-mail addresses are public records. If you do not want your E-mail address released in response to a public records request, do not send electronic mail to this entity. Instead, contact this office by phone or in writing.