Rule: 61N-1.028 Prev   Up   Next

Rule Title: Product Tracking and Tracing – Definitions
Department: DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION    Add to MyFLRules Favorites
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Division: Drugs, Devices and Cosmetics
Chapter: REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Latest version of the final adopted rule presented in Florida Administrative Code (FAC):

VIEW_RULE Effective Date: 5/16/2016
History Notes: Rulemaking Authority 499.0121, 499.05 FS. Law Implemented 499.002, 499.0121, 499.05, 499.052 FS. History–New 5-16-16.
References in this version: Ref-06712 21CFR3.2
Ref-06713 21U.S.C..s.353(e)
Ref-06714 21 U.S.C. s.360eee-3(b)
Ref-06715 21 U.S.C.355
Ref-06716 42 U.S.C. s.262
Ref-06717 21U.S.C.s. 360(b)(2)
Ref-06718 21U.S.C. s.801 et seq.
Ref-06719 600.3(ee) of title 21, Code of Federal Regulations
Ref-06720 42U.S.C. s.2021
Ref-06721 21U.S.C.360ddd
Ref-06722 21U.S.C.s.353a
Ref-06723 21U.S.C.s. 353b
Ref-06724 42U.S.C. s. 247d
Ref-06725 21 U.S.C. s. 353(b)(1)
Ref-06726 21U.S.C.s.353(d)
Ref-06727 26U.S.C. s.501(c)(3) Internal Reveue Code
Ref-06729 21U.S.C. s.321(h)
Ref-06731 21U.S.C. s. 360
Ref-06732 21U.S.C. s. 360eee-1
History of this Rule since Jan. 6, 2006
Notice /
Adopted
Section Description ID Publish
Date
View Text Final
61N-1.028
Product Tracking and Tracing – Definitions 17495907 Effective:
05/16/2016
View Text Change
61N-1.028
Product Tracking and Tracing – Definitions 17339931 3/24/2016
Vol. 42/58
View Text Correction
61N-1.028
Product Tracking and Tracing – Definitions 17294050 3/17/2016
Vol. 42/53
View Text Change
61N-1.028
Product Tracking and Tracing – Definitions 17255347 3/9/2016
Vol. 42/47
View Text Proposed
61N-1.028
The Division proposes the rule amendment to define terms used in the Division’s product tracking and tracing rules which implement federal requirements. 17155146 2/17/2016
Vol. 42/32
View Text Development
61N-1.028
......
To adopt and incorporate the federal requirements pertaining to the tracking and tracing of certain prescription drug products. 16162060 6/30/2015
Vol. 41/126