Rule: 61N-1.012 Prev   Up   Next

Rule Title: Records of Drugs, Cosmetics and Devices
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: 11/16/2015
History Notes: Rulemaking Authority 499.05, 499.0121 FS. Law Implemented 499.01, 499.012, 499.0121, 499.01212, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067 FS. History–New 1-1-77, Amended 12-12-82, 7-8-84, 1-30-85, Formerly 10D-45.53, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.053, Amended 1-26-99, 4-17-01, 10-7-03, 1-1-04, 6-15-04, 8-2-04, 1-19-06, 8-6-06, Formerly 64F-12.012, Amended 3-4-13, 11-16-15.
References in this version: No reference(s).
History of this Rule since Jan. 6, 2006
Notice /
Adopted
Section Description ID Publish
Date
View Text Final
61N-1.012
Records of Drugs, Cosmetics and Devices 16719131 Effective:
11/16/2015
View Text Proposed
61N-1.012
The Division proposes the rule amendment to specify record keeping requirements. 16306202 8/11/2015
Vol. 41/155
View Text Workshop
61N-1.001
......
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, ....
  June 10, 2015 - 9:00 a.m. - 10:00 a.m.
  Department of Business and Professional Regulation Professions ....
15984841 5/12/2015
Vol. 41/92
View Text Workshop
61N-1.001
......
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, ....
  April 10, 2015, 9:00 a.m. – 12:00 p.m.
  Department of Business and Professional Regulation ABT Board ....
15775903 3/12/2015
Vol. 41/49
View Text Development
61N-1.012
Set forth recordkeeping requirements for Florida manufacturers engaging in "limited quantities" of Rx drugs obtained from non-Florida licensed entities. 13939596 12/17/2013
Vol. 39/243
View Text Withdrawal
61N-1.012
Records of Drugs, Cosmetics and Devices 13810489 11/13/2013
Vol. 39/221
View Text Proposed
61N-1.001
......
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 .... 13073677 6/7/2013
Vol. 39/111
View Text Development
61N-1.001
......
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 .... 13017999 5/20/2013
Vol. 39/98
View Text Final
61N-1.012
Records of Drugs, Cosmetics and Devices 12659584 Effective:
03/04/2013
View Text Proposed
61N-1.012
The purpose and effect of the proposed rule is to amend the language to expand the return period of seven days for the exception to the pedigree documentation requirement for prescription drugs that are delivered in error .... 12311451 11/26/2012
Vol. 38/77
View Text Development
61N-1.012
The purpose and effect of the proposed rule amendment is to alleviate burden on business by requiring distributions that are the result of an error do not have to be listed on the pedigree if the return occurs within 14 .... 11798709 8/3/2012
Vol. 38/31
View Text Final
61N-1.012
Records of Drugs, Cosmetics and Devices 11028529 Effective:
08/06/2006