Rule: 61N-1.012 Prev Up Next
| Rule Title: Records of Drugs, Cosmetics and Devices | |||
| Department: | DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION |
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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):
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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). |
| Notice / Adopted |
Description | ID | Publish Date |
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Stericycle, Inc., 2355 Waukegan Road, Bannockburn, IL 60015 The Petition seeks a formal opinion from the Department as to whether a single Restricted Rx Drug Distributor – Destruction permit .... |
26549693 |
11/16/2022 Vol. 48/223 |
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Records of Drugs, Cosmetics and Devices | 16719131 |
Effective: 11/16/2015 |
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The Division proposes the rule amendment to specify record keeping requirements. | 16306202 |
8/11/2015 Vol. 41/155 |
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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 |
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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 |
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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 |
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Records of Drugs, Cosmetics and Devices | 13810489 |
11/13/2013 Vol. 39/221 |
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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 |
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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 |
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Records of Drugs, Cosmetics and Devices | 12659584 |
Effective: 03/04/2013 |
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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 |
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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 |
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Records of Drugs, Cosmetics and Devices | 11028529 |
Effective: 08/06/2006 |
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