Florida Department of State and Division of Library and Information Services

Rule Chapter: 61N-1
Chapter Title: REGULATIONS FOR DRUGS, DEVICES AND COSMETICS Add to MyFLRules Favorites
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Version		 Rule No. Rule Title Effective
Date
Rule file 61N-1.001 General Regulations; Definitions 5/4/2025
Rule file 61N-1.006 Drugs and Devices; Labeling Requirements 9/18/2022
Rule file 61N-1.007 Compressed Medical Gases 1/1/2004
Rule file 61N-1.008 Complimentary Human Prescription Drug Samples: Distribution and Disposal 4/17/2001
Rule file 61N-1.009 Cosmetic Labeling Requirements 9/18/2022
Rule file 61N-1.010 Requirements for Manufacturing Cosmetics 7/5/2015
Rule file 61N-1.011 Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized 11/24/2019
Rule file 61N-1.012 Records of Drugs, Cosmetics and Devices 11/16/2015
Rule file 61N-1.013 Prescription Drugs; Receipt, Storage and Security 5/4/2025
Rule file 61N-1.014 Devices or Over-the-Counter Drugs; Storage and Receipt 1/26/1999
Rule file 61N-1.015 Licensing, Application, Permitting 1/19/2006
Rule file 61N-1.016 Product Registration 11/2/2017
Rule file 61N-1.017 Certificates of Free Sale 10/24/2017
Rule file 61N-1.018 Fees 11/2/2017
Rule file 61N-1.019 Inspections, Investigations, Monitoring 4/17/2001
Rule file 61N-1.020 Forms (Repealed) 6/30/2015
Rule file 61N-1.021 Trade Secrets 7/1/1996
Rule file 61N-1.022 Ether Applications; Licensing; Permitting; Records; Security; Distributing; Disposal 9/18/2022
Rule file 61N-1.023 Restricted Prescription Drug Distributor Permits; Special Provisions 4/17/2001
Rule file 61N-1.024 Administrative Enforcement 3/16/2025
Rule file 61N-1.0245 Notice of Non Compliance; Minor Violations 11/2/2017
Rule file 61N-1.025 Certification Authority and Digital Signatures for Self-Authenticating Electronic Pedigree 9/5/2007
Rule file 61N-1.026 Cancer Drug Donation Program 8/6/2007
Rule file 61N-1.027 Distribution of Medical Oxygen for Emergency Use 1/19/2016
Rule file 61N-1.028 Product Tracking and Tracing – Definitions 5/16/2016
Rule file 61N-1.029 Product Tracking and Tracing – Manufacturer Requirements 5/11/2016
Rule file 61N-1.030 Product Tracking and Tracing – Wholesale Distributor Requirements 5/11/2016
Rule file 61N-1.031 Product Tracking and Tracing – Dispenser Requirements 5/11/2016
Rule file 61N-1.032 Product Tracking and Tracing – Repackager Requirements 5/11/2016


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