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CS/CS/SB 1604: Drugs, Devices, and Cosmetics

GENERAL BILL by Appropriations ; Health Policy ; Grimsley

Drugs, Devices, and Cosmetics; Authorizing a certain type of specialty hospital to conduct research on cannabidiol and low-THC cannabis if contracted with the Department of Health to perform such research; providing, revising, and deleting definitions for purposes of the Florida Drug and Cosmetic Act; revising prohibited acts related to the distribution of prescription drugs; providing that a restricted prescription drug distributor permit is not required for distributions between certain pharmacies; providing for the expiration, renewal, and issuance of certain drug, device, and cosmetic product registrations, etc.

Effective Date: 7/1/2016
 Last Action: 4/8/2016 - Chapter No. 2016-212
Bill Text: Web Page | PDF
Senate Committee References:
  1. Health Policy (HP)
  2. Appropriations Subcommittee on General Government (AGG)
  3. Appropriations (AP)

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  • Bill History

    Date Chamber Action
    1/8/2016 Senate • Filed
    1/14/2016 Senate • Referred to Health Policy; Appropriations Subcommittee on General Government; Appropriations -SJ 202
    • Introduced -SJ 202
    1/21/2016 Senate • On Committee agenda-- Health Policy, 01/26/16, 9:00 am, 412 Knott Building
    1/26/2016 Senate • CS by Health Policy; YEAS 8 NAYS 0 -SJ 246
    • Pending reference review under Rule 4.7(2) - (Committee Substitute)
    1/27/2016 Senate • Now in Appropriations Subcommittee on General Government -SJ 246
    • CS by Health Policy read 1st time -SJ 255
    2/8/2016 Senate • On Committee agenda-- Appropriations Subcommittee on General Government, 02/11/16, 10:00 am, 110 Senate Office Building
    2/11/2016 Senate • Subcommittee Recommendation: CS/CS by Appropriations Subcommittee on General Government; YEAS 5 NAYS 0 -SJ 425
    2/15/2016 Senate • Now in Appropriations -SJ 425
    2/22/2016 Senate • On Committee agenda-- Appropriations, 02/25/16, 10:00 am, 412 Knott Building
    2/25/2016 Senate • CS/CS by- Appropriations; YEAS 17 NAYS 0 -SJ 497
    2/29/2016 Senate • Pending reference review -under Rule 4.7(2) - (Committee Substitute)
    • Placed on Calendar, on 2nd reading -SJ 497
    • Placed on Special Order Calendar, 03/02/16
    3/1/2016 Senate • CS/CS by Appropriations read 1st time -SJ 510
    3/2/2016 Senate • Read 2nd time -SJ 534
    • Amendment(s) adopted (577444) -SJ 535
    • Ordered engrossed -SJ 535
    • Placed on 3rd reading
    3/3/2016 Senate • Read 3rd time -SJ 634
    • Amendment(s) adopted (506164) -SJ 635
    • CS passed as amended; YEAS 28 NAYS 0 -SJ 635
    3/3/2016 House • In Messages
    3/7/2016 House • Referred to Calendar -HJ 894
    • Placed on Special Order Calendar, 03/08/16
    • Received -HJ 893
    3/8/2016 House • Read 2nd time -HJ 926
    • Substituted for CS/CS/HB 1211 -HJ 926
    • Amendment(s) adopted (509371, 720097, 914947) -HJ 926
    • Placed on 3rd reading
    3/9/2016 House • Read 3rd time -HJ 943
    • CS passed as amended; YEAS 117 NAYS 0 -HJ 944
    3/9/2016 Senate • In returning messages
    3/11/2016 Senate • Concurred in 3 amendment(s) (509371, 720097, 914947) -SJ 1025, 1027
    • CS passed as amended; YEAS 39 NAYS 0 -SJ 1028
    • Ordered engrossed, then enrolled -SJ 1028
    3/25/2016 • Signed by Officers and presented to Governor
    4/8/2016 • Approved by Governor
    • Chapter No. 2016-212

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  • CS/CS/SB 1604, Enrolled (Current Bill Version) Posted 3/11/2016 at 4:21 PM

    Bill Text:   Web Page | PDF
    Analyses:   None

    Related Bills (3)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    H 1211 (c2) Drugs, Devices, and Cosmetics Plakon Similar Last Action: 3/8/2016 H Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
    Location: Laid on Table     		Track This Bill
    H 1329 Drug Safety Diaz Compare Last Action: 3/11/2016 H Died in Health Quality Subcommittee, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212)
    Location: In committee/council (HQS)     		Track This Bill
    S 1378 (c2) Drug Safety Garcia Compare Last Action: 3/11/2016 H Died in Messages, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212)
    Location: In messages from Senate     		Track This Bill

    Citations - Statutes (22)

    Citation Catchline Location in Bill Location In Bill Help
    385.211 Refractory and intractable epilepsy treatment and research at recognized medical centers. Page 5 (pdf)
    409.9201 Medicaid fraud. Page 95 (pdf)
    499.003 Definitions of terms used in this part. Page 5 (pdf)
    499.005 Prohibited acts. Page 27 (pdf)
    499.0051 Criminal acts. Page 28 (pdf)
    499.006 Adulterated drug or device. Page 31 (pdf)
    499.01 Permits. Page 33 (pdf)
    499.012 Permit application requirements. Page 58 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 83 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 84 (pdf)
    499.01212 Pedigree paper. Page 95 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 89 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 90 (pdf)
    499.05 Rules. Page 91 (pdf)
    499.051 Inspections and investigations. Page 92 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 95 (pdf)
    499.82 Definitions. Page 93 (pdf)
    499.83 Permits. Page 94 (pdf)
    499.89 Recordkeeping. Page 94 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 96 (pdf)
    893.30 Page 122 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 96 (pdf)

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  • CS/CS/SB 1604, Engrossed 3 Posted 3/11/2016 at 3:29 PM

    Bill Text:   Web Page | PDF
    Analyses:   None

    Related Bills (1)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    H 1211 (c2) Drugs, Devices, and Cosmetics Plakon Similar Last Action: 3/8/2016 H Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
    Location: Laid on Table     		Track This Bill

    Citations - Statutes (22)

    Citation Catchline Location in Bill Location In Bill Help
    385.211 Refractory and intractable epilepsy treatment and research at recognized medical centers. Page 5 (pdf)
    409.9201 Medicaid fraud. Page 95 (pdf)
    499.003 Definitions of terms used in this part. Page 5 (pdf)
    499.005 Prohibited acts. Page 27 (pdf)
    499.0051 Criminal acts. Page 28 (pdf)
    499.006 Adulterated drug or device. Page 31 (pdf)
    499.01 Permits. Page 33 (pdf)
    499.012 Permit application requirements. Page 58 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 83 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 84 (pdf)
    499.01212 Pedigree paper. Page 95 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 89 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 90 (pdf)
    499.05 Rules. Page 91 (pdf)
    499.051 Inspections and investigations. Page 92 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 95 (pdf)
    499.82 Definitions. Page 93 (pdf)
    499.83 Permits. Page 94 (pdf)
    499.89 Recordkeeping. Page 94 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 96 (pdf)
    893.30 Page 122 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 96 (pdf)

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  • CS/CS/SB 1604, Engrossed 2 Posted 3/3/2016 at 3:48 PM

    Bill Text:   Web Page | PDF
    Analyses:   House Message Summary (pdf)

    Related Bills (1)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    H 1211 (c2) Drugs, Devices, and Cosmetics Plakon Similar Last Action: 3/8/2016 H Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
    Location: Laid on Table     		Track This Bill

    Floor Amendments (3)

    Amendment Sponsor Filed Last Floor Action Format
    914947 - Amendment
    Between lines 108 and 109, insert:     		Sprowls 3/8/2016
    7:28 AM     		Senate: Concurred
    3/11/2016     		PDF
    720097 - Amendment
    Remove lines 2651-2687     		Plakon 3/7/2016
    4:05 PM     		Senate: Concurred
    3/11/2016     		PDF
    509371 - Amendment
    Between lines 2971 and 2972, insert:     		Miller 3/7/2016
    9:53 PM     		Senate: Concurred
    3/11/2016     		PDF

    Floor Votes (2)

    Date Chamber Result
    3/9/2016 1:55 PM House 117 Yeas - 0 Nays
    3/11/2016 10:54 AM Senate 39 Yeas - 0 Nays

    Citations - Statutes (21)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 95 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 26 (pdf)
    499.0051 Criminal acts. Page 27 (pdf)
    499.006 Adulterated drug or device. Page 30 (pdf)
    499.01 Permits. Page 32 (pdf)
    499.012 Permit application requirements. Page 57 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 82 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 83 (pdf)
    499.01212 Pedigree paper. Page 95 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 88 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 89 (pdf)
    499.05 Rules. Page 90 (pdf)
    499.051 Inspections and investigations. Page 91 (pdf)
    499.066 Penalties; remedies. Page 92 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 95 (pdf)
    499.82 Definitions. Page 93 (pdf)
    499.83 Permits. Page 94 (pdf)
    499.89 Recordkeeping. Page 95 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 96 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 96 (pdf)

    Top of SectionTop of Page

  • CS/CS/SB 1604, Engrossed 1 Posted 3/2/2016 at 11:39 AM

    Bill Text:   Web Page | PDF
    Analyses:   None

    Related Bills (1)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    H 1211 (c2) Drugs, Devices, and Cosmetics Plakon Similar Last Action: 3/8/2016 H Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
    Location: Laid on Table     		Track This Bill

    Floor Amendments (1)

    Amendment Sponsor Filed Last Floor Action Format
    506164 - Amendment
    Delete line 845 and insert:     		Grimsley 3/3/2016
    10:27 AM     		Senate: Adopted
    3/3/2016     		Web Page
    PDF

    Floor Votes (1)

    Date Chamber Result
    3/3/2016 3:20 PM Senate 28 Yeas - 0 Nays

    Citations - Statutes (21)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 95 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 26 (pdf)
    499.0051 Criminal acts. Page 27 (pdf)
    499.006 Adulterated drug or device. Page 30 (pdf)
    499.01 Permits. Page 32 (pdf)
    499.012 Permit application requirements. Page 57 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 82 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 83 (pdf)
    499.01212 Pedigree paper. Page 95 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 88 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 89 (pdf)
    499.05 Rules. Page 90 (pdf)
    499.051 Inspections and investigations. Page 91 (pdf)
    499.066 Penalties; remedies. Page 92 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 95 (pdf)
    499.82 Definitions. Page 93 (pdf)
    499.83 Permits. Page 94 (pdf)
    499.89 Recordkeeping. Page 95 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 96 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 96 (pdf)

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  • CS/CS/SB 1604, Committee Substitute 2 Posted 2/29/2016 at 2:46 PM

    Bill Text:   Web Page | PDF
    Analyses:   None

    Related Bills (1)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    H 1211 (c2) Drugs, Devices, and Cosmetics Plakon Similar Last Action: 3/8/2016 H Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
    Location: Laid on Table     		Track This Bill

    Floor Amendments (1)

    Amendment Sponsor Filed Last Floor Action Format
    577444 - Amendment
    Between lines 2699 and 2700 insert:     		Grimsley 3/1/2016
    4:39 PM     		Senate: Adopted
    3/2/2016     		Web Page
    PDF

    Citations - Statutes (20)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 94 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 25 (pdf)
    499.0051 Criminal acts. Page 26 (pdf)
    499.006 Adulterated drug or device. Page 30 (pdf)
    499.01 Permits. Page 32 (pdf)
    499.012 Permit application requirements. Page 56 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 82 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 83 (pdf)
    499.01212 Pedigree paper. Page 94 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 88 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 89 (pdf)
    499.05 Rules. Page 90 (pdf)
    499.051 Inspections and investigations. Page 91 (pdf)
    499.066 Penalties; remedies. Page 92 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 94 (pdf)
    499.82 Definitions. Page 93 (pdf)
    499.89 Recordkeeping. Page 94 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 95 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 95 (pdf)

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  • CS/SB 1604, Committee Substitute 1 Posted 1/26/2016 at 3:41 PM

    Bill Text:   Web Page | PDF
    Analyses:   Appropriations Subcommittee on General Government (Pre-Meeting) 2/9/2016 (pdf)
    Appropriations Subcommittee on General Government (Post-Meeting) 2/15/2016 (pdf)
    Appropriations (Pre-Meeting) 2/24/2016 (pdf)
    Appropriations PCS 141410 (Pre-Meeting) 2/24/2016 (pdf)
    Appropriations (Post-Meeting) 2/29/2016 (pdf)

    Related Bills (1)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    H 1211 (c2) Drugs, Devices, and Cosmetics Plakon Similar Last Action: 3/8/2016 H Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
    Location: Laid on Table     		Track This Bill

    Proposed Committee Substitutes (1)

    PCS and Amendments Sponsor Filed Last Committee Action Format
    141410 - Proposed Committee Substitute Appropriations 2/15/2016
    3:03 PM     		Replaced by Committee Substitute
    2/26/2016    		 Web Page
    PDF
    hierarchy 389370 - Amendment (141410)
    Delete line 655 and insert:     		Appropriations
    (Grimsley)     		2/24/2016
    4:55 PM     		Replaced by Committee Substitute
    2/26/2016     		Web Page
    PDF
    hierarchy 308272 - Amendment (141410)
    Between lines 1167 and 1168 insert:     		Appropriations
    (Grimsley)     		2/24/2016
    2:58 PM     		Replaced by Committee Substitute
    2/26/2016     		Web Page
    PDF
    hierarchy 338814 - Amendment (141410)
    Delete lines 1592 - 1594 and insert:     		Appropriations
    (Grimsley)     		2/24/2016
    10:35 AM     		Replaced by Committee Substitute
    2/26/2016     		Web Page
    PDF
    hierarchy 847704 - Amendment (141410)
    Delete lines 2374 - 2421 and insert:     		Appropriations
    (Grimsley)     		2/24/2016
    4:56 PM     		Replaced by Committee Substitute
    2/26/2016     		Web Page
    PDF

    Committee Amendments (2)

    Amendment Sponsor Filed Last Committee Action Format
    457132 - Amendment
    Delete lines 1918 - 1920 and insert:     		Appropriations Subcommittee on General Government
    (Altman)     		2/9/2016
    3:56 PM     		Replaced by Committee Substitute
    2/15/2016     		Web Page
    PDF
    356636 - Amendment
    Between lines 2414 and 2415 insert:     		Appropriations Subcommittee on General Government
    (Simpson)     		2/8/2016
    4:39 PM     		Replaced by Committee Substitute
    2/15/2016     		Web Page
    PDF

    Committee Votes (2)

    Date Committee Result
    2/11/2016 10:00 AM Appropriations Subcommittee on General Government 5 Yeas - 0 Nays
    2/25/2016 10:00 AM Appropriations 17 Yeas - 0 Nays

    Citations - Statutes (20)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 90 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 25 (pdf)
    499.0051 Criminal acts. Page 26 (pdf)
    499.006 Adulterated drug or device. Page 29 (pdf)
    499.01 Permits. Page 31 (pdf)
    499.012 Permit application requirements. Page 55 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 81 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 81 (pdf)
    499.01212 Pedigree paper. Page 89 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 84 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 84 (pdf)
    499.05 Rules. Page 86 (pdf)
    499.051 Inspections and investigations. Page 87 (pdf)
    499.066 Penalties; remedies. Page 87 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 90 (pdf)
    499.82 Definitions. Page 89 (pdf)
    499.89 Recordkeeping. Page 89 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 91 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 91 (pdf)

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  • SB 1604, Original Filed Version Posted 1/8/2016 at 3:35 PM

    Bill Text:   Web Page | PDF
    Analyses:   Health Policy (Pre-Meeting) 1/25/2016 (pdf)
    Health Policy (Post-Meeting) 1/26/2016 (pdf)

    Related Bills (3)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    H 1211 Drugs, Devices, and Cosmetics Plakon Similar Last Action: 3/8/2016 H Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
    Location: Laid on Table     		Track This Bill
    H 261 Cosmetic Product Registration Latvala Compare Last Action: 3/11/2016 H Died in Government Operations Appropriations Subcommittee
    Location: In committee/council (GOAS)     		Track This Bill
    S 176 Cosmetic Product Registration Brandes Compare Last Action: 3/11/2016 S Died in Appropriations
    Location: In committee/council (AP)     		Track This Bill

    Committee Amendments (2)

    Amendment Sponsor Filed Last Committee Action Format
    864912 - Amendment
    Delete line 930 and insert:     		Health Policy
    (Grimsley)     		1/25/2016
    2:55 PM     		Replaced by Committee Substitute
    1/26/2016     		Web Page
    PDF
    669120 - Amendment
    Delete lines 2419 - 2476 and insert:     		Health Policy
    (Grimsley)     		1/25/2016
    5:27 PM     		Replaced by Committee Substitute
    1/26/2016     		Web Page
    PDF

    Committee Votes (1)

    Date Committee Result
    1/26/2016 9:00 AM Health Policy 8 Yeas - 0 Nays

    Citations - Statutes (20)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 91 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 25 (pdf)
    499.0051 Criminal acts. Page 26 (pdf)
    499.006 Adulterated drug or device. Page 29 (pdf)
    499.01 Permits. Page 31 (pdf)
    499.012 Permit application requirements. Page 55 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 81 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 81 (pdf)
    499.01212 Pedigree paper. Page 91 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 84 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 86 (pdf)
    499.05 Rules. Page 87 (pdf)
    499.051 Inspections and investigations. Page 88 (pdf)
    499.066 Penalties; remedies. Page 89 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 91 (pdf)
    499.82 Definitions. Page 90 (pdf)
    499.89 Recordkeeping. Page 91 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 92 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 92 (pdf)

    Top of SectionTop of Page