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CS/CS/HB 1211: Drugs, Devices, and Cosmetics

GENERAL BILL by Health and Human Services Committee ; Health Quality Subcommittee ; Plakon

Drugs, Devices, and Cosmetics; Revises various provisions of Florida Drug & Cosmetic Act; repeals provisions relating to pedigree papers; prohibits distribution of prescription drugs without delivering transaction history, transaction information, & transaction statement; revises various permit requirements relating to prescription drug manufacturing, repackaging, & distribution; revises recordkeeping requirements; revises labeling requirements for prescription drug active pharmaceutical ingredient packaging; authorizes issuance of nondisciplinary citations.

Effective Date: 7/1/2016
 Last Action: 3/8/2016 House - Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926
Bill Text: PDF

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  • Bill History

    Date Chamber Action
    1/7/2016 House • Filed
    1/12/2016 House • Introduced -HJ 102
    1/15/2016 House • Referred to Health Quality Subcommittee; Government Operations Appropriations Subcommittee; Health and Human Services Committee -HJ 228
    1/21/2016 House • On Committee agenda-- Health Quality Subcommittee, 01/25/16, 4:00 pm, 306 HOB
    1/25/2016 House • CS by Health Quality Subcommittee; YEAS 13 NAYS 0 -HJ 307
    1/27/2016 House • Pending review of CS under Rule 7.19(c)
    • CS by Health Quality Subcommittee read 1st time -HJ 304
    1/28/2016 House • Now in Government Operations Appropriations Subcommittee -HJ 322
    2/4/2016 House • On Committee agenda-- Government Operations Appropriations Subcommittee, 02/08/16, 3:00 pm, Morris Hall
    2/8/2016 House • Favorable by Government Operations Appropriations Subcommittee; YEAS 10 NAYS 0 -HJ 413
    • Now in Health and Human Services Committee -HJ 413
    2/15/2016 House • On Committee agenda-- Health and Human Services Committee, 02/17/16, 9:00 am, Morris Hall
    2/17/2016 House • CS/CS by- Health and Human Services Committee; YEAS 14 NAYS 0 -HJ 519
    2/22/2016 House • Pending review of CS -under Rule 7.19(c)
    • CS/CS by Health and Human Services Committee read 1st time -HJ 516
    2/23/2016 House • Placed on Calendar -HJ 560
    3/7/2016 House • Placed on Special Order Calendar, 03/08/16
    3/8/2016 House • Substituted CS/CS/SB 1604 -HJ 926
    • Laid on Table, companion bill(s) passed, see CS/CS/SB 1604 (Ch. 2016-212) -HJ 926

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  • CS/CS/HB 1211, Committee Substitute 2 (Current Bill Version) Posted 2/22/2016 at 8:56 AM

    Bill Text:   PDF
    Analyses:   None

    Related Bills (1)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    S 1604 (er) Drugs, Devices, and Cosmetics Grimsley Similar Last Action: 4/8/2016 Chapter No. 2016-212
    Location: Became Law     		Track This Bill

    Citations - Statutes (20)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 100 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 28 (pdf)
    499.0051 Criminal acts. Page 29 (pdf)
    499.006 Adulterated drug or device. Page 33 (pdf)
    499.01 Permits. Page 33 (pdf)
    499.012 Permit application requirements. Page 60 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 89 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 90 (pdf)
    499.01212 Pedigree paper. Page 99 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 93 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 94 (pdf)
    499.05 Rules. Page 95 (pdf)
    499.051 Inspections and investigations. Page 96 (pdf)
    499.066 Penalties; remedies. Page 97 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 100 (pdf)
    499.82 Definitions. Page 99 (pdf)
    499.89 Recordkeeping. Page 99 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 101 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 101 (pdf)

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  • CS/HB 1211, Committee Substitute 1 Posted 1/27/2016 at 3:26 PM

    Bill Text:   PDF
    Analyses:   Government Operations Appropriations Subcommittee (Post-Meeting) 2/8/2016 (pdf)
    Health and Human Services Committee (Post-Meeting) 2/21/2016 (pdf)

    Related Bills (1)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    S 1604 (c1) Drugs, Devices, and Cosmetics Grimsley Similar Last Action: 4/8/2016 Chapter No. 2016-212
    Location: Became Law     		Track This Bill

    Committee Amendments (4)

    Amendment Sponsor Filed Last Committee Action Format
    653989 - Amendment
    Remove line 654 and insert:     		Plakon 2/16/2016
    7:08 PM     		Adopted without Objection
    2/17/2016     		PDF
    214363 - Amendment
    Remove line 869 and insert:     		Plakon 2/16/2016
    7:09 PM     		Adopted without Objection
    2/17/2016     		PDF
    005391 - Amendment
    Between lines 1105 and 1106, insert:     		Plakon 2/16/2016
    7:10 PM     		Adopted without Objection
    2/17/2016     		PDF
    417005 - Amendment
    Remove lines 1530-1532 and insert:     		Plakon 2/16/2016
    7:12 PM     		Adopted without Objection
    2/17/2016     		PDF

    Citations - Statutes (20)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 99 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 28 (pdf)
    499.0051 Criminal acts. Page 29 (pdf)
    499.006 Adulterated drug or device. Page 32 (pdf)
    499.01 Permits. Page 33 (pdf)
    499.012 Permit application requirements. Page 60 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 88 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 89 (pdf)
    499.01212 Pedigree paper. Page 99 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 92 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 93 (pdf)
    499.05 Rules. Page 94 (pdf)
    499.051 Inspections and investigations. Page 96 (pdf)
    499.066 Penalties; remedies. Page 96 (pdf)
    499.067 Denial, suspension, or revocation of permit, certification, or registration. Page 99 (pdf)
    499.82 Definitions. Page 98 (pdf)
    499.89 Recordkeeping. Page 99 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 100 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 101 (pdf)

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  • HB 1211, Original Filed Version Posted 1/7/2016 at 3:10 PM

    Bill Text:   PDF
    Analyses:   Health Quality Subcommittee (Post-Meeting) 4/11/2016 (pdf)

    Related Bills (3)

    Bill Number Subject Filed By Relationship Last Action and Location Track Bills
    S 1604 (c1) Drugs, Devices, and Cosmetics Grimsley Similar Last Action: 4/8/2016 Chapter No. 2016-212
    Location: Became Law     		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 (3)

    Amendment Sponsor Filed Last Committee Action Format
    861535 - Amendment
    Between lines 2363 and 2364, insert:     		Plakon 1/22/2016
    6:10 PM     		Adopted without Objection
    1/25/2016     		PDF
    091179 - Amendment
    Remove lines 2364-2422 and insert:     		Plakon 1/22/2016
    5:26 PM     		Adopted without Objection
    1/25/2016     		PDF
    777409 - Amendment
    Remove lines 2584-2707 and insert:     		Plakon 1/22/2016
    5:37 PM     		Adopted without Objection
    1/25/2016     		PDF

    Citations - Statutes (19)

    Citation Catchline Location in Bill Location In Bill Help
    409.9201 Medicaid fraud. Page 99 (pdf)
    499.003 Definitions of terms used in this part. Page 4 (pdf)
    499.005 Prohibited acts. Page 28 (pdf)
    499.0051 Criminal acts. Page 29 (pdf)
    499.006 Adulterated drug or device. Page 32 (pdf)
    499.01 Permits. Page 33 (pdf)
    499.012 Permit application requirements. Page 60 (pdf)
    499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data. Page 88 (pdf)
    499.0121 Storage and handling of prescription drugs; recordkeeping. Page 89 (pdf)
    499.01212 Pedigree paper. Page 99 (pdf)
    499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale. Page 91 (pdf)
    499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. Page 94 (pdf)
    499.05 Rules. Page 95 (pdf)
    499.051 Inspections and investigations. Page 96 (pdf)
    499.066 Penalties; remedies. Page 97 (pdf)
    499.82 Definitions. Page 98 (pdf)
    499.89 Recordkeeping. Page 99 (pdf)
    794.075 Sexual predators; erectile dysfunction drugs. Page 100 (pdf)
    921.0022 Criminal Punishment Code; offense severity ranking chart. Page 100 (pdf)

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