Last Action | signed by Governor (Acts, ch. 73) |
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Title | AN ACT relating to biological products. |
Bill Documents |
Bill
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Bill Request Number | 400 |
Sponsors | R. Alvarado, R. Thomas |
Summary of Original Version | Amend KRS 217.814 to define "biological product" and "interchangeable biological product" and to re-order other definitions; amend KRS 217.822 to require lower-priced biological products to be dispensed when appropriate unless notified otherwise and require labeling and notification of biological product substitutions; amend KRS 217.895 to add biological products to inspection requirements; EFFECTIVE October 1, 2016. |
Index Headings of Original Version |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Proposed Amendments |
Senate Committee Substitute 1 Senate Floor Amendment 1 Senate Floor Amendment 2 Senate Floor Amendment 3 Senate Floor Amendment 4 Senate Floor Amendment 5 Senate Floor Amendment 6 Senate Floor Amendment 7 House Floor Amendment 1 House Floor Amendment 2 House Floor Amendment 3 |
Votes | Vote History |
01/28/16 |
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02/01/16 |
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02/03/16 |
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02/04/16 |
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02/05/16 |
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02/09/16 |
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02/10/16 |
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02/29/16 |
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03/02/16 |
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03/03/16 |
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03/07/16 |
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03/10/16 |
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03/17/16 |
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03/18/16 |
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03/21/16 |
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03/22/16 |
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03/23/16 |
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03/24/16 |
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03/29/16 |
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04/09/16 |
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Amendment | Senate Committee Substitute 1 |
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Summary | Establish language to specify when communication from a pharmacist to a prescribing practitioner is not required; establish language related to what a prescribing practitioner does with communications received from a pharmacist; amend KRS 217.216 to provide a pharmacist sufficient information to meet newly established communication requirements; delete language related to the delayed effective date. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | Senate Floor Amendment 1 |
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Sponsor | D. Givens |
Summary | Delete Section 4 related to the delayed effective date. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | Senate Floor Amendment 2 |
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Sponsor | D. Givens |
Summary | Retain original provisions; establish language to require communications received by the prescribing practitioner to be entered into the patient's electronic medical record or physical file maintained by the prescribing practitioner within five business days of being received; effective October 1, 2016. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | Senate Floor Amendment 3 |
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Sponsor | D. Givens |
Summary | Retain original provisions; amend KRS 217.216 to provide a pharmacist sufficient information to meet newly established communication requirements; effective October 1, 2016. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | Senate Floor Amendment 4 |
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Sponsor | J. Higdon |
Summary | Establish language related to communication entries by a retail pharmacy into a pharmacy benefit management system. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | Senate Floor Amendment 5 |
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Sponsor | R. Alvarado |
Summary | Add requirement that information received by the prescribing practitioner be treated in accordance with medical practice standards as they relate to medical records; effective October 1, 2016. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | Senate Floor Amendment 6 |
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Sponsor | J. Higdon |
Summary | Establish language to specify that required communication from a pharmacist to a prescribing practitioner is not required after December 31, 2018. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | Senate Floor Amendment 7 |
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Sponsor | J. Higdon |
Summary | Delete all language that requires communications from a pharmacist to a prescribing practitioner following the dispensing of a biological product. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | House Floor Amendment 1 |
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Sponsor | J. Richards |
Summary | Delete all language that requires communications from a pharmacist to a prescribing practitioner following the dispensing of a biological product. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | House Floor Amendment 2 |
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Sponsor | J. Richards |
Summary | Amend KRS 217.822 to provide a presumption that communication to a practitioner's office that prescribed a biological product to patient is notice to that prescribing practitioner. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Amendment | House Floor Amendment 3 |
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Sponsor | J. Richards |
Summary | Amend KRS 217.822 to provide a presumption that communication by facsimile, telephone, electronic transmission, or other prevailing means to a practitioner's office, or a practitioner's office personnel, that prescribed a biological product to patient is notice to that prescribing practitioner. |
Index Headings |
Drugs and Medicines - Biological products, prescribing Effective Dates, Delayed - Biological products October 1, 2016 Federal Laws and Regulations - Biological products, prescribing Health and Medical Services - Biological products, prescribing Pharmacists - Biological products, prescribing Physicians and Practitioners - Biological products, prescribing Public Health - Biological products, prescribing |
Last updated: 1/16/2019 3:08 PM (EST)