Senate Bill 134

Actions | Amendments
Last Action signed by Governor (Acts, ch. 73)
Title AN ACT relating to biological products.
Bill Documents Bill
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

Actions

Top | Amendments
01/28/16
  • introduced in Senate
02/01/16
  • to Health & Welfare (S)
  • floor amendment (1), (2), (3) filed
02/03/16
  • reported favorably, 1st reading, to Calendar
02/04/16
  • 2nd reading, to Rules
  • floor amendment (4) filed
02/05/16
  • floor amendment (5) filed
02/09/16
  • taken from Rules
  • recommitted to Health & Welfare (S)
02/10/16
  • floor amendments (6) and (7) filed to Committee Substitute
  • reported favorably, to Rules with Committee Substitute (1)
02/29/16
  • posted for passage in the Regular Orders of the Day for Wednesday, March 2, 2016
03/02/16
  • 3rd reading
  • floor amendments (1) (2) (3) (4) (5) (6) and (7) withdrawn
  • passed 36-1 with Committee Substitute (1)
03/03/16
  • received in House
03/07/16
  • to Health & Welfare (H)
03/10/16
  • posted in committee
03/17/16
  • reported favorably, 1st reading, to Consent Calendar
  • floor amendment (1) filed
03/18/16
  • 2nd reading, to Rules
  • posted for passage in the Consent Orders of the Day for Tuesday, March 22, 2016
03/21/16
  • floor amendment (2) filed
03/22/16
  • taken from the Consent Orders of the Day, placed in the Regular Orders of the Day
  • floor amendment (3) filed
03/23/16
  • 3rd reading
  • floor amendments (1) and (2) withdrawn
  • passed 96-0 with floor amendment (3)
03/24/16
  • received in Senate
03/29/16
  • posted for passage for concurrence in House floor amendment (3)
  • Senate concurred in House floor amendment (3)
  • passed 36-0
  • enrolled, signed by each presiding officer
  • delivered to Governor
04/09/16
  • signed by Governor (Acts, ch. 73)

Proposed Amendments

Top | Actions
Amendment Senate Committee Substitute 1
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
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
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
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
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
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
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
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
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
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
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)