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SB134 (BR400) - R. Alvarado, R. Thomas

     AN ACT relating to biological products.
     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.


SB134 - AMENDMENTS

     SCS1 - 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.
     SFA1( D. Givens ) - Delete Section 4 related to the delayed effective date.
     SFA2( D. Givens ) - 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.
     SFA3( D. Givens ) - Retain original provisions; amend KRS 217.216 to provide a pharmacist sufficient information to meet newly established communication requirements; effective October 1, 2016.
     SFA4( J. Higdon ) - Establish language related to communication entries by a retail pharmacy into a pharmacy benefit management system.
     SFA5( R. Alvarado ) - 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.
     SFA6( J. Higdon ) - Establish language to specify that required communication from a pharmacist to a prescribing practitioner is not required after December 31, 2018.
     SFA7( J. Higdon ) - Delete all language that requires communications from a pharmacist to a prescribing practitioner following the dispensing of a biological product.
     HFA1( J. Richards ) - Delete all language that requires communications from a pharmacist to a prescribing practitioner following the dispensing of a biological product.
     HFA2( J. Richards ) - 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.
     HFA3( J. Richards ) - 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.

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     Mar 02, 2016 - 3rd reading; floor amendments (1) (2) (3) (4) (5) (6) and (7) withdrawn; passed 36-1 with Committee Substitute (1)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