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194A.458 Required administrative regulations.

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194A.458 Required administrative regulations. The Cabinet for Health and Family Services shall promulgate administrative regulations to <br>establish: <br>(1) The requirements for health facilities and pharmacies to accept and dispense donated legend drugs or supplies needed to administer legend drugs under KRS 194A.452 and <br>194A.454, including all of the following: <br>(a) Eligibility criteria for health facilities; <br>(b) Standards and procedures for accepting, safely storing, and dispensing donated legend drugs or supplies needed to administer legend drugs; (c) Standards and procedures for inspecting donated legend drugs or supplies needed to administer legend drugs to determine if these are in their original, unopened, sealed, <br>and tamper-evident unit dose packaging or, if packaged in single-unit doses, the <br>single-unit dose packaging is unopened; and (d) Standards and procedures for inspecting donated legend drugs or supplies needed to administer legend drugs to determine that these are not adulterated or misbranded; (2) Eligibility criteria for individuals to receive donated legend drugs or supplies needed to administer legend drugs dispensed under KRS 194A.452 and 194A.454; (3) Standards for prioritizing the dispensation to individuals who are uninsured or indigent, or to others if an uninsured or indigent individual is unavailable; (4) A means by which an individual who is eligible to receive a donated legend drug or supplies needed to administer a legend drug may indicate that eligibility; (5) Necessary forms for administration of the legend drug repository program; <br>(6) The maximum handling fee that a health facility may charge for accepting, distributing, or dispensing donated legend drugs or supplies needed to administer legend drugs; (7) A list of legend drugs and supplies needed to administer legend drugs that the legend drug repository program may accept for dispensing; and (8) A list of legend drugs and supplies needed to administer legend drugs that the legend drug repository program shall not accept for dispensing, including the reason why the legend <br>drug or supply is ineligible for donation. Effective: June 20, 2005 <br>History: Created 2005 Ky. Acts ch. 136, sec. 5, effective June 20, 2005. <br>Legislative Research Commission Note (6/20/2005). 2005 Ky. Acts chs. 11, 85, 95, 97, 98, 99, 123, and 181 instruct the Reviser of Statutes to correct statutory references to agencies and <br>officers whose names have been changed in 2005 legislation confirming the reorganization of <br>the executive branch. Such a correction has been made in this section.