194A.458 Required administrative regulations.

The Cabinet for Health and Family Services shall promulgate administrative regulations
to establish:
(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 194A.454, including all of the following:
(a) Eligibility criteria for health facilities;
(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, and tamper-evident unit dose packaging or, if packaged in
single-unit doses, the 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;

(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 drug or supply is ineligible for donation.

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