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Code · Kentucky · Chapter 315 — Pharmacists and pharmacies

315.458 Required administrative regulations.

308 words·~1 min read·/ky/chapter-315/315-458

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

The board 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 315.452 and 315.454, 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 315.452 and
315.454;
(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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