KRS 315.458: Required administrative regulations.

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.