Kentucky Statutes 315.458 – Required administrative regulations
Current as of: 2024 | Check for updates
|
Other versions
15.458 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 KRS § 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.
Effective:June 29, 2017
History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 16, effective June 29, 2017 — Created 2005 Ky. Acts ch. 136, sec. 5, effective June
20, 2005.
Legislative Research Commission (6/20/2015). 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 officers whose names have been changed in 2005 legislation confirming the reorganization of the executive branch. Such a correction has been made in this section.
Formerly codified as KRS § 194A.458.
The board shall promulgate administrative regulations to establish:
Terms Used In Kentucky Statutes 315.458
- Administer: means the direct application of a drug to a patient or research subject by injection, inhalation, or ingestion, whether topically or by any other means. See Kentucky Statutes 315.010
- Board: means the Kentucky Board of Pharmacy. See Kentucky Statutes 315.010
- dispensing: means to deliver one (1) or more doses of a prescription drug in a suitable container, appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug. See Kentucky Statutes 315.010
- Drug: means any of the following:
(a) Articles recognized as drugs or drug products in any official compendium or supplement thereto. See Kentucky Statutes 315.010
(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 KRS § 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.
Effective:June 29, 2017
History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 16, effective June 29, 2017 — Created 2005 Ky. Acts ch. 136, sec. 5, effective June
20, 2005.
Legislative Research Commission (6/20/2015). 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 officers whose names have been changed in 2005 legislation confirming the reorganization of the executive branch. Such a correction has been made in this section.
Formerly codified as KRS § 194A.458.