Kentucky Statutes 315.454 – Requirements for accepting and dispensing legend drug or administration supplies
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15.454 Requirements for accepting and dispensing legend drug or administration supplies.
(1) A legend drug or supplies used to administer a legend drug may be accepted and dispensed under the program established in KRS § 315.452 only if the following requirements are met:
(a) The legend drug or supplies needed to administer the legend drug is in its original, unopened, sealed, and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened;
(b) The legend drug is not classified as a controlled substance;
(c) The legend drug or supplies needed to administer a legend drug is not adulterated or misbranded, as determined by a pharmacist employed by, or under contract with, the health facility or pharmacy, who shall inspect the drug or supplies needed to administer a legend drug before the drug or supplies are dispensed; and
(d) The legend drug or supplies needed to administer a legend drug are prescribed by a physician, advanced practice registered nurse, or physician assistant and dispensed by a pharmacist.
(2) No legend drug or supplies needed to administer a legend drug that are donated for use under this section may be resold.
Effective:June 29, 2017
History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 14, effective June 29, 2017 — Amended 2010 Ky. Acts ch. 85, sec. 32, effective July
15, 2010 — Created 2005 Ky. Acts ch. 136, sec. 3, effective June 20, 2005.
Formerly codified as KRS § 194A.454.
(1) A legend drug or supplies used to administer a legend drug may be accepted and dispensed under the program established in KRS § 315.452 only if the following requirements are met:
Terms Used In Kentucky Statutes 315.454
- 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
- Contract: A legal written agreement that becomes binding when signed.
- 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 - Pharmacist: means a natural person licensed by this state to engage in the practice of the profession of pharmacy. See Kentucky Statutes 315.010
- Pharmacy: means every place where:
(a) Drugs are dispensed under the direction of a pharmacist. See Kentucky Statutes 315.010
(a) The legend drug or supplies needed to administer the legend drug is in its original, unopened, sealed, and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened;
(b) The legend drug is not classified as a controlled substance;
(c) The legend drug or supplies needed to administer a legend drug is not adulterated or misbranded, as determined by a pharmacist employed by, or under contract with, the health facility or pharmacy, who shall inspect the drug or supplies needed to administer a legend drug before the drug or supplies are dispensed; and
(d) The legend drug or supplies needed to administer a legend drug are prescribed by a physician, advanced practice registered nurse, or physician assistant and dispensed by a pharmacist.
(2) No legend drug or supplies needed to administer a legend drug that are donated for use under this section may be resold.
Effective:June 29, 2017
History: Repealed, reenacted, and renumbered 2017 Ky. Acts ch. 136, sec. 14, effective June 29, 2017 — Amended 2010 Ky. Acts ch. 85, sec. 32, effective July
15, 2010 — Created 2005 Ky. Acts ch. 136, sec. 3, effective June 20, 2005.
Formerly codified as KRS § 194A.454.