Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:440 - Legend drug repository

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				217.816,
				315.191,
				315.450,
				315.452,
				315.454,
				315.456,
				315.458,
				315.460,
				21 U.S.C. 340B,
				21
				U.S.C. 360-1 to 360-4,
				21 U.S.C. 381
				to
				384g
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.191(1) authorizes the
				Kentucky Board of Pharmacy to promulgate administrative regulations pursuant to
				KRS Chapter 13A necessary to regulate and control all matters relating to
				pharmacists, pharmacist interns, pharmacy technicians, pharmacies, wholesale
				distributors, and manufacturers.
				KRS
				315.452 and
				315.458
				require the board to promulgate regulations to establish the legend drug
				repository program. This administrative regulation establishes the legend drug
				repository program and the requirements to participate in the program.
Section 1. Definitions.
(1) "Authorized recipient" means a recipient
			 that has received authorization from the board to participate in the legend
			 drug repository program pursuant to Section 2 and whose authorization has not
			 been revoked by the board pursuant to Section 3.
(2) "Board" means the Kentucky Board of
			 Pharmacy.
(3) "Controlled
			 substance" is defined by
			 KRS
			 218A.010.
(4) "Dispense" is defined by
			 KRS
			 315.010.
(5) "Distribute" is defined by
			 KRS
			 315.400.
(6) "Donor" means:
(a) Any entity legally authorized and
			 permitted to possess drugs, such as a wholesaler or distributor, third party
			 logistic provider, pharmacy, clinic, surgical or health center, detention and
			 rehabilitation center, laboratory, medical or pharmacy school, prescriber or
			 other health care provider, or health facility; or
(b) Government agencies and entitles that are
			 federally authorized to possess drugs, such as:
1. Drug manufacturers;
2. Repackagers;
3. Relabelers;
4. Outsourcing facilities;
5. Veteran Affairs hospitals;
6. Prisons; and
7. FDA authorized importers, such as those
			 under
			 21 U.S.C.
			 384g or similar provisions.
(7) "Drug" is defined
			 by
			 KRS
			 315.010.
(8) "Eligible patient" means:
(a) An individual who is indigent, uninsured,
			 or underinsured; and
(b) Other
			 patients, if a need for the donated drugs is not identified among indigent,
			 uninsured, and underinsured individuals.
(9) "Health care provider" is defined by
			 KRS
			 304.17A-005(23).
(10) "Health facility" is defined by
			 KRS
			 216B.015(13).
(11) "Original packaging" means the packaging
			 in which the drug was donated by the donor.
(12) "Pharmacist" is defined by
			 KRS
			 315.010(17).
(13) "Recipient" means a pharmacy as defined
			 by
			 KRS
			 315.010(19).
(14) "Relabeler" means any person who owns or
			 operates an establishment that changes the content of the labeling from that
			 supplied from the original manufacturer for distribution under the
			 establishment's own name, except for establishments that do not change the
			 original labeling, but merely add their own name.
(15) "Repackager" is defined by
			 KRS
			 315.400(16).
(16) "Returns processor":
(a) Is defined by
			 21
			 U.S.C. Section 360ee e(18); and
(b) Includes a reverse distributor or similar
			 entity.
(17) "Unopened
			 tamper-evident packaging" is defined by the United States Pharmacopeia (USP)
			 General Chapter 659, Packaging and Storage Requirements, and includes unopened
			 unit-dose, multiple dose, immediate, secondary, and tertiary
			 packaging.