Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
315.191(1)(a),
321.441
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
315.191(1)(a) authorizes the
board to promulgate administrative regulations necessary to regulate and
control all matters relating to pharmacists, pharmacist interns, pharmacy
technicians, and pharmacies. This administrative regulation establishes
requirements for compounding for veterinary use.
Section 1. The pharmacist shall receive a
written, verbal, facsimile, or electronic request for a compounded drug from a
practitioner, indicating the formulation, strength, and quantity
ordered.
Section 2. A compounded
drug containing a controlled substance shall only be compounded for patient
specific dispensation from the pharmacy to the ultimate user.
Section 3.
(1) A pharmacist, pharmacist intern, or
pharmacy technician may prepare a non-controlled compounded drug to be
dispensed for veterinary use or administration that is either institutional or
ambulatory, and which does not designate a specific patient for the purpose of
direct administration to patients for:
(a)
Emergency treatment;
(b) Situations
when a time delay would negatively affect a patient outcome; or
(c) Diagnostic purposes.
(2) The compounded drug shall have a beyond
use date.
(3) The veterinary
institution or ambulatory unit shall maintain only an emergency stock
supply.
(4) A veterinarian or
licensed veterinary technician, as defined in
KRS
321.441, may administer a compounded drug for
veterinary use.
Section
4. Label Requirements. Except as provided for in Section 5, a
label shall be generated for the compounded drug and shall include:
(1) The name of the requesting
veterinarian;
(2) The designated
name and strength of the compounded drug;
(3) The quantity dispensed;
(4) If for a specific patient and the patient
is a food producing animal, the withdrawal time;
(5) A lot or batch number of the compounded
drug;
(6) The beyond use date for
the compounded drug;
(7) The date
the compounded drug is dispensed;
(8) The pharmacy's name, address, and
telephone number;
(9) Any special
storage requirements;
(10) A
notation stating "For veterinary use"; and
(11) Any auxiliary label required for the
compounded drug.
Section
5.
(1) A non-controlled
substance compounded drug shall be dispensed by a veterinarian for emergency
take home use when in his or her professional judgment, failure to provide the
drug would result in potential harm to the patient.
(2) If dispensed from the veterinary
institution or ambulatory unit, a compounded drug prescription for a veterinary
patient shall be for up to a 14-day supply in accordance with the veterinarian
prescription and dispensation labeling requirements as established in
201
KAR 16:600.
Section 6. The prescription for the
compounded drug shall be kept pursuant to
201 KAR
2:170.
STATUTORY AUTHORITY:
KRS
315.191(1)(a)
