KRS § 216B.204 — KY Code / Title XVIII / Chapter 216B / Section 216B.204
216B.204 Duties of cabinet -- Eligibility for certification
Status: in_force

216B.204 Duties of cabinet -- Eligibility for certification.

(1) The cabinet, shall, at a minimum:

(a) Require completion of the certification process for pharmacies,

manufacturers, distributors, and abortion facilities;

(b) Notify certified pharmacies, manufacturers, distributors, and abortion

facilities which physicians are registered as nonsurgical abortion

providers with the cabinet;

(c) Prohibit intentionally, knowingly, or recklessly shipping abortion-inducing

drugs to physicians who become unregistered;

(d) Audit newly certified pharmacies, manufacturers, and distributors within

ninety (90) calendar days after certification and annually thereafter, to

ensure that all processes and procedures are in place and functioning to

support the requirements of the Abortion-Inducing Drug Certification

Program;

(e) Suspend immediately a pharmacist's, manufacturer's, or distributor's

certification if found to be noncompliant until full compliance is

demonstrated;

(f) Enforce compliance and develop a compliance reporting system;

(g) Prohibit pharmacies from intentionally, knowingly, or recklessly

dispensing or distributing abortion-inducing drugs directly to a patient in

the Commonwealth; and

(h) Require manufacturers and distributors of abortion-inducing drugs to

intentionally and knowingly distribute only to certified pharmacies and

in-person dispensing clinics, medical offices, and hospitals that are in

compliance with the United States Federal Drug Administration's outlined

Mifepristone Risk Evaluation and Mitigation Strategy in effect on April 14,

2022.

(2) To be eligible for certification, pharmacies, manufacturers, and distributors of

abortion-inducing drugs shall:

(a) Have either obtained a Kentucky license as a distributor, or a Kentucky

permit as a pharmacy or manufacturer;

(b) Only distribute to or fulfill prescriptions requested by qualified physicians

who are registered as nonsurgical abortion providers with the cabinet;

(c) Abide by all applicable standards of the National Association of Boards of

Pharmacy;

(d) For online sales or orders, hold a current pharmacy or pharma domain

and abide by all required standards by the National Association of Boards

of Pharmacy to maintain the domain;

(e) Follow all other applicable state or federal laws related to the

dispensation, distribution, or delivery of legend drugs, including

abortion-inducing drugs; and

(f) Follow all acceptable processes and procedures to maintain a

dispensation, distribution, or delivery system that is secure, confidential,

and follows all processes and procedures, including those for storage,

handling, shipping, tracking packages, serial numbers, National Drug

Codes, lot numbers, expiration dates, proof of delivery, and controlled

returns of abortion-inducing drugs.

(3) To be eligible for certification, pharmacies shall:

(a) Be certified by the United States Food and Drug Administration to

dispense abortion-inducing drugs;

(b) Submit proof of certification by the abortion-inducing drug manufacturer

for the distribution of abortion-inducing drugs; and

(c) Only fulfill prescriptions that are accompanied by the required patient

consent form.