KRS § 311.7731 — KY Code / Title XXVI / Chapter 311 / Section 311.7731
311.7731 Definitions for KRS 311.7731 to 311.7739
Status: in_force

311.7731 Definitions for KRS 311.7731 to 311.7739.

As used in KRS 311.7731 to 311.7739, unless the context otherwise requires:

(1) "Abortion" has the same meaning as in KRS 311.720;

(2) "Abortion-inducing drug" means a medicine, drug, or any other substance or

combination of substances prescribed or dispensed with the intent of

terminating the clinically diagnosable pregnancy of a woman, with knowledge

that the termination will, with reasonable likelihood, cause the death of the

unborn child. This includes the off-label use of drugs known to have

abortion-inducing properties, which are prescribed specifically with the intent of

causing an abortion, such as mifepristone (mifeprex), misoprostol (cytotec),

and methotrexate, or any generic or therapeutic equivalents thereof. The use of

such drugs to induce abortion is also known as "medical," "medication,"

"RU(cid:19)486," "mifeprex regimen," or "drug-induced" abortion. This definition does

not apply to drugs that may be known to cause an abortion but which are

prescribed for other medical indications (e.g., chemotherapeutic agents,

diagnostic drugs, etc.);

(3) "Adverse event" means, as defined by the Food and Drug Administration in 21

C.F.R. sec. 312.32, any untoward medical occurrence associated with the use

of a drug in humans, whether or not considered drug-related. "Adverse event"

does not include an adverse event or suspected adverse reaction that, had it

occurred in a more severe form, might have caused death;

(4) "Associated physician" means a physician who has entered into an associated

physician agreement established in KRS 216B.206;

(5) "Cabinet" means the Cabinet for Health and Family Services;

(6) "Complication" or "abortion complication" means only the following physical or

psychological conditions which, in the reasonable medical judgment of a

licensed healthcare professional, arise as a primary or secondary result of an

induced abortion: uterine perforation, cervical laceration, infection, vaginal

bleeding that qualifies as a Grade 2 or higher adverse event according to the

Common Terminology Criteria for Adverse Events, pulmonary embolism, deep

vein thrombosis, failure to actually terminate the pregnancy, incomplete

abortion (retained tissue), pelvic inflammatory disease, missed ectopic

pregnancy, cardiac arrest, respiratory arrest, renal failure, shock, amniotic fluid

embolism, coma, death, free fluid in the abdomen, allergic reactions to

anesthesia and abortion-inducing drugs, psychological complications as

diagnosed that are listed in the current Diagnostic and Statistical Manual of

Mental Disorders, and any other "adverse event" as defined by the Food and

Drug Administration criteria provided in the MedWatch Reporting System;

(7) "Gestational age" has the same meaning as in KRS 311.7701;

(8) "Hospital" has the same meaning as in KRS 311.720;

(9) "Manufacturer" or "distributor" means an individual or entity that creates,

produces, supplies, transports, or sells drugs, including any substances:

(a) Recognized by an official pharmacopoeia or formulary;

(b) Intended for use in the diagnosis, cure, mitigation, treatment, or

prevention of disease;

(c) Other than food, intended to affect the structure or any function of the

body; and

(d) Intended for use as a component of a medicine but not a device or a

component, part, or accessory of a device;

(10) "Nonsurgical abortion provider" means a qualified physician who is registered

with the Cabinet for Health and Family Services;

(11) "Physician" has the same meaning as in KRS 311.720;

(12) "Pregnancy" or "pregnant" has the same meaning as intrauterine pregnancy as

defined in KRS 311.7701;

(13) "Provide" or "provision" means any act of giving, selling, dispensing,

administering, transferring possession, delivering, transporting to, or otherwise

providing or prescribing an abortion-inducing drug;

(14) "Qualified physician" means a physician who is credentialed and competent to:

(a) Identify and document a viable intrauterine pregnancy;

(b) Assess the gestational age of pregnancy and to inform the patient of

gestational age-specific risks;

(c) Diagnose ectopic pregnancy;

(d) Determine blood type and administer the prevailing medical standard of

care to prevent harmful fetal or child outcomes or Rh incompatibility in

future pregnancies if a pregnant patient is Rh negative;

(e) Assess for signs of domestic abuse, reproductive control, human

trafficking, and other signals of coerced abortion;

(f) Provide surgical intervention or has entered into a contract with another

qualified physician to provide surgical intervention; and

(g) Supervise and bear legal responsibility for any agent, employee, or

contractor who is participating in any part of the procedure, including but

not limited to pre-procedure evaluation and care; and

(15) "Unborn child" has the same meaning as in KRS 311.781.