Section 311.7731 - [Newly enacted section not yet numbered] Definitions for KRS 311.7731 to 311.7739As 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," "RU486," "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.Added by 2022 Ky. Acts ch. 210,§ 5, eff. 4/14/2022.