1 STATE OF OKLAHOMA
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2 1st Session of the 58th Legislature (2021)
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3 SENATE BILL 779 By: Daniels
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6 AS INTRODUCED
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7 An Act relating to abortion; defining terms;
7 specifying applicability of act; creating the
8 Oklahoma Abortion-Inducing Drug Certification
8 Program; limiting provision of abortion-inducing
9 drugs to certain practitioners and procedures;
9 directing State Board of Pharmacy to establish
10 certain requirements for manufacturers, distributors
10 and physicians; providing certification systems and
11 requirements for manufacturers, distributors and
11 physicians; requiring physician to maintain hospital
12 admitting privileges or enter into certain written
12 agreement; stating conditions of agreement; requiring
13 Board to adopt certain reporting system; stating
13 criteria of reporting system; requiring certain
14 reporting of physicians; providing for reporting of
14 adverse events; providing criminal penalties;
15 providing for certain civil remedies, disciplinary
15 sanctions and injunctive relief; specifying certain
16 judicial procedures; directing Board to develop
16 certain enforcement scheme; specifying criteria of
17 enforcement scheme; providing for certain
17 restitution; directing creation of certain public
18 portal; requiring portal to list certain names and
18 allow for certain complaints; providing for
19 disposition of complaints; providing for
19 confidentiality of complaints; providing certain
20 construction and intent; authorizing certain
20 intervention; providing severability; providing for
21 codification; and providing an effective date.
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24 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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 1 SECTION 1. NEW LAW A new section of law to be codified
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2 in the Oklahoma Statutes as Section 1-756.1 of Title 63, unless
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3 there is created a duplication in numbering, reads as follows:
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4 As used in this act:
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5 1. “Abortion” means the act of using or prescribing any
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6 instrument, medicine, drug or any other substance, device or means
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7 with the intent to terminate the pregnancy of a woman known to be
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8 pregnant, with knowledge that the termination by those means will
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9 with reasonable likelihood cause the death of the unborn child.
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10 Such use, prescription or means is not an abortion if done with the
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11 intent to:
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12 a. save the life or preserve the health of the unborn
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13 child,
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14 b. remove a dead unborn child caused by spontaneous
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15 abortion, accidental trauma or a criminal assault on
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16 the pregnant woman or her unborn child,
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17 c. remove an ectopic pregnancy, or
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18 d. treat a maternal disease or illness for which the
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19 prescribed drug is indicated;
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20 2. “Abortion-inducing drug” means a medicine, drug or any other
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21 substance prescribed or dispensed with the intent of terminating the
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22 pregnancy of a woman known to be pregnant, with knowledge that the
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23 termination will with reasonable likelihood cause the death of the
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24 unborn child. This includes the off-label use of drugs known to
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 1 have abortion-inducing properties, which are prescribed specifically
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2 with the intent of causing an abortion, such as mifepristone
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3 (Mifeprex), misoprostol (Cytotec) and methotrexate. This definition
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4 does not apply to drugs that may be known to cause an abortion, but
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5 which are prescribed for other medical indications, such as
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6 chemotherapeutic agents and diagnostic drugs. The use of such drugs
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7 to induce abortion is also known as “medical”, “medication”, “RU–
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8 486”, “chemical”, “Mifeprex regimen” or “drug-induced” abortion;
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9 3. “Adverse Event”, according to the Food and Drug
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10 Administration, means any untoward medical occurrence associated
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11 with the use of a drug in humans, whether or not considered drug-
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12 related. It does not include an adverse event or suspected adverse
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13 reaction that, had it occurred in a more severe form, might have
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14 caused death;
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15 4. “Associated physician” means a person licensed to practice
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16 medicine in the state including medical doctors and doctors of
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17 osteopathy, that has entered into an associated physician agreement;
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18 5. “Complication” means any adverse physical or psychological
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19 condition arising from the performance of an abortion which
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20 includes, but is not limited to, uterine perforation, cervical
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21 perforation, infection, heavy or uncontrolled bleeding, hemorrhage,
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22 blood clots resulting in pulmonary embolism or deep vein thrombosis,
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23 failure to actually terminate the pregnancy, incomplete abortion
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24 (retained tissue), pelvic inflammatory disease, endometritis, missed
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 1 ectopic pregnancy, cardiac arrest, respiratory arrest, renal
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2 failure, metabolic disorder, shock, embolism, coma, placenta previa
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3 in subsequent pregnancies, preterm delivery in subsequent
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4 pregnancies, free fluid in the abdomen, hemolytic reaction due to
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5 the administration of ABO-incompatible blood or blood products,
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6 adverse reactions to anesthesia and other drugs, subsequent
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7 development of breast cancer, psychological complications such as
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8 depression, suicidal ideation, anxiety, sleeping disorders, death
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9 and any other adverse event as defined by the Food and Drug
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10 Administration criteria provided in the Medwatch Reporting System;
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11 6. “Gestational age” means the time that has elapsed since the
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12 first day of the woman’s last menstrual period, also known as “last
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13 menstrual period” or “LMP”;
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14 7. “Hospital” means an institution providing medical and
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15 surgical treatment and nursing care for sick or injured people, or
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16 institutions defined under Section 1-701 of Title 63 of the Oklahoma
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17 Statutes;
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18 8. “Manufacturers and distributors” means individuals or
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19 entities that create, produce, supply, transport or sell drugs,
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20 which include:
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21 a. any substances recognized by an official pharmacopoeia
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22 or formulary,
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23 b. any substances intended for use in the diagnosis,
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24 cure, mitigation, treatment or prevention of disease,
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 1 c. any substances other than food intended to affect the
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2 structure or any function of the body, or
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3 d. any substances intended for use as a component of a
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4 medicine but not a device or a component, part or
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5 accessory of a device;
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6 9. “Obstetrician/gynecologist”, also known as OB/GYN, means a
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7 licensed physician who specializes in the care of women during
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8 pregnancy and childbirth and in the diagnosis and treatment of
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9 diseases of the female reproductive organs and specializes in other
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10 women’s health issues such as menopause, hormone problems,
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11 contraception or birth control, and infertility;
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12 10. “Physician” means any person licensed to practice medicine
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13 in this state. The term includes medical doctors and doctors of
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14 osteopathy;
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15 11. “Pregnant” or “pregnancy” means that female reproductive
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16 condition of having an unborn child in the mother’s uterus;
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17 12. “Provide” or “provision” means, when used regarding
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18 abortion-inducing drugs, any act of giving, selling, dispensing,
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19 administering, transferring possession to or otherwise providing or
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20 prescribing an abortion-inducing drug; and
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21 13. “Unborn child” means an individual organism of the species
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22 homo sapiens, beginning at fertilization, until the point of being
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23 born-alive as defined in Title 1 U.S.C., Section 8(b).
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 1 SECTION 2. NEW LAW A new section of law to be codified
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2 in the Oklahoma Statutes as Section 1-756.2 of Title 63, unless
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3 there is created a duplication in numbering, reads as follows:
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4 This act applies to any physician, health care provider or other
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5 person who is providing abortion-inducing drugs for use within this
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6 state, or any manufacturer or distributor providing abortion-
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7 inducing drugs within this state.
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8 SECTION 3. NEW LAW A new section of law to be codified
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9 in the Oklahoma Statutes as Section 1-756.3 of Title 63, unless
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10 there is created a duplication in numbering, reads as follows:
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11 A. The State Board of Pharmacy shall promulgate rules to create
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12 a certification program to oversee and regulate the provision of
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13 abortion-inducing drugs. Abortion-inducing drugs shall be
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14 transported and provided in this state only by manufacturers or
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15 distributors certified to do so under this program. The drugs shall
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16 only be provided to patients by physicians certified to do so under
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17 this program.
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18 B. The program shall be known as the Oklahoma Abortion-Inducing
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19 Drug Certification Program.
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20 C. Abortion-inducing drugs shall not be provided directly to
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21 the patient through the mail, or otherwise outside of the parameters
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22 of the Oklahoma Abortion-Inducing Drug Certification Program.
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 1 SECTION 4. NEW LAW A new section of law to be codified
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2 in the Oklahoma Statutes as Section 1-756.4 of Title 63, unless
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3 there is created a duplication in numbering, reads as follows:
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4 A. The State Board of Pharmacy shall establish the following
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5 requirements for manufacturers and distributors of abortion-inducing
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6 drugs, at a minimum:
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7 1. Require completion of the certification process for
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8 physicians as described in paragraph 6 of this subsection, and for
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9 manufacturers and distributors, as described in paragraph 5 of this
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10 subsection;
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11 2. Notify manufacturers and distributors of physicians
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12 certified under the Oklahoma Abortion-Inducing Drug Certification
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13 Program;
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14 3. Develop a reporting system as specified in Section 8 of this
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15 act;
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16 4. Prohibit shipment of abortion-inducing drugs to physicians
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17 who become de-certified from the Oklahoma Abortion-Inducing Drug
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18 Certification Program;
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19 5. Audit newly certified manufacturers and distributors within
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20 ninety (90) calendar days after the manufacturer or distributor is
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21 authorized, and annually thereafter, to ensure that all processes
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22 and procedures are in place and functioning to support the
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23 requirements of the Oklahoma Abortion-Inducing Drug Certification
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24 Program;
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 1 6. If a manufacturer or distributor is found to be non-
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2 compliant, immediately suspend manufacturer’s or distributor’s
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3 certification until the manufacturer or distributor demonstrates
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4 full compliance; and
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5 7. Enforce compliance according to Section 11 of this act.
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6 B. The State Board of Pharmacy shall establish the following
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7 requirements for physicians providing abortion-inducing drugs, at a
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8 minimum:
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9 1. Require completion of the certification process;
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10 2. Audit newly certified physicians within ninety (90) calendar
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11 days after the physician is authorized, and annually thereafter, to
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12 ensure that all required processes and procedures are in place and
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13 functioning to support the requirements of the Oklahoma Abortion-
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14 Inducing Drug Certification Program;
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15 3. If a physician is found to be non-compliant, immediately
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16 suspend the physician’s certification until such time that the
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17 physician demonstrates full compliance; and
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18 4. Enforce compliance according to Section 11 of this act.
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19 SECTION 5. NEW LAW A new section of law to be codified
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20 in the Oklahoma Statutes as Section 1-756.5 of Title 63, unless
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21 there is created a duplication in numbering, reads as follows:
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22 The State Board of Pharmacy shall adopt a certification system
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23 for any manufacturer or distributor intending to provide abortion-
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 1 inducing drugs in the state. To be eligible to be certified under
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2 this section, manufacturers and distributors shall:
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3 1. Be licensed by the Board;
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4 2. Only distribute to physicians certified under this act;
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5 3. Record each serial number from pharmaceutical packages
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6 distributed to each certified physician;
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7 4. Abide by all applicable the standards of the Utilization
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8 Review Accreditation Commission (URAC) or National Association of
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9 the Boards of Pharmacy (NABP);
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10 5. For online sales or orders, hold a current “.pharmacy” or
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11 “.pharma” domain and abide by all the standards required by the NABP
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12 to maintain the domain;
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13 6. Follow all other applicable state or federal laws related to
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14 the distribution or delivery of legend drugs including abortion-
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15 inducing drugs; and
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16 7. Follow all acceptable processes and procedures to maintain a
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17 distribution or delivery system that is secure, confidential and
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18 follows all processes and procedures including those for storage,
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19 handling, shipping, tracking package serial numbers, proof of
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20 delivery and controlled returns of abortion-inducing drugs.
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21 SECTION 6. NEW LAW A new section of law to be codified
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22 in the Oklahoma Statutes as Section 1-756.6 of Title 63, unless
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23 there is created a duplication in numbering, reads as follows:
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 1 The State Board of Pharmacy shall adopt a certification system
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2 for any physician intending to provide abortion-inducing drugs to
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3 patients in the state. Individuals or physicians providing
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4 abortion-inducing drugs in other states are not automatically
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5 certified in this state and shall be fully certified under this law
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6 prior to providing any abortion-inducing drugs to any pregnant women
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7 in this state. To be eligible to be certified under this section
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8 physicians shall:
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9 1. Be licensed to practice medicine and in good standing in the
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10 state;
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11 2. Examine any patient in-person prior to providing abortion-
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12 inducing drugs;
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13 3. Sign an annual “Dispensing Agreement Form,” to be developed
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14 and provided by the State Board of Pharmacy, before providing
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15 abortion-inducing drugs;
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16 4. Inform the patient of gestational age-specific risks of
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17 using abortion-inducing drugs;
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18 5. Assess for signs of domestic abuse, reproductive control,
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19 human trafficking and other signals of coerced abortion, per current
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20 state guidelines;
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21 6. Adequately inform the patient of gestational age-specific
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22 age risks of using abortion-inducing drugs;
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23 7. Inform the patient that she may see the remains of her
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24 unborn child in the process of completing the abortion;
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 1 8. Inform the patient that studies show that babies born
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2 following the abortion reversal process have a rate o