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ENGROSSED HOUSE AMENDME NT
TO
ENGROSSED SENATE BILL NO . 779 By: Daniels, Bullard, Stephens,
David and Taylor of the
Senate
and
Lepak of the House
An Act relating to abortion; creating the Oklahoma
Abortion-Inducing Drug Certification Program Act ;
defining terms; specifying applicability of act;
directing creation of certification program; limiting
provision of abortion -inducing drugs to certain
practitioners and procedures; authorizing certain
fees and contracts; directing State Board of Pharmacy
to establish certain requirements for manufacturers,
distributors and physicians; providing certification
systems and requirements for manufacturers,
distributors and physicians; requiring physician to
maintain hospital admitting privileges or enter into
certain written agreement; stating conditions of
agreement; requiring Board to adopt certain reporting
system; stating criteria of reporting system;
requiring certain reporting of physicians; providing
for reporting of adverse events; providing criminal
penalties; providing for certain civil remedies,
disciplinary sanctions and injunctive relief;
specifying certain judicial procedures; directing
Board to develop certain enforcement scheme;
specifying criteria of enforcement scheme; providing
for certain restitution; directing creation of
certain public portal; requiring portal to list
certain names and allow for certain complaints;
providing for disposition of complaints; providing
for confidentiality of complaints; providing certain
construction and intent; authorizing certain
intervention; providing severability; amending 59
O.S. 2011, Section 353.7, as last amended by Section
4, Chapter 106, O.S.L. 2018 (59 O.S. Supp. 2020,
Section 353.7), which relates to powers and duties of
the Board; broadening allowed uses of fees; providing
for codification; and providing an effective date.
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AUTHORS: Add the following House Coauthor s: Dills, Gann and Smith
AUTHOR: Add the following Senate Coauthor: Jett and Bergstrom
AMENDMENT NO. 1. Delete the title, enacting c lause and entire bill
and replace with:
"[ abortion - creating the Oklahoma Abortion -Inducing
Drug Certification Program Act - directing the
State Boards of Medical Licensure and Supervision
and Osteopathic Examiners to create a certain
certification program - effective date ]
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.1 of Title 63, unless
there is created a duplication in numbering, reads as follows:
Sections 1 through 16 of this act shall be known and may be
cited as the “Oklahoma Abortion -Inducing Drug Certification Program
Act”.
SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.2 of Title 63, unless
there is created a duplication in numbering, reads as follows:
As used in this act:
1. “Abortion” means the act of using or prescribing any
instrument, medicine, drug or any other substance, device or mea ns
with the intent to terminate the pregnancy of a woman known to be
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pregnant, with knowledge that the termination by those means will
with reasonable likelihood cause the death of the unborn child.
Such use, prescription or means is not an abortion if do ne with the
intent to:
a. save the life or preserve the health of the unborn
child,
b. remove a dead unborn child caused by spontaneous
abortion, accidental trauma or a criminal assault on
the pregnant woman or her unborn child,
c. remove an ectopic pregna ncy, or
d. treat a maternal disease or illness for which the
prescribed drug is indicated;
2. “Abortion-inducing drug” means a medicine, drug or any other
substance prescribed or dispensed with the intent of terminating the
pregnancy of a woman known to b e pregnant, 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. This definition
does not apply to drugs that may be known to cause an abortion, but
which are prescribed for other medical indications, such as
chemotherapeutic agents and diagnostic drugs. The use of such drugs
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to induce abortion is also known as “medical”, “medication”, “RU –
486”, “chemical”, “Mifeprex regimen” or “drug -induced” abortion;
3. “Adverse event”, according to the Food and Drug
Administration, means any untoward medical occurrence associated
with the use of a drug in humans, whether or not considered drug -
related. It 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 person fully licensed and in
good standing to practice medicine in the state including medical
doctors and doctors of osteopathy, who has entered into an
associated physician agreement;
5. “Complication” means any adverse physical or psychological
condition arising from the performance of an abortion which
includes, but is not limited to, uterine perforation, cervical
perforation, infection, heavy or uncontrolled bleeding, hemorrhage,
blood clots resulting in pulmonary emb olism or deep vein thrombosis,
failure to actually terminate the pregnancy, incomplete abortion
(retained tissue), pelvic inflammatory disease, endometritis, missed
ectopic pregnancy, cardiac arrest, respiratory arrest, renal
failure, metabolic disorder, s hock, embolism, coma, placenta previa
in subsequent pregnancies, preterm delivery in subsequent
pregnancies, free fluid in the abdomen, hemolytic reaction due to
the administration of ABO -incompatible blood or blood products,
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adverse reactions to anesthesi a and other drugs, subsequent
development of breast cancer, psychological complications such as
depression, suicidal ideation, anxiety, sleeping disorders, death
and any other adverse event as defined by the Food and Drug
Administration criteria provided i n the Medwatch Reporting System;
6. “Gestational age” means the time that has elapsed since the
first day of the woman’s last menstrual period, also known as “last
menstrual period” or “LMP”;
7. “Hospital” means an institution providing medical and
surgical treatment and nursing care for sick or injured people, or
institutions defined under Section 1 -701 of Title 63 of the Oklahoma
Statutes;
8. “Manufacturers and distributors” means individuals or
entities that create, produce, supply, transport or sell drugs,
which include:
a. any substances recognized by an official pharmacopoeia
or formulary,
b. any substances intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease,
c. any substances other than food intended to affect t he
structure or any function of the body, or
d. any substances intended for use as a component of a
medicine but not a device or a component, part or
accessory of a device;
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9. “Obstetrician/gynecologist”, also known as OB/GYN, means a
licensed physician w ho specializes in the care of women during
pregnancy and childbirth and in the diagnosis and treatment of
diseases of the female reproductive organs and specializes in other
women’s health issues such as menopause, hormone problems,
contraception or birth control, and infertility;
10. “Physician” means any person fully licensed by and in good
standing with the State Board of Medical Licensure and Supervision
or the State Board of Osteopathic Examiners to practice medicine in
this state. The term includes medical doctors and doctors of
osteopathy;
11. “Pregnant” or “pregnancy” means that female reproductive
condition of having an unborn child in the mother’s uterus;
12. “Provide” or “provision” means, when used regarding
abortion-inducing drugs, any act o f giving, selling, dispensing,
administering, transferring possession to or otherwise providing or
prescribing an abortion -inducing drug; and
13. “Unborn child” means an individual organism of the species
Homo sapiens, beginning at fertilization, until th e point of being
born-alive as defined in Title 1 U.S.C., Section 8(b).
SECTION 3. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.3 of Title 63, unless
there is created a duplication in numberi ng, reads as follows:
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This act applies to any physician, health care provider or other
person who is providing abortion -inducing drugs for use within this
state, or any manufacturer or distributor providing abortion -
inducing drugs within this state.
SECTION 4. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.4 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall promulgate rules to
create a certification program to oversee and regulate the provision
of abortion-inducing drugs by their licensee - physicians. The
drugs shall only be provided to patients by fully licensed
physicians certified to do so under this program by their respective
state licensing boards .
B. The program shall be known as the Oklahoma Abortion -Inducing
Drug Certification Program.
C. The State Board of Medical Licensure and Supervision and t he
State Board of Osteopathic Examiners may assess reasonable fees on
their respective licensees and enter into contracts with persons or
entities to implement the Oklahoma Abortion -Inducing Drug
Certification Program.
D. Abortion-inducing drugs shall not be provided directly to
the patient through the mail, telemedicine, or otherwise outside of
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the parameters of the Oklahoma Abortion -Inducing Drug Certification
Program.
SECTION 5. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.5 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Board of Pharmacy shall establish the following
requirements for manufacturers and distributors of abortion -inducing
drugs, at a minimum:
1. Require completion of the certification process for
physicians as described in Section 7 of this act, and for
manufacturers and distributors, as described in Section 6 of this
act;
2. Abortion-inducing drugs shall be transported and pr ovided in
this state only by manufacturers or distributors certified to do so
under this program;
3. Notify manufacturers and distributors of physicians
certified under the Oklahoma Abortion -Inducing Drug Certification
Program;
4. Develop a reporting sys tem as specified in Section 9 of this
act;
5. Prohibit shipment of abortion -inducing drugs to physicians
who become de-certified from the Oklahoma Abortion -Inducing Drug
Certification Program;
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6. Audit newly certified manufacturers and distributors withi n
ninety (90) calendar days after the manufacturer or distributor is
authorized, and annually thereafter, to ensure that all processes
and procedures are in place and functioning to support the
requirements of the Oklahoma Abortion -Inducing Drug Certificat ion
Program;
7. If a manufacturer or distributor is found to be
noncompliant, immediately suspend manufacturer’s or distributor’s
certification until the manufacturer or distributor demonstrates
full compliance; and
8. Enforce compliance according to Sec tion 12 of this act.
B. The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall establish the following
requirements for physicians providing abortion -inducing drugs, at a
minimum:
1. Require completion of the certification process;
2. Audit newly certified physicians within ninety (90) calendar
days after the physician is authorized, and annually thereafter, to
ensure that all required processes and procedures are in place and
functioning to support the re quirements of the Oklahoma Abortion -
Inducing Drug Certification Program;
3. If a physician is found to be noncompliant, immediately
suspend the physician’s certification until such time that the
physician demonstrates full compliance; and
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4. Enforce compliance according to Section 12 of this act.
SECTION 6. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.6 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The State Board of Pharmacy shall adopt a certification system
for any manufacturer or distributor intending to provide abortion -
inducing drugs in the state. To be eligible to be certified under
this section, manufacturers and distributors shall:
1. Be licensed by the Board;
2. Only distribute to physicians certified under this act;
3. Record each serial number from pharmaceutical packages
distributed to each certified physician;
4. Abide by all applicable standards of the Utilization Review
Accreditation Commission (URAC) or National Association of Boards of
Pharmacy (NABP);
5. For online sales or orders, hold a current “.pharmacy” or
“.pharma” domain and abide by all the standards required by the NABP
to maintain the domain;
6. Follow all other applicable state or federal laws related to
the distribution or delivery of legend drugs including abortion -
inducing drugs; and
7. Follow all acceptable processes and procedures to maintain a
distribution or delivery system that is secure, confidential and
follows all processes and procedures including those for storage,
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handling, shipping, tracking package serial numbers, proof of
delivery and controlled returns of abortion -inducing drugs.
SECTION 7. NEW LAW A new section of law to be codifi ed
in the Oklahoma Statutes as Section 1 -757.7 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall adopt a certification
system for any physician intending to provide abortion -inducing
drugs to patients in the state. Individuals or physicians providing
abortion-inducing drugs in other states are not automatically
certified in this state, and shall be fully certified under t his law
prior to providing any abortion -inducing drugs to any pregnant women
in this state. To be eligible to be certified under this section
physicians shall:
1. Be fully licensed by and in good standing with either the
State Board of Medical Licensure and Supervision or the State Board
of Osteopathic Examiners to practice medicine in the state;
2. Examine any patient in person prior to providing abortion -
inducing drugs;
3. Sign an annual “Dispensing Agreement Form” , to be developed
and provided by the physician's state licensing board , before
providing abortion-inducing drugs;
4. Inform the patient of gestational age -specific risks of
using abortion-inducing drugs;
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5. Assess for signs of domestic abuse, reproductive control,
human trafficking and oth er signals of coerced abortion, per current
state guidelines;
6. Adequately inform the patient of gestational age -specific
age risks of using abortion -inducing drugs;
7. Inform the patient that she may see the remains of her
unborn child in the process o f completing the abortion;
8. Inform the patient that studies show that babies born
following the abortion reversal process have a rate of birth defects
no higher than the general population;
9. Inform the patient that studies show that following this
reversal process or otherwise treating a woman with progesterone
during pregnancy does not lead to increased mortality rates;
10. Refrain from knowingly supplying abortion -inducing drugs to
patients who present with any of the following:
a. absence of a pregnancy,
b. being post-seventy days gestation or post -ten weeks of
pregnancy, and
c. having risk factors associated with abortion -inducing
drugs including, but not limited to:
(1) ectopic pregnancies,
(2) problems with the adrenal glands near the
kidneys,
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(3) being treated with long -term corticosteroid
therapy,
(4) allergic reactions to abortion -inducing drugs,
mifepristone, misoprostol or similar drugs,
(5) bleeding problems or is taking anticoagulant drug
products,
(6) has inherited porphyria,
(7) has an intrauterine device in place, or
(8) being Rh Negative, requiring administration of
Rhogam before providing abortion -inducing drugs;
11. Provide or refer for emergency surgical intervention in
cases of incomplete abortion, severe bleeding or other medical
complications, through maintaining hospital admitting privileges or
entering into a written agreement with an associated physician as
specified in Section 8 of this act;
12. Assure patient access to medical facilities equipped to
provide blood transfusion s and resuscitation or other necessary
treatments, if necessary;
13. Sign, and ensure that the patient signs, all legally
required informed consent material, providing patient with a copy
showing both signatures, and placing the original in the patient’s
medical record;
14. Record the serial number from each package of each
abortion-inducing drug given to the patient in her medical record;
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15. Submit a written protocol of how efforts will be made to
schedule with the patient the medically indic ated follow-up
appointment within fourteen (14) days to assure a completed
abortion;
16. Report to the State Board of Pharmacy, the physician's
state licensing board, as well as the Food and Drug Administration,
any death associated with abortion -inducing drugs with the following
guidelines:
a. the patient shall be noted by a non -identifiable
reference and the serial number from each package of
abortion-inducing drug given, whether or not
considered drug-related,
b. this shall be done as soon as possible but no late r
than fifteen (15) calendar days from the initial
receipt of the information by the physician, and
c. this requirement does not affect the physician’s other
reporting and follow -up requirements under the
Oklahoma Abortion-Inducing Drug Certification Progr am
or any additional requirements by another department
that oversees the abortion industry in this state;
17. Submit a written protocol of how complications will be
handled by the certified physician and submit a copy of a signed
contract with an associa ted physician credentialed to handle certain
complications as outlined in Section 8 of this act;
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18. Abide by all applicable state and federal laws regarding
medical records retention, confidentiality and privacy; and
19. Agree to follow and document com pliance with all other
legally required conditions for performing abortion in the state
where the patient presents for her appointment including, but not
limited to, waiting periods, informed consent requirements,
statistical reporting, parental consent or notification, and
required inspections.
SECTION 8. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.8 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall also require the
following of certified physicians:
1. Maintaining hospital admitting privileges at one or more
hospitals in the county or contiguous county whe re the abortion-
inducing drug was provided, and informing the patient of any
hospital where the physician holds admitting privileges.
2. Alternatively, the physician may enter into a written
agreement with an associated physician in the county or contiguo us
county where the abortion -inducing drug was provided. The written
agreement shall meet these conditions:
a. a physician who provides an abortion -inducing drug
shall notify the patient of the location of the
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hospital at which the associated physician ha s
admitting privileges,
b. the physician shall keep, at the location of his or
her practice, a copy of the written agreement,
c. the physician shall submit a copy of the written
agreement to their state licensing board and the State
Department of Health as part of any required clinic
licensure,
d. the State Department of Health shall verify the
validity of the document, and shall remove any
personal identifying information of the patient from
the document before releasing the document in
accordance with the following:
(1) the State Department of Health shall annually
submit a copy of the written agreement described
in this paragraph to each hospital located in the
county or a county that is contiguous to the
county where the abortion was performed, and
(2) the State Department of Health shall confirm to a
member of the public, upon request, that the
written agreement required to be submitted under
this section for an abortion clinic has been
received by the Department,
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e. the agreement shall be renewed annual ly, or more often
as required by the physician's state licensing board ,
f. the agreement shall include a requirement that the
physician provide to the patient and require the
patient to sign all legally required informed consent
material, and
g. the agreement shall require the adherence to all
reporting requirements from the State Department of
Health, and the physician's licensing board.
SECTION 9. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.9 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall adopt an electronically
based reporting system for certified p hysicians to report annually
the following:
1. The number of patients served;
2. Age of patients served;
3. Race of patients served;
4. County and state of residence of patients served;
5. If the patient resides outside the United States, city and
country of residence;
6. County and state of service;
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7. A list of staff attending patients including licensing
numbers and evidence of other qualifications;
8. Each medication used or provided per patient, by date;
9. Any known complications or adverse e vents, and how they were
addressed, by date; and
10. Unresolved cases.
B. This reporting system shall also be used by emergency
department physicians and private physicians who treat post -abortion
complications.
C. Physicians shall protect from disclosu re any personally
identifiable information of the patient in accordance with
applicable federal and state law.
D. A certified physician shall also report to their licensing
board, the State Board of Pharmacy, as well as the Medwatch
Reporting System of th e Food and Drug Administration (FDA), any
complication or adverse event as defined according to the FDA
criteria given in the Medwatch Reporting System.
E. The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall develop a system of
reporting adverse events from the use of abortion -inducing drugs for
this state. The system shall require reporting of complications and
adverse events including, but not limited to:
1. Death;
2. Blood loss including hemorrhage;
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3. Infection including sepsis;
4. Blood transfusions;
5. Administer drug for an ectopic pregnancy; and
6. Other adverse effects requiring hospitalization or
additional medical care.
F. The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall require the following
providers and entities to report complications and adverse events in
writing:
1. Physicians certified to provide abortion -inducing drugs;
2. Emergency room physicians;
3. Any doctor licensed i n this state including an
obstetrician/gynecologist who treats women with adverse events;
4. Provision of certification requires that the physician shall
also report adverse events and any patient deaths to the FDA; and
5. Other individuals or entities a s determined by the State
Board of Pharmacy.
SECTION 10. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.10 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. Individuals or entities not certified under the Oklahoma
Abortion-Inducing Drug Certification Program that provide drugs for
the purpose of inducing abortion are in violation of this act.
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B. Individuals or entities that provide abortion -inducing drugs
to any person or entity that is not certified, or otherwise
authorized, to provide abortion -inducing drugs under the Oklahoma
Abortion-Inducing Drug Certification Program are in violation of
this act.
C. A person who intentionally, knowingly or recklessly vi olates
any provision of this act is guilty of a misdemeanor.
D. A person who intentionally, knowingly or recklessly violates
any provision of this act by fraudulent use of an abortion -inducing
drug, with or without the knowledge of the pregnant woman, is guilty
of a felony.
E. No civil or criminal penalty may be assessed against the
pregnant woman upon whom the drug -induced abortion is attempted,
induced or performed.
SECTION 11. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.11 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. In addition to whatever remedies are available under the
common or statutory law of this state, failure to comply with the
requirements of this act shall:
1. Provide a basis for a civil malpractice action for actual
and punitive damages;
2. Provide a basis for a professional disciplinary action; and
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3. Provide a basis for recovery for the woman’s survivors for
the wrongful death of t he woman.
B. When requested, the court shall allow a woman to proceed
using solely her initials or a pseudonym and may close any
proceedings in the case and enter other protective orders to
preserve the privacy of the woman upon whom the drug -induced
abortion was attempted, induced or performed.
C. If judgment is rendered in favor of the plaintiff, the court
shall also render judgment for reasonable attorney fees in favor of
the plaintiff against the defendant.
D. If judgment is rendered in favor of the defendant and the
court finds that the plaintiff’s suit was frivolous and brought in
bad faith, the court may render judgment for reasonable attorney
fees in favor of the defendant against the plaintiff.
E. A cause of action for injunctive relief against a person who
has provided an abortion -inducing drug in violation of this act may
be maintained by:
1. A woman to whom such an abortion -inducing drug was provided;
2. A person who is the spouse, parent or guardian of, or a
current or former licensed healt h care provider of, a woman to whom
such an abortion-inducing drug was provided; or
3. A prosecuting attorney with appropriate jurisdiction.
The injunction shall prevent the defendant from providing
further abortion-inducing drugs in violation of this act .
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SECTION 12. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.12 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Board of Pharmacy , the State Board of Medical
Licensure and Supervision and the State Board of Osteopathic
Examiners shall develop an enforcement scheme for their licensees to
enforce this act, which includes:
1. When an individual or entity provides abortion -inducing
drugs without first seeking certification under this act, the State
Board of Pharmacy shall:
a. immediately report the illegal act to local law
enforcement, or other applicable state and local
agencies for investigation or other appropriate
action, where appropriate, and
b. impose a fine of no less than Five Million Dollars
($5,000,000.00) for manufacturers or distributors and
Two Hundred Fifty Thousand Dollars ($250,000.00) for
physicians;
2. When a certified manufacturer , distributor or physician is
determined to be in non compliance, suspend certification until
compliance is proven to the satisfaction of their licensing board ;
3. Where a current or previously certified manufacturer or
distributer is found to have intentionally or knowingly violated
this act, or refuses to bring operations into compliance within
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ninety (90) calendar days, remove certification and prohibit
continued provision of abortion -inducing drugs by the manufacturer
or distributor until compliance is demonstrated to the satisfaction
of their licensing board;
4. When a certified manufacturer, dis tributor or physician is
in noncompliance, suspend all annual recertification until
compliance is demonstrated to the satisfaction of their licensing
board; and
5. Where a current or previously certified manufac turer,
distributor or physician is found to have intentionally or knowingly
violated this act, or refuses to bring operations into compliance:
a. immediately suspend the manufacturer’s, distributor’s
or physician’s certification until full compliance is
demonstrated,
b. for certified manufacturers or distributors, impose
fines of not less than One Million Dollars
($1,000,000.00) per offense, by the State Board of
Pharmacy,
c. for certified physicians, impose fines of not less
than One Hundred Thousand Dolla rs ($100,000.00) per
offense, by the physician's licensing board,
d. permanently revoke the certification of the offender
if offender fails to demonstrate compliance with their
licensing board within ninety (90) calendar days,
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e. impose remedial actions, w hich may include additional
education, additional reporting or other actions as
required by the relevant licensing board ,
f. in the case of a manufacturer or distributor,
recommend sanctioning to the appropriate disciplinary
committee of the State Board of Pharmacy,
g. in the case of a physician, report the violation to
the appropriate physician licensing board,
h. publicly report any disciplinary actions, consistent
with the practices of the relevant licensing board ,
i. permanently revoke the certification of the offender,
j. in the case of a licensed manufacturer or distributor,
recommend permanent revocation of licensure,
k. in the case of a physician, recommend appropriate
sanctioning to the appropriate physician licensing
board, and
l. publicly report any disciplinary actions consistent
with the practices of the relevant licensing board .
B. Individuals have a Private Right of Action to seek
restitution in any court of law with appropriate jurisdiction for
any and all damages suffered due to a violation of this act.
SECTION 13. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.13 of Title 63, unless
there is created a duplication in numbering, reads as follows:
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A. The State Board of Pharmacy shal l develop on its website a
complaint portal for patients, pharmacy, nursing and medical
professionals and the public to submit information about potential
violations by nonphysicians at no charge to the parties named in
this subsection.
B. The State Board of Medical Licensure and Supervision and the
State Board of Osteopathic Examiners shall develop on their
respective websites a complaint portal for patients, pharmacy,
nursing and medical professionals, and the public to submit
information about potential violations by physicians at no charge to
the parties named in this subsection.
C. The portal developed by the State Board of Pharmacy shall
list the names of manufacturers and distributors that are certified
under the program.
D. The portals developed b y the State Board of Medical
Licensure and Supervision and the State Board of Osteopathic
Examiners shall list the names of the fully licensed physicians
certified under the program.
E. The portal shall allow the party to make a complaint
anonymously.
F. The State Board of Pharmacy and physician licensing boards
shall review each complaint and determine a disposition including
referral to another appropriate state agency, within thirty (30)
days of receipt of a complaint .
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G. Confidentiality of the origin ator of the complaint shall be
protected at all times except for intra -state referrals for
investigation or if any disciplinary action is brought by a
licensing board pursuant to this act .
SECTION 14. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.14 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. Nothing in this act shall be construed as creating or
recognizing a right to abortion.
B. It is not the intenti on of this act to make lawful an
abortion that is otherwise unlawful.
C. Nothing in this act repeals, replaces or otherwise
invalidates existing federal or state laws, regulations or policies.
SECTION 15. NEW LAW A new section of la w to be codified
in the Oklahoma Statutes as Section 1 -757.15 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The Legislature, by joint resolution, may appoint one or more of
its members, who sponsored or cosponsored this act in his or her
official capacity, to intervene as a matter of right in any case in
which the constitutionality of this act is challenged.
SECTION 16. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1-757.16 of Title 63, unless
there is created a duplication in numbering, reads as follows:
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If any one or more provisions, sections, subsections, sentences,
clauses, phrases or words of this act or the application thereof to
any person or circumstance is found to be unconstitutional, the same
is hereby declared to be severable and the balance of this act shall
remain effective notwithstanding such unconstitutionality. The
Legislature hereby declares that it would have passed this act, and
each provision, section, subsection, sentence, clause, phrase or
word thereof, irrespective of the fact that any one or more
provisions, sections, subsections, sentences, clauses, phrases or
words be declared unconstitutional.
SECTION 17. AMENDATORY 59 O.S. 2011, Section 353.7, as
last amended by Section 4, Chapter 106, O.S.L. 2018 (59 O.S. Supp.
2020, Section 353.7), is amended to read as follows:
Section 353.7 The State Board of Pharmacy shall have the power
and duty to:
1. Regulate the practic e of pharmacy;
2. Regulate the sale and distribution of drugs, medicines,
chemicals and poisons;
3. Regulate the dispensing of drugs and medicines in all places
where drugs and medicines are compounded and/or dispensed;
4. Examine and issue appropriate certificates of licensure as
Doctor of Pharmacy to all applicants whom the Board deems qualified
under the provisions of the Oklahoma Pharmacy Act;
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5. Issue licenses to manufacturers, repackagers, outsourcing
facilities, wholesale distributors, third -party logistics providers,
pharmacies, and other dispensers, medical gas suppliers , and medical
gas distributors;
6. Issue sterile compounding and drug supplier permits for
pharmacies at the fee set by the Board, with the expiration date of
such permits to coincide with the pharmacy license annual expiration
date;
7. Prescribe minimum standards with respect to floor space and
other physical characteristics of pharmacies and hospital drug rooms
as may be reasonably necessary for the maintenance of professional
surroundings and for the protection of the safety and welfare of the
public, and to refuse the issuance of new or renewal licenses for
failure to comply with such standards. Minimum standards for
hospital drug rooms shall be consistent with the State Dep artment of
Health, Hospital Standards, as defined in OAC 310:667;
8. Authorize its inspectors, compliance officers , and duly
authorized representatives to enter and inspect any and all places ,
including premises, vehicles, equipment, contents and records, where
drugs, medicines, chemicals , or poisons are stored, sold, vended,
given away, compounded, dispensed, manufactured, repackaged or
transported;
9. Employ the number of inspectors and pharmacist compliance
officers necessary in the investigation of cr iminal activity or
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preparation of administrative actions at an annual salary to be
fixed by the Board, and to authorize necessary expenses. Any
inspector certified as a peace officer by the Council of Enforcement
Education and Training shall have statewid e jurisdiction to perform
the duties authorized by this section. In addition, the inspectors
shall be considered peace officers and shall have the same powers
and authority as that granted to peace officers. In addition, such
inspectors or pharmacist com pliance officers shall have the
authority to take and copy records and the duty to confiscate all
drugs, medicines, chemicals or poisons found to be stored, sold,
vended, given away, compounded, dispensed or manufactured contrary
to the provisions of the O klahoma Pharmacy Act;
10. Investigate complaints, subpoena witnesses and records,
initiate prosecution , and hold hearings;
11. Administer oaths in all manners pertaining to the affairs
of the Board and to take evidence and compel the attendance of
witnesses on questions pertaining to the enforcement of the Oklahoma
Pharmacy Act;
12. Reprimand, place on probation, suspend, revoke permanently
and levy fines not to exceed Three Thousand Dollars ($3,000.00) for
each count for which any person charged with vi olating the Oklahoma
Pharmacy Act or Oklahoma Board of Pharmacy administrative rules has
been convicted in Board hearings. The Board also may take other
disciplinary action. The Board may impose as part of any
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disciplinary action the payment of costs exp ended by the Board for
any legal fees and costs , including, but not limited to, staff time,
salary and travel expense, witness fees and attorney fees. The
Board may also require additional continuing education , including
attendance at a live continuing ed ucation program, and may require
participation in a rehabilitation program for the impaired. The
Board may take such actions singly or in combination, as the nature
of the violation requires;
13. Adopt and establish rules of professional conduct
appropriate to the establishment and maintenance of a high standard
of integrity and dignity in the profession of pharmacy. Such rules
shall be subject to amendment or repeal by the Board as the need may
arise;
14. Make and publish rules such as may be necessary for
carrying out and enforcing the provisions of the Oklahoma Pharmacy
Act, Oklahoma drug laws and rules, federal drug laws and
regulations, and make such other rules as in its discretion may be
necessary to protect the health, safety , and welfare of the public;
15. Establish and collect appropriate fees for licenses,
permits, inspections , and services provided; and such fees shall be
nonrefundable. Such fees shall be promulgated to implement the
provisions of the Oklahoma Pharmacy Act under the provisio ns of the
Administrative Procedures Act and the Oklahoma Abortion -Inducing
Drug Certification Program Act ;
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16. Regulate:
a. personnel working in a pharmacy, such as interns and
supportive personnel , including technicians, and issue
pharmacy technician per mits and intern licenses,
b. interns, preceptors and training areas through which
the training of applicants occurs for licensure as a
pharmacist, and
c. such persons regarding all aspects relating to the
handling of drugs, medicines, chemicals , and poisons;
17. Acquire by purchase, lease, gift, solicitation of gift or
by any other manner, and to maintain, use and operate or to contract
for the maintenance, use and operation of or lease of any and all
property of any kind, real, personal or mixed or any in terest
therein unless otherwise provided by the Oklahoma Pharmacy Act;
provided, all contracts for real property shall be subject to the
provisions of Section 63 of Title 74 of the Oklahoma Statutes;
18. Perform other such duties, exercise other such powe rs and
employ such personnel as the provisions and enforcement of the
Oklahoma Pharmacy Act may require; and
19. Approve pilot projects designed to utilize new or expanded
technology or processes and provide patients with better pharmacy
products or provide pharmacy services in a more safe and efficient
manner. Such approvals may include provisions granting exemptions
to any rule adopted by the Board.
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SECTION 18. This act shall become effective November 1, 2021. "
Passed the House of Repres entatives the 21st day of April, 2021.
Presiding Officer of the House of
Representatives
Passed the Senate the ____ day of __________, 2021.
Presiding Officer of the Senate
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ENGROSSED SENATE
BILL NO. 779 By: Daniels, Bullard, Stephens,
David and Taylor of the
Senate
and
Lepak of the House
An Act relating to abortion; creating the Oklahoma
Abortion-Inducing Drug Certification Program Act;
defining terms; specifying applicability of act;
directing creation of certification program; limiting
provision of abortion -inducing drugs to certain
practitioners and procedures; authorizing certain
fees and contracts; directing State Board of Pharmacy
to establish certain requirements for manufacturers,
distributors and physicians; providing cer tification
systems and requirements for manufacturers,
distributors and physicians; requiring physician to
maintain hospital admitting privileges or enter into
certain written agreement; stating conditions of
agreement; requiring Board to adopt certain rep orting
system; stating criteria of reporting system;
requiring certain reporting of physicians; providing
for reporting of adverse events; providing criminal
penalties; providing for certain civil remedies,
disciplinary sanctions and injunctive relief;
specifying certain judicial procedures; directing
Board to develop certain enforcement scheme;
specifying criteria of enforcement scheme; providing
for certain restitution; directing creation of
certain public portal; requiring portal to list
certain names and allow for certain complaints;
providing for disposition of complaints; providing
for confidentiality of complaints; providing certain
construction and intent; authorizing certain
intervention; providing severability; amending 59
O.S. 2011, Section 353.7, as last amended by Section
4, Chapter 106, O.S.L. 2018 (59 O.S. Supp. 2020,
Section 353.7), which relates to powers and duties of
the Board; broadening allowed uses of fees; providing
for codification; and providing an effective date.
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BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 19. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.1 of Title 63, unless
there is created a duplication in numbering, reads as follows:
Sections 1 through 16 of this act shall be known and may be
cited as the “Oklahoma Abortion -Inducing Drug Certification Program
Act”.
SECTION 20. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.2 of Title 63, unless
there is created a duplication in numbering, reads as follows:
As used in this act:
1. “Abortion” means the act of using or prescribing any
instrument, medicine, drug or any other substance, device or means
with the intent to terminate the pregn ancy of a woman known to be
pregnant, with knowledge that the termination by those means will
with reasonable likelihood cause the death of the unborn child.
Such use, prescription or means is not an abortion if done with the
intent to:
a. save the life or preserve the health of the unborn
child,
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b. remove a dead unborn child caused by spontaneous
abortion, accidental trauma or a criminal assault on
the pregnant woman or her unborn child,
c. remove an ectopic pregnancy, or
d. treat a maternal disease or il lness for which the
prescribed drug is indicated;
2. “Abortion-inducing drug” means a medicine, drug or any other
substance prescribed or dispensed with the intent of terminating the
pregnancy of a woman known to be pregnant, 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. This definition
does not apply to drugs that may be known to cause an abortion, but
which are prescribed for other medical indications, such as
chemotherapeutic agents and diagnostic drugs. The use of such drugs
to induce abortion is also known as “medical”, “medication”, “RU –
486”, “chemical”, “Mifeprex regimen” or “drug -induced” abortion;
3. “Adverse Event”, according to the Food and Drug
Administration, means any untoward medical occurrence associate d
with the use of a drug in humans, whether or not considered drug -
related. It does not include an adverse event or suspected adverse
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reaction that, had it occurred in a more severe form, might have
caused death;
4. “Associated physician” means a person licensed to practice
medicine in the state including medical doctors and doctors of
osteopathy, that has entered into an associated physician agreement;
5. “Complication” means any adverse physical or psychological
condition arising from the performance o f an abortion which
includes, but is not limited to, uterine perforation, cervical
perforation, infection, heavy or uncontrolled bleeding, hemorrhage,
blood clots resulting in pulmonary embolism or deep vein thrombosis,
failure to actually terminate the pr egnancy, incomplete abortion
(retained tissue), pelvic inflammatory disease, endometritis, missed
ectopic pregnancy, cardiac arrest, respiratory arrest, renal
failure, metabolic disorder, shock, embolism, coma, placenta previa
in subsequent pregnancies, pr eterm delivery in subsequent
pregnancies, free fluid in the abdomen, hemolytic reaction due to
the administration of ABO -incompatible blood or blood products,
adverse reactions to anesthesia and other drugs, subsequent
development of breast cancer, psychol ogical complications such as
depression, suicidal ideation, anxiety, sleeping disorders, death
and any other adverse event as defined by the Food and Drug
Administration criteria provided in the Medwatch Reporting System;
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6. “Gestational age” means the ti me that has elapsed since the
first day of the woman’s last menstrual period, also known as “last
menstrual period” or “LMP”;
7. “Hospital” means an institution providing medical and
surgical treatment and nursing care for sick or injured people, or
institutions defined under Section 1 -701 of Title 63 of the Oklahoma
Statutes;
8. “Manufacturers and distributors” means individuals or
entities that create, produce, supply, transport or sell drugs,
which include:
a. any substances recognized by an official p harmacopoeia
or formulary,
b. any substances intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease,
c. any substances other than food intended to affect the
structure or any function of the body, or
d. any substances intended for use as a component of a
medicine but not a device or a component, part or
accessory of a device;
9. “Obstetrician/gynecologist”, also known as OB/GYN, means a
licensed physician who specializes in the care of women during
pregnancy and childbirth and in the diagnosis and treatment of
diseases of the female reproductive organs and specializes in other
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women’s health issues such as menopause, hormone problems,
contraception or birth control, and infertility;
10. “Physician” means any person license d to practice medicine
in this state. The term includes medical doctors and doctors of
osteopathy;
11. “Pregnant” or “pregnancy” means that female reproductive
condition of having an unborn child in the mother’s uterus;
12. “Provide” or “provision” mean s, when used regarding
abortion-inducing drugs, any act of giving, selling, dispensing,
administering, transferring possession to or otherwise providing or
prescribing an abortion -inducing drug; and
13. “Unborn child” means an individual organism of the s pecies
homo sapiens, beginning at fertilization, until the point of being
born-alive as defined in Title 1 U.S.C., Section 8(b).
SECTION 21. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.3 of Title 63, unless
there is created a duplication in numbering, reads as follows:
This act applies to any physician, health care provider or other
person who is providing abortion -inducing drugs for use within this
state, or any manufacturer or distributor pr oviding abortion-
inducing drugs within this state.
SECTION 22. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.4 of Title 63, unless
there is created a duplication in numbering, reads as follows:
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A. The State Board of Pharmacy shall promulgate rules to create
a certification program to oversee and regulate the provision of
abortion-inducing drugs. Abortion -inducing drugs shall be
transported and provided in this state only by manufacturers or
distributors certified to do so under this program. The drugs shall
only be provided to patients by physicians certified to do so under
this program.
B. The program shall be known as the Oklahoma Abortion -Inducing
Drug Certification Program.
C. The Board may assess reasonable fees and enter into
contracts with persons or entities to implement the Oklahoma
Abortion-Inducing Drug Certification Program.
D. Abortion-inducing drugs shall not be provided directly to
the patient through the mail, or otherwise ou tside of the parameters
of the Oklahoma Abortion -Inducing Drug Certification Program.
SECTION 23. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.5 of Title 63, unless
there is created a duplicat ion in numbering, reads as follows:
A. The State Board of Pharmacy shall establish the following
requirements for manufacturers and distributors of abortion -inducing
drugs, at a minimum:
1. Require completion of the certification process for
physicians as described in Section 7 of this act, and for
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manufacturers and distributors, as described in Section 6 of this
act;
2. Notify manufacturers and distributors of physicians
certified under the Oklahoma Abortion -Inducing Drug Certification
Program;
3. Develop a reporting system as specified in Section 9 of this
act;
4. Prohibit shipment of abortion -inducing drugs to physicians
who become de-certified from the Oklahoma Abortion -Inducing Drug
Certification Program;
5. Audit newly certified manufacturers and distributors within
ninety (90) calendar days after the manufacturer or distributor is
authorized, and annually thereafter, to ensure that all processes
and procedures are in place and functioning to support the
requirements of the Oklahoma Abortion -Inducing Drug Certification
Program;
6. If a manufacturer or distributor is found to be non -
compliant, immediately suspend manufacturer’s or distributor’s
certification until the manufacturer or distributor demonstrates
full compliance; and
7. Enforce compliance according to Section 12 of this act.
B. The State Board of Pharmacy shall establish the following
requirements for physicians providing abortion -inducing drugs, at a
minimum:
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1. Require completion of the certification process;
2. Audit newly certifi ed physicians within ninety (90) calendar
days after the physician is authorized, and annually thereafter, to
ensure that all required processes and procedures are in place and
functioning to support the requirements of the Oklahoma Abortion -
Inducing Drug Certification Program;
3. If a physician is found to be non -compliant, immediately
suspend the physician’s certification until such time that the
physician demonstrates full compliance; and
4. Enforce compliance according to Section 12 of this act.
SECTION 24. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.6 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The State Board of Pharmacy shall adopt a certification system
for any manufacturer or distributor intending to provide abortion -
inducing drugs in the state. To be eligible to be certified under
this section, manufacturers and distributors shall:
1. Be licensed by the Board;
2. Only distribute to physicians certified under this act;
3. Record each serial number from pharmaceutical packages
distributed to each certified physician;
4. Abide by all applicable standards of the Utilization Review
Accreditation Commission (URAC) or National Association of Boards of
Pharmacy (NABP);
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5. For online sales or orders, hold a current “.pharmacy” or
“.pharma” domain and abide by all the standards required by the NABP
to maintain the domain;
6. Follow all other applicable state or federal laws related to
the distribution or delivery of legend drugs including abortion -
inducing drugs; and
7. Follow all acceptable processes and procedures to maintain a
distribution or delivery system that is secure, confidential and
follows all processes and procedures including those for storage,
handling, shipping, tracking package serial numbers, proof of
delivery and controlled returns of abortion -inducing drugs.
SECTION 25. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.7 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The State Board of Pharmacy shall adopt a certification system
for any physician intending to provide abortion -inducing drugs to
patients in the state. Individuals or physici ans providing
abortion-inducing drugs in other states are not automatically
certified in this state, and shall be fully certified under this law
prior to providing any abortion -inducing drugs to any pregnant women
in this state. To be eligible to be certi fied under this section
physicians shall:
1. Be licensed to practice medicine and in good standing in the
state;
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2. Examine any patient in person prior to providing abortion -
inducing drugs;
3. Sign an annual “Dispensing Agreement Form,” to be developed
and provided by the State Board of Pharmacy, before providing
abortion-inducing drugs;
4. Inform the patient of gestational age -specific risks of
using abortion-inducing drugs;
5. Assess for signs of domestic abuse, reproductive control,
human trafficking and other signals of coerced abortion, per current
state guidelines;
6. Adequately inform the patient of gestational age -specific
age risks of using abortion -inducing drugs;
7. Inform the patient that she may see the remains of her
unborn child in the process of completing the abortion;
8. Inform the patient that studies show that babies born
following the abortion reversal process have a rate of birth defects
no higher than the general population;
9. Inform the patient that studies show that followin g this
reversal process or otherwise treating a woman with progesterone
during pregnancy does not lead to increased mortality rates;
10. Refrain from knowingly supplying abortion -inducing drugs to
patients who present with any of the following:
a. absence of a pregnancy,
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b. being post-seventy days gestation or post -ten weeks of
pregnancy, and
c. having risk factors associated with abortion -inducing
drugs including, but not limited to:
(1) ectopic pregnancies,
(2) problems with the adrenal glands near the
kidneys,
(3) being treated with long -term corticosteroid
therapy,
(4) allergic reactions to abortion -inducing drugs,
mifepristone, misoprostol or similar drugs,
(5) bleeding problems or is taking anticoagulant drug
products,
(6) has inherited porphyria,
(7) has an intrauterine device in place, or
(8) being Rh Negative, requiring administration of
Rhogam before providing abortion -inducing drugs;
11. Provide or refer for emergency surgical intervention in
cases of incomplete abortion, severe bleeding or other medical
complications, through maintaining hospital admitting privileges or
entering into a written agreement with an associated physician as
specified in Section 8 of this act;
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12. Assure patient access to medical facilities equipped to
provide blood transfusions and resuscitation or other necessary
treatments, if necessary;
13. Sign, and ensure that the patient signs, all legally
required informed consent material, providing patient with a copy
showing both signatures, and placing the original in the p atient’s
medical record;
14. Record the serial number from each package of each
abortion-inducing drug given to the patient in her medical record;
15. Submit a written protocol of how efforts will be made to
schedule with the patient the medically indict ed follow-up
appointment within fourteen (14) days to assure a completed
abortion;
16. Report to the State Board of Pharmacy, as well as the Food
and Drug Administration, any death associated with abortion -inducing
drugs with the following guidelines:
a. the patient shall be noted by a non -identifiable
reference and the serial number from each package of
abortion-inducing drug given, whether or not
considered drug-related,
b. this shall be done as soon as possible but no later
than fifteen (15) calendar da ys from the initial
receipt of the information by the physician, and
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c. this requirement does not affect the physician’s other
reporting and follow -up requirements under the
Oklahoma Abortion-Inducing Drug Certification Program
or any additional requiremen ts by another department
that oversees the abortion industry in this state;
17. Submit a written protocol of how complications will be
handled by the certified physician and submit a copy of a signed
contract with an associated physician credentialed to h andle certain
complications as outlined in Section 8 of this act;
18. Abide by all applicable state and federal laws regarding
medical records retention, confidentiality and privacy; and
19. Agree to follow and document compliance with all other
legally required conditions for performing abortion in the state
where the patient presents for her appointment including, but not
limited to, waiting periods, informed consent requirements,
statistical reporting, parental consent or notification, and
required inspections.
SECTION 26. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.8 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The State Board of Pharmacy shall also r equire the following of
certified physicians:
1. Maintaining hospital admitting privileges at one or more
hospitals in the county or contiguous county where the abortion -
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inducing drug was provided, and informing the patient of any
hospital where the physi cian holds admitting privileges.
2. Alternatively, the physician may enter into a written
agreement with an associated physician in the county or contiguous
county where the abortion -inducing drug was provided. The written
agreement shall meet these cond itions:
a. a physician who provides an abortion -inducing drug
shall notify the patient of the location of the
hospital at which the associated physician has
admitting privileges,
b. the physician shall keep, at the location of his or
her practice, a copy o f the written agreement,
c. the physician shall submit a copy of the written
agreement to the State Department of Health as part of
any required clinic licensure,
d. the State Department of Health shall verify the
validity of the document, and shall remove any
personal identifying information of the patient from
the document before releasing the document in
accordance with the following:
(1) the State Department of Health shall annually
submit a copy of the written agreement described
in this paragraph to e ach hospital located in the
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county or a county that is contiguous to the
county where the abortion was performed, and
(2) the State Department of Health shall confirm to a
member of the public, upon request, that the
written agreement required to be submit ted under
this section for an abortion clinic has been
received by the Department,
e. the agreement shall be renewed annually, or more often
as required by the State Board of Pharmacy,
f. the agreement shall include a requirement that the
physician provide to the patient and require the
patient to sign all legally required informed consent
material, and
g. the agreement shall require the adherence to all
reporting requirements from the State Board of
Pharmacy and the State Department of Health.
SECTION 27. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.9 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Board of Pharmacy shall adopt an electronically
based reporting system for certified physicians to report annually
the following:
1. The number of patients served;
2. Age of patients served;
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3. Race of patients served;
4. County and state of residence of patients served;
5. If the patient resides o utside the United States, city and
country of residence;
6. County and state of service;
7. A list of staff attending patients including licensing
numbers and evidence of other qualifications;
8. Each medication used or provided per patient, by date;
9. Any known complications or adverse events, and how they were
addressed, by date; and
10. Unresolved cases.
B. This reporting system shall also be used by emergency
department physicians and private physicians who treat post -abortion
complications.
C. Physicians shall protect from disclosure any personally
identifiable information of the patient in accordance with
applicable federal and state law.
D. A certified physician shall also report to the State Board
of Pharmacy, as well as the Medwatch Reporti ng System of the Food
and Drug Administration (FDA), any complication or adverse event as
defined according to the FDA criteria given in the Medwatch
Reporting System.
E. The State Board of Pharmacy shall develop a system of
reporting adverse events from the use of abortion-inducing drugs for
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this state. The system shall require reporting of complications and
adverse events including, but not limited to:
1. Death;
2. Blood loss including hemorrhage;
3. Infection including sepsis;
4. Blood transfusions ;
5. Administer drug for an ectopic pregnancy; and
6. Other adverse effects requiring hospitalization or
additional medical care.
F. The State Board of Pharmacy shall require the following
providers and entities to report complications and adverse event s in
writing:
1. Physicians certified to provide abortion -inducing drugs;
2. Emergency room physicians;
3. Any doctor licensed in this state including an
obstetrician/gynecologist who treats women with adverse events;
4. Provision of certification requ ires that the physician shall
also report adverse events and any patient deaths to the FDA; and
5. Other individuals or entities as determined by the State
Board of Pharmacy.
SECTION 28. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.10 of Title 63, unless
there is created a duplication in numbering, reads as follows:
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A. Individuals or entities not certified under the Oklahoma
Abortion-Inducing Drug Certification Program that provide drugs for
the purpose of inducing abortion are in violation of this act.
B. Individuals or entities that provide abortion -inducing drugs
to any person or entity that is not certified, or otherwise
authorized, to provide abortion -inducing drugs under the Oklahoma
Abortion-Inducing Drug Certification Program are in violation of
this act.
C. A person who intentionally, knowingly or recklessly violates
any provision of this act is guilty of a misdemeanor.
D. A person who intentionally, knowingly or recklessly violates
any provision of this act by fraudulent use of an abortion -inducing
drug, with or without the knowledge of the pregnant woman, is guilty
of a felony.
E. No civil or criminal penalty may be assessed against the
pregnant woman upon whom the drug -induced abortion is attempted,
induced or performed.
SECTION 29. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.11 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. In addition to whatever remedies are available under the
common or statutory law of this state, failure to comply with the
requirements of this act shall:
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1. Provide a basis for a civil malpractice action for actual
and punitive damages;
2. Provide a basis for a professional disciplinary action; and
3. Provide a basis for recovery for the woman’s survivors for
the wrongful death of the woman.
B. When requested, the court shall allow a woman to proceed
using solely her initials or a pseudonym and may close any
proceedings in the case and enter other protective orders to
preserve the privacy of the woman upon whom the drug -induced
abortion was attempted, induced or performed.
C. If judgment is rendered in favor of the plaintiff, the court
shall also render judgment for reasonable attorney’s fees in favor
of the plaintiff against the defendant.
D. If judgment is rendered in favor of the defendant and the
court finds that the plaintiff’s suit was frivolous and brought in
bad faith, the court may render judgme nt for reasonable attorney’s
fees in favor of the defendant against the plaintiff.
E. A cause of action for injunctive relief against a person who
has provided an abortion -inducing drug in violation of this act may
be maintained by:
1. A woman to whom su ch an abortion-inducing drug was provided;
2. A person who is the spouse, parent or guardian of, or a
current or former licensed health care provider of, a woman to whom
such an abortion-inducing drug was provided; or
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3. A prosecuting attorney with appro priate jurisdiction.
The injunction shall prevent the defendant from providing
further abortion-inducing drugs in violation of this act.
SECTION 30. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.12 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Board of Pharmacy shall develop an enforcement
scheme to enforce this act, which includes:
1. When an individual or entity provides abortion -inducing
drugs without first seeking certification under this act, the State
Board of Pharmacy shall:
a. immediately report the illegal act to local law
enforcement, or other applicable state and local
agencies for investigation or other appropriate
action, where appropriate,
b. impose a fine of no less than Five Million Dollars
($5,000,000.00) for manufacturers or distributors and
Two Hundred Fifty Thousand Dollars ($250,000.00) for
physicians;
2. When a certified manufacturer or distributor or physician is
determined to be in non-compliance, suspend certification until
compliance is proven to the satisfaction of the State Board of
Pharmacy;
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3. Where a current or previously certified manufacturer or
distributer is found to have intentionally or knowingly violated
this act, or refuses to bring operations into compliance within
ninety (90) calendar days, remove certification and prohibit
continued provision of abortion -inducing drugs by the manufacturer
or distributor until compliance is demonstrated to the satisfaction
of the State Board of Pharmacy;
4. When a certified manufacturer, distributor or physician is
in non-compliance, suspend all annual recertification until
compliance is demonstrated to the satisfaction of the State Board of
Pharmacy; and
5. Where a current or previously certified manufacturer,
distributer or physician is found to have intentionally or knowingly
violated this act, or refuses to bring operations into compliance:
a. immediately suspend the manufacturer’s, distributor’s
or physician’s certifi cation until full compliance is
demonstrated,
b. for certified manufacturers or distributors, impose
fines of not less than One Million Dollars
($1,000,000.00) per offense,
c. for certified physicians, impose fines of not less
than One Hundred Thousand Dol lars ($100,000.00) per
offense,
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d. permanently revoke the certification of the offender
if offender fails to demonstrate compliance within
ninety (90) calendar days,
e. impose remedial actions, which may include additional
education, additional reporting o r other actions as
required by the State Board of Pharmacy,
f. in the case of a licensed manufacturer or distributor,
recommend sanctioning to the appropriate disciplinary
committee of the State Board of Pharmacy,
g. in the case of a licensed physician, re port the
violation to the appropriate medical licensing board,
h. publicly report any disciplinary actions, consistent
with the practices of the State Board of Pharmacy,
i. permanently revoke the certification of the offender,
j. in the case of a licensed manufacturer or distributor,
recommend permanent revocation of licensure,
k. in the case of a licensed physician, recommend
appropriate sanctioning to the appropriate medical
licensing board, and
l. publicly report any disciplinary actions consistent
with the practices of the State Board of Pharmacy.
B. Individuals have a Private Right of Action to seek
restitution in any court of law with appropriate jurisdiction for
any and all damages suffered due to a violation of this act.
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SECTION 31. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.13 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Board of Pharmacy shall develop on its website a
complaint portal for patients, pharmacy, nursing and medical
professionals and the public to submit information about potential
violations offered at no charge to the parties named in this
subsection.
B. The portal shall list the names of manufacturers and
distributors that are certified under the program, as well as the
physicians that are certified under the program.
C. The portal shall allow the party to make a complaint
anonymously.
D. The State Board of Pharmacy shall review each complaint and
determine a disposition including referral to another appropriate
state agency, within thirty (30) days.
E. Confidentiality of the originator of the complaint shall be
protected at all times except for intra -state referrals for
investigation.
SECTION 32. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.14 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. Nothing in this act shall be construed as creating or
recognizing a right to abortion.
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B. It is not the intention of this act to make lawful an
abortion that is otherwise unlawful.
C. Nothing in this act repeals, replaces or otherwise
invalidates existing federal or state laws, regulations or policies.
SECTION 33. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.15 of Title 63, unless
there is created a duplication in numbering, reads as follows:
The Legislature, by joint resolution, may appoint one or more of
its members, who sponsored or cosponsored this act in his or her
official capacity, to intervene as a matter of right in any case in
which the constitutionality of this act is challenged.
SECTION 34. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 1 -757.16 of Title 63, unless
there is created a duplication in numbering, reads as follows:
If any one or more provisions, sections, subsections, sentences,
clauses, phrases or words of this act or the application there of to
any person or circumstance is found to be unconstitutional, the same
is hereby declared to be severable and the balance of this act shall
remain effective notwithstanding such unconstitutionality. The
Legislature hereby declares that it would have p assed this act, and
each provision, section, subsection, sentence, clause, phrase or
word thereof, irrespective of the fact that any one or more
provisions, sections, subsections, sentences, clauses, phrases or
words be declared unconstitutional.
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SECTION 35. AMENDATORY 59 O.S. 2011, Section 353.7, as
last amended by Section 4, Chapter 106, O.S.L. 2018 (59 O.S. Supp.
2020, Section 353.7), is amended to read as follows:
Section 353.7. The State Board of Pharmacy shall have the power
and duty to:
1. Regulate the practice of pharmacy;
2. Regulate the sale and distribution of drugs, medicines,
chemicals and poisons;
3. Regulate the dispensing of drugs and medicines in all places
where drugs and medicines are compounded and/or dispense d;
4. Examine and issue appropriate certificates of licensure as
Doctor of Pharmacy to all applicants whom the Board deems qualified
under the provisions of the Oklahoma Pharmacy Act;
5. Issue licenses to manufacturers, repackagers, outsourcing
facilities, wholesale distributors, third -party logistics providers,
pharmacies, and other dispensers, medical gas suppliers , and medical
gas distributors;
6. Issue sterile compounding and drug supplier permits for
pharmacies at the fee set by the Board, with the expiration date of
such permits to coincide with the pharmacy license annual expiration
date;
7. Prescribe minimum standards with respect to floor space and
other physical characteristics of pharmacies and hospital drug rooms
as may be reasonably necessar y for the maintenance of professional
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surroundings and for the protection of the safety and welfare of the
public, and to refuse the issuance of new or renewal licenses for
failure to comply with such standards. Minimum standards for
hospital drug rooms s hall be consistent with the State Department of
Health, Hospital Standards, as defined in OAC 310:667;
8. Authorize its inspectors, compliance officers , and duly
authorized representatives to enter and inspect any and all places ,
including premises, vehic les, equipment, contents and records, where
drugs, medicines, chemicals , or poisons are stored, sold, vended,
given away, compounded, dispensed, manufactured, repackaged or
transported;
9. Employ the number of inspectors and pharmacist compliance
officers necessary in the investigation of criminal activity or
preparation of administrative actions at an annual salary to be
fixed by the Board, and to authorize necessary expenses. Any
inspector certified as a peace officer by the Council of Enforcement
Education and Training shall have statewide jurisdiction to perform
the duties authorized by this section. In addition, the inspectors
shall be considered peace officers and shall have the same powers
and authority as that granted to peace officers. In additi on, such
inspectors or pharmacist compliance officers shall have the
authority to take and copy records and the duty to confiscate all
drugs, medicines, chemicals or poisons found to be stored, sold,
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vended, given away, compounded, dispensed or manufacture d contrary
to the provisions of the Oklahoma Pharmacy Act;
10. Investigate complaints, subpoena witnesses and records,
initiate prosecution , and hold hearings;
11. Administer oaths in all manners pertaining to the affairs
of the Board and to take evidenc e and compel the attendance of
witnesses on questions pertaining to the enforcement of the Oklahoma
Pharmacy Act;
12. Reprimand, place on probation, suspend, revoke permanently
and levy fines not to exceed Three Thousand Dollars ($3,000.00) for
each count for which any person charged with violating the Oklahoma
Pharmacy Act or Oklahoma Board of Pharmacy administrative rules has
been convicted in Board hearings. The Board also may take other
disciplinary action. The Board may impose as part of any
disciplinary action the payment of costs expended by the Board for
any legal fees and costs , including, but not limited to, staff time,
salary and travel expense, witness fees and attorney fees. The
Board may also require additional continuing education , including
attendance at a live continuing education program, and may require
participation in a rehabilitation program for the impaired. The
Board may take such actions singly or in combination, as the nature
of the violation requires;
13. Adopt and establish r ules of professional conduct
appropriate to the establishment and maintenance of a high standard
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of integrity and dignity in the profession of pharmacy. Such rules
shall be subject to amendment or repeal by the Board as the need may
arise;
14. Make and publish rules such as may be necessary for
carrying out and enforcing the provisions of the Oklahoma Pharmacy
Act, Oklahoma drug laws and rules, federal drug laws and
regulations, and make such other rules as in its discretion may be
necessary to protect th e health, safety, and welfare of the public;
15. Establish and collect appropriate fees for licenses,
permits, inspections , and services provided; and such fees shall be
nonrefundable. Such fees shall be promulgated to implement the
provisions of the Okl ahoma Pharmacy Act under the provisions of the
Administrative Procedures Act and the Oklahoma Abortion -Inducing
Drug Certification Program Act ;
16. Regulate:
a. personnel working in a pharmacy, such as interns and
supportive personnel , including technicians, and issue
pharmacy technician permits and intern licenses,
b. interns, preceptors and training areas through which
the training of applicants occurs for licensure as a
pharmacist, and
c. such persons regarding all aspects relating to the
handling of drugs, medicines, chemicals , and poisons;
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17. Acquire by purchase, lease, gift, solicitation of gift or
by any other manner, and to maintain, use and operate or to contract
for the maintenance, use and operation of or lease of any and all
property of any kind, real, personal or mixed or any interest
therein unless otherwise provided by the Oklahoma Pharmacy Act;
provided, all contracts for real property shall be subject to the
provisions of Section 63 of Title 74 of the Oklahoma Statutes;
18. Perform other such duties, exercise other such powers and
employ such personnel as the provisions and enforcement of the
Oklahoma Pharmacy Act may require; and
19. Approve pilot projects designed to utilize new or expanded
technology or processes and provide patients w ith better pharmacy
products or provide pharmacy services in a more safe and efficient
manner. Such approvals may include provisions granting exemptions
to any rule adopted by the Board.
SECTION 36. This act shall become effective November 1, 2021.
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Passed the Senate the 10th day of March, 2021.
Presiding Officer of the Senate
Passed the House of Representatives the ____ day of __________,
2021.
Presiding Officer of the House
of Representatives