OK
Oklahoma Senate Bill SB779

Oklahoma 2022 Regular Session

Oklahoma Senate Bill SB779 Compare Versions

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327
4-An Act
5-ENROLLED SENATE
6-BILL NO. 779 By: Daniels, Bullard, Stephens,
28+STATE OF OKLAHOMA
29+
30+1st Session of the 58th Legislature (2021)
31+
32+CONFERENCE COMMITTEE SUBSTITUTE
33+FOR ENGROSSED
34+SENATE BILL 779 By: Daniels, Bullard, Stephens,
735 David, Taylor, Jett and
836 Bergstrom of the Senate
937
1038 and
1139
12- Lepak, Dills, Gann, Smith,
13-Patzkowsky and Roberts
14-(Sean) of the House
40+ Lepak, Dills, Gann and
41+Smith of the House
1542
1643
1744
45+
46+CONFERENCE COMMITTEE SUBSTITUTE
1847
1948 An Act relating to abortion; creating the Oklahoma
2049 Abortion-Inducing Drug Certification Program Act ;
2150 defining terms; specifying applicability of act;
2251 directing creation of certification program;
2352 authorizing certain fees and contracts; limiting
2453 provision of abortion -inducing drugs to certain
2554 practitioners and procedures; directing promulgation
2655 of certain rules; directing establishment of certain
2756 requirements for manufacturers, distributors and
2857 physicians; providing certification systems and
2958 requirements for manufacturers, distributors and
3059 physicians; requiring physician to maintain hospital
3160 admitting privileges or enter into certain written
3261 agreement; stating con ditions of agreement; requiring
3362 adoption of certain reporting system; stating
3463 criteria of reporting system; requiring certain
3564 reporting of physicians; providing for reporting of
3665 adverse events; providing criminal pe nalties;
3766 providing for certain civil reme dies, disciplinary
3867 sanctions and injuncti ve relief; specifying certain
3968 judicial procedures; directing development of certain
4069 enforcement scheme; specifying criteria of
4170 enforcement scheme; providing for certain
4271 restitution; directing creation of certain pub lic
4372 portals; requiring portals to list certain names and
4473 allow for certain complaints; providing for
4574 disposition of complaints; providing for
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46101 confidentiality of complaints; providing certain
47-
48-ENR. S. B. NO. 779 Page 2
49102 construction and intent; authorizing certain
50103 intervention; provid ing severability; amending 59
51104 O.S. 2011, Section 353.7, as last amended by Section
52105 4, Chapter 106, O.S.L. 2018 (59 O.S. Supp. 2020,
53106 Section 353.7), which relates to powers and duties of
54107 the State Board of Pharmacy; broadening allowed uses
55108 of fees; amending 59 O.S. 2011, Section 643 , which
56109 relates to the State Board of Osteopathic Examin ers
57110 Revolving Fund; amending 59 O.S. 2011, Section 644,
58111 as amended by Section 266, Chapter 304, O.S.L. 2012
59112 (59 O.S. Supp. 2020, Section 644) , which relates to
60113 the State Board of Osteopath ic Examiners Revolving
61114 Fund; broadening sources and allowed uses of monies;
62115 providing for codification; and providing an
63116 effective date.
64117
65118
66119
67120
68-SUBJECT: Oklahoma Abortion-Inducing Drug Certifi cation Program Act
69-
70121 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
71-
72122 SECTION 1. NEW LAW A new secti on of law to be codified
73123 in the Oklahoma Statutes as Section 1-757.1 of Title 63, unless
74124 there is created a duplication in numbering, reads as follows:
75-
76125 Sections 1 through 16 of this act shall be known and may be
77126 cited as the “Oklahoma Abortion-Inducing Drug Certification Program
78127 Act”.
79-
80128 SECTION 2. NEW LAW A new section of law to be codified
81129 in the Oklahoma Statutes as Section 1 -757.2 of Title 63, unless
82130 there is created a duplication in numbering, reads as follows:
83-
84131 As used in this act:
85-
86132 1. “Abortion” means the act of using or prescribing any
87133 instrument, medicine, drug or any other substance, device or mea ns
88134 with the intent to terminate the pregnancy of a woman known to be
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89161 pregnant, with knowledge that the termination by those means will
90162 with reasonable likelihood cau se the death of the unborn child.
91-
92-ENR. S. B. NO. 779 Page 3
93163 Such use, prescription or means is not an abortion if do ne with the
94164 intent to:
95-
96165 a. save the life or preserve the health of the unborn
97166 child,
98-
99167 b. remove a dead unborn child caused by spontaneou s
100168 abortion, accidental trauma o r a criminal assault on
101169 the pregnant woman or her unborn child,
102-
103170 c. remove an ectopic pregna ncy, or
104-
105171 d. treat a maternal disease or illness for which the
106172 prescribed drug is indicated;
107-
108173 2. “Abortion-inducing drug” means a medicine, drug or any other
109174 substance prescribed or dispensed with the intent of terminating the
110175 pregnancy of a woman known to b e pregnant, with knowledge that the
111176 termination will with reasonable likelihood cause the death of the
112177 unborn child. This includes th e off-label use of drugs known to
113178 have abortion-inducing properties, which are prescribed specifically
114179 with the intent of causing an abortion, such as mifepristone
115180 (Mifeprex), misoprostol (Cytotec) and methotrexate. This definition
116181 does not apply to drugs that may be known to cause an abortion, but
117182 which are prescribed for other medical indications, such as
118183 chemotherapeutic agents and diagnostic drugs. The use of such drugs
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119210 to induce abortion is also known as “medical”, “medication”, “RU–
120211 486”, “chemical”, “Mifeprex regimen” or “drug-induced” abortion;
121-
122212 3. “Adverse event”, according to the Food and Drug
123213 Administration, means any untoward medical occurrence associated
124214 with the use of a drug in humans, whether or not considered drug -
125215 related. It does not incl ude an adverse event or suspect ed adverse
126216 reaction that, had it occurred in a more severe form, might have
127217 caused death;
128-
129218 4. “Associated physician ” means a person fully licensed and in
130219 good standing to practice medicine in the state including medical
131220 doctors and doctors of osteopathy, who has entered into an
132221 associated physician agreement;
133-
134-
135-ENR. S. B. NO. 779 Page 4
136222 5. “Complication” means any adverse physical or psychological
137223 condition arising from the performance of an abortion which
138224 includes, but is not limited to, uterine perfor ation, cervical
139225 perforation, infection, heavy or uncontrolled bleeding, hemorrhage,
140226 blood clots resulting in pulmonary emb olism or deep vein thrombosis,
141227 failure to actually terminate the pregnancy, incomplete abortion
142228 (retained tissue), pelvic inflammatory disease, endometritis, missed
143229 ectopic pregnancy, cardiac arrest, respiratory arrest, renal
144230 failure, metabolic disorder, s hock, embolism, coma, placenta previa
145231 in subsequent pregnancies, preterm delivery in subsequent
146232 pregnancies, free fluid in the abdomen , hemolytic reaction due to
147233 the administration of ABO-incompatible blood or blood products,
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148260 adverse reactions to anesthesi a and other drugs, subsequent
149261 development of breast cancer, psychological complications such as
150262 depression, suicidal ideation, anxiety , sleeping disorders, death
151263 and any other adverse event as defined by the Food and Drug
152264 Administration criteria provided i n the Medwatch Reporting System;
153-
154265 6. “Gestational age” means the time that has elapsed since the
155266 first day of the woman ’s last menstrual period, also known as “last
156267 menstrual period” or “LMP”;
157-
158268 7. “Hospital” means an institution providing medical and
159269 surgical treatment and nursing care for sick or injured people, or
160270 institutions defined under Section 1 -701 of Title 63 of the Oklahoma
161271 Statutes;
162-
163272 8. “Manufacturers and distributors” means individuals or
164273 entities that create, produce, supply, transport or sell drugs,
165274 which include:
166-
167275 a. any substances recognized by an official pharmacopoeia
168276 or formulary,
169-
170277 b. any substances intended for use in th e diagnosis,
171278 cure, mitigation, treatment or prevention of disease,
172-
173279 c. any substances other than food intended to affect t he
174280 structure or any function of the body, or
175-
176-
177-ENR. S. B. NO. 779 Page 5
178281 d. any substances intended for use as a component of a
179282 medicine but not a device or a com ponent, part or
180283 accessory of a device;
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181309
182310 9. “Obstetrician/gynecologist ”, also known as OB/GYN, means a
183311 licensed physician w ho specializes in the care of women during
184312 pregnancy and childbirth and in the diagnosis and treatment of
185313 diseases of the female repro ductive organs and specializes i n other
186314 women’s health issues such as menopause, hormone problems,
187315 contraception or birth control, and infertility;
188-
189316 10. “Physician” means any person fully licensed by and in good
190317 standing with the State Board of Medical Lic ensure and Supervision
191318 or the State Board of Osteopathic Examiners to practice medicine in
192319 this state. The term includes medical doctors and doctors of
193320 osteopathy;
194-
195321 11. “Pregnant” or “pregnancy” means that female reproductive
196322 condition of having an unborn child in the mother’s uterus;
197-
198323 12. “Provide” or “provision” means, when used regarding
199324 abortion-inducing drugs, any act o f giving, selling, dispensing,
200325 administering, transferring possession to or otherwise providing or
201326 prescribing an abortion -inducing drug; and
202-
203327 13. “Unborn child” means an individual organism of the species
204328 Homo sapiens, beginning at fertilization, until th e point of being
205329 born-alive as defined in Title 1 U.S.C., Section 8(b).
206-
207330 SECTION 3. NEW LAW A new section of la w to be codified
208331 in the Oklahoma Statutes as Section 1-757.3 of Title 63, unless
209332 there is created a duplication in numberi ng, reads as follows:
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210358
211359 This act applies to any physician, health care provider or other
212360 person who is providing abortion -inducing drugs for use within this
213361 state, or any manufacturer or distributor providing abortion -
214362 inducing drugs within this state.
215-
216363 SECTION 4. NEW LAW A new section of law to be codified
217364 in the Oklahoma Statutes as Section 1 -757.4 of Title 63, unle ss
218365 there is created a duplicatio n in numbering, reads as follows:
219-
220-
221-ENR. S. B. NO. 779 Page 6
222366 A. The State Board of Pharmacy, the State Boar d of Medical
223367 Licensure and Supervision and the State Board of Osteopathic
224368 Examiners shall create a certification program for abortion-inducing
225369 drugs. The program shall be kno wn as the Oklahoma Abortion -Inducing
226370 Drug Certification Program.
227-
228371 B. The State Board of Medical Licensure and Supervision , the
229372 State Board of Osteopathic Examiners and the State Board of Pharmacy
230373 may assess reasonable fees on their respective licensees and enter
231374 into contracts with persons or en tities to implement the Oklahoma
232375 Abortion-Inducing Drug Certification Program.
233-
234376 C. Abortion-inducing drugs shall not be provided directly to
235377 the patient through the mail, telemedicine or otherwise outside of
236378 the parameters of the Oklahoma Abortion -Inducing Drug Certification
237379 Program.
238-
239380 SECTION 5. NEW LAW A new section of law to be codified
240381 in the Oklahoma Statutes as Section 1 -757.5 of Title 63, unless
241382 there is created a duplication in numbering, reads as follows:
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242408
243409 A. The State Board of Pharmacy shall promulgate r ules to create
244410 a certification program to oversee and regulate the manufacture and
245411 distribution of abortion-inducing drugs by manufacturers and
246412 distributors licensed by the State Board of Pharmacy.
247-
248413 B. The State Board of Pharmacy shall establish the following
249414 requirements for manufacturers and distributors of abortion -inducing
250415 drugs, at a minimum:
251-
252416 1. Require completion of the certification process for
253417 manufacturers and distributors as described in Section 6 of this
254418 act;
255-
256419 2. Require that abortion-inducing drugs be transported and
257420 provided in this state only by manufacturers or distributors
258421 certified to do so under this program;
259-
260422 3. Notify manufacturers and d istributors of physicians
261423 certified under the Oklahoma Abortion -Inducing Drug Certification
262424 Program;
263-
264-
265-ENR. S. B. NO. 779 Page 7
266425 4. Prohibit shipment of abortion -inducing drugs to physicians
267426 who become de-certified from the Oklahoma Abortion -Inducing Drug
268427 Certification Program;
269-
270428 5. Audit newly certified manufacture rs and distributors withi n
271429 ninety (90) calendar days after the manufacturer or distributor is
272430 authorized, and annually thereafter, to ensure that all processes
273431 and procedures are in place and functioning to support the
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274458 requirements of the Oklahoma Abortion -Inducing Drug Certificat ion
275459 Program;
276-
277460 6. If a manufacturer or distributor is found to be
278461 noncompliant, immediately suspend manufacturer ’s or distributor’s
279462 certification until the manufacturer or distributor demonstrates
280463 full compliance; and
281-
282464 7. Enforce compliance according to Sec tion 12 of this act.
283-
284465 C. The State Board of Medical Licensure and Supervision and the
285466 State Board of Osteopathic Examiners shall promulgate rules to
286467 create a certification program to oversee and reg ulate the provision
287468 of abortion-inducing drugs by physicians licensed by the respective
288469 state licensing board. The drugs shall only be provided to patients
289470 by fully licensed physicians certified to do so under this program
290471 by their respective state licens ing boards.
291-
292472 D. The State Board o f Medical Licensure and Supervision and the
293473 State Board of Osteopathic Examiners shall establish the following
294474 requirements for physicians providing abortion -inducing drugs, at a
295475 minimum:
296-
297476 1. Require completion of the certification process for
298477 physicians as described in Section 7 of this act ;
299-
300478 2. Audit newly certified physicians within ninety (90) calendar
301479 days after the physician is authorized, and annually thereafter, to
302480 ensure that all required processes and procedures are in place and
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303507 functioning to support the requirements of the Oklahoma Abortion -
304508 Inducing Drug Certification Program;
305-
306-
307-ENR. S. B. NO. 779 Page 8
308509 3. If a physician is found to be noncompliant, immediately
309510 suspend the physician ’s certification until such time that the
310511 physician demonstrates full compliance;
311-
312512 4. Develop a reporting system as specified in Section 9 of this
313513 act; and
314-
315514 5. Enforce compliance according to Section 12 of this act.
316-
317515 SECTION 6. NEW LAW A new section of law to be codified
318516 in the Oklahoma Statutes as Section 1-757.6 of Title 63, unless
319517 there is created a duplication in numbering, reads as follows:
320-
321518 The State Board of Pharmacy shall adopt a certification system
322519 for any manufacturer or distributor intending to provide abortion -
323520 inducing drugs in the state. To be eligible to be c ertified under
324521 this section, manufacturers and distributors shall:
325-
326522 1. Be licensed by the Board;
327-
328523 2. Only distribute to physicians certified under this act;
329-
330524 3. Record each serial number from pharmaceutical packages
331525 distributed to each certified physician;
332-
333526 4. Abide by all applicable standards of the Utilization Review
334527 Accreditation Commission (URAC) or National Association of Boards of
335528 Pharmacy (NABP);
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337555 5. For online sales or orders, hold a current “.pharmacy” or
338556 “.pharma” domain and abide by all the stand ards required by the NABP
339557 to maintain the domain;
340-
341558 6. Follow all other applicable state or federal laws related to
342559 the distribution or delivery of legend drugs including abortion -
343560 inducing drugs; and
344-
345561 7. Follow all accept able processes and procedures to mai ntain a
346562 distribution or delivery system that is secure, confidential and
347563 follows all processes and procedures including those for storage,
348564 handling, shipping, tracking package serial numbers, proof of
349565 delivery and controlled returns of abortion-inducing drugs.
350-
351-ENR. S. B. NO. 779 Page 9
352-
353566 SECTION 7. NEW LAW A new section of law to be codifi ed
354567 in the Oklahoma Statutes as Section 1 -757.7 of Title 63, unless
355568 there is created a duplication in numbering, reads as follows:
356-
357569 The State Board of Medical Licensure and Supe rvision and the
358570 State Board of Osteopathic Examiners shall adopt a certification
359571 system for any physician intending to provide abortion -inducing
360572 drugs to patients in the state. Individuals or physicians providing
361573 abortion-inducing drugs in other states ar e not automatically
362574 certified in this state, and shall be fully certified under t his law
363575 prior to providing any abortion -inducing drugs to any pregnant women
364576 in this state. To be eligible to be certified under this sect ion
365577 physicians shall:
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367604 1. Be fully licensed by and in good standing with either the
368605 State Board of Medical Licensure and Supervision or the State Board
369606 of Osteopathic Examiners to practice medicine in the state;
370-
371607 2. Examine any patient in person prior to p roviding abortion-
372608 inducing drugs;
373-
374609 3. Sign an annual “Dispensing Agreement Form ”, to be developed
375610 and provided by the physician’s state licensing board , before
376611 providing abortion-inducing drugs;
377-
378612 4. Inform the patient of gestational age -specific risks of
379613 using abortion-inducing drugs;
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381614 5. Assess for signs of domestic abuse, reproductive control,
382615 human trafficking and oth er signals of coerced abortion, per current
383616 state guidelines;
384-
385617 6. Adequately inform the patient of gestational age -specific
386618 age risks of using abortion-inducing drugs;
387-
388619 7. Inform the patient that she may see the remains of her
389620 unborn child in the process o f completing the abortion;
390-
391621 8. Inform the patient that studies show that babies born
392622 following the abortion reversal process have a rate of birth defects
393623 no higher than the ge neral population;
394-
395-ENR. S. B. NO. 779 Page 10
396-
397624 9. Inform the patient that studies show that following this
398625 reversal process or otherwise treating a woman with progesterone
399626 during pregnancy does not lead to increased mortality rates;
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401653 10. Refrain from knowingly supplying abortion -inducing drugs to
402654 patients who present with any of the following:
403-
404655 a. absence of a pregnancy,
405-
406656 b. being post-seventy days gestation or post -ten weeks of
407657 pregnancy, and
408-
409658 c. having risk factors associated with abortion -inducing
410659 drugs including, but not limited to:
411-
412660 (1) ectopic pregnancies,
413-
414661 (2) problems with the adrenal glands near the
415662 kidneys,
416-
417663 (3) being treated with long -term corticosteroid
418664 therapy,
419-
420665 (4) allergic reactions to abortion -inducing drugs,
421666 mifepristone, misoprostol or sim ilar drugs,
422-
423667 (5) bleeding problems or is taking anticoagulant drug
424668 products,
425-
426669 (6) has inherited porphyria,
427-
428670 (7) has an intrauterine device in place, or
429-
430671 (8) being Rh Negative, requiring administration of
431672 Rhogam before providing abortion -inducing drugs;
432-
433673 11. Provide or refer for emergency surgica l intervention in
434674 cases of incomplete abortion, severe bleeding or other medical
435675 complications, through maintaining hospital admitting privileges or
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436702 entering into a written agreement with an associated physician as
437703 specified in Section 8 of this act;
438-
439-ENR. S. B. NO. 779 Page 11
440-
441704 12. Assure patient access to medical facilities equipped to
442705 provide blood transfusion s and resuscitation or other necessary
443706 treatments, if necessary;
444-
445707 13. Sign, and ensure that the patient signs, all legally
446708 required informed consent material, providing patien t with a copy
447709 showing both signatures, and placing the original in the patient ’s
448710 medical record;
449-
450711 14. Record the serial number from each package of each
451712 abortion-inducing drug given to the patient in her medical record;
452-
453713 15. Submit a written protocol of ho w efforts will be made to
454714 schedule with the patient the medically indic ated follow-up
455715 appointment within fourteen (14) days to assure a completed
456716 abortion;
457-
458717 16. Report to the State Board of Pharmacy, the physician’s
459718 state licensing board and the Food and Drug Administration, any
460719 death associated with abortion -inducing drugs with the following
461720 guidelines:
462-
463721 a. the patient shall be noted by a non -identifiable
464722 reference and the serial number from each package of
465723 abortion-inducing drug given, whether or not
466724 considered drug-related,
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468751 b. this shall be done as soon as possible but no late r
469752 than fifteen (15) calendar days from the initial
470753 receipt of the information by the physician, and
471-
472754 c. this requirement does not affect the physici an’s other
473755 reporting and follow -up requirements under the
474756 Oklahoma Abortion-Inducing Drug Certification Progr am
475757 or any additional requirements by another department
476758 that oversees the abortion industry in this state;
477-
478759 17. Submit a written protocol of how co mplications will be
479760 handled by the certified physician and submit a copy of a signed
480761 contract with an associa ted physician credentialed to handle certain
481762 complications as outlined in Section 8 of this act;
482-
483-ENR. S. B. NO. 779 Page 12
484-
485763 18. Abide by all applicable state and federal law s regarding
486764 medical records retentio n, confidentiality and privacy; and
487-
488765 19. Agree to follow and document com pliance with all other
489766 legally required conditions for performing abortion in the state
490767 where the patient presents for her appointment including, b ut not
491768 limited to, waiting periods, informed consent requirements,
492769 statistical reporting, parental consent or notification and required
493770 inspections.
494-
495771 SECTION 8. NEW LAW A new section of law to be codified
496772 in the Oklahoma Statutes as Section 1-757.8 of Title 63, unless
497773 there is created a duplication in numbering, reads as follows:
498774
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499800 The State Board of Medical Licensure and Supervision and the
500801 State Board of Osteopathic Examiners shall also require the
501802 following of certified physicians:
502-
503803 1. Maintaining hospital admitting pr ivileges at one or more
504804 hospitals in the county or contiguous county whe re the abortion-
505805 inducing drug was provided, and informing the patient of any
506806 hospital where the physician holds admitting privileges ; or
507-
508807 2. Alternatively, the physician may enter into a written
509808 agreement with an associated physician in the county or contiguo us
510809 county where the abortion -inducing drug was provided. The written
511810 agreement shall meet these conditions:
512-
513811 a. a physician who provides an abor tion-inducing drug
514812 shall notify the patient of the location of the
515813 hospital at which the associated physician ha s
516814 admitting privileges,
517-
518815 b. the physician shall keep, at the location of his or
519816 her practice, a copy of the written agreement,
520-
521817 c. the physician shall submit a copy of the written
522818 agreement to their state licensing board and the State
523819 Department of Health as part of any required clinic
524820 licensure,
525-
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527-ENR. S. B. NO. 779 Page 13
528821 d. the State Department of Health shall verify the
529822 validity of the document, and shall remove any
530823 personal identifying information of the pat ient from
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531850 the document before releasing the document in
532851 accordance with the following:
533-
534852 (1) the State Department of Health shall annually
535853 submit a copy of the written agreement described
536854 in this paragraph to each hospita l located in the
537855 county or a county t hat is contiguous to the
538856 county where the abortion was performed, and
539-
540857 (2) the State Department of Health shall confirm to a
541858 member of the public, upon request, that the
542859 written agreement required to be submitted under
543860 this section for an abortion clinic ha s been
544861 received by the Department,
545-
546862 e. the agreement shall be renewed annual ly, or more often
547863 as required by the physician’s state licensing board ,
548-
549864 f. the agreement shall include a requirement that the
550865 physician provide to the patient and require the
551866 patient to sign all legally required informed consent
552867 material, and
553-
554868 g. the agreement shall require the adherence to all
555869 reporting requirements from the State Department of
556870 Health and the physician’s licensing board.
557-
558871 SECTION 9. NEW LAW A n ew section of law to be codified
559872 in the Oklahoma Statutes as Section 1 -757.9 of Title 63, unless
560873 there is created a duplication in numbering, reads as follows:
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561899
562900 A. The State Board of Medical Licensure and Supervision an d the
563901 State Board of Osteopathic Exam iners shall adopt an electronically
564902 based reporting system for certified p hysicians to report annually
565903 the following:
566-
567904 1. The number of patients served;
568-
569905 2. Age of patients served;
570-
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572-
573906 3. Race of patients served;
574-
575907 4. County and state of residence of patients served;
576-
577908 5. If the patient resides outside the United States, city and
578909 country of residence;
579-
580910 6. County and state of service;
581-
582911 7. A list of staff attending patients including licensing
583912 numbers and evidence of other qual ifications;
584-
585913 8. Each medication used or provided per patient, by date;
586-
587914 9. Any known complications or adverse e vents, and how they were
588915 addressed, by date; and
589-
590916 10. Unresolved cases.
591-
592917 B. This reporting system shall also be used by emergency
593918 department physicians and private physicians who tre at post-abortion
594919 complications.
595-
596920 C. Physicians shall protect from disclosu re any personally
597921 identifiable information of the patient in accordance with
598922 applicable federal and state law.
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599948
600949 D. A certified physician shall also report to their licensing
601950 board, the State Board of Pharmacy and the Medwatch Reporting System
602951 of the Food and Drug Administration (FDA), any complication or
603952 adverse event as defined according to the FDA criteria given in the
604953 Medwatch Reporting System.
605-
606954 E. The State Board of Medical Licensure and Supervision and the
607955 State Board of Osteopathic Examiners shall develop a system of
608956 reporting adverse events from the use of abortion -inducing drugs for
609957 this state. The system shall require reporting of complica tions and
610958 adverse events including, b ut not limited to:
611-
612959 1. Death;
613-
614-
615-ENR. S. B. NO. 779 Page 15
616960 2. Blood loss including hemorrhage;
617-
618961 3. Infection including sepsis;
619-
620962 4. Blood transfusions;
621-
622963 5. Administer drug for an ectopic pregnancy; and
623-
624964 6. Other adverse effects requiring hospitaliz ation or
625965 additional medical care.
626-
627966 F. The State Board of Medical Licensure and Supervision and the
628967 State Board of Osteopathic Examiners shall require the following
629968 providers and entities to report complications and adverse events in
630969 writing:
970+1. Physicians certified to provide abortion -inducing drugs;
971+2. Emergency room physicians;
631972
632-1. Physicians certified to provide abortion -inducing drugs;
633-
634-2. Emergency room physicians;
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635997
636998 3. Any doctor licensed i n this state including an
637999 obstetrician/gynecologist who treats women with adverse events;
638-
6391000 4. Provision of certification requires that the physician shal l
6401001 also report adverse events and any patient deaths to the FDA; and
641-
6421002 5. Other individuals or entities a s determined by the State
6431003 Board of Medical Licensure and Supervision or the State B oard of
6441004 Osteopathic Examiners .
645-
6461005 SECTION 10. NEW LAW A new section of law to be codifi ed
6471006 in the Oklahoma Statutes as Section 1 -757.10 of Title 63, unless
6481007 there is created a duplication in numbering, reads as follows:
649-
6501008 A. Individuals or entities not certified under the Oklahoma
6511009 Abortion-Inducing Drug Certification Program that provide drugs for
6521010 the purpose of inducing abortion are in violation of this act.
653-
6541011 B. Individuals or entities that provide abortion -inducing drugs
6551012 to any person or entity that is not certified, or otherwise
6561013 authorized, to provide abor tion-inducing drugs under the Oklahom a
657-
658-ENR. S. B. NO. 779 Page 16
6591014 Abortion-Inducing Drug Certification Program are in violation of
6601015 this act.
661-
6621016 C. A person who intentionally, knowingly or recklessly vi olates
6631017 any provision of this act is guilty of a misdemeanor.
664-
6651018 D. A person who intent ionally, knowingly or recklessly viol ates
6661019 any provision of this act by fraudulent use of an abortion -inducing
6671020 drug, with or without the knowledge of the pregnant woman, is guilty
6681021 of a felony.
6691022
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6701048 E. No civil or criminal penalty may be assessed against the
6711049 pregnant woman upon whom the drug -induced abortion is attempted,
6721050 induced or performed.
673-
6741051 SECTION 11. NEW LAW A new section of law to be codified
6751052 in the Oklahoma Statutes as Section 1 -757.11 of Title 63, unless
6761053 there is created a duplicati on in numbering, reads as follows:
677-
6781054 A. In addition to whatever remedies are available under the
6791055 common or statutory law of this state, failure to comply with the
6801056 requirements of this act shall:
681-
6821057 1. Provide a basis for a civil malpractice action for actual
6831058 and punitive damages;
684-
6851059 2. Provide a basis for a professional disciplinary action; and
686-
6871060 3. Provide a basis for recovery for the woman ’s survivors for
6881061 the wrongful death of t he woman.
689-
6901062 B. When requested, the court shall allow a woman to proceed
6911063 using solely her initials or a pseudonym and may c lose any
6921064 proceedings in the case and enter other protective orders to
6931065 preserve the privacy of the woman upon whom the drug -induced
6941066 abortion was attempted, induced or performed.
695-
6961067 C. If judgment is rendered in favor of th e plaintiff, the court
6971068 shall also render judgment for reasonable attorney fees in favor of
6981069 the plaintiff against the defendant.
699-
700-
701-ENR. S. B. NO. 779 Page 17
7021070 D. If judgment is rendered in favor of the defendant and the
7031071 court finds that the plaintiff ’s suit was frivolous and brought in
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7041098 bad faith, the court may render judg ment for reasonable attorney
7051099 fees in favor of the defendant against the plaintiff.
706-
7071100 E. A cause of action for injunctive relief against a person who
7081101 has provided an abortion -inducing drug in violation of this act may
7091102 be maintained by:
710-
7111103 1. A woman to whom su ch an abortion-inducing drug was provided;
712-
7131104 2. A person who is the spouse, parent or guardian of, or a
7141105 current or former licensed healt h care provider of, a woman to whom
7151106 such an abortion-inducing drug was provided; or
716-
7171107 3. A prosecuting attorney with appro priate jurisdiction.
718-
7191108 The injunction shall prevent the defendant from providing
7201109 further abortion-inducing drugs in violation of this act .
721-
7221110 SECTION 12. NEW LAW A new section of law to be codified
7231111 in the Oklahoma Statutes as Section 1 -757.12 of Title 63, unless
7241112 there is created a duplication in numbering, reads as follows:
725-
7261113 A. The State Board of Pharmacy , the State Board of Medical
7271114 Licensure and Supervision and the State Board of Osteopathic
7281115 Examiners shall develop an enforcement scheme for their licensees to
7291116 enforce this act, which includes:
730-
7311117 1. When an individual or entity provides abortion -inducing
7321118 drugs without first seeking certification under this act, the
7331119 appropriate licensing board shall:
734-
7351120 a. immediately report the illegal act to lo cal law
7361121 enforcement, or other applicable state and local
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7371148 agencies for investigation or other appropriate
7381149 action, where appropriate, and
739-
7401150 b. impose a fine of no less than Five Million Dollars
7411151 ($5,000,000.00) for manufactu rers or distributors and
7421152 Two Hundred Fifty Thousand Dollars ($250,000.00) for
7431153 physicians;
744-
745-ENR. S. B. NO. 779 Page 18
746-
7471154 2. When a certified manufacturer , distributor or physician is
7481155 determined to be in non compliance, suspend certification until
7491156 compliance is proven to the satisfaction of their licensing board ;
750-
7511157 3. Where a current or previously certified manufacturer or
7521158 distributer is found to have intentionally or knowingly violated
7531159 this act, or refuses to bring operations into compliance within
7541160 ninety (90) calendar days, remove certif ication and prohibit
7551161 continued provision of abortion-inducing drugs by the manufacturer
7561162 or distributor until compliance is demonstrated to the satisfaction
7571163 of their licensing board;
758-
7591164 4. When a certified manufacturer, dis tributor or physician is
7601165 in noncompliance, suspend all annual recertifica tion until
7611166 compliance is demonstrated to the satisfaction of their licensing
7621167 board; and
763-
7641168 5. Where a current or previously certified manufac turer,
7651169 distributor or physician is found to have intentionally or knowingly
7661170 violated this act, or refuses to bring op erations into compliance:
7671171
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7681197 a. immediately suspend the manufacturer ’s, distributor’s
7691198 or physician’s certification until full compliance is
7701199 demonstrated,
771-
7721200 b. for certified manufacturers or distributors, impose
7731201 fines of not less than One Million Dollars
7741202 ($1,000,000.00) per offense, by the State Board of
7751203 Pharmacy,
776-
7771204 c. for certified physicians, impose fines of not less
7781205 than One Hundred Thousand Dolla rs ($100,000.00) per
7791206 offense, by the physician’s licensing board,
780-
7811207 d. permanently revoke the certification of the offe nder
7821208 if offender fails to demonstrate compliance with their
7831209 licensing board within ninety (90) calendar days,
784-
7851210 e. impose remedial actions, w hich may include additional
7861211 education, additional reporting or other actions as
7871212 required by the relevant licensing bo ard,
788-
789-ENR. S. B. NO. 779 Page 19
790-
7911213 f. in the case of a manufacturer or distributor,
7921214 recommend sanctioning to the appropriate disciplinary
7931215 committee of the State Board of Pharmacy,
794-
7951216 g. in the case of a physician, report the violation to
7961217 the appropriate physician licensing board,
797-
7981218 h. publicly report any disciplinary actions, consistent
7991219 with the practices of the relevant licensing board ,
1220+i. permanently revoke the certification of the offender,
8001221
801-i. permanently revoke the certification of the offender,
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8021246
8031247 j. in the case of a licensed manufacturer or distributor,
8041248 recommend permanent revocation of licensu re,
805-
8061249 k. in the case of a physician, recommend appropriate
8071250 sanctioning to the appropriate physician licensing
8081251 board, and
809-
8101252 l. publicly report any disciplinary actions consistent
8111253 with the practices of the relevant licensing board.
812-
8131254 B. Individuals have a Private Right of Action to seek
8141255 restitution in any court of law with appropriate jurisdiction for
8151256 any and all damages suffered due to a violation of this act.
816-
8171257 SECTION 13. NEW LAW A new section of law to be codified
8181258 in the Oklahoma Statutes as Section 1-757.13 of Title 63, unless
8191259 there is created a duplication in numbering, reads as follows:
820-
8211260 A. The State Board of Pharmacy shal l develop on its website a
8221261 complaint portal for patients, pharmacy, nursing and medical
8231262 professionals and the public to submit information about potential
8241263 violations by nonphysicians at no charge to the parties named in
8251264 this subsection.
826-
8271265 B. The State Board of Medical Licensure and Supervision and the
8281266 State Board of Osteopathic Examine rs shall develop on their
8291267 respective websites a complaint portal for patients, pharmacy,
8301268 nursing and medical professionals and the public to submit
831-
832-ENR. S. B. NO. 779 Page 20
8331269 information about potential violations by physicians at no charge to
8341270 the parties named in this subsection.
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8351296
8361297 C. The portal developed by the State Board of Pharmacy shall
8371298 list the names of manufacturers and distributors that are certified
8381299 under the program.
839-
8401300 D. The portals developed b y the State Board of Medical
8411301 Licensure and Supervision and the State Board of Os teopathic
8421302 Examiners shall list the nam es of the fully licensed physicians
8431303 certified under the program.
844-
8451304 E. The portal shall allow the party to make a complaint
8461305 anonymously.
847-
8481306 F. The State Board of Pharmacy and physician licensing boards
8491307 shall review each co mplaint and determine a disposition in cluding
8501308 referral to another appropriate state agency, within thirty (30)
8511309 days of receipt of a complaint .
852-
8531310 G. Confidentiality of the origin ator of the complaint shall be
8541311 protected at all times except for intra -state referrals for
8551312 investigation or if any disciplinary action is brought by a
8561313 licensing board pursuant to this act .
857-
8581314 SECTION 14. NEW LAW A new section of law to be codified
8591315 in the Oklahoma Statutes as Section 1 -757.14 of Title 63, unless
8601316 there is created a duplication in numberi ng, reads as follows:
861-
8621317 A. Nothing in this act shall be construed as creating or
8631318 recognizing a right to abortion.
864-
8651319 B. It is not the intenti on of this act to make lawful an
8661320 abortion that is otherwise unlawful.
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8681347 C. Nothing in this act repeals, replaces or oth erwise
8691348 invalidates existing federal or state laws, regulations or policies.
870-
8711349 SECTION 15. NEW LAW A new section of la w to be codified
8721350 in the Oklahoma Statutes as Section 1 -757.15 of Title 63, unles s
8731351 there is created a duplication in nu mbering, reads as follows:
874-
875-
876-ENR. S. B. NO. 779 Page 21
8771352 The Legislature, by joint resolution, may appoint one or more of
8781353 its members, who sponsored or cosponsored this act in his or her
8791354 official capacity, to intervene as a matter of right in any c ase in
8801355 which the constitutionality of this act is challenged.
881-
8821356 SECTION 16. NEW LAW A new section of law to be codified
8831357 in the Oklahoma Statutes as Section 1-757.16 of Title 63, unless
8841358 there is created a duplication in numbering, reads as follows:
885-
8861359 If any one or more provis ions, sections, subsections, sentences,
8871360 clauses, phrases or words of this act or the application thereof to
8881361 any person or circumstance is found to be unconstitutional, the same
8891362 is hereby declared to be severable and th e balance of this act shall
8901363 remain effective notwithstanding such unconstitutionality. The
8911364 Legislature hereby declares that it would have passed this act, and
8921365 each provision, section, subsection, sentence, clause, phrase or
8931366 word thereof, irrespective of t he fact that any one or more
8941367 provisions, sections, subsections, sentences, clauses, phrases or
8951368 words be declared unconstitutional.
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8971395 SECTION 17. AMENDATORY 59 O.S. 2011, Section 353.7, as
8981396 last amended by Section 4, Chapter 106, O.S.L . 2018 (59 O.S. Supp.
8991397 2020, Section 353.7), is amended to read as follows:
900-
9011398 Section 353.7. The State Board of Pharmacy shall have the power
9021399 and duty to:
903-
9041400 1. Regulate the practic e of pharmacy;
905-
9061401 2. Regulate the sale and distribution of drugs, medicines,
9071402 chemicals and poisons;
908-
9091403 3. Regulate the dispensing of drugs and medicines in all places
9101404 where drugs and medicines are compounded and/or dispensed;
911-
9121405 4. Examine and issue appropriate certificates of licensure as
9131406 Doctor of Pharmacy to all applicants whom the Board deems qualified
9141407 under the provisions of the Oklahoma Pharmacy Act;
915-
9161408 5. Issue licenses to manufacturers, repackagers, outsourcing
9171409 facilities, wholesale distributors, third -party logistics providers,
918-
919-ENR. S. B. NO. 779 Page 22
9201410 pharmacies, and other dispensers, medical gas suppliers , and medical
9211411 gas distributors;
922-
9231412 6. Issue sterile compounding and drug supplier permits for
9241413 pharmacies at the fee set by the Board, with the expiration date of
9251414 such permits to coincide with the pharmacy license annual expiration
9261415 date;
927-
9281416 7. Prescribe minimum s tandards with respect to floor space and
9291417 other physical characteristics of pharmacies and hospital drug rooms
9301418 as may be reasonably necessary for the maintenance of professional
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9311445 surroundings and for the protection of the safety and welfare of the
9321446 public, and to refuse the issuance of new or re newal licenses for
9331447 failure to comply with such standards. Minimum standards for
9341448 hospital drug rooms shall be consistent with the State Dep artment of
9351449 Health, Hospital Standards, as defined in OAC 310:667;
936-
9371450 8. Authorize its inspectors, compliance officers , and duly
9381451 authorized representatives to enter and inspect any and all places ,
9391452 including premises, vehicles, equipment, contents and records, where
9401453 drugs, medicines, chemicals , or poisons are stored, sold, vended,
9411454 given away, compounded, dispensed, manufactu red, repackaged or
9421455 transported;
943-
9441456 9. Employ the number of inspectors and pharmacist compliance
9451457 officers necessary in the investigation of cr iminal activity or
9461458 preparation of administrative actions at an annual salary to be
9471459 fixed by the Board, and to authori ze necessary expenses. Any
9481460 inspector certified as a peace officer by the Council of Enforcement
9491461 Education and Training shall have statewid e jurisdiction to perform
9501462 the duties authorized by this section. In addition, t he inspectors
9511463 shall be considered pea ce officers and shall have the same powers
9521464 and authority as that granted to peace officers. In addition, such
9531465 inspectors or pharmacist com pliance officers shall have the
9541466 authority to take and copy records and the duty to confiscate all
9551467 drugs, medicines, chemicals or poisons found to be stored, sold,
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9561494 vended, given away, compounded, dispensed or manufactured contrary
9571495 to the provisions of the O klahoma Pharmacy Act;
958-
9591496 10. Investigate complaints, subpoena witnesses and record s,
9601497 initiate prosecution, and hold hearings;
961-
962-
963-ENR. S. B. NO. 779 Page 23
9641498 11. Administer oaths in all manners pertaining to the affairs
9651499 of the Board and to take evidence and compel the attendance of
9661500 witnesses on questions pertaining to the enforcement of the Oklahoma
9671501 Pharmacy Act;
968-
9691502 12. Reprimand, place on probation, susp end, revoke permanently
9701503 and levy fines not to exceed Three Thousand Dollars ($3,000.00) for
9711504 each count for which any person charged with vi olating the Oklahoma
9721505 Pharmacy Act or Oklahoma Board of Pharmacy administrative r ules has
9731506 been convicted in Board hear ings. The Board also may take other
9741507 disciplinary action. The Board may impose as part of any
9751508 disciplinary action the payment of costs exp ended by the Board for
9761509 any legal fees and costs , including, but not limited to, staff time,
9771510 salary and travel expense , witness fees and attorney fees. The
9781511 Board may also require additional continuing education , including
9791512 attendance at a live continuing ed ucation program, and may require
9801513 participation in a rehabilitation program for t he impaired. The
9811514 Board may take such actions singly or in combination, as the nature
9821515 of the violation requires;
983-
9841516 13. Adopt and establish rules of professional conduct
9851517 appropriate to the establishment and maintenance of a high standard
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9861544 of integrity and dig nity in the profession of pharmacy. Such rules
9871545 shall be subject to amendment or repeal by the Board as the need may
9881546 arise;
989-
9901547 14. Make and publish rules such as may be necessary for
9911548 carrying out and enforcing the provisions of the Oklahoma Pharmacy
9921549 Act, Oklahoma drug laws and rules, federal dr ug laws and
9931550 regulations, and make such other rules as in its discretion may be
9941551 necessary to protect the health, safety , and welfare of the public;
995-
9961552 15. Establish and collect appropriate fees for licenses,
9971553 permits, inspections, and services provided; and su ch fees shall be
9981554 nonrefundable. Such fees shall be promulgated to implement the
9991555 provisions of the Oklahoma Pharmacy Act and the Oklahoma Abortion -
10001556 Inducing Drug Certification Program Act under the provisions of the
10011557 Administrative Procedures Act ;
1002-
10031558 16. Regulate:
1004-
1005-
1006-ENR. S. B. NO. 779 Page 24
10071559 a. personnel working in a pharmacy, such as interns and
10081560 supportive personnel , including technicians, and issue
10091561 pharmacy technician per mits and intern licenses,
1010-
10111562 b. interns, preceptors and training areas through whic h
10121563 the training of applicants occurs f or licensure as a
10131564 pharmacist, and
1014-
10151565 c. such persons regarding all aspects relating to the
10161566 handling of drugs, medicines, chemicals , and poisons;
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10171592
10181593 17. Acquire by purchase, lease, gift, solicitation of gift or
10191594 by any other manner, and to maintain, use and opera te or to contract
10201595 for the maintenance, use and operation of or lease of any and all
10211596 property of any kind, real, personal or mixed or any in terest
10221597 therein unless otherwise provided by the Oklahoma Pharmacy Act;
10231598 provided, all contracts for real property shal l be subject to the
10241599 provisions of Section 63 of Title 74 of the Oklahoma Statutes;
1025-
10261600 18. Perform other such duties, exercise other such powe rs and
10271601 employ such personnel as the provisions and enforcement of the
10281602 Oklahoma Pharmacy Act may require; and
1029-
10301603 19. Approve pilot projects designed to utilize new or expanded
10311604 technology or processes and provide patients with better pharmacy
10321605 products or provide pharmacy services in a more safe and efficient
10331606 manner. Such approvals may in clude provisions granting exemptions
10341607 to any rule adopted by the Board.
1035-
10361608 SECTION 18. AMENDATORY 59 O.S. 2011, Section 643, is
10371609 amended to read as follows:
1038-
10391610 Section 643. The funds received pursuant to the Oklahom a
10401611 Osteopathic Medicine Act or the Oklahoma Abortion-Inducing Drug
10411612 Certification Program Act shall be deposited to the credit of the
10421613 State Board of Osteopathic Examiners Revolving Fund and may be
10431614 expended by the State Board of Osteopathic Examiners and und er its
10441615 direction in assisti ng in the enforcement of the laws of this state
10451616 prohibiting the unlawful practice of osteopathic medicine, assisting
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10461643 in the support of a peer assistance program, and for the
10471644 dissemination of information to prevent the violation o f such laws,
10481645 and for the purchasing of supplies and such othe r expense as is
1049-
1050-ENR. S. B. NO. 779 Page 25
10511646 necessary to properly carry out the provisions of the Oklahoma
10521647 Osteopathic Medicine Act or the Oklahoma Abortion-Inducing Drug
10531648 Certification Program Act .
1054-
10551649 SECTION 19. AMENDATORY 59 O .S. 2011, Section 644, as
10561650 amended by Section 266, Chapter 304, O.S.L. 2012 (59 O.S. Supp.
10571651 2020, Section 644), is amended to read as follows:
1058-
10591652 Section 644. There is hereby created in the State Treasury a
10601653 revolving fund for the State Board of Osteopathic Exa miners, to be
10611654 designated the “State Board of Osteopathic Examiner ’s Revolving
10621655 Fund”. The fund shall be a continu ing fund, not subject to fiscal
10631656 year limitations, and shall consist of all monies received by the
10641657 Board pursuant to the provisions of the Oklah oma Osteopathic
10651658 Medicine Act or the Oklahoma Abortion-Inducing Drug Certification
10661659 Program Act. All monies accrui ng to the credit of said fund are
10671660 hereby appropriated and may be budgeted and expended by the Board
10681661 for the purpose of enforcing the laws of th is state which prohibit
10691662 the unlawful practice of osteopathic medicine, for the dissemination
10701663 of information to pr event the violation of such laws , and for the
10711664 purchase of supplies and such other expense as is necessary to
10721665 properly implement the provisions of the Oklahoma Osteopathic
10731666 Medicine Act or the Oklahoma Abortion-Inducing Drug Certification
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10741693 Program Act. Expenditures from said fund shall be made upon
10751694 warrants issued by the State Treasurer against claims signed by a n
10761695 authorized employee or employees o f the State Board of Osteopathic
10771696 Examiners and filed as prescribed by law with the Director of the
10781697 Office of Management and Enterprise Services for approval and
10791698 payment.
1080-
10811699 SECTION 20. This act shall become effective November 1, 2021.
10821700
1083-
1084-ENR. S. B. NO. 779 Page 26
1085-Passed the Senate the 19th day of May, 2021.
1086-
1087-
1088-
1089- Presiding Officer of the Senate
1090-
1091-
1092-Passed the House of R epresentatives the 25th day of May, 2021.
1093-
1094-
1095-
1096- Presiding Officer of the House
1097- of Representatives
1098-
1099-OFFICE OF THE GOVERNOR
1100-Received by the Office of the Governor this _______ _____________
1101-day of _________________ __, 20_______, at _______ o'clock _______ M .
1102-By: _________________________________
1103-Approved by the Governor of the State of Oklahoma this _____ ____
1104-day of _________________ __, 20_______, at _______ o'clock _______ M.
1105-
1106- _________________________________
1107- Governor of the State of Oklahoma
1108-
1109-
1110-OFFICE OF THE SECRETARY OF STATE
1111-Received by the Office of the Secretary of State this _______ ___
1112-day of __________________, 20 _______, at _______ o'clock _______ M.
1113-By: _______________________________ __
1701+58-1-2131 DC 5/14/2021 12:53:13 PM