{"data":{"id":"us-ok/okla.-stat.-tit.-63-63-1-729a","jurisdiction":"us-ok","citation":"Okla. Stat. tit. 63, § 63-1-729a","heading":"Sale or distribution of RU-486","body":"A. The Legislature finds that:\n\n1. The U.S. Food and Drug Administration (FDA) approved the\n\ndrug mifepristone (brand name \"Mifeprex\"), a first-generation\n\n[selective] progesterone receptor modulator ([S]PRM), as an\n\nabortion-inducing drug with a specific gestation, dosage, and\n\nadministration protocol;\n\n2. The FDA approved mifepristone (brand name Mifeprex) under\n\nthe rubric of 21 C.F.R., Section 314.520, also referred to as\n\n\"Subpart H\", which is the only FDA approval process that allows for\n\npostmarketing restrictions. Specifically, the Code of Federal\n\nRegulations (CFR) provides for accelerated approval of certain drugs\n\nthat are shown to be effective but \"can be safely used only if\n\ndistribution or use is restricted\";\n\n3. The FDA does not treat Subpart H drugs in the same manner as\n\ndrugs which undergo the typical approval process;\n\n4. As approved by the FDA, and as outlined in the Mifeprex\n\nfinal printed labeling (FPL), an abortion by mifepristone consists\n\nof three two-hundred-milligram tablets of mifepristone taken orally,\n\nfollowed by two two-hundred-microgram tablets of misoprostol taken\n\norally, through forty-nine (49) days LMP (a gestational measurement\n\nusing the first day of the woman's \"last menstrual period\" as a\n\nmarker). The patient is to return for a follow-up visit in order to\n\nconfirm that the abortion has been completed. This FDA-approved\n\nprotocol is referred to as the \"Mifeprex regimen\" or the \"RU-486\n\nregimen\";\n\n5. The aforementioned procedure requires three office visits by\n\nthe patient, and the dosages may only be administered in a clinic,\n\nmedical office, or hospital and under supervision of a physician;\n\n6. The Mifeprex final printed labeling (FPL) outlines the FDA-\n\napproved dosage and administration of both drugs in the Mifeprex\n\nregimen, namely mifepristone and misoprostol;\n\n7. When the FDA approved the Mifeprex regimen under Subpart H,\n\nit did so with certain restrictions. For example, the distribution\n\nand use of the Mifeprex regimen must be under the supervision of a\n\nphysician who has the ability to assess the duration of pregnancy,\n\ndiagnose ectopic pregnancies, and provide surgical intervention (or\n\nhas made plans to provide surgical intervention through other\n\nqualified physicians);\n\n8. One of the restrictions imposed by the FDA as part of its\n\nSubpart H approval is a written agreement that must be signed by\n\nboth the physician and patient. In that agreement, the woman\n\nattests to the following, among other statements:\n\na. \"I believe I am no more than 49 days (7 weeks)\n\npregnant\",\n\nb. \"I understand that I will take misoprostol in my\n\nprovider's office two days after I take Mifeprex (Day\n\n3)\", and\n\nc. \"I will do the following: return to my provider's\n\noffice in two days (Day 3) to check if my pregnancy\n\nhas ended. My provider will give me misoprostol if I\n\nam still pregnant\";\n\n9. The FDA concluded that available medical data did not\n\nsupport the safety of home use of misoprostol, and it specifically\n\nrejected information in the Mifeprex final printed labeling (FPL) on\n\nself-administering misoprostol at home;\n\n10. The use of abortion-inducing drugs presents significant\n\nmedical risks to women, including but not limited to abdominal pain,\n\ncramping, vomiting, headache, fatigue, uterine hemorrhage, viral\n\ninfections, and pelvic inflammatory disease;\n\n11. Abortion-inducing drugs are associated with an increased\n\nrisk of complications relative to surgical abortion. The risk of\n\ncomplications increases with advancing gestational age, and, in the\n\ninstance of the Mifeprex regimen, with failure to complete the two-\n\nstep dosage process;\n\n12. In July 2011, the FDA reported 2,207 adverse events in the\n\nUnited States after women used abortion-inducing drugs. Among those\n\nwere 14 deaths, 612 hospitalizations, 339 blood transfusions, and\n\n256 infections (including 48 \"severe infections\");\nons increases with advancing gestational age, and, in the\n\ninstance of the Mifeprex regimen, with failure to complete the two-\n\nstep dosage process;\n\n12. In July 2011, the FDA reported 2,207 adverse events in the\n\nUnited States after women used abortion-inducing drugs. Among those\n\nwere 14 deaths, 612 hospitalizations, 339 blood transfusions, and\n\n256 infections (including 48 \"severe infections\");\n\n13. \"Off-label\" or so-called \"evidence-based\" use of abortion-\n\ninducing drugs may be deadly. To date, fourteen women have\n\nreportedly died after administering abortion-inducing drugs, with\n\neight deaths attributed to severe bacterial infection. All eight of\n\nthose women administered the drugs in an \"off-label\" or \"evidence-\n\nbased\" manner advocated by many abortion providers. The FDA has\n\nreceived no reports of women dying from bacterial infection\n\nfollowing administration according to the FDA-approved protocol for\n\nthe Mifeprex regimen. The FDA has not been able to conclude one way\n\nor another whether off-label use led to the eight deaths;\n\n14. Medical evidence demonstrates that women who utilize\n\nabortion-inducing drugs incur more complications than those who have\n\nsurgical abortions;\n\n15. Based on the foregoing findings, it is the purpose of this\n\nact to:\n\na. protect women from the dangerous and potentially\n\ndeadly off-label use of abortion-inducing drugs, and\n\nb. ensure that physicians abide by the protocol approved\n\nby the FDA for the administration of abortion-inducing\n\ndrugs, as outlined in the drugs' final printed\n\nlabeling (FPL); and\n\n16. In response to the Oklahoma Supreme Court's decision in\n\nCline v. Oklahoma Coalition for Reproductive Justice (No. 111,939),\n\nin which the Oklahoma Supreme Court determined, in contravention of\n\nthis Legislature's intent, that this act prohibits all uses of\n\nmisoprostol for chemical abortion and prohibits the use of\n\nmethotrexate in treating ectopic pregnancies, it is also the purpose\n\nof this act to legislatively overrule the decision of the Oklahoma\n\nSupreme Court and ensure that should such questions be presented\n\nbefore that Court in the future it will reach the proper result that\n\nthis act does not ban use of misoprostol in chemical abortion (and\n\nallows it as part of the FDA-approved Mifeprex regimen) nor prevent\n\nthe off-label use of drugs for the treatment of ectopic pregnancy.\n\nB. As used in this section:\n\n1. \"Abortion-inducing drug\" means a medicine, drug, or any\n\nother substance prescribed or dispensed with the intent of inducing\n\nan abortion. This includes off-label use of drugs known to have\n\nabortion-inducing properties, which are prescribed specifically with\n\nthe intent of causing an abortion, such as misoprostol (Cytotec),\n\nand methotrexate. This definition does not apply to drugs that may\n\nbe known to cause an abortion, but which are prescribed for other\n\nmedical indications, such as chemotherapeutic agents or diagnostic\n\ndrugs, or for treatment of an ectopic pregnancy;\n\n2. \"Abortion\" means the use or prescription of any instrument,\n\nmedicine, drug, or any other substance or device intentionally to\n\nterminate the pregnancy of a female known to be pregnant with an\n\nintention other than to increase the probability of a live birth, to\n\npreserve the life or health of the child after live birth, to remove\n\nan ectopic pregnancy, or to remove a dead unborn child who died as\n\nthe result of a spontaneous miscarriage, accidental trauma, or a\n\ncriminal assault on the pregnant female or her unborn child;\n\n3. \"Drug label\" or \"drug's label\" means the pamphlet\n\naccompanying an abortion-inducing drug which outlines the protocol\n\nauthorized by the U.S. Food and Drug Administration (FDA) and agreed\n\nupon by the drug company applying for FDA authorization of that\n\ndrug. Also known as \"final printed labeling (FPL)\" or referred to\nl trauma, or a\n\ncriminal assault on the pregnant female or her unborn child;\n\n3. \"Drug label\" or \"drug's label\" means the pamphlet\n\naccompanying an abortion-inducing drug which outlines the protocol\n\nauthorized by the U.S. Food and Drug Administration (FDA) and agreed\n\nupon by the drug company applying for FDA authorization of that\n\ndrug. Also known as \"final printed labeling (FPL)\" or referred to\n\nas the \"FDA-approved label\", it is the FDA-approved document which\n\ndelineates how a drug is to be used according to the FDA approval;\n\n4. \"Mifeprex regimen\" means the abortion-inducing drug regimen\n\nthat is described in the FDA-approved Mifeprex final printed\n\nlabeling, and which involves administration of mifepristone (brand\n\nname \"Mifeprex\") and misoprostol. It is the only abortion-inducing\n\ndrug regimen approved by the FDA, and it does not include any dosage\n\nor administration not explicitly approved in Mifeprex final printed\n\nlabeling. It is also commonly referred to as the \"RU-486 regimen\"\n\nor simply \"RU-486\";\n\n5. \"Mifepristone\" means the first drug used in the Mifeprex\n\nregimen;\n\n6. \"Misoprostol\" means the second drug used in the Mifeprex\n\nregimen;\n\n7. \"Personal identifying information\" means any information\n\ndesigned to identify a person and any information commonly used or\n\ncapable of being used alone or in conjunction with any other\n\ninformation to identify a person; and\n\n8. \"Physician\" means a doctor of medicine or osteopathy legally\n\nauthorized to practice medicine in the state.\n\nC. No person shall knowingly or recklessly give, sell,\n\ndispense, administer, prescribe, or otherwise provide an abortion-\n\ninducing drug, including the Mifeprex regimen, unless the person who\n\ngives, sells, dispenses, administers, prescribes, or otherwise\n\nprovides the abortion-inducing drug is a physician who:\n\n1. Has the ability to assess the duration of the pregnancy\n\naccurately;\n\n2. Has the ability to diagnose ectopic pregnancies;\n\n3. Has the ability to provide surgical intervention in cases of\n\nincomplete abortion or severe bleeding, or has made and documented\n\nin the patient's medical record plans to provide such care through\n\nother qualified physicians; and\n\n4. Is able to assure patient access to medical facilities\n\nequipped to provide blood transfusions and resuscitation, if\n\nnecessary.\n\nD. No physician who provides an abortion-inducing drug,\n\nincluding the Mifeprex regimen, shall knowingly or recklessly fail\n\nto provide or prescribe the drug according to the protocol\n\nauthorized by the U.S. Food and Drug Administration and as outlined\n\nin the FDA-approved label. In the specific case of the Mifeprex\n\nregimen, the Mifeprex label includes the FDA-approved dosage and\n\nadministration instructions for both mifepristone (brand name\n\nMifeprex) and misoprostol, and any provision accomplished according\n\nto that labeling is not prohibited.\n\nE. No physician who provides an abortion-inducing drug,\n\nincluding the Mifeprex regimen, shall knowingly or recklessly fail\n\nto:\n\n1. Provide each patient with a copy of the drug manufacturer's\n\nmedication guide and drug label for the drug(s) being used; when the\n\nMifeprex regimen is being utilized, this requirement is satisfied so\n\nlong as the patient is provided the FDA-approved Mifeprex medication\n\nguide and final printed labeling;\n\n2. Fully explain the procedure to the patient, including, but\n\nnot limited to, explaining that the drug is being used in accordance\n\nwith the protocol authorized by the U.S. Food and Drug\n\nAdministration and as outlined in the drug label for the abortion-\n\ninducing drug;\n\n3. Provide the female with a copy of the drug manufacturer's\n\npatient agreement and obtain the patient's signature on the patient\n\nagreement;\n\n4. Sign the patient agreement; and\n\n5. Record the drug manufacturer's package serial number in the\n\npatient's medical record.\n\nF. Because the failure and complications rates from abortion-\nand as outlined in the drug label for the abortion-\n\ninducing drug;\n\n3. Provide the female with a copy of the drug manufacturer's\n\npatient agreement and obtain the patient's signature on the patient\n\nagreement;\n\n4. Sign the patient agreement; and\n\n5. Record the drug manufacturer's package serial number in the\n\npatient's medical record.\n\nF. Because the failure and complications rates from abortion-\n\ninducing drugs increase with increasing gestational age, and because\n\nthe physical symptoms of an abortion induced by drugs can be\n\nidentical to the symptoms of ectopic pregnancy, thereby increasing\n\nthe risk of ruptured ectopic pregnancy, the physician giving,\n\nselling, dispensing, administering, or otherwise providing or\n\nprescribing the abortion-inducing drug shall first examine the woman\n\nand document, in the woman's medical chart, gestational age and\n\nintrauterine location of the pregnancy prior to giving, selling,\n\ndispensing, administering, or otherwise providing or prescribing the\n\nabortion-inducing drug.\n\nG. An abortion-inducing drug must be administered in the same\n\nroom and in the physical presence of the physician who prescribed,\n\ndispensed, or otherwise provided the drug to the patient. The\n\nphysician inducing the abortion, or a person acting on behalf of the\n\nphysician inducing the abortion, shall schedule the patient for a\n\nfollow-up appointment and make all reasonable efforts to ensure that\n\nthe patient returns twelve (12) to eighteen (18) days after the\n\nadministration or use of the abortion-inducing drug for a follow-up\n\nvisit so that the physician can confirm that the pregnancy has been\n\nterminated and assess the patient's medical condition. A brief\n\ndescription of the efforts made to comply with this subsection,\n\nincluding the date, time, and identification by name of the person\n\nmaking such efforts, shall be included in the patient's medical\n\nrecord.\n\nH. 1. If a physician provides an abortion-inducing drug and\n\nknows that the female who uses the abortion-inducing drug\n\nexperiences within one (1) year after the use of the abortion-\n\ninducing drug an incomplete abortion, severe bleeding, or an adverse\n\nreaction to the abortion-inducing drug or is hospitalized, receives\n\na transfusion, or experiences any other serious event, the physician\n\nshall, as soon as is practicable, but in no case more than sixty\n\n(60) days after the physician learns of the adverse reaction or\n\nserious event, provide a written report of the incomplete abortion,\n\nsevere bleeding, adverse reaction, hospitalization, transfusion, or\n\nserious event to the drug manufacturer. If the physician is a\n\ndoctor of medicine, the physician shall simultaneously provide a\n\ncopy of the report to the State Board of Medical Licensure and\n\nSupervision. If the physician is a doctor of osteopathy, the\n\nphysician shall simultaneously provide a copy of the report to the\n\nState Board of Osteopathic Examiners. The relevant Board shall\n\ncompile and retain all reports it receives pursuant to this\n\nsubsection. All reports the relevant Board receives under this\n\nsubsection are public records open to inspection pursuant to the\n\nOklahoma Open Records Act; however, absent an order by a court of\n\ncompetent jurisdiction, neither the drug manufacturer nor the\n\nrelevant Board shall release the name or any other personal\n\nidentifying information regarding a person who uses or provides the\n\nabortion-inducing drug for the purpose of inducing an abortion and\n\nwho is the subject of a report the drug manufacturer or the relevant\n\nBoard receives under this subsection.\n\n2. No physician who provides an abortion-inducing drug to a\n\npregnant female shall knowingly or recklessly fail to file a report\n\nrequired under paragraph 1 of this subsection. Knowing or reckless\n\nfailure to comply with this subsection shall subject the physician\n\nto sanctioning by the licensing board having administrative\n\nauthority over such physician.\nnt\n\nBoard receives under this subsection.\n\n2. No physician who provides an abortion-inducing drug to a\n\npregnant female shall knowingly or recklessly fail to file a report\n\nrequired under paragraph 1 of this subsection. Knowing or reckless\n\nfailure to comply with this subsection shall subject the physician\n\nto sanctioning by the licensing board having administrative\n\nauthority over such physician.\n\nI. Any female upon whom an abortion has been performed, the\n\nfather of the unborn child who was the subject of the abortion if\n\nthe father was married to the woman who received the abortion at the\n\ntime the abortion was performed, or a maternal grandparent of the\n\nunborn child may maintain an action against the person who performed\n\nthe abortion in knowing or reckless violation of this section for\n\nactual and punitive damages. Any female upon whom an abortion has\n\nbeen attempted in knowing or reckless violation of this section may\n\nmaintain an action against the person who attempted to perform the\n\nabortion for actual and punitive damages.\n\nJ. If a judgment is rendered in favor of the plaintiff in any\n\naction described in this section, the court shall also render\n\njudgment for a reasonable attorney fee in favor of the plaintiff\n\nagainst the defendant. If a judgment is rendered in favor of the\n\ndefendant and the court finds that the plaintiff's suit was\n\nfrivolous and brought in bad faith, the court shall also render\n\njudgment for a reasonable attorney fee in favor of the defendant\n\nagainst the plaintiff.\n\nK. No pregnant female who obtains or possesses an abortion-\n\ninducing drug to terminate her own pregnancy shall be subject to any\n\naction brought under subsection I of this section.\n\nL. If some or all of the language in this section is ever\n\ntemporarily or permanently restrained or enjoined by judicial order,\n\nthen this section shall be enforced as though such restrained or\n\nenjoined provisions had not been adopted; provided, however, that\n\nwhenever such temporary or permanent restraining order or injunction\n\nis stayed or dissolved, or otherwise ceases to have effect, such\n\nprovisions shall have full force and effect.","path":["OK Code","Title 63"],"source_url":"https://www.oklegislature.gov/OK_Statutes/CompleteTitles/os63.pdf","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:36Z","sha256":"b647390e2c3b58ea718627d7be2f88b546c3eeaa625ee74be4ae8666dc84dc30","source_id":"us-ok","stale":false,"prev":"us-ok/okla.-stat.-tit.-63-63-1-729.7","next":"us-ok/okla.-stat.-tit.-63-63-1-730"},"notice":"GroundRules: Original legal text. Not legal advice."}