FDA Decides to End the In-Person Dispensing Requirement for Mifepristone (2021)

Table of Contents

1. What the FDA Did in 2021
2. The Drug and Its Approved Use
3. What a REMS Is, and the Mifepristone REMS
4. The In-Person Dispensing Requirement Before 2021
5. April 12, 2021: Enforcement Discretion During the Public Health Emergency
6. The 2021 Review: What the FDA Considered
7. December 16, 2021: The Decision and Its Two Changes
8. What the 2021 Decision Did Not Do
9. January 2023: The Modified Program Is Approved
10. Dates and Legal Status as of October 18, 2026
11. How It Fits Earlier and Later FDA Actions
12. Primary Documents
13. Key Research Papers
14. Connections
15. Featured Videos

1. What the FDA Did in 2021

The FDA’s actions on mifepristone in 2021 came in three steps, all described on the agency’s question-and-answer page about the drug:

• April 12, 2021. The FDA “stated its intent to exercise enforcement discretion with respect to the in-person dispensing requirement during the COVID-19 public health emergency.” Enforcement discretion means the agency says it does not intend to enforce a requirement for a period, while the requirement itself stays on the books.
• May 7, 2021. The FDA and the plaintiffs in a pending lawsuit over the drug’s safety program filed a joint motion to pause (stay) that case; the court granted the stay the same day. The FDA states that its 2021 review of the program “was related to” that litigation.
• December 16, 2021. After what it calls “a comprehensive review,” the FDA announced that the program must be modified by removing the in-person dispensing requirement and adding a requirement that pharmacies dispensing the drug be certified. The same day it sent letters, called REMS Modification Notification letters, to the two companies that hold approvals for the drug (the brand-name product and a generic).

These were decisions about a drug’s safety program, not a regulation. They were not published as rules in the Federal Register (the U.S. government’s daily publication of rules and official notices), and the FDA documents cited on this page give no Federal Register docket for them. The FDA reports them on its drug-safety information pages.

Back to Table of Contents

2. The Drug and Its Approved Use

The FDA describes mifepristone as “a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue.” Used together with misoprostol, it is approved to end an intrauterine pregnancy (one inside the womb) through ten weeks gestation, which the FDA defines as 70 days or less since the first day of the last menstrual period.

The approved regimen, as the FDA states it, is 200 mg of mifepristone by mouth on day one; 800 mcg of misoprostol taken buccally (in the cheek pouch) 24 to 48 hours later; and a follow-up with the health care provider about seven to fourteen days after taking mifepristone.

According to the FDA, the drug was first approved in September 2000 for use through seven weeks of pregnancy; this was extended to ten weeks in 2016. A generic version was approved in April 2019, which the FDA determined to be therapeutically equivalent to the brand-name product. The FDA’s page also notes that mifepristone has been approved for the same use in France since 1988 and in the United Kingdom, Sweden and about 100 other countries.

The FDA lists the situations in which the regimen is not to be used (its contraindications): more than 70 days since the first day of the last menstrual period, an ectopic pregnancy (a pregnancy outside the uterus), problems with the adrenal glands, long-term corticosteroid therapy, an allergic reaction to mifepristone, misoprostol or similar drugs, bleeding problems or use of blood-thinning drugs, inherited porphyria, and an intrauterine device (IUD) in place, which must be removed first. The FDA’s page explains that ectopic pregnancies occur in about two percent of all pregnancies and that a ruptured ectopic pregnancy can be fatal.

Back to Table of Contents

3. What a REMS Is, and the Mifepristone REMS

A REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program the FDA can require on top of a drug’s label. The FDA explains that whether a REMS is needed is “a drug-specific evaluation”: the agency asks whether a drug carries particular risks and whether “additional risk mitigation measures beyond the FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks.”

For mifepristone, the FDA states that when it approved the original application in 2000 it concluded that certain restrictions were necessary to ensure safe use. The drug was deemed to have an approved REMS under the Food and Drug Administration Amendments Act of 2007, and the restrictions were approved as a REMS in 2011 and modified since. In April 2019, when the generic was approved, the FDA approved a single, shared-system program for both products, called the Mifepristone REMS Program.

The FDA describes the program as intended “to mitigate the risk of serious complications” by, among other things, requiring that prescribers have the qualifications to assess whether patients are appropriate candidates and to provide intervention in case of complications (or have arranged for others to do so), and that patients be informed of the risks. It calls the program “a closed system, meaning prescribers, pharmacies, and distributors are certified or authorized and verified under the REMS prior to distribution or dispensing of the drug.”

Each REMS includes periodic assessments by the companies, reviewed by the FDA. In the FDA’s words, the agency “may require applicants to modify a REMS if the agency determines that an element is no longer necessary to ensure that the benefits of the drug outweigh the risks or to minimize the burden on the health care delivery system.” (An applicant is the company that holds the approved drug application.)

Back to Table of Contents

4. The In-Person Dispensing Requirement Before 2021

Before the changes approved in January 2023, the FDA states, the program “required mifepristone to be dispensed in person in a clinic, medical office, or hospital.” This was called the “in-person dispensing requirement.”

The FDA reports that there were periods when this requirement was not enforced. The first came from a court order: from July 13, 2020, until January 12, 2021, the FDA was enjoined (barred by a court order called an injunction) from enforcing the requirement, in a lawsuit in the U.S. District Court for the District of Maryland.

Back to Table of Contents

5. April 12, 2021: Enforcement Discretion During the Public Health Emergency

Three months after the injunction ended, on April 12, 2021, the FDA “stated its intent to exercise enforcement discretion with respect to the in-person dispensing requirement during the COVID-19 public health emergency.” This opened the second period in which the requirement was not enforced.

The FDA describes how the drug reached patients during those periods: the companies “used mail order pharmacies to receive and hold mifepristone on behalf of the certified prescribers who purchased the product,” and, on a prescription, the mail-order pharmacy “would ship the product to a named patient.”

The FDA’s question-and-answer page reports the April 2021 statement only in summary; the letter itself is not reproduced there.

Back to Table of Contents

6. The 2021 Review: What the FDA Considered

The FDA states that, to decide whether a change was warranted, it “conducted a comprehensive review of the published literature, other relevant safety and adverse event data, and information provided by advocacy groups, individuals, and the applicants related to the modifications that were under consideration.” The review also examined literature references provided by the plaintiffs in the pending lawsuit.

On why the review took place in 2021, the FDA says the review “was related to the litigation” in that lawsuit, which had been paused by the joint motion of May 7, 2021.

Part of the review compared the periods with and without the requirement. The FDA “analyzed postmarketing data to determine if there was a difference in adverse events between periods when in-person dispensing was and was not enforced,” and concluded that “there did not appear to be a difference in adverse events between periods when in-person dispensing was and was not enforced.” Postmarketing data are reports and other information gathered after a drug is on the market; an adverse event is a harmful or unwanted medical event reported after a drug is used, whether or not the drug caused it.

Back to Table of Contents

7. December 16, 2021: The Decision and Its Two Changes

The FDA states that “after conducting a comprehensive review of the Mifepristone REMS Program,” it determined, “based on the available data and information, that the REMS must be modified to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks.” On December 16, 2021, it announced that the modifications would consist of:

1. removing the “in-person dispensing requirement”; and
2. adding a requirement that pharmacies that dispense the drug be certified.

The FDA explains what pharmacy certification is for: it “incorporates pharmacies into the REMS, ensures that pharmacies are aware of and agree to follow applicable REMS requirements, and ensures that mifepristone is only dispensed pursuant to prescriptions that are written by certified prescribers.” Any pharmacy that meets the program’s requirements is eligible.

The decision did not change the program on that day. Following what the FDA calls “the typical process for REMS modifications,” it sent REMS Modification Notification letters to the two companies. The companies then prepared proposed changes and submitted them to their applications for FDA review. The FDA’s pages summarize the decision; the December 2021 decision memorandum and letters are not reproduced on them, and they were not read for this page.

Back to Table of Contents

8. What the 2021 Decision Did Not Do

• It did not change the program by itself. The December 2021 decision required the companies to submit modifications; the modified program was approved on January 3, 2023.
• It did not make the drug available without a prescription. The FDA states that mifepristone for this use “is only available by prescription,” and that a switch to over-the-counter status would need an application and evidence that the drug can be used safely and effectively without a health care provider’s supervision.
• It did not remove prescriber certification or the Patient Agreement Form. The FDA states that the modified program “continues to require the Patient Agreement Form and certification of health care providers who prescribe mifepristone.”
• It was not a response to later court rulings or state laws. The FDA states that the modification approved in 2023 was not made in response to the Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization or to state abortion laws; it traces the change to the 2021 review. Questions about state law, the FDA says, are for the Department of Justice.
• It does not set prices or insurance coverage. The FDA states that it has no authority to regulate drug prices and no control over whether an insurer covers a drug.

Back to Table of Contents

9. January 2023: The Modified Program Is Approved

After reviewing the companies’ supplemental applications, the FDA approved the modified Mifepristone REMS Program on January 3, 2023. As the FDA lists them, its requirements include, among others:

• Mifepristone must be prescribed by a health care provider who meets certain qualifications and is certified under the program, by completing a Prescriber Agreement Form.
• The Patient Agreement Form must be reviewed with and signed by the patient and the provider, and the risks of the regimen fully explained, before the drug is prescribed; the patient receives a copy of the form and the Medication Guide (FDA-approved information for patients).
• Mifepristone may be dispensed only by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription from a certified prescriber; pharmacies certify by completing a Pharmacy Agreement Form.
• Certified pharmacies must be able to ship the drug with a shipping service that provides tracking, and must dispense it to the patient in a timely manner.

To be certified, the FDA states, prescribers must be able to date pregnancies accurately and diagnose ectopic pregnancies, be able to provide any necessary surgical intervention or have arranged for others to do so, and be able to ensure patients have access to medical facilities for emergency care. The FDA’s information page sums up the result: under the program, mifepristone “may be dispensed in person or by mail.” The FDA also notes that the 2023 change removed the restriction that had kept retail pharmacies from dispensing the drug.

The FDA states that the program “does not require patients to see a health care provider in person before obtaining mifepristone,” and that it determined it is not necessary for the REMS to mandate how providers assess the length of a pregnancy or check for ectopic pregnancy; the prescribing information gives prescribers guidance on both.

Back to Table of Contents

10. Dates and Legal Status as of October 18, 2026

• September 2000: first approval, through seven weeks of pregnancy.
• 2011: the drug’s restrictions approved as a REMS.
• 2016: approved use extended to ten weeks.
• April 2019: a generic approved, together with the single, shared-system Mifepristone REMS Program.
• July 13, 2020 – January 12, 2021: a federal court injunction bars enforcement of the in-person dispensing requirement.
• April 12, 2021: the FDA states its intent to exercise enforcement discretion during the COVID-19 public health emergency.
• May 7, 2021: joint motion to stay a pending lawsuit over the program, granted the same day.
• December 16, 2021: the FDA announces that the program must be modified and sends REMS Modification Notification letters.
• January 3, 2023: the FDA approves the modified program.
• February 28, 2023: according to the FDA, the paused lawsuit is reopened, with the plaintiffs now challenging the modified program.

Status as of October 18, 2026: the program as modified on January 3, 2023, is in effect; an FDA safety study is under way. The FDA’s question-and-answer page, current as of April 8, 2026, states that the FDA “is conducting a safety study of mifepristone,” that the next steps are data exploration, evaluation of data integrity, analysis, validation and peer review, and that “Once the FDA finishes its analysis of the data, the agency will decide whether to make substantive changes to the REMS.” The agency says it generally does not comment on pending litigation. A check of the Federal Register for later documents could not be made for this page because the Federal Register’s interface refused requests from this server. The FDA documents on this page cite no Federal Register document for these steps.

The same FDA page reports other later facts, which postdate 2021:

• Litigation. On November 18, 2022, the FDA and the Department of Health and Human Services were sued in the U.S. District Court for the Northern District of Texas over the approval of mifepristone. The FDA states that in June 2024 the Supreme Court held that the original plaintiffs lacked standing (the legal right to bring the case), that those plaintiffs voluntarily dismissed their claims in November 2024, and that several states (Missouri, Idaho and Kansas) had intervened in the case before the ruling.
• Adverse event reports. The FDA states that, as of December 31, 2024, it had received 36 reports of deaths in patients associated with mifepristone since its approval in September 2000, including two cases of ectopic pregnancy and several cases of severe systemic infection (sepsis). It adds that the events “cannot with certainty be causally attributed to mifepristone” because of other drugs, other treatments, coexisting conditions and gaps in information, and that its review “did not identify any new safety signals.” These figures are from the FDA’s summary through 2024, not from its 2021 review.
• Online purchase. The FDA’s information page states that the FDA “does not recommend purchasing mifepristone outside of the Mifepristone REMS Program,” for example online or from a foreign country, because the FDA cannot ensure the safety, effectiveness or quality of medicines from outside the U.S. drug supply chain. The FDA reports that it has sent warning letters to websites selling unapproved and misbranded mifepristone and misoprostol.

These are the FDA’s statements. Decisions about any medicine belong with a clinician.

Back to Table of Contents

11. How It Fits Earlier and Later FDA Actions

The 2021 decision is one step in a sequence of changes to the same program, each described in the FDA documents above: the 2000 approval with restrictions, the 2011 REMS, the 2016 extension to ten weeks, the 2019 shared-system program with the generic, the 2020–2021 periods when the in-person requirement was not enforced, the December 2021 decision, the January 2023 modified program, and the safety study the FDA reports as under way in 2026. No later page on this site yet covers the 2023 approval or the safety study.

Among the FDA’s 2021 actions, other drug-safety decisions reported on this site include the 2021 request to remove the strongest warning against statin use in pregnancy, which also concerned pregnancy, and the boxed warnings required on JAK inhibitors. A different drug used around pregnancy is covered on the 2022 levonorgestrel emergency contraceptive label update page. Another case in which the FDA used enforcement discretion is the 2022 NAC supplement enforcement discretion.

Mifepristone is also mentioned, for a different use, on the site’s Cushing’s Syndrome page. The program described on this page concerns mifepristone for ending a pregnancy through ten weeks gestation.

Back to Table of Contents

12. Primary Documents

1. U.S. Food and Drug Administration. Questions and Answers on Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation. Postmarket Drug Safety Information for Patients and Providers, content current as of April 8, 2026. No Federal Register docket — fda.gov mifepristone questions and answers
2. U.S. Food and Drug Administration. Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation. Postmarket Drug Safety Information for Patients and Providers, content current as of January 17, 2025. No Federal Register docket — fda.gov mifepristone information page

The December 16, 2021 decision memorandum, the REMS Modification Notification letters and the April 12, 2021 letter were not read for this page; every fact about them above comes from the two FDA pages listed.

Back to Table of Contents

Key Research Papers

1. Raymond EG, Shannon C, Weaver MA, Winikoff B (2013). First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review. Contraception 87(1):26-37 — PubMed PMID: 22898359
2. Daniel S, Schulkin J, Grossman D (2021). Obstetrician-gynecologist willingness to provide medication abortion with removal of the in-person dispensing requirement for mifepristone. Contraception 104(1):73-76 — PubMed PMID: 33811840
3. Rasmussen KN, Janiak E, Cottrill AA, Stulberg DB (2021). Expanding access to medication abortion through pharmacy dispensing of mifepristone: Primary care perspectives from Illinois. Contraception 104(1):98-103 — PubMed PMID: 33781760
4. Grossman D, Raifman S, Morris N, Arena A, Bachrach L, Beaman J, Biggs MA, Hannum C, Ho S, Schwarz EB, Gold M (2022). Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment. Contraception 107:36-41 — PubMed PMID: 34555420
5. Koenig LR, Raymond EG, Gold M, Boraas CM, Kaneshiro B, Winikoff B, Coplon L, Upadhyay UD (2023). Mailing abortion pills does not delay care: A cohort study comparing mailed to in-person dispensing of abortion medications in the United States. Contraception 121:109962 — PubMed PMID: 36736715
6. Upadhyay UD, Koenig LR, Meckstroth K, Ko J, Valladares ES, Biggs MA (2024). Effectiveness and safety of telehealth medication abortion in the USA. Nature Medicine 30(4):1191-1198 — PubMed PMID: 38361123
7. Grossman D, Raifman S, Morris N, Arena A, Bachrach L, Beaman J, Biggs MA, Collins A, Hannum C, Ho S, Seibold-Simpson SM, Sobota M, Tocce K, Schwarz EB, Gold M (2024). Mail-Order Pharmacy Dispensing of Mifepristone for Medication Abortion After In-Person Screening. JAMA Internal Medicine 184(8):873-881 — PubMed PMID: 38739404

The first paper is a systematic review of studies of the 200 mg mifepristone regimen with misoprostol in the first trimester. The second and third are 2021 surveys of clinicians about prescribing and pharmacy dispensing if the in-person requirement were removed. The last four are U.S. studies of mailed, pharmacy-dispensed or telehealth medication abortion. They are listed for readers who want the research literature; the FDA’s 2021 decision rests on its own review, summarized in section 6, and the FDA pages do not say which papers it weighed.

PubMed Topic Searches

1. PubMed: mifepristone REMS
2. PubMed: mifepristone in-person dispensing
3. PubMed: mifepristone pharmacy dispensing
4. PubMed: telehealth medication abortion safety

Back to Table of Contents

Connections

• FDA Actions of 2021
• FDA and Regulation
• Reproductive Medicine
• Ectopic Pregnancy
• Cushing’s Syndrome
• Levonorgestrel Emergency Contraceptive Label Update (2022)
• NAC Supplement Enforcement Discretion (2022)
• Statins Pregnancy Warning Removed (2021)
• JAK Inhibitor Boxed Warnings (2021)
• Aducanumab Accelerated Approval (2021)

Back to Table of Contents

Featured Videos