Walgreens Statement on U.S. Supreme Court Ruling on Mifepristone
The U.S. Supreme Court’s ruling on mifepristone access allows Walgreens to continue to dispense mifepristone under the FDA guidelines.
Frequently Asked Questions
1. Where is Walgreens dispensing mifepristone? Do you have a list of stores?
As part of our phased rollout, we are now dispensing mifepristone in select locations in more than 20 states consistent with federal and state laws. This phased approach allows us to ensure quality, safety and privacy for our patients, providers and team members. Walgreens remains committed to providing access to women’s reproductive health through education, medical services and filling FDA approved medications. Certified prescribers can contact the manufacturer, Danco Laboratories, for more information on locations.
Walgreens has completed the FDA certification process to dispense mifepristone and is now dispensing, consistent with federal and state laws.
We are beginning with a phased rollout in select locations to allow us to ensure quality, safety, and privacy for our patients, providers, and team members.
Certified medical providers will be able to direct patients to locations to pick up their prescriptions. But in the interests of pharmacist and patient safety, we will not disclose the number of sites per state nor identify the pharmacies that are dispensing.
2. In which states have you chosen to begin dispensing mifepristone?
To ensure safety and privacy for our patients, providers, and team members we are not disclosing locations or specific states. Certified prescribers may locate pharmacies by contacting Danco Laboratories (brand manufacturer) at 1-877-4 Early Option (1-877-432-7596).
As part of our preparation to dispense mifepristone, Walgreens conducted a rigorous process to select the initial sites within legally permissible states.
Our goals in identifying these locations were to meet patient demand and remain consistent with how we have provided access to other medications where a Risk Evaluation and Mitigation Strategy (REMS) program is required by the U.S. Food and Drug Administration (FDA).
3. What is REMS?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the FDA requires for certain medications with safety concerns to help ensure the benefits of a medication outweigh its risks.
The FDA modified the mifepristone REMS program in January 2023 to remove the restriction that did not allow mifepristone to be dispensed from retail pharmacies.
Please find more information about REMS below in the “What is the REMS Program?” section of this page.
4. Will you be expanding to additional states? When?
Yes. Our goal is to gradually expand availability to locations in all legally permissible states in a phased approach.
5. What’s the turnaround time from when a prescription is sent to Walgreens and then dispensed to a patient?
As with all Risk Evaluation and Mitigation Strategy (REMS) medications, Walgreens will dispense mifepristone to patients in a timely manner pursuant to the FDA’s REMS requirements.
6. How will my doctor know where to send my prescription?
Certified prescribers may locate pharmacies by contacting Danco Laboratories (brand manufacturer) at 1-877-4 Early Option (1-877-432-7596).
If a prescription is received at a non-certified Walgreens in an active state, Walgreens team members will assist the patient to locate an alternate pharmacy that is able to dispense the medication.
7. How do I get a prescription for mifepristone?
A certified medical provider must provide Walgreens with a prescription for mifepristone in order for Walgreens to dispense it to you.
8. Why did you choose to do an initial launch first? Why not just go nationwide?
We are beginning with a phased rollout in select locations to allow us to ensure quality, safety, and privacy for our patients, providers, and team members.
Our goal is to gradually expand availability to locations in all legally permissible states in a phased approach.
9. What is Walgreens doing to ensure patient privacy?
Walgreens is committed to patient privacy and has a robust patient privacy program in place to protect our patients’ pharmacy information for all medications. Our Notice of Privacy Practices outline how Walgreens may use or disclose their information in accordance with law.
For the dispensing of mifepristone, the FDA’s Mifepristone Risk Evaluation and Mitigation Strategies (REMS) program requires additional patient and provider privacy standards that go beyond existing laws. As a result, Walgreens has worked hard to develop new processes designed to provide enhanced privacy protections for data covered by the program.
10. Are you requiring all your pharmacists to dispense mifepristone? Can pharmacists request religious accommodations?
Walgreens has strict policies in place to uphold federal and state laws that protect health care provider conscience rights so that any team member who is unable to perform a task due to moral, religious, and/or ethical objections can request an exemption/accommodation consistent with these laws.
We will engage in an interactive process with any team member making such a request to determine what accommodations can be offered while ensuring that patients’ healthcare needs are met.
11. How does Walgreens protect the personal data of patients who receive a prescription for mifepristone from cyberattacks and other risks?
The protection of our patients’ privacy and personal data is our priority.
Walgreens’ processes and controls, our business and employees, contractors and third parties work every day to ensure the confidentiality, integrity and availability of our IT systems are maintained.
Walgreens also partners with HITRUST, a third-party organization, to assess the security and privacy controls around Walgreens’ patient data.
12. Can any provider prescribe mifepristone? What steps must providers take to be able to prescribe it?
Mifepristone is a medication that must align with a specific U.S. Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) program.
Consistent with several other medications that require a REMS program, mifepristone must be prescribed by a healthcare provider that meets certain qualifications and is certified under the mifepristone REMS program.
Providers who are seeking to become certified should complete the latest Prescriber Agreement Form. This should be done through the medication’s manufacturer, such as Danco Laboratories or GenBioPro. Please visit the FDA’s website for the most up-to-date information.
13. What must healthcare providers do to have their prescriptions filled at Walgreens?
When sending a prescription for mifepristone to Walgreens for the first time, providers must provide Walgreens—either via email or fax—with a signed copy of the Prescriber Agreement Form issued after the most recent REMS update in January 2023. Walgreens must have this form on file at each individual certified pharmacy location in order for that Walgreens pharmacy to dispense the medication.
In the event Walgreens does not have a recent Prescriber Agreement Form on file, pharmacy team members will work directly with the provider, when a prescription is received, to ensure the appropriate information is received and will keep the patient informed throughout the process.
Additional resources related to mifepristone and certification:
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) requires for certain medications with safety concerns to help ensure the benefits of a medication outweigh its risks.
The FDA determines that a REMS is necessary, specifies the requirements, and approves the specific programs based on the following considerations:
Whether there is a particular risk(s) associated with the medication that, on balance, outweigh(s) its benefits;
Whether additional interventions beyond FDA-approved labeling are necessary to ensure that the drug’s benefits outweigh its risks;
Potential burden of the REMS requirements.
REMS are designed to instruct patients on the safe use of that medication and reduce the occurrence of any serious adverse event. For example:
A REMS may be required for a drug that can cause a severe allergic reaction immediately after administration to ensure the drug is administered only in a healthcare facility with personnel trained to manage severe allergic reactions.
A REMS may ensure certain lab testing is completed and the results are checked before a medication prescription is refilled.
A REMS may educate healthcare providers about which patients may be at greatest risk of experiencing an adverse event and should therefore not be prescribed a medication.
Drugs that require a REMS may not be available at every pharmacy location due to these specific requirements.
Examples of Potential REMS Medications:
Pomalidomide (Pomalyst®), for treatment of multiple myeloma
Isotretinoin (Accutane®), for treatment of severe recalcitrant cystic acne vulgaris (nodular acne) in patients with multiple inflammatory nodules with a diameter of at least 5 mm
Once the FDA determines a REMS is necessary for a drug, the medication’s manufacturer is responsible for developing and implementing the program, as well as determining if the REMS is meeting its goal. Pharmacies are bound by the guidelines set by the manufacturer.
Without a REMS, these medications would not be approved or would be withdrawn from the market because of known or potential serious risks associated with medication.
The REMS@FDA website includes information about the current approved REMS, or individuals may contact the FDA at (855) 543-3784 or (301) 796-3400, or by email at druginfo@fda.hhs.gov.
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