Contraceptive Pearl: New FDA REMS Requirement on Nexplanon
Written by Nikeeta Shah, DO, MPH
On February 23, 2026, the US Food and Drug Administration (FDA) released a new REMS certification requirement for all clinicians who offer the contraceptive implant Nexplanon. The Nexplanon, or implant, is a safe and commonly used form of long-acting contraception.1 It is a rod-shaped progestin-only contraception that is inserted subdermally into the upper arm. It contains 68 mg of etonogestrel, which is slowly released over time and is more than 99% effective at preventing pregnancy.2
For clinicians, one of the main differences in provision between the Nexplanon and other forms of contraception is the training requirement. As part of the FDA update, all clinicians must now complete a 90-minute online module and attend an in-person training through the pharmaceutical company Organon to be able to insert and remove the Nexplanon. If you completed the training before 2018, you would have had to complete a recertification due to the change in the recommended placement location. If you have not done the recertification, you must redo the online and in-person trainings. The FDA’s REMS certification is a new additional step required subsequent to these trainings.
Visit https://www.nexplanonrems.com/ to become certified. The certification process consists of registering an account, reviewing a Healthcare Provider Guide and a Prescribing Information pamphlet, taking a 7-question Knowledge Assessment, and completing an Enrollment Form.3 The entire process should take about 10 minutes total. The certification must be completed by August 23, 2026. Here is a step-by-step guide from ReproHH that fully details the process: Nexplanon REMS certification steps. If you have not completed the in-person training, visit the Nexplanon REMS website for healthcare providers to enroll in the training and complete a competency checklist in addition to the steps above.
The FDA’s recent announcement included another significant update: Nexplanon is now FDA-approved for 5 years, an extension from 3 years. A clinical trial involving over 200 people found no increase in pregnancy rates in the 4-5-year range, with a cumulative pregnancy rate of 0.6 per 100 person-years.5 Furthermore, studies also showed that the serum etonogestrel levels remained above ovulation threshold for people of all BMI classes (which ranged from 16.5 to 62.7) in the years 3-5.6
The FDA implemented the REMS requirement to ensure proper insertion and removal of Nexplanon, despite the low overall incidence of complications.4 The FDA has also placed a REMS requirement on the new Copper IUD, Miudella. Given reproductive health clinicians’ experiences with the REMS requirement on mifepristone restricting access to abortion care, this potential pattern elicits a concern that there may be increasing and unnecessary barriers to reproductive health care more broadly in the name of “safety.”
As of 2024, national survey data have shown that almost one-third of reproductive health clinicians were still counseling patients that Nexplanon was effective for three years rather than five.7 This may have been influenced by the lack of prior FDA approval, and hopefully, there will be a continued shift in counseling practices. For all clinicians offering Nexplanon, take this as a reminder to complete the REMS certification, so all contraceptive options continue to be available to patients.
RHAP Resources:
Your Birth Control Choices Fact Sheet
Download and print our resources for free from our website or visit our store to buy physical copies!
Partner Resources:
Reproductive Health Hotline (ReproHH): A free, confidential phone service (1-844-737-7644) offering evidence-based clinical information for healthcare providers across the US who have questions related to sexual and reproductive health.
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