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  1. Postmarket Drug Safety Information for Patients and Providers

iPLEDGE Risk Evaluation and Mitigation Strategy (REMS)

iPLEDGE REMS Program for Isotretinoin Products

The iPLEDGE Program was originally implemented in early 2005 and approved as the iPLEDGE REMS in 2010. The goals of the iPLEDGE REMS  are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions.  It is a “shared system” REMS, meaning that it includes all FDA-approved isotretinoin products. It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used. 

In an effort to provide timely isotretinoin information to prescribers, pharmacies, patients, and distributors, the FDA will post any related updates on isotretinoin and the iPLEDGE REMS  on this page.

Please see the iPLEDGE REMS website, for up-to-date and detailed information about the program.


iPLEDGE Update (October 8, 2021):

FDA approved a modification to the iPLEDGE REMS  effective December 13, 2021 with system changes for health care professionals and patients.. Please note that prior to this modification, the iPLEDGE website and iPLEDGE REMS Contact Center phone service will undergo maintenance starting Friday, December 10 at 11:59 p.m. EST until Sunday, December 12 at 11:59 p.m. EST. During this time, iPLEDGE will be completely unavailable.

Important changes for Health Care Providers
Patient risk categories in the iPLEDGE REMS will be reduced from three options to two. The new risk category options are: patients who can get pregnant and patients who cannot get pregnant. Health care providers must assign and confirm their currently enrolled patients’ risk category for each patient upon their first login into the iPLEDGE REMS Website on or after December 13, 2021.  The iPLEDGE REMS Prescriber Guide describes the qualification criteria for determining the reproductive potential of a patient.  

Prescribers and their designees should ensure that any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires on December 11-12, 2021 is instructed to obtain their prescription before 11:59 p.m. (Eastern) on December 10, 2021.

Important changes for Pharmacies
The REMS administrator has changed and the current “switch” pharmacy management system is being removed as a method to verify authorization to dispense isotretinoin. With the changes to the pharmacy management system, pharmacists will no longer use the switch system to obtain a pre-dispense authorization, known as a risk management authorization (RMA). Starting on December 13, 2021, all pharmacists need to obtain an RMA prior to dispensing isotretinoin by accessing the iPLEDGE REMS website or the iPLEDGE REMS Contact Center. 

Pharmacies will not be able to obtain an RMA number to dispense isotretinoin between December 11-12, 2021. Isotretinoin manufacturers anticipate the phone and internet systems for the modified iPLEDGE REMS will be available on December 13, 2021.

Important changes for Patients
Starting on December 13, 2021, patients will be assigned to one of two risk categories: patients who can get pregnant and patients who cannot get pregnant.  Patients will also have the option of presenting a unique QR code at the pharmacy on their smartphone instead of providing their iPLEDGE identification number. Patients can access their unique QR code by logging into their account on the iPLEDGE REMS Website. 

Any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires during the weekend of December 11-12, 2021 must obtain their prescription before 11:59 p.m. (Eastern) on Friday, December 10, 2021.  If the RMA expires before the prescription is picked up from the pharmacy, the patient must go back to their prescriber and start the authorization process again.

For complete information on the new iPLEDGE REMS requirements and to learn more about the new QR code for patients, please visit the iPLEDGE REMS website  or contact the iPLEDGE REMS Contact Center at 866-495-0654. 

Related Information

iPLEDGE REMS Frequently Asked Questions 


iPLEDGE Update (March 15, 2018):
Please be advised that the isotretinoin manufacturers have informed FDA that the iPLEDGE REMS Program website will undergo maintenance on March 17 and March 18, 2018.  The isotretinoin manufacturers have informed FDA that, during this time, their website will be completely unavailable. The iPLEDGE Program Contact Center will be open during its normal hours of operation (9:00 AM to 12:00 AM midnight ET, Monday through Saturday) and will be able to answer general information questions.  The iPLEDGE Program Contact Center is available toll-free by calling 1-866-495-0654.
Specifically,

  • Prescribers will not be able to interact with the iPLEDGE Program,
  • Patients will not be able to complete Patient Monthly Comprehension Questions, and
  • Pharmacies will not be able to obtain a Risk Management Authorization (RMA) number.

Prescriber Action:
Prescribers and their designees should ensure that any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires March 17 or March 18, 2018 is instructed to obtain their prescription before 11:59 p.m. (Eastern) on March 16, 2018.
The isotretinoin manufacturers anticipate that their system will be available again starting Monday, March 19, and FDA will update this posting accordingly.

Patient Action:
Any patient whose isotretinoin prescription RMA (i.e., iPLEDGE authorization) expires during the weekend of March 17-18, 2018 must obtain their prescription before 11:59 p.m. (Eastern) on Friday March 16, 2018.  If the RMA expires before the prescription is picked up from the pharmacy, the patient must go back to their prescriber and start the authorization process again.

 


iPLEDGE Update (10/22/2010): Today, FDA approved iPledge as a Risk Evaluation and Mitigation Strategy (REMS) in accordance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). This approval does not substantively change the program for patients, prescribers, dispensers, and wholesalers for approved uses of isotretinoin. FDAAA required the conversion to REMS of those RiskMAPs approved before FDAAA was enacted that contained certain features such as those of the iPledge program requiring prescriber and pharmacist certification, and documentation of safe use conditions before the drug can be dispensed, including pregnancy testing and agreement to use contraception.

iPLEDGE Update (10/2007): FDA is providing an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). FDA approved several changes to the program. See IPLEDGE Update

 

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