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FDA Publishes Final Rule on Requirement for Patient Medication


FDA is proposing to amend its drug product labeling rules for Medication Guide and other information templates provided to consumers/patients, by replacing it with, new type of document, Patient Medication Information, or PMI. Proposed rule is pre-published here in the Federal Register and is open for comments for 180 days.


Currently, Patients may receive a medication guide, consumer medication information (CMI) or Instruction of Use documents, if required. These documents are often either repetitive, incomplete or difficult to comprehend. Current rules require Medication guide for the products where FDA determines, either-

  1. Information can reduce serious adverse effects

  2. Prescription product has serious risk/(s), and patients should be made aware for ease of decision or

  3. Instruction of use is crucial for effective use.


This new implementation is aimed to “provide patients with clear, concise, accessible, and useful written information for prescription drugs and certain biological products and would be delivered in a consistent and easy-to-understand format to help patients use their prescription drug and certain biological products safely and effectively”.


Under the new proposed rules, PMI will be one-page document, of a standard format, consisting of-

[Drug Name]

Important Safety Information

Common Side Effects

Directions for Use


Once the rule is finalized, FDA will require the applicants of All NDA and BLA to create PMI for all prescription drug products and biologics intended for out-patients. The Agency will also require all new and approved ANDAs referring to RLD which has an approved PMI, to supplement/amend ANDAs. FDA will also create a PMI template for approved ANDAs if: (1) the ANDA references a listed drug whose approval has been withdrawn and (2) no PMI was approved for the RLD before the approval of the RLD was withdrawn. FDA has proposed a maximum 5 year implementation schedule for PMI, depending on the approval date and whether the Medication Guide was already approved. Once the final rule is approved, the applicants are required to submit PMI, in appropriate amendment or supplement, as the case may be.


Though, there are few waivers available under the proposed guidance, such as extension of timelines (if it creates drug shortage and supply disruptions) or waiver from one-page document (if necessary for safe and effective use).


It is an interesting yet developing regulation that is expected to have a long range impact on a lot of prescription products (especially those that are used for outpatient use. Industry will have to make plans for implementation, once the rule is finalized and will have to be ready for implementation schedule.


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