What is the classification of an isotretinoin product dispensed without going through the required REMS?

Isotretinoin is classified under a risk evaluation and mitigation strategy (REMS) program due to its potential for severe side effects, including birth defects and psychiatric issues. If an isotretinoin product is dispensed without going through the necessary REMS procedures, it fails to comply with the required safety measures that ensure the medication is dispensed safely and with proper patient education.

A product that is not issued in accordance with its REMS requirements would not necessarily meet the definition of "misbranded." A misbranded drug reflects issues like labeling that is false or misleading in any particular way, or its labeling fails to meet the required information to advise the user of its safe and effective use. However, improper REMS adherence speaks more to the fulfillment of safety protocols than to the labeling or presentation of the product itself.

Therefore, while a violation of REMS could suggest issues with how the drug is marketed or dispensed, it does not directly classify it as misbranded. The focus is on the failure to adhere to mandatory safe dispensing protocols rather than incorrect labeling.

Thus, while the product may not have gone through the proper REMS, it does not fulfill the criteria for being considered misbranded, making the most accurate classification