The US Food and Drug Administration (FDA) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The final rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify the FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States. The rule takes effect September 8, 2015.
The rule requires notification to the FDA at least six months prior to date of the permanent discontinuance or interruption in manufacturing, or, if six months' advance notice is not possible, as soon as practicable thereafter, but in no case later than five business days after the permanent discontinuance or interruption in manufacturing occurs.
The rule also provides that the FDA will issue a noncompliance letter to an applicant for failure to notify the FDA under the rule; specifies minimum information that must be included in the notification; codifies the FDA's current practice of publicly disseminating information on shortages and maintaining public lists of drugs and biological products in shortage (subject to certain confidentiality protections); and defines the terms “drug shortage,” “biological product shortage,” “meaningful disruption,” “significant disruption,” “life supporting or life sustaining,” and “intended for use in the prevention or treatment of a debilitating disease or condition” in the context of the related drug-shortage measures.
The FDA published a proposed rule to implement certain drug shortages provisions of the FD&C Act, as amended by FDASIA in 2013, and has published this final rule in the July 8, 2015 Federal Register, to take effect September 8, 2015.
Source: Federal Register