FDA Releases Guidance for Industry on Notifying the Agency of Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act

FDA Releases Guidance for Industry on Notifying the Agency of Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act

The U.S. Food and Drug Administration has issued a guidance, “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the U.S. This guidance is intended to help applicants and manufacturers provide the agency with timely and informative notifications about changes in the production of certain drugs and biological products. In urging the submission of these notifications, the guidance may assist in our efforts to prevent or mitigate shortages of such products, including under circumstances outside of the COVID-19 public health emergency.

This information will allow FDA to better assess the specific situation and identify appropriate tools to help prevent or mitigate shortages of these products.

The guidance describes the requirement under section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356c) and FDA’s implementing regulations that manufacturers notify FDA of a permanent discontinuance in the manufacture of certain drug or biological products or an interruption in the manufacture of certain drugs or biological products that is likely to lead to a meaningful disruption in the supply of such products in the U.S., and the reasons for such discontinuance or interruption.

The products covered by the notification requirement are prescription drugs and biological products (including blood or blood components for transfusion) that are (1) life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such product used in emergency medical care or during surgery; and (2) not radiopharmaceutical drug products or any other products designated by FDA. The guidance also recommends that applicants and manufacturers provide FDA with additional details and follow additional procedures to assist the agency in its efforts to prevent and mitigate shortages.

The guidance reiterates the requirements under section 506C of the FD&C Act and FDA’s implementing regulations concerning the timing and circumstances under which manufacturers must notify FDA regarding changes in the production of certain drugs and biological products. The guidance recommends that after initial notification of an interruption in manufacturing, manufacturers should provide updates every two weeks until the situation is resolved.

The guidance includes a list of questions for manufacturers to consider when notifying FDA that may yield information that would help FDA determine appropriate steps to help prevent or mitigate a shortage.  These questions cover such issues as manufacturers’ estimated market share, their historic volume of sales, the availability of current inventory and emergency supply, and ways they think FDA can help to prevent a supply disruption.

FDA has a similar interest in preventing and mitigating animal drug shortages. Although the requirements in section 506C of the FD&C Act do not apply to animal drugs, FDA asks that animal drug manufacturers voluntarily report information about animal drug shortages to the agency.