Department of Health and Human Services September 10, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.'' The purpose of the meeting is to give stakeholders, including health care providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages, and make recommendations for actions to prevent or mitigate drug shortages. Members of Congress have asked the Agency to examine the root causes and drivers of these shortages, and to recommend measures that will provide more enduring solutions. To this end, the Commissioner has convened an inter-Agency task force of senior Federal officials of FDA, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, and the Department of Defense. After receiving input from stakeholders, the task force intends to provide a report to Congress regarding the root causes of drug shortages. The report will also include recommendations regarding new authorities FDA or other Federal agencies could use to help provide enduring solutions to shortages.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the availability of the Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children.

The Food and Drug Administration (FDA or the Agency) is announcing the availability for public comment of a revised draft standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration'' (revised draft standard MOU). The revised draft standard MOU describes the responsibilities of a State that chooses to sign the MOU in investigating and responding to complaints related to compounded drug products compounded in the State and distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded drug products. FDA is also announcing the withdrawal of an earlier draft standard MOU entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration,'' which was issued in February 2015 (2015 draft standard MOU). The 2015 draft standard MOU is superseded by the revised draft standard MOU.