US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry:
As of October 10, 2024, under section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)), HHS Secretary Becerra has declared public health emergencies (PHEs) in North Carolina, Florida, Georgia, Tennessee, and South Carolina due to the impacts of Hurricane Helene, as well as in Florida because of Hurricane Milton. In late September 2024, Hurricane Helene severely affected one of the largest manufacturers of specific intravenous and peritoneal dialysis solutions in the U.S. The FDA is collaborating with this manufacturer and alternative suppliers to enhance the supply and mitigate the risk of shortages of essential drug products.
The regulation of dietary supplements by the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA) emphasizes the responsibility of manufacturers and distributors to ensure their products are safe and accurately labelled. Here are some key points regarding recent updates and resources related to dietary supplements:
Central drug standard control organizations has released version 2.0 pharmacovigilance guidance, enacting changes such as extending the deadline for reporting non-serious adverse events and revising record-keeping requirements.
The FDA oversees both finished dietary supplement products and dietary components. The FDA regulates dietary supplements differently than it does “conventional” foods and drugs. According to the Dietary Supplement Health and Education Act of 1994 (DSHEA):
Nitrosamine impurities guidance updated with more information related to root causes of formation, mitigation and implementation of recommended AI limits and setting of specification for the recommended acceptable intake in drug products.
Guidance has updated from February 2021 Revision 1 to September 2024 Revision 2 complete details provided below: