FDA Alerts Compounders to Changes Resulting from NDA to BLA Transition
The FDA said it does not plan to take enforcement action, under certain conditions, against outsourcing facilities that use four bulk drug substances that will no longer be eligible for mixing, diluting or repackaging following the agency’s transition of nearly 100 biological products from NDAs to BLAs on March 23.
The four substances include three hormone products — human chorionic gonadotropin (hCG), follicle stimulation hormone (FSH) and menotropins — and hyaluronidase, a protein enzyme used to help the body absorb injected fluids or medicines.
The agency said it will remove hyaluronidase from its list of substances currently under evaluation for inclusion on the bulk substances list.
In a guidance, the FDA spelled out the conditions under which it will not take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling.