In what is called a “victory for public health,” FDA officials Tuesday reported a US District Court choice that maintains the agency’s interpretation of the clinical requirement for bulk substances that might be utilized by redistributing offices in drug compounding.
In an announcement, Acting Commissioner Norman E. “Ned” Sharpless, MD, and Janet Woodcock MD, chief of the Center for Drug Evaluation and Research, said that they are pleased with the court’s decision maintaining the FDA’s choice to prohibit vasopressin from the list of bulk substances that can be utilized by outsourcing facilities to make drugs, the 503B Bulks List. Athenex legitimately moved the choice to reject vasopressin from the 503B Bulks List.
FDA oversight of compounding continues remain essential, while important to patients who need them, present on-going and serious risks if they are not manufactured properly. Every year, the FDA learns of instances of patient illness and deaths due to improperly compounded drugs and caused by issues like contamination in drugs that need to be sterile because they are entering the bloodstream, the eye, or the spine or because they are not made at the right strength and are super-potent.
In that announcement, then-Commissioner Scott Gottlieb, MD, said that the 2 substances were excluded from the list because the nominator did not give a medicinal reason. The law guides the FDA to constrain compounding from bulk substances to circumstances where there’s a clinical requirement for such drugs or in circumstances where the drugs are judged by the FDA to be in shortage. These limits protect patients from unnecessary exposure to the risks related to drugs compounded from bulk drug substances, while also protecting the integrity of the drug approval process.