FDA Removes Two Bulk Drug Substances Nominated for Use in 503B Outsourcing Facilities

This month, the FDA published final guidance for the list of bulk drug substances 503B facilities may use in compounding. The FDA decided to remove two substances, nicardipine hydrochloride and vasopressin, from the previous version. This is a huge win for pharma company Endo International, maker of commercially available vasopressin, and a major loss for the compounding industry.

While the pharmaceutical industry puts pressure on the Agency to preserve the new drug approval process, the bulk lists (for both 503A’s and 503B’s) are in jeopardy of being whittled down further. Keep in mind, the FDA is in a tough spot of trying to keep pharmaceutical manufacturers happy while still supporting and educating a quality-centered sterile compounding industry.

What does the future look like for the bulk list?

The 503B sector is still in its infancy and was enacted by congress to provide the nation with high quality high volume compounds. It’s still a mystery as to how the field will develop, but it appears compounders will have to scientifically defend the clinical need of compounding with bulk drug substances if they want to maintain patient access to a wide variety of these substances.