There are many reasons sterile compounding facilities hit a ceiling on output. When throughput stalls, the most common response is often to invest in more space, more equipment, or more headcount. But in practice, the root cause is not always solely a lack of resources. More often, workflow clarity, sequencing, utilization, and documentation design also contribute to the constraint.
Read MoreFollowing increased regulatory scrutiny and safety incidents linked to inconsistent oversight by state boards of pharmacy, the FDA established two designations for compounding facilities: 503A and 503B. This guide explains the defining features of each designation, the key differences between them, and what 503A compounding pharmacies and 503B outsourcing facilities need to know to remain compliant with evolving FDA and state regulations.
Read More
