Outsourced Compounding

June 2019 - Vol.16 No. 6 - Page #8
Category: Outsourced Compounding Services (503B)

Strong regulatory activity continues to define the outsourced compounding marketplace, and yet it is not uncommon for pharmacy directors to be unaware of their vendor’s experience with their state board and FDA inspections. Conversely, those pharmacy directors who monitor their outsourced vendor’s response to Form 483 issuances and other quality problems report strong satisfaction with their vendor’s corrective actions. This confidence is reflected in solid satisfaction scores and an ongoing commitment to maintain or increase current outsourcing volumes.

While many pharmacy directors (61%) are aware of their vendor’s cGMP inspection status, it is incumbent upon all pharmacy directors utilizing outsourced compounders to know when their vendor last underwent an FDA inspection and to review any 483s that may have been issued. This data is easily accessible on the FDA’s website.

Like the FDA, state boards are continuing their active inspections of outsourced compounders. Nonetheless, more than half (57%) of pharmacy directors do not know whether their vendor has undergone a state board inspection.

FDA Form 483s have been issued frequently since the onset of FDA inspections of 503B pharmacies. More than half of pharmacy directors are aware that their vendor has been issued a 483. A resounding 96% of those pharmacy directors are satisfied with the corrective actions undertaken by their outsourcer.

Most QA reports are received quarterly or upon request only. Nonetheless, almost one-quarter (24%) of facilities receive a QA report with each product, up from a mere 7% 5 years ago.

An impressive 94% of pharmacy directors are satisfied with their outsourced compounders, although it is notable that excellent ratings remain elusive.

Over the last 3 years, 18% of outsourced compounding clients have experienced a quality problem, such as a mislabeled or incorrect CSP. Notably, the vast majority found the corrective actions taken by their vendor to be satisfactory.

With the FDA’s recent changes to registration requirements for 503B compounders, a significant number of pharmacy directors (47%) are either planning to switch vendors or are considering the possibility.

As volatility has become a hallmark of medication sourcing due to ongoing shortages and product discontinuations, a majority of pharmacy directors (62%) plan to maintain their current outsourced compounding volume. An additional 20% are looking to increase the number of CSPs they purchase from their outsourced vendor over the next 3 years.

Pharmedium, CAPS, and Quva remain the leading vendors under consideration. Pharmacy directors are giving extra attention this year to Quva, Avella Specialty Pharmacy, SCA Pharmaceuticals, and Leiters as they review their options.

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