Update on Cardioplegia Compounding

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Update on Cardioplegia Compounding
To All US Perfusionists;

Central Admixture Pharmacy (CAPS) has asked me to update all perfusionists in the United States regarding some upcoming changes to their business model due to the passage of new federal guidelines for the compounding industry entitled the Drug Quality and Security Act (DQSA).

The DQSA establishes two distinct types of compounding pharmacies:

503A Pharmacies are otherwise known as "traditional pharmacies" and dispense patient specific prescriptions. CAPS has 23 503A pharmacies across the US that dispense patient specific prescriptions (such as TPN solutions) and will continue to operate under 503A of the act.

503B Pharmacies are now known as "Outsourcing Facilities". CAPS has 2 facilities that distribute non-patient specific "anticipatory compounding" and have voluntarily registered with the FDA under Section 503B of the DQSA. It is important to note that, according to the DQSA, the only legal way to distribute cardioplegia solutions without a specific prescription for an individually identified patient is through a 503B Outsourcing Facility.

CAPS will continue to admix and distribute cardioplegia prescriptions to hospitals across the United States. The majority of these solutions will be compounded as non-patient specific prescriptions, "anticipatory compounded", and delivered from their 503B registered outsourcing facility in Lehigh Valley, PA. In fact, some of you are receiving cardioplegia solutions from the Lehigh facility already. Another option is to order cardioplegia as a patient-specific prescription from a regional CAPS facility.

Furthermore, as part of CAPS' ongoing compliance with the new FDA guidelines, any solution that is compounded at their Lehigh 503B location, will undergo full sterility, endotoxin and potency testing.

What does this mean for United States perfusionists?

First, as a result of all the extensive testing that CAPS will carry out in compliance with DQSA, some standardization of formulas will need to take place.

Second, we are actively seeking a dialogue with ALL perfusionists throughout the US, and in particular CAPS customers, to better understand how we may dovetail the new standards of DQSA within your practice modality.

I request all perfusionists in the United States to please contact me privately so we may schedule a site visit to discuss this issue in person or please contact CAPS at: www.capspharmacy.com

Only with your input can we take cardioplegia solutions to the next level of quality.

Warm regards, Tom

Thomas Muziani PA,CP
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