CAPS is fully supportive of the drug quality and security act. Our input was requested by staffers of the House Energy and Commerce committee to provide expertise on the drafting of the bill.
Yes. The DQSA establishes two distinct types of compounding pharmacies: 503A otherwise known as “traditional pharmacies,” and 503B now known as “outsourcing facilities.” CAPS Pharmacies that distribute non-patient specific CSPs (anticipatory compounding) will voluntarily register under section 503B of the DQSA. Further, all CAPS pharmacies that dispense patient-specific prescriptions only (such as TPN solutions) will continue to operate under Section 503A of the act. These patient-specific only pharmacies will continue to be registered with individual State Boards of Pharmacies as 503A traditional pharmacies.
Registering under Section 503B as an "Outsourcing Facility" requires the registrant to follow applicable cGMPs. The current thinking is that cGMPs includes batch sterility, potency, and endotoxin testing. The challenge with this for patient specific TPNs is that they are individual "batches of one,” which would require us to make two bags for each order, test the first bag for sterility, endotoxin, and potency, and then quarantine the patient prescription bag for 14 days until the test results are available. This process would be impractical and prevent shipping the prescription before it would expire. For this reason, since CAPS patient-specific only pharmacies meet all the requirements of a 503A traditional compounding pharmacy, we will limit our FDA registration to our anticipatory compounding pharmacies.
503B outsourcing facilities are permitted to compound drug shortage items. CAPS will make drug shortage items such as TPN electrolytes in FDA registered 503B outsourcing facilities. These TPN ingredients will be shipped to CAPS patient-specific 503A traditional compounding pharmacies for use in patient-specific TPN admixing.
CAPS will admix and distribute all Cardioplegia prescriptions that contain components that were made from non-sterile to sterile compounding from 503B registered outsourcing facilities.
CAPS will compound and dispense all controlled substances from a 503B registered outsourcing facility that is also registered as a DEA manufacturer. This facility will also hold various state licenses and registrations depending on the requirements of each individual state.
FDA is required to develop a MOU between the agency and the individual states that describes how the states will ensure that pharmacies are not distributing an “inordinate amount” of compounded sterile preparations interstate. If a state did not sign the MOU, FDA interprets that inordinate amount as no more than 5% of total orders. FDA is working on the draft MOU and more information will be forthcoming. This will not affect TPN deliveries by CAPS as we only compound and ship after receipt of a patient-specific prescription, which is defined as “dispensing” in the DQSA. The MOU and 5% rule specifically refers to “Distribution”, which is shipping without a prescription. In any event, all CAPS pharmacies will operate as either a Section 503A traditional pharmacy or a Section 503B outsourcing facility.
CAPS is unique by having a two model approach to compounding. The pharmacies that perform AC compounding and non-sterile to sterile compounding will be registered with the FDA as a 503B like most other companies. What is unique to CAPS is the local pharmacies and our ability to offer patient specific customization providing what patients need, and when they need it. The localized pharmacies will offer superior service for patient-specific requirements and will continue to run as 503A pharmacies.