The CAPSLink online portal allows secure ordering via the web, offering built-in safety checks throughout the ordering process. There is no equipment to install, so you can be setup to order your prescription solutions from CAPS in as little as a day.
Pharmacists review orders upon receipt, and prepare your order using our automated compounding process featuring a barcoded manual add system (MAS) to verify ingredient accuracy. CAPS preparations are admixed in a laminar flow, ISO Class-5 zone, within an ISO Class-7 buffer zone.
Stability is more than a simple potency test at CAPS. Our BUD is assigned to compounded solutions based on advanced techniques.
CAPS uses method development/validation procedures, including forced degradation or specificity studies to ensure that no false positives from impurities occur when testing for stability. BUD validation includes sterility, concentration, pH, color, clarity, endotoxin, and particulate matter to establish BUD of each CSP.
Container Closer Integrity (CCI) testing is performed on containers (bags, syringes, devices, vials) to ensure that sterility is maintained over the shelf life of the preparation.
CAPS provides professional, high contrast labeling based on FDA and ISMP standards for tall man lettering, and ASTM color coding standards where appropriate. Specific product codes are assigned for each anticipatory solution based on drug concentration, diluents, and container.
CAPS follows a cGMP compounding process for high-risk compounded solutions. The process includes end product testing of every batch utilizing the FDA-approved BacT/Alert® testing system, bubble-point testing of
the filter, and a full quarantine period to ensure chemistry, sterility, and other release criteria are met. Highrisk solutions are released for use only when they pass all release specification tests.
CAPS employs licensed pharmacists, chemists, microbiologists, and certified technicians, including Quality Assurance personnel who have independent accountability from the admixture staff.
All CAPS 503A patient-specific pharmacies are registered in both the states they reside in and the states they dispense to with the state boards of pharmacy. Each CAPS 503B Outsourcing Facility is registered with the FDA and with the individual states, as required.
A quarterly QA report is provided to each customer.
503A compounding utilizes USP <797> standards and focuses on customized, patient-specific compounding dispensed only upon prior receipt of a prescription. CAPS is the market leader in customized parenteral nutrition and has the largest network of 503A regional pharmacies (twenty-three) in the industry. CAPS also offers patient-specific chemotherapy and hydration from our regional 503A pharmacies for daily delivery. 503B compounding is essentially batch compounding utilizing federal cGMP regulations including Test, Hold and Release (THR) quality assurance.
THR is the new quality standard created by the Drug Quality and Security Act (DQSA) for 503B outsourcing facilities engaged in anticipatory compounding. CAPS’ industry-leading Compounded Sterile Preparation (CSP) release program will incorporate THR steps following compounding. After successful completion of a validation phase, every CSP batch will be quarantined prior to release, pending the outcome of tests for sterility, endotoxin and potency (drug strength). When it comes to patient safety and your reputation, CAPS believes that THR for every batch—every day—is the only way to assure the level of quality you require.
Does the FDA require batch level sterility and endotoxin testing in their draft guidance for 503B outsourcing facilities?
Yes. The FDA requires sterility and endotoxin testing of each batch in 503B outsourcing facilities. CAPS is proud to incorporate the FDA standards to our 503B Outsourcing Facilities and will release products only after testing of every batch of CSP’s for sterility, potency, and endotoxin testing. It is CAPS’ intention to meet the stringent quality standards and to provide the greatest confidence to our customers. Strict quality control has been the foundation of CAPS for over 20 years and will continue to be so.
Batch level sterility and endotoxin testing are required in the FDA’s draft guidance for 503B (http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-0779-0002) outsourcing facilities. In addition, the FDA has issued warning letters for 503B facilities who are not meeting these standards.
With CAPS, you can provide your patients with release-tested batch compounded products. If your current outsourcing company does not do Test, Hold, and Release per batch, consider switching to CAPS.
CAPS can help you turn fixed costs into variable costs with a true pay-as-you-go advantage. CAPS allows you to free up space in the pharmacy and storeroom and reduce inventory of expensive drugs. Moreover, our ready-to-administer compounded products are delivered to you and feature the highest quality assurance standards. The ready-to-administer preparations may also allow for redeployment of pharmacist labor for:
- Managing patient outcomes
- Pharmaceutical care/clinical interventions
- Cost control activities
CAPS features two consulting services:
CAPS ConsultingSM: We recognize that the new Federal regulations can be difficult to decipher. CAPS Consulting is a team of compounding experts prepared to help pharmacies like yours meet the new compliance standards. We have over twenty years of active pharmacy and clean room experience with expertise in <USP 797>, the Drug Quality and Security Act (DQSA), and more.
ReadyCheckSM: The signature program of CAPS Consulting, “A full 797 Gap Analysis”
• 2 Consultants
• 2 Days
• 200 Criteria
Whether you’re preparing for an expansion, recovering from an audit, or anything in between, CAPS Consulting can provide expert pharmacy compounding assistance. Let our CAPS Consulting team help your team.CAPS Clinical PN Training Services:
CAPS, the market leader in customized PN, is proud to announce the addition of a Clinical Nutrition Support Pharmacist who serves a vital role as clinical liaison to our partners for training, education, and consulting needs.
The training is enhanced with case studies, live interactive discussion, and competency testing at the conclusion of the program. Training/reference materials are also provided. With our exclusive one-on-one training, the program can be tailored to your specific area of need. If interested in learning more, please contact us at PNTraining.email@example.com.