Frequently Asked Questions About CAPS
How do I order solutions from CAPS?
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 set up to order your prescription solutions from CAPS in as little as a day.
How does CAPS admix the solutions that I order?
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.
How does CAPS establish beyond use dating (BUD) for batch prepared compounded sterile preparation (CSPs)?
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 and 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, and vials) to ensure that sterility is maintained over the shelf life of the preparation.
How does CAPS label its preparations?
CAPS provides high contrast labeling based on FDA and ISMP standards for TALLman lettering, and ASTM color coding standards where appropriate. Specific product codes are assigned for each anticipatory solution based on drug concentration, diluents, and container.
How does CAPS prepare high-risk, non-sterile to sterile solutions?
CAPS follows a cGMP compounding process for high-risk compounded solutions. The process includes end product testing of every batch using 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. High risk solutions are released for use only when they pass all release specification tests.
What is the CAPS staffing model?
CAPS employs licensed pharmacists, chemists, microbiologists, and certified technicians, including Quality Assurance personnel who have independent accountability from the admixture staff.
What registrations and licenses does CAPS maintain?
All CAPS 503A patient-specific pharmacies are registered with the state boards of pharmacy in both the states they reside in and the states to which they dispense. Each CAPS 503B Outsourcing Facility is registered with the FDA and with the individual states, as required.
What CAPS Quality Assurance (QA) reports are available to customers?
A quarterly QA report is provided to each customer.
What is the difference between 503A and 503B compounding?
503A compounding uses 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 (PN) and has the largest network of 503A regional pharmacies (22) 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 using federal cGMP regulations including100% release testing.
What is THR® and why is it important?
THR (Test Hold and Release℠) is the quality assurance program created by CAPS in response to the Drug Quality and Security Act’s (DQSA) requirements for 503B outsourcing facilities engaged in anticipatory compounding product batches without prescription. CAPS’ industry-leading compounded sterile preparation (CSP) release program will incorporate THR 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 THR for every batch—every day—is the only way to assure the level of quality you expect.
How can I be assured that Release Testing was completed for my product?
A Certificate of Release (CoR) is available online for every batch. It includes essential information including Lot Number, Compounding Date, Expiration Date, Test Specifications, Test Results, and Signature of the Quality Assurance Manager.
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. 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 more than 25 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.
With CAPS, you can provide your patients with release-tested batch compounded products. If your current outsourcing company does not do 100% release testing, consider switching to CAPS.
Why should I choose CAPS for my compounding needs?
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 also may allow for redeployment of pharmacist labor for:
- Managing patient outcomes
- Pharmaceutical care/clinical interventions
- Cost control activities
What is the CAPS℠ Consulting Service?
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 more than 25 years of active pharmacy and clean room experience with expertise in USP <800>, the Drug Quality and Security Act (DQSA), and more
ReadyCheckSM: A full gap analysis and the signature program of CAPS Consulting
- 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. Learn more at CAPSpharmacy.com.
CAPS Clinical PN Training Services:
CAPS, the market leader in customized Parenteral Nutrition (PN), offers the services 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 also are 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.firstname.lastname@example.org.