USP 800

Medications

Hazardous

closed system transfer device

Prefilled syringes with

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USP 795

Formulations

Nonsterile

Creams, ointments, solutions

Nonsterile Cantharidin

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USP 797

Medications

Sterile

For ophthalmology, neurology,

urology, ENT, and more.

Alum sterile solution

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USP 797

Compounded

Treatment Sets

Allergy

Allergy Extracts

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Open Account

Test batch logs available

Contracted with UroGPO

Outstanding customer service

Creative Solutions

should you buy from us?

WHY

Edge Pharma - 503B Outsourcing Facility

Edge Pharma is an FDA-registered 503B Outsourcing Facility specializing in innovative solutions for the healthcare community. The world-class scientific, pharmacy, and engineering staff at Edge Pharma understands the challenges healthcare organizations, whether large or small, are tackling. As your compliance partner, we are dedicated to providing turnkey 503B outsourcing with the highest level of quality, easy ordering, simple logistics, and excellent customer support. [ more…]

Stable Supply

Edge Pharma is committed to maintaining a reliable and steady supply of products. We are constantly forecasting and procuring materials to streamline our supply chain and avoid shortages. Edge recognizes that we earn our customers’ trust through the safety of our products, and also through on-time delivery.

Product Safety

Product safety is paramount. All incoming materials to Edge are visually inspected and tested against compendial standards. Products are inspected and tested for endotoxin, subvisible particles, pH levels, and other qualities. Before they are released, sterile products are tested for sterility and potency; nonsterile products are tested for potency and bioburden.

QR Reports

Each quarter, Edge Pharma publishes and makes available to its customers a comprehensive Environmental Monitoring (EM) Trend Report. This report includes results of Quality Control Testing, including sterility, potency and stability testing, and personnel monitoring data. [ more…]

Batch Test Logs

Edge’s batch test logs provide the complete history of each product and assure that the product conforms to CGMP. Traceability throughout the process – from the time materials enter the Edge facility to the time the products arrive to the customer – is critical.

CGMP Compliant

Edge Pharma adheres to Current Good Manufacturing Practices (CGMP). Edge’s Quality program, designed according to CGMP, includes strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. [ more…]

GPO Membership

Edge Pharma has ongoing contracts with Group Purchasing Organizations (GPOs). These memberships are beneficial in a number of ways, including providing access to educational programs and clinical presentations. Additionally, membership in a group such as UroGPO enables our customers to use combined purchasing power to realize cost savings.

Listening to Your Compliance Challenges.
Delivering Creative Solutions.

Listening to your compliance challenges.
Delivering Creative Solutions.

Creative Solutions

Sterile Concentrated Alum Solution
Alum sterile solution

Problem

Aluminum Potassium Sulfate is obtained as a bulk, raw material and must be compounded in a sterile setting. This nonsterile to sterile compounding is considered a high-risk procedure, according to the U.S. Pharmacopeial Convention. As a result, many hospitals no longer compound alum for bladder irrigation.

Solution

Edge Pharma produces 30g/300mL Sterile Concentrated Alum Solution, compounded in our ISO Class 5 environment, compliant with USP standards and CGMP. The product only requires dilution, thus eliminating the need for nonsterile to sterile compounding. This enables hospitals to readily offer this option to their urology departments.

Gynecologic Methotrexate Injection Kit

Problem

Methotrexate, a hazardous chemotherapy drug, is occasionally prescribed and administered in the Emergency Department for an off-label use. Since there are no preparation instructions for this use, USP 800 compounding standards must be followed. Many hospitals do not have a USP 800 hazardous cleanroom, making this task impossible.

Solution

Edge Pharma offers the Emergency Gynecologic Methotrexate Injection Kit, enabling hospitals and clinics to administer adjustable patient-specific body surface area-based doses of methotrexate up to 125mg. The kit comes prefilled with 5mL of methotrexate 25 mg/mL in an administration syringe. The administration syringe is connected to a waste syringe through a closed system transfer device (CSTD).

Bladder Instillation Kits
Gemcitabine

Problem

Hazardous drugs used off-label create a unique challenge in healthcare. When there are no preparation instructions for an off-label use, USP 800 compounding standards must be followed. Within urology, two drugs in this category are gemcitabine and mitomycin, both used off-label for bladder irrigation.

Solution

Edge Pharma produces ready-to-administer kits for both gemcitabine and mitomycin instillation. These kits include a pre-filled syringe, a closed system transfer device (CSTD), and catheter tip. This eliminates the need to compound a hazardous drug in the hospital pharmacy or clinic, resulting in better compliance for organizations, improved safety for practitioners, and greater access for patients.

CSF Capsules
CSF otic powder 2
CSF otic powder 1

Problem

For some ear infections, providers find otic powders to be useful, allowing patients to avoid the systemic effects of antibiotics. Powders can have different components; however, some components used commonly in the past are no longer available due to FDA regulations.

Solution

Edge Pharma chemists developed a new formulation for its CSF capsule, to be used in an insufflator. The components are sulfacetamide sodium, ciprofloxacin, and amphotericin. Hydrocortisone can also be added. Capsules may be ordered in bulk, to be stored in a provider’s office for patients on an as-needed basis. No individual prescriptions are necessary to order.