503B Registered Facilities - Compounding Pharmacies

Research the Leading 503B Registered Facilities / Compounding Pharmacies for Outsourcing Compounding Services

503B Registered Facilities - Compounding Pharmacies Booth #13817
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Request More Information Visit the PharMEDium Website

PharMEDium

PharMEDium is the national leader in customized pharmacy sterile compounding for hospital intravenous and epidural therapies.

503B:

PharMEDium is registered with the U.S. Food and Drug Administration (FDA) as a 503B large-scale sterile compounding "outsourcing facility" under the recently enacted Drug Quality and Security Act (DQSA).

Compounding Services:

As the national leading provider of compounded sterile preparations, we assume the responsibility for the drug preparation process allowing you to focus on the the patient. PharMEDium has worked collaboratively to help hospital pharmacists find solutions to today's challenges associated with compounded sterile preparations: budgets, workload, regulations, shortages, technology, treatment advancements, and above all, maintaining quality and efficiency to enhance patient safety.

Dedication to Quality
PharMEDium utilizes only FDA-approved, sterile drug components, providing the highest quality preparations. PharMEDium conducts rigorous routine monitoring of its processes, facilities, personnel and admixtures.

Commitment to Innovation
We are committed to enhancing patient safety through innovation. Our research and development efforts provide customers with tomorrow’s technologically-driven service enhancements. Our strategic partnerships with drug and device manufacturers and clinical thought leaders work synergistically to enhance quality of care.

At PharMEDium, Our Customers Come First
Dedicated 24/7 service and streamlined ordering provides you what you need when you need it. For more than ten years, our clinical and technical experts have dedicated themselves to ensuring you have the tools and information to enhance the best care possible. Our critical back-up support systems and geographically diversified compounding centers can minimize supply disruptions.

Our mission is to be the preeminent provider of choice for pharmacy outsourced sterile intravenous admixture compounding services, supporting the triad of care that exists between patients, clinicians and pharmacists. Our goal is to provide the highest quality service, facilitating the best clinical care and patient safety.

Hospitals considering PharMEDium are invited to visit our centers and learn about the processes that have been instrumental in helping us to attain and maintain our industry leadership position. We are available to discuss how we can help you improve your economic efficiency by reducing waste.

Pharmedium on Pharmacy Admixture Compounding Services. Outsourcing pharmacy provider in compounding pharmacy services, compounding centers and Pharmacy Admixture Compounding Services. Custom admixture services compounding pharmacy services Pain Management Services or Anesthesia Admixtures and Standard Admixture Services Intrathecal Services Custom Admixture Services with Pharmedium


PharMEDium Compounding Pharmacy Services
PharMEDium Pharmacy Admixture Compounding Services

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503B Registered Facilities - Compounding Pharmacies Booth #13846
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Request More Information Visit the SCA Pharma Website

SCA Pharma

Critical Medicine Your Patients Can Depend On. From the Company You Can Trust.

Quality. Compliance. Support. And above all, patient safety. At SCA Pharma, we’re committed to meeting your sterile compounding needs for years to come. That’s why we’re laser-focused on quality, safety and exceeding compliance standards every single day, every single batch, every single dose.

SCA Pharma is a privately held, FDA 503B outsourcing facility. Our goal is to provide the highest quality sterile admixtures and pre-filled syringes for our clients and their patients.

SCA performs 100% final product sterility testing and full endotoxin testing on every batch of sterile products, prior to release. We also perform Visual Inspection, Potency, and Identification testing on every batch prior to release.

Environmental Monitoring (EM) results are also a part of release criteria. SCA Pharma can provide a Certificate of Conformance (C of C) Lab Report for every lot produced, to help ensure hospital pharmacy teams have the documentation they need.

Superior customer service that goes above and beyond makes an enormous difference when partnering with SCA Pharmaceuticals. We take pride in being an extension of your pharmacy, that is always there when you need us.

You can have confidence in every product in our broad and diverse portfolio. And our unique, personalized customer support means there will always be a real person on the other end of the line, ready and able to answer questions and ensure your satisfaction.

For more information, please contact customerservice@scapharma.com.

CONTACT INFORMATION:
SCA Pharma
755 Rainbow Road, Suite B
Windsor, CT 06095
PHONE: 877-550-5059
customerservice@scapharma.com

503B Registered, Compounding, Pharmacy, Pharma, SCA Pharma
503B Registered
SCA Pharma
Pharma
Compounding Pharmacies
compounding
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503B Registered Facilities - Compounding Pharmacies | NEWS / BUZZ

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503B Registered Facilities - Compounding Pharmacies

FDA: Facilities Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm

The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an "outsourcing facility."
The law defines an "outsourcing facility" as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.

An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from current good manufacturing practice (CGMP) requirements.

Outsourcing facilities:
- must comply with CGMP requirements
- will be inspected by FDA according to a risk-based schedule
- must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.

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