503B Registered Facilities - Compounding Pharmacies

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

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
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Case Studies Sub Header
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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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