503B Registered Facilities - Compounding Pharmacies

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

503B Registered Facilities - Compounding Pharmacies Booth #13847
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Leiters

Helping you deliver better medicine to more people.

Leiters is a trusted FDA-registered 503B outsourcing provider of high-quality ophthalmology and hospital-based services.

We are committed to providing healthcare professionals and their patients with high-quality medications.

Our team of experts in sterile pharmaceutical manufacturing, repackaging, and pharmacy provides a sophisticated understanding of what it takes to elevate the quality and consistency of supply in outsourcing.

We combine our team, our robust processes, and our state-of-the-art outsourcing facilities to ensure the highest quality products and services.

We believe the most important consumer of our products are patients, and patients have trusted Leiters with their health for nearly a century.

The People

We are defining a new standard of quality that starts with an experienced, passionate team that cares about the health and safety of the patient. Our multi-disciplinary team of professionals consists of quality assurance experts, microbiologists chemists, and pharmacists. The experienced team ensures only the highest and most rigorous standards are satisfied for each batch of product manufactured, tested and released. The Leitersí multi-disciplinary team brings years of experience from large sterile injectable pharmaceutical companies, hospital pharmacies, and academia. A quality mindset is deep rooted in our highly skilled team through extensive training, which includes cGMP training, and aseptic processing training. This highly trained team ensures quality, consistency and compliance with all released products. Leiters stands apart by focusing on one singular purpose: bringing health to outsourcing.

The Place

This is the place where quality means everything.

Our FDA-registered 503B outsourcing facility is located in Denver, Colorado. With increasing regulatory pressure, there is a growing need for higher standards in pharmaceutical outsourcing. Leitersí facility in Denver was designed to exceed traditional outsourcing facilities and was constructed with the patient in mind. We are defining a source for greater accountability with our facility in Colorado. Our state-of-the-art facility ensures quality, consistency and compliance with all released products.

  • FDA-registered cGMP compliant 503B outsourcing provider
  • Licensed to ship to all 50 states (+ the District of Columbia)
  • Continuous facility environmental monitoring to maintain product quality standards
  • Inspected by the FDA, State of California Board of Pharmacy, multiple health systems, group purchasing organizations, and other independent accreditation organizations

We invite you to visit our facility to better understand the cGMP regulations, sterile manufacturing processes, and automation we use to elevate the quality of our products and services. Come join the growing list of organizations who have visited our facilities.

The Product

Defining a source for greater accountability is imperative to drive better medicine. We believe that making better medicine starts with a broader perspective. Prioritizing what matters most and putting patients at the center of everything that we do helps us make better medicine. All sterile hospital and ophthalmology preparations are produced under the Human Drug Outsourcing Facilities under 503B of the FD&C Act (503B Guidance), Current Good Manufacturing Practices (cGMP) and exceed USP <797>. This strict set of manufacturing standards is designed to ensure the highest quality of compounded medications and maximum patient safety. For a full list of available hospital and ophthalmology products, see Products tab. Leiters compliance with strict guidance ensures quality, consistency, and compliance with all released products. Leiters stands apart by focusing on one singular purpose: bringing health to outsourcing.

Leiters, FDA, 503B outsourcing provider, patients, better medicine, hospital-based services, FDA-registered, cGMP compliant
503B
FDA-Registered
Admixture Compounding
Hospital Pharmacy
Leiters
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Case Studies Sub Header
Advancing Health by Supporting Safe Pharmaceutical Compounding

Advancing Health by Supporting Safe Pharmaceutical Compounding

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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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