503B Outsourcing Facilities, Compounding Services

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

503B Outsourcing Facilities, Compounding Services Booth #13847
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Request More Information Visit the Leiters Website

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 Leiters’ 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. Leiters’ 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
 Mobile Infimary Pilots Innovative Concentrated Norepinephrine Vials

Mobile Infimary Pilots Innovative Concentrated Norepinephrine Vials

Leiters

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Summa Health and Leiters Collaborate to Reduce Opioid Use

Summa Health and Leiters Collaborate to Reduce Opioid Use

Leiters

Extensive efforts were applied to find an FDA-registered 503B outsourcing partner that could efficiently and effectively manufacture and deliver the opioid-free nerve block agent to Summa health system

Read More
Advancing Health by Supporting Safe Pharmaceutical Compounding

Advancing Health by Supporting Safe Pharmaceutical Compounding

Charles River

Charles River provides a range of microbiological testing services and equipment to support drug discovery, development, and manufacturing that can be tailored to a facility's specific needs and ensure patient safety...

Read More

503B Outsourcing Facilities, Compounding Services | NEWS / BUZZ

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May 21, 2024 | Announcements

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February 9, 2024 | SPOTLIGHTS

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January 23, 2024 | Product Awareness

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January 1, 2024 | Announcements

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october ecosystem 503B

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october ecosystem 503B

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September 21, 2023 | Product Awareness

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August 23, 2023 | Product Awareness

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August 14, 2023 | Product Awareness

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August 11, 2023 | SPOTLIGHTS

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July 26, 2023 | Product Awareness

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May 12, 2023 | Product Awareness

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June 9, 2022 | Press Releases

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May 16, 2022 | Product Awareness

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April 26, 2022 | Product Awareness

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April 19, 2022 | Product Awareness

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March 31, 2022 | Announcements

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March 22, 2022 | Announcements

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March 16, 2022 | Press Releases

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March 11, 2022 | Product Awareness

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March 3, 2022 | Announcements

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February 23, 2022 | Announcements

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February 17, 2022 | Product Awareness

Leiters 2022 Catalog: Hospital and Ophthalmology 503B Products and Services


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February 9, 2022 | Product Awareness

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February 8, 2022 | Press Releases

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February 2, 2022 | Announcements

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February 1, 2022 | Press Releases

Leiters Awarded a National GPO Agreement with AmerisourceBergen IPN Solutions


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January 24, 2022 | Product Awareness

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January 19, 2022 | Product Awareness

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January 13, 2022 | Product Awareness

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January 3, 2022 | Announcements

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December 31, 2021 | Product Awareness

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December 28, 2021 | Product Awareness

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December 14, 2021 | Product Awareness

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December 7, 2021 | Announcements

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November 30, 2021 | Product Awareness

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November 29, 2021 | Product Awareness

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November 22, 2021 | Announcements

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November 16, 2021 | Product Awareness

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November 9, 2021 | Press Releases

Welsh, Carson, Anderson & Stowe Acquires Majority Stake in Leiters, A 503B Outsourced Pharmaceutical Compounding Industry Leader, in Partnership with Leading Health Systems


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October 29, 2021 | SPOTLIGHTS

Providing Healthcare Professionals and Patients with High-Quality Outsourced Medications


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October 22, 2021 | Product Awareness

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October 19, 2021 | Product Awareness

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October 15, 2021 | SPOTLIGHTS

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October 12, 2021 | Product Awareness

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October 6, 2021 | Product Awareness

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October 1, 2021 | Product Awareness

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October 1, 2021 | Product Awareness

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october ecosystem

October 1, 2021 | Product Awareness

October Market Leaders: Admixture Compounding Services (503B Outsourcing Facilities)


october ecosystem

October 1, 2021 | Product Awareness

October Market Leaders: Admixture Compounding Services (503B Outsourcing Facilities)


october ecosystem

October 1, 2021 | Product Awareness

October Market Leaders: Admixture Compounding Services (503B Outsourcing Facilities)


October 1, 2021 | Product Awareness

Leiters -- FDA-registered 503B Outsourcing Provider


Leiters

August 23, 2021 | Case Studies

Summa Health and Leiters Collaborate to Reduce Opioid Use [VIDEO]


Leiters

July 28, 2021 | Case Studies

Summa Health and Leiters Collaborate to Reduce Opioid Use


Leiters

July 23, 2021 | Product Awareness

Leiters. We Are Compounding Health(TM)


QuVa

June 30, 2021 | Product Awareness

503B Accountability [VIDEO]


Fagron Sterile Services

June 22, 2021 | Product Awareness

MasterControl at Fagron: Rapid Production of High-Quality Drug Products


QuVa Pharma

June 7, 2021 | Product Awareness

Supporting Hospital Pharmacy's Operational Efficiency


QuVa

June 3, 2021 | Product Awareness

503B Accountability


Leiters

May 27, 2021 | Product Awareness

Helping you deliver better medicine to more people.


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May 26, 2021 | Press Releases

QuVa Pharma Expands Leadership Team with Appointment of Industry Veteran Scott Aladeen as Chief Operating Officer


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May 25, 2021 | Announcements

New Look. Same Great Resource. | 20Ways SUMMER Hospital 2021 Issue is Here


Leiters

May 25, 2021 | Product Awareness

Your Journey to Better Medicine Begins Here [VIDEO]


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May 21, 2021 | Press Releases

QuVa Pharma Completes $275 Million Financing with Syndicate Led by Goldman Sachs


Fagron Sterile Services

May 20, 2021 | Product Awareness

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Fagron Sterile Services

May 13, 2021 | Product Awareness

Current Good Manufacturing Practice (cGMP) in 503B Outsourcing Facilities: Essentials of Drug Quality and Patient Safety


Nephron

May 4, 2021 | Product Awareness

Life Saving Generic Respiratory & 503B Outsourcing Products [VIDEO]


Leiters

April 1, 2021 | Product Awareness

Your Journey to Better Medicine Begins Here


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March 30, 2021 | Press Releases

Intravenous Bag Platform Launches, Supports COVID-19 Medication Demand


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March 19, 2021 | SPOTLIGHTS

Creating the Future of Personalized Medicine


QuVa Pharma

February 15, 2021 | Product Awareness

QuVa Connections 2021: New & Noteworthy Updates


SCA Pharma

February 12, 2021 | Product Awareness

From PRE-OP To PACU, We Deliver The Critical Medicines You Depend On


Leiters

January 12, 2021 | Product Awareness

Helping you deliver better medicine to more people [VIDEO]


QuVa

January 8, 2021 | Product Awareness

503B Accountability [VIDEO]


Nephron

January 8, 2021 | Product Awareness

Life Saving Generic Respiratory & 503B Outsourcing Products


Fagron Sterile Services

January 7, 2021 | Product Awareness

Not Just Another 503B Outsourcing Facility [VIDEO]


Leiters

January 2, 2021 | Must-See Exhibits & Booths

Visit the Leiters "Registered Facilities - Compounding Pharmacies" Booth in the Virtual Pharmacy Trade Show


SCA Pharma

December 1, 2020 | Product Awareness

From PRE-OP To PACU, We Deliver The Critical Medicines You Depend On [VIDEO]


Leiters

November 30, 2020 | Product Awareness

Helping you deliver better medicine to more people.


Leiters

November 27, 2020 | Product Awareness

FDA-Registered and Inspected 503B Outsourcing Provider - Leiters [VIDEO]


Fagron Sterile Services

November 25, 2020 | Product Awareness

Not Just Another 503B Outsourcing Facility


20Ways winter hospital

November 23, 2020 | Announcements

20Ways SUMMER Hospital 2020 Issue is Here!


SCA Pharma

November 13, 2020 | Product Awareness

Critical Medicines Your Patients Can Depend On. From The Company You Can Trust - SCA Pharma [VIDEO]


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November 10, 2020 | Press Releases

Leiters and EyeConnect International Announce Corporate Partnership


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November 5, 2020 | Press Releases

Leiters Awarded a National Group Purchasing Agreement by Intalere


Fagron Sterile Services

November 3, 2020 | Product Awareness

Choose Quality. Choose Consistency. Choose Fagron Sterile Services for All Your Outsourcing Needs - Fagron Sterile Services


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October 23, 2020 | Product Awareness

Our Products Help Make Miracles Happen - SCA Pharma [VIDEO]


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October 20, 2020 | Press Releases

Fagron Sterile Services US (FSS) Delivers Pharmaceutical Innovation in Sterile Topical L.E.T. Gel


October 20, 2020 | Product Awareness

SCA Pharma To Offer Virtual Tours at Health Connect Partners Fall Conference


Leiters

October 20, 2020 | Product Awareness

COMPOUNDING HEALTH(TM) - Leiters


press release

October 19, 2020 | Press Releases

SCA Pharma touts Kit Check partnership during HCP Roundtable


october ecosystem

October 10, 2020 | Product Awareness

October Market Leaders: Admixture Compounding Services (503B Outsourcing Facilities)


october ecosystem

October 10, 2020 | Product Awareness

October Market Leaders: Admixture Compounding Services (503B Outsourcing Facilities)


october ecosystem

October 10, 2020 | Product Awareness

October Market Leaders: Admixture Compounding Services (503B Outsourcing Facilities)


Fagron Sterile Services

October 1, 2020 | Product Awareness

Is Your Drug Supply Truly Supporting Operations? - Fagron Sterile Services [VIDEO]


SCA Pharma

September 23, 2020 | Product Awareness

Milton Boyer, Matt White participate in FDA's Compounding Quality Center of Excellence Virtual Conference


SCA Pharma

August 10, 2020 | Product Awareness

Critical Medicine Your Patients Can Depend On. From the Company, You Can Trust. - SCA Pharma


press release

July 22, 2020 | Press Releases

SCA Pharma to Expand Production Facility in Little Rock


Leiters

July 21, 2020 | Product Awareness

FDA-Registered and Inspected 503B Outsourcing Provider - Leiters


press release

July 16, 2020 | Press Releases

SCA Pharma to Expand Production Facility For Compounded Sterile Medications


Fagron Sterile Services

July 13, 2020 | Product Awareness

A Founding Partner of Healthcare Supply Chain Initiative


Leiters

July 8, 2020 | Product Awareness

Helping You Deliver Better Medicine to More People - Leiters


Fagron Sterile Services

July 7, 2020 | Product Awareness

Quality Drug Supply Turning Your World Upside Down? - Fagron Sterile Services [VIDEO]


press release

June 25, 2020 | Press Releases

SCA Pharma Maintain Focus on Quality During COVID-19


Spotlights by RXinsider

June 24, 2020 | SPOTLIGHTS

Supplying Service and Standards - Fagron Sterile Services


Leiters

June 4, 2020 | Product Awareness

Helping You Deliver Better Medicine to More People - Leiters [VIDEO]


Fagron Sterile Services

June 3, 2020 | Product Awareness

Quality Drug Supply Turning Your World Upside Down? - Fagron Sterile Services


SCA Pharma

June 1, 2020 | Product Awareness

Our Products Help Make Miracles Happen - SCA Pharma


20ways summer 2020

May 27, 2020 | Announcements

20Ways SUMMER Hospital 2020 Issue is Here!


press release

May 26, 2020 | Press Releases

SCA Pharma to Attend Health Connect Partners 2020 Spring Virtual Hospital Pharmacy Conference


press release

May 13, 2020 | Press Releases

Leiters Awarded a Group Purchasing Agreement by Comprehensive Pharmacy Services


press release

May 13, 2020 | Press Releases

Leiters Awarded a Group Purchasing Agreement by Comprehensive Pharmacy Services


Fagron Sterile Services

May 4, 2020 | Product Awareness

Is Your Drug Supply Truly Supporting Operations? - Fagron Sterile Services


April 29, 2020 | Announcements

Product Videos are now Available in the 2020 Pharmacy Platinum Pages!


SCA Pharma

April 22, 2020 | Announcements

SCA Pharma Partners With Bausch Advanced Technologies to Provide Free Hand Sanitizer to First Responders and Front-Line Healthcare Workers in Connecticut


fda announcment

April 16, 2020 | Announcements

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities


press release

April 15, 2020 | Press Releases

QuVa Pharma Confirms Two Partnerships to Increase Patient Safety and Support Patient Access to Higher Quality Sterile-Compounded Medications


Spotlights by RXinsider

April 13, 2020 | SPOTLIGHTS

Meet KIRO(R) Oncology - Next Generation Robotics for Sterile Compounding


leiters covid-19

April 13, 2020 | Announcements

Leiters Continues to Closely Monitor COVID-19 Drug Shortages


COREreadiness Closed System Transfer Devices

April 8, 2020 | Training / Professional Development

What are CSTDs? Learn about Closed System Transfer Devices (CSTDs) in less than 9 minutes.


Fagron Sterile Services

April 2, 2020 | Announcements

Coronavirus Spreads, Patient Safety Top of Mind - Fagron Sterile Services


Compounding with Mortar and Pestle

March 27, 2020 | Announcements

FDA Addition of Hydroxychloroquine to the 503B Bulks List


press release

March 2, 2020 | Press Releases

SCA Pharma to Attend 2020 Federation of American Hospitals Conference and Business Exposition


press release

February 27, 2020 | Press Releases

Leiters Announces Facility Expansion to Increase Capacity and Accommodate Growth


February 19, 2020 | Announcements

The 2020 Pharmacy Platinum Pages is Here!


503B

February 19, 2020 | Training / Professional Development

Understand the role of 503B Outsourcing Facilities and Admixture Compounding Services in less than 7 minutes.


Spotlights by RXinsider

February 14, 2020 | SPOTLIGHTS

Quality Compounding that Exceeds Expectations - SCA Pharma


press release

January 31, 2020 | Press Releases

SCA Pharma CEO Boyer to Take Part in HSCA Panel Discussion


Leiters

January 30, 2020 | Product Awareness

Your Journey to Better Medicine Begins Here - Leiters [VIDEO]


compounding pharmacy

January 28, 2020 | Product Awareness

USP Changes Directly Impacts Compounding Pharmacies


Fagron Sterile Services

January 13, 2020 | Product Awareness

FDA Registered 503B Outsourced Pharmacy Compounder - Fagron Sterile Services [VIDEO]


SCA Pharma

January 9, 2020 | Product Awareness

Critical Medicines Your Patients Can Depend On. From The Company You Can Trust - SCA Pharma [VIDEO]


QuVa Pharma

January 1, 2020 | Product Awareness

Leading Compounding Innovation in 503B Outsourcing - QuVa Pharma


press release

December 11, 2019 | Press Releases

Leiters and Prodigy Health Enter into National Sales and Marketing Agreement


Fagron Sterile Services

December 6, 2019 | Product Awareness

FDA Registered 503B Outsourced Pharmacy Compounder - Fagron Sterile Services


SCA Pharma

December 4, 2019 | Product Awareness

Critical Medicines Your Patients Can Depend On. From The Company You Can Trust - SCA Pharma


Leiters

December 3, 2019 | Product Awareness

Your Journey to Better Medicine Begins Here - Leiters


USP 800

November 27, 2019 | Training / Professional Development

Familiarize yourself with USP <800> in 9 minutes | Hazardous Drugs


QuVa Pharma

November 26, 2019 | Product Awareness

Leading Compounding Innovation in 503B Outsourcing - QuVa Pharma [VIDEO]


20Ways Winter Hospital

November 25, 2019 | Announcements

20Ways WINTER Hospital 2019 Issue is Here!


Q&A Winter Hospital 2019

November 25, 2019 | Q&A

503B Outsourced Compounding Facilities & Services Q&A | Gregory Burger and Fred Massoomi, Visante


press release

November 20, 2019 | Press Releases

SCA Pharma to Exhibit at American Society of Health-System Pharmacists Midyear Conference


Leiters

November 1, 2019 | Product Awareness

Leiters | FDA-Registered and Inspected 503B Outsourcing Provider [Video]


press release

October 25, 2019 | Press Releases

SCA Pharma to be a Sponsor of Health Connect Partners Fall Hospital Pharmacy Conference


Pharmacy CE Alert, CPE Continuing education for pharmacists, ACPE

October 23, 2019 | CE / CPE Alert (Continuing Education)

Bloodborne Pathogens Training 2019


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October 18, 2019 | Press Releases

SCA Pharma to Exhibit at California Society of Health-System Pharmacists Conference


USP 797

October 15, 2019 | Training / Professional Development

Understand USP <797> and Sterile Compounding in 9 minutes.


Leiters

September 24, 2019 | Product Awareness

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SCA Pharma 503B Profile

August 6, 2019 | Product Awareness

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August 5, 2019 | SPOTLIGHTS

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Leiters

July 5, 2019 | Product Awareness

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QuVa

June 26, 2019 | Product Awareness

QuVa Pharma | Leading Compounding Innovation in 503B Outsourcing [Video]


Leiters

June 19, 2019 | Product Awareness

Your Journey to Better Medicine Begins Here


QuVa

June 19, 2019 | Product Awareness

Leading Compounding Innovation in 503B Outsourcing


20Ways SUMMER Hospital

June 4, 2019 | Announcements

20Ways SUMMER Hospital 2019 Issue is Here!


Leiters 503B Profile

May 22, 2019 | Product Awareness

COMPOUNDING HEALTH(TM)


press release

January 10, 2019 | Press Releases

SCA Pharma Awarded National Outsourced I.V. Admixture Services Agreement with Premier Inc.


NuAire

January 4, 2019 | Product Awareness

NuAire | The Safer Choice For Your Pharmacy [Video]


NuAire

January 4, 2019 | Product Awareness

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ARxIUM Riva

November 28, 2018 | Announcements

ARxIUM Introduces cGMP IV Compounding System for 503B Facilities


IJPC

July 7, 2018 | Product Awareness

Protect and Prepare Your Pharmacy for FDA/State Board Inspections: IJPC


IJPC

July 7, 2018 | Product Awareness

Protect and Prepare Your Pharmacy for FDA/State Board Inspections: IJPC [Video]


Fagron 503B Profile

January 31, 2018 | Product Awareness

Choose Quality. Choose Consistency. Choose Fagron Sterile Services for All Your Outsourcing Needs.


Cantrell Drug Company

December 6, 2017 | Video Series

Cantrell Drug Company | Compounding in the Hospital Pharmacy Market | Lance Lanier, R.Ph


Cantrell Drug Company

December 6, 2017 | Video Series

(#1 of 5): What is 503B? | Lance Lanier, R.Ph | Cantrell Drug Company


Cantrell Drug Company

December 6, 2017 | Video Series

(#2 of 5): How is Cantrell Drug Company best positioned to meet market challenges? | Lance Lanier, R.Ph | Cantrell Drug Company


Cantrell Drug Company

December 6, 2017 | Video Series

(#3 of 5): Describe the importance of quality | Lance Lanier, R.Ph | Cantrell Drug Company


Cantrell Drug Company

December 6, 2017 | Video Series

(#4 of 5): What is outsourced compounding? | Lance Lanier, R.Ph | Cantrell Drug Company


Cantrell Drug Company

December 6, 2017 | Video Series

(#5 of 5): How has the compounding market changed in recent times? | Lance Lanier, R.Ph | Cantrell Drug Company

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503B Outsourcing Facilities, Compounding Services

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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