Pentec Health Omnisourcing Solutions Improve Your IV Room Workflow and Patient Care
IV sterile compounding solutions that enable hospital pharmacies to combine the control of insourcing with the flexibility to make doses from sterile, concentrated compounds from a trusted 503B outsourcing provider, a concept that we call Omnisourcing.Read More Summer 2018 Edition | Health System - Infusion
340B Drug Discounts and Quality 503A, 503B Compounding Make Avella an Industry Leader
By partnering with Avella Specialty Pharmacy, hospitals have access to one partner for all of their specialty drug and 503A and 503B outsourcing needs. We've become a recognized industry leader by providing premier service, rapid turnarounds, and rigorous quality assurance.Read More Summer 2018 Edition | Health System - Infusion
Providing the Highest-Quality Sterile Compounded Services - PharMEDium
100% of PharMEDium CSP batches are tested. We put patient safety first. Because a life is touched by every preparation we produce.Read More Summer 2018 Edition | Health System - Infusion
Hospital Solutions by Fagron, Inc.
Optimizing and innovating customized pharmaceutical care.Read More Summer 2018 Edition | Health System - Infusion
The operation and design of the equipment offers high level accuracy and ease-of-use, thus helping ensure repeatability for everyday compounding activities through a wide range of pharmacy customized features.Read More Spring 2018 Edition | Community - Specialty - LTC
Providing the Highest Quality Sterile Compounded Services - PharMEDium
100% of PharMEDium CSP batches are tested. We put patient safety first. Because a life is touched by every preparation we produce.Read More Winter 2017 Edition | Health System - Infusion
PharMEDium is Compounding to the FDA's Strict 503B Standards
100% of PharMEDium CSP batches are tested. We put patient safety first. Because a life is touched by every preparation we produce.Read More Summer 2017 Edition | Health System - Infusion
Fagron Specialty Pharmacy Services - 503B Outsourcing Facilities
Choose a family of companies; JCB Laboratories, Fagron Sterile Services, and AnazaoHealth, as your experts in sterile compounding solutions.Read More Summer 2017 Edition | Health System - Infusion
FDA Registered 503B Outsourcing Facility by Cantrell Drug Company
Our experience with cGMP focused policies and procedures; along with carefully designed facilities, equipment, training, and testing; provide confidence to our customers in the quality of our services.Read More Winter 2016 Edition | Health System - Infusion
With PCCA, Membership Means Partnership
Compounding pharmacists make a difference for patients. As the industry's most comprehensive resource, PCCA makes a difference for compounding pharmacists, offering the highest quality products, education, and support.Read More Winter 2016 Edition | Community - Specialty - LTC
PharMEDium - Compounding by 503B Registered Outsourcing Facilities
PharMEDium is the national leader in customized pharmacy sterile compounding for hospital intravenous and epidural therapies. PharMEDium has been committed to developing quality processes that facilitate the highest level of safety.Read More Summer 2016 Edition | Health System - Infusion
Cantrell Drug Company - Pharmaceutical Outsourcing Specialists
Our experience with cGMP focused policies and procedures along with carefully designed facilities, equipment, training, and testing provide confidence to our customers in the quality of our services.Read More Summer 2016 Edition | Health System - Infusion
Leading 503B Outsourcing FacilityRead More
There's one step to eliminating dozens of steps for IV Compounding, Call Pentec HealthRead More
The leading FDA 503B outsourcing facility and only certified HUBZone 503B in the U.S.Read More
There's just one leader in outsourced CSP production.Read More
Products. Education. Support.Read More
Four 503B Outsourcing FacilitiesRead More
Cantrell Drug Company
503B Compounding Outsourcing FacilityRead More
Experience how PharMEDium has redefined ready to use compounded sterile preparationsRead More
Cantrell Drug Company
FDA registered 503B human drug compounding outsourcing facilityRead More
Introducing a nimble alternative to the same old rigid way of doing businessRead More
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)
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.
- must comply with CGMP requirements;
- will be inspected by FDA according to a risk-based schedule; and
- must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
Cantrell Drug Company today announced it has entered into an exclusive agreement to become the first human drug compounding outsourcing facility to utilize Aseptic Technologies' closed vial system for aseptic filling of injectable drugs. Outsourcing facilities were created under the federal Drug Quality and Security Act (DQSA) enacted in November 2013.