5 Most Important Benefits Healthcare Providers receive by using a 503B Outsourcing Facility for Compounded Sterile Preparations (CSPs)
Why would a hospital want to outsource CSPs? To answer this, one needs to understand how production has been handled in the past.
Prior to 2013, hospitals and surgical centers either compounded medication in-house or relied on 503A pharmacies, which were guided by regulations, for compounded medications. But, in an effort to enhance quality, scale on a larger level, and decrease production inaccuracies — in response to the Drug Quality and Security Act (DQSA) — FDA-registered 503B Outsourcing Facilities came into existence.
Since 2013, 503B Outsourcing Facilities have produced and provided CSPs in bulk quantities under DQSA, the aforementioned law that helps control the quality and safety in which compounding pharmacies manufacture medication. Registered 503B Outsourcers must comply with state and federal guidelines, meet strict Current Good Manufacturing Process (cGMP) standards and are routinely inspected by the FDA.
By abiding by these laws and meeting these strict standards, hospitals and surgical centers that work with FDA-approved 503B outsourcers are providing the highest level of safe, high-quality preparations for their patients.
Wells Pharma, an FDA-inspected 503B outsourcing facility of CSPs, is licensed to provide Ready-To-Use (RTU) medications to hospitals and surgical centers across the United States, offering a reliable supply of safe preparations at a competitive cost.
Here are the benefits:
1. SAFE, QUALITY PRODUCTS
Medications produced by 503B Outsourcing Facilities are required by the FDA to follow strict testing standards for sterility, potency, and endotoxins. Hospital pharmacies are not licensed by the FDA, so the regulations set by the Administration hold 503B facilities to higher standards of safety and quality. Not only do 503B outsourcers provide safe products, but they also provide longer BUDs as a result of the testing that is done. These standards include:
- Exchange of transactional documentation, including Transactional Information, Transactional History, and Transactional Statements
- Inclusion of proper Product Information, including Product NDC number (Global Trade Item Number), Product Lot Number, Product Expiration Date, Product Serial Number
2. COST SAVINGS!
CSPs manufactured by 503B Outsourcing Facilities are produced in high volumes, which saves time and costs associated with compounding, documenting, and wasting/scrapping of products. The ability for 503B Outsourcers, like Wells Pharma, to produce higher volumes, often through automation, provides major cost savings to 503B customers and healthcare partners.
Another major benefit healthcare providers receive by partnering with 503B Outsourcers is the ability to have easier access to the medications they need. Sterile-To-Sterile 503B Outsourcing facilities, (like Wells Pharma), are able to produce commercially-available drugs in a Ready-To-Use format, as well as produce drugs that are on the FDA Drug Shortage list from API. Also, should a commercial manufacturer elect to withdraw a drug product from the market for reasons not relating to safety or efficacy, 503B Outsourcers can bridge the gap by producing that drug until it becomes commercially accessible again. They can also meet market demand by providing drugs approved for in-office use without the requirement of a patient prescription.
4. CURRENT GOOD MANUFACTURING PRACTICES (cGMP)
Because 503B Outsourcing Facilities are required to be registered with the FDA, they must ALSO comply with requirements dictated by Current Good Manufacturing Practices. Examples of these requirements include:
- Providing for systems that assure proper design, monitoring, and control of manufacturing processes and facilities
- Assuring the identity, strength, quality, and purity of drug products
- Establishing strong quality management systems, obtaining quality raw materials, detecting and investigating product quality deviations
- Maintaining reliable testing laboratories
Complying with cGMP requirements ensures that products manufactured by 503B Outsourcers are safe for their intended use.
5. DEALING WITH REGULATORY COMPLIANCE & THE FDA
FDA requirements for compounding sterile drugs have become stricter in recent years. Because many healthcare organizations do not have the personnel, equipment, or resources to maintain or keep up with FDA requirements, 503B Outsourcers have become welcome and trusted partners. 503B Outsourcers have the expertise to know what is required because they have individuals who know what is required by the FDA and state regulatory boards, and possess the ability to provide sterile, compounded drugs to their healthcare clients quickly and at competitive prices.
So, whether it’s their ability to produce quality medications in a time of need, or to help keep clients in tune with FDA requirements, 503B Outsourcers have become a valuable asset to healthcare organizations. Although increased scrutiny of sterile drug compounding has resulted in stricter regulations, there is no question that 503B Outsourcers can provide healthcare organizations with a range of options. The focus on patient safety and cost-effective care has never been more scrutinized, and because of that, organizations should carefully assess their needs and individual circumstances before deciding on a 503B partner.