Benefits of 503B Outsourcing Facilities

503B Outsourcing Facilities create many valuable benefits for healthcare and medical settings.

Prior to 2013, healthcare and medical settings relied on traditional 503A pharmacies for their compounded medications. Since then, FDA registered 503B Outsourcing Facilities began providing sterile, compounded medications. These Outsourcing Facilities have created numerous benefits for healthcare settings and their patients.

There are many differences between 503B Outsourcing Facilities and traditional 503A pharmacies. The main differences between the two types of facilities are:

Prescription Requirements
Safety and Quality
Cost Savings
Availability
Liability
Regulatory Authority

Prescription Requirements

While traditional 503A pharmacies require a patient prescription, 503B Outsourcing Facilities do not. Compounded medications manufactured by 503B Outsourcing Facilities are approved for in-office use, making ordering more convenient.

Safety and Quality

Compounded medications manufactured by 503B Outsourcing Facilities are required by the FDA to follow strict testing standards for sterility, potency, and endotoxins. Outsourcing Facilities also manufacture products in ISO clean rooms that are continuously monitored for particulate matter and environmental conditions. Traditional 503A pharmacies are not licensed by the FDA. Therefore, the FDA is unaware of potential problems with the compounding practices of these traditional pharmacies. The regulations set forth by the FDA hold 503B facilities to higher standards of safety and quality than traditional 503A pharmacies.

Cost Savings

Sterile compounds manufactured by 503B Outsourcing Facilities utilize lower-cost bulk drug ingredients than traditional 503A pharmacies. Higher production volume and lower-cost drug ingredients provide substantial cost savings to 503B partners and customers.

Availability

503B Outsourcing Facilities are able to produce drugs that are currently on the FDA Short List. Outsourcing Facilities are also able to meet market demand without the requirement of patient prescriptions. On the other hand, traditional 503A pharmacies produce products that require a patient prescription. 503B Outsourcing Facilities create more product availability for their partners because of their ability to provide drugs that are approved for in-office use and on the FDA Short List.

Liability

All FDA-registered 503B Outsourcing Facilities must comply with current good manufacturing practice (cGMP) requirements and US Pharmacopeia Guidelines (USP). However, traditional 503A pharmacies are not required to comply with cGMP requirements. Complying with cGMP requirements ensures that products produced by 503B Outsourcing Facilities are safe for their intended use.

Regulatory Authority

While traditional 503A pharmacies are only regulated by State Board of Pharmacies, 503B Outsourcing Facilities must follow state regulations and voluntarily register with the FDA.

503B Outsourcing Facilities create many benefits for their partners in various healthcare and medical settings. Overall, Outsourcing Facilities strive to provide their partners with high quality, safe compounded medications.