New Era is advancing healthcare with the development of its new 503B FDA-registered Outsourcing Facility.
A 503B facility is authorized to compound large-batch, “office-use” medications for hospitals, clinics, and physician offices—without the need for a patient-specific prescription. The FDA established this designation to raise the national standard for quality, safety, and consistency in compounded medications.
503B outsourcing facilities must follow the same Current Good Manufacturing Practices (cGMP) required of pharmaceutical manufacturers. This includes validated production systems, environmental controls, sterility assurance programs, and comprehensive quality documentation.
At New Era, each formulation is produced under strict sterile conditions, monitored daily through environmental sampling and quality checks. Every batch undergoes independent third-party laboratory testing for sterility, endotoxins, and potency before release—ensuring the highest standard of pharmaceutical integrity.
Because these FDA requirements are so demanding, only a limited number of compounders in the U.S. meet the 503B designation. New Era’s new facility, built from the ground up for 503B compliance, represents a significant milestone for Puerto Rico’s healthcare and pharmaceutical industry.
For additional information about FDA outsourcing facility registration, visit the FDA’s Outsourcing Facility Q&A page. (https://www.fda.gov/drugs/human-drug-compounding/questions-and-answers-outsourcing-facility-registration)
New Era is advancing healthcare with the development of its new 503B FDA-registered Outsourcing Facility.
Pharmaceutical quality impacts every patient, every day. The U.S. Food and Drug Administration (FDA) enforce strict standards to ensure that all medications meet the highest levels of safety, strength, and purity.
The foundation of these standards is the Current Good Manufacturing Practice (cGMP) regulation. cGMPs require pharmaceutical manufacturers to maintain systems that guarantee the proper design, control, and monitoring of facilities and processes throughout production.
Compliance with cGMP ensures that every batch of medicine is consistent and free from contamination or error. This involves:
- Establishing robust quality management systems
- Sourcing verified raw materials
- Following validated operating procedures
- Investigating and correcting deviations
- Maintaining advanced testing and documentation practices
The “C” in cGMP stands for “Current”, meaning manufacturers must continually adopt the latest technologies and practices to prevent contamination, mix-ups, and other failures.
What was state-of-the-art a decade ago may no longer meet today’s expectations—continuous improvement is not optional; it’s required.
By adhering to cGMP, companies like New Era ensure every medication produced meets the highest pharmaceutical quality standards and patient expectations.
At New Era, each formulation is produced under strict sterile conditions, monitored daily through environmental sampling and quality checks. Every batch undergoes independent third-party laboratory testing for sterility, endotoxins, and potency before release—ensuring the highest standard of pharmaceutical integrity.
Because these FDA requirements are so demanding, only a limited number of compounders in the U.S. meet the 503B designation. New Era’s new facility, built from the ground up for 503B compliance, represents a significant milestone for Puerto Rico’s healthcare and pharmaceutical industry.
For additional information about FDA outsourcing facility registration, visit the FDA’s Outsourcing Facility Q&A page. (https://www.fda.gov/drugs/human-drug-compounding/questions-and-answers-outsourcing-facility-registration)