The United States Pharmacopeia published new 797 standards for pharmaceutical compounding – sterile preparation. Many of the new standards change/affect how 503a’s and 503b’s who also must comply with the FDA’s current Good Manufacturing Practice (cGMP) standards (21 CFR Parts 210 and 211) make sterile compounds. Medizap / SteriTek have read the USP 797 standards to develop a position. The goal is to share this position with you. By being thought leaders, we hope to educate on the USP 797 standard relative to ISO 11137:2016 Sterilization of healthcare products while also building the advocacy and trust of the 503a compounding and the 503b outsourcing facility industries.

Medizap / SteriTek are uniquely positioned to bring a scientific perspective to the newly proposed guidelines and ensure understanding and use of ISO guidelines for all irradiation validation and ongoing testing since USP 797 omits detailed irradiation guidelines; therefore, we believe defaults to ISO regulatory guidelines. Read more >