F.A.Q. USP 797 Certification Program

Frequently asked questions about the USP 797 Certification and Compliance Program

What is the Allersafe Program?

The Allersafe USP 797 Certification and compliance program is a turnkey solution to help you and your personnel to confidently and conveniently meet the mandatory federal requirements of this regulation

Why can't I just make my compounding personnel the designated person?

A compounder cannot perform their own assessments or provide supervision of their own activities.

However if you have more than one compounding personnel than one may qualify as a designated person in which case you would select designated person with online certification and hands on clinical certification during enrollment for that individual rather than compounding personnel

What types of subscribers are there?
  • Supervising Practitioner: Name, Professional Address, Board Certification, NPI number, contact number
  • Designated Person: (Can be Supervising Physician, Physician Assistant, Nurse Practitioner, Registered Nurse, Licensed Practical Nurse, MA, Manager)
  • Compounding Personnel:(Can be Physician, PA, NP, RN, LPN or Medical Assistant)
Can I self assess if I'm a Supervising Practitioner?

Yes but you still need to perform the media fill test and gloved finger tip test.