About The USP 797 Certification Program

About The USP 797 Certification and Compliance Program

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

The Two-Part Program

The Allersafe USP 797 Certification and compliance program is comprised of two parts:

  1. Annual USP 797 Certification Course including protocol training materials, off-site Media Fill Test,/Glove Fingertip Test Authorization and Exam
  2. Weekly Compliance Tracking of Facility and Personnel Regulatory Requirements via our simple to use proprietary platform to collect, document and store required compliance activities performed by your authorized personnel. Our platform also includes monthly oversight tools for the supervising practitioner or designated person to satisfy the supervision requirements necessary to maintain compliance with USP 797

The Certification Course

The Allersafe USP 797 Certification Course is drawn from the regulation materials and designed to meet or exceed the requirements for USP 797 in an allergy practice. Key knowledge areas are covered in a straight forward manner with supporting media where applicable. Upon subscription a media fill test and glove fingertip test kits ( with pre-paid return container ) will be mailed to compounding facility for use when called for within the coursework.

Progress is tracked as each area of coursework is completed, allowing participants to complete coursework in multiple sessions if necessary. The Allersafe program is mobile and smart device friendly allowing for convenient engagement of materials, testing and checklist reporting tasks.

Once compounding personnel have reached the media fill and glove fingertip test portion of the curriculum they will follow the instuctions provided to carry out that important task including returning the media fill and glove fingertip test kit to our Allersafe Testing Facility. Once Allersafe receives the kit materials, it takes two full weeks to perform the incubation of the kit samples and deliver the results so timely delivery of the completed kit and return to Allersafe is critical in getting your personnel certified.

Upon completion of all certification requirements, each participant will receive a certificate of completion as proof of authorization to compound for that year.

Certification and  Compliance Records are securely stored and can be produced via the dashboard as a PDF file for each individual participant upon completion of program.

Weekly Compliance Tracking

Weekly Compliance Tracking of Facility and Compounding Personnel is required by the USP 797 regulation. We have created a system to meet this requirement conveniently.

Allersafe provides an email reminder to compounding personnel once per week, with a web link to our quick and easy to use online checkbox compliance platform. Once the user logs in, they simply complete the weekly checklist and submit. That completed requirement is then stored in our database for reference and proof of compliance for each week throughout the year.

Once per month an email reminder is sent to the supervising practitioner / designated person . This notice contains a login link to the Allersafe system. Once logged in the S/P or D/P is then responsible to authorize each week’s checklist as completed by each compounding personnel. A user friendly dashboard and checkbox field is provided in order to easily facilitate this regulatory requirement. Once that task is completed the records are stored within our database for reference as well as made available as a PDF to download and / or print out the authorized months completed checklists. This required documentation will be needed when re-certifiying every year.

Records can be provided upon re-certification for proof of weekly checklist compliance for the year.

Subscriber Types & Details

  • 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)