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USP & FDA

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We would like to thank everyone that participated in the live streaming session. This recorded session is now available for viewing in our site archive.  If you would like to purchase this recording for viewing, you are welcome to visit our here.  Once purchased, you may return to this page and login.  

- Updated Information Regarding Webinar -

We have some updates to assist you, in case you have questions on how to access the webinar that is located in our online archive. Reference the toggle boxes below.

Accessing the Webinar Archive

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Viewing Timeframe Updated - Now 60 Days

Initially, the access was 15 days. Dr. Anderson suggested extending this access to 60 days. As always, his goal is to foster an educational culture that supports your ability to get the information you need. He felt allowing longer access helps you and supports this vision.

Accessing the CME Certificate

  • Please review the steps in the section above to login (Accessing Webinar Archive)
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OANP Special Webinar Overview

Critical Updates on FDA Regulation of In-Office Use Compounded Injectable Materials: “Oh No! Do I have to comply with all this?”

Wednesday April 20, 2016 – 5:30 – 8:30 PM (Webinar and Q&A)

  1. “Can I order compounded injectables for in-office use?”
  2. “Can I have an IV Happy Hour Bar?”
  3. “Do I need to buy my own laminar flow hood to continue doing IVs?”

For all these questions and more, the answer is “it depends…”

The FDA has cracked down on compounded injectable solutions for in-office use after an outbreak of fungal meningitis was attributed to a contaminated compounded product that killed 55 people and sickened 700 nationally. FDA regulations have been an ever moving and baffling target, largely resulting in providers needing to order compounded injectables in individual doses for specific patients only, thereby increasing costs, delaying timely treatment, and creating barriers to patient care.

Dr. Paul Anderson has spent the last two years sorting through official documents, consulting with industry experts including pharmacy and legal professionals, and conducting personal investigations for private medical practices impacted by the FDA rules. In this course, Dr. A consolidates the laws and rules you need to observe, will walk you through best clinical practices for enhanced patient safety, and will answer all your questions about how to legally use injectable compounded medications in your practice.

This is a MUST TAKE seminar for anyone who does IVs.

OANP Webinar Topics

Who are the players and what roles do they play?

  • USP
  • FDA
  • Any State Health Department – Professional Board

Office Use rules:

  • Non-sterile products (oral, topical etc.) – USP 795
  • Sterile Product (IM, IV, Nebulized, Eye drops etc.) – USP 797
  • Patient Specific Prescriptions
  • Hoods, clean rooms and other engineering issues

Injection Rules:

  • USP 797 rules for sterility and length of use for injections: How long can I use a vial? How long can I keep a syringe or IV bag after making it?
  • CDC: Site preparation rules for IM versus IV versus IA injections and IV access device rules
  • 503A: When do you (and do you not) need a laminar flow hood? What are the rules for use of the hood?
  • 503B: Do I need to comply and what is it?
  • USP Tables for environmental standards, cleanroom requirements overview, recommendations for sterile vial handling