USP & FDA Updates
FDA – USP Updates for the Physician Office
Available for Streaming in Site Archive
(Webinar and Q&A)
The webinar will remain available for purchase in our archive. For those purchasing for the first time, you have 60 days to review it from the date of purchase.
CME Total 1.5 hours – Of that pharmacology CME is 1.5 hours
AANP CE Approved
Available for Streaming (Webinar and Q&A)
- “Can I order compounded injectables for in-office use?”
- “Can I have an IV Happy Hour Bar?”
- “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.
Who are the players and what roles do they play?
- 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
- 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