IV Vitamin Regulations: Your Guide for USP 797 Pharmacy Compliance

IV Vitamin Regulations: Your Guide for USP 797 Pharmacy Compliance

This is everything you need to safely run your IV vitamin infusion center and be prepared for the inevitable pharmacy inspectors that will be coming your way. Even if you are administering IV vitamins in a doctor's office, you are compounding -- USP 797 applies to you. Key Topics Included in this Book: -What is USP 797 and how does it relate to my IV vitamin center -Take the Quiz: Find out if your center is USP 797 compliant -Quality-of-practice standards for sterile compounding issued by USP for IV vitamin centers -Guidelines, procedures, and compliance requirements for compounding sterile preparations -Training (and re-training) your staff, including suggested approaches for documenting competency -Infection Control best practices -Learning key differences between a 503A and 503B pharmacy -What to do if you get a surprise inspection from your Department of Health, Department of Pharmacy, or the FDA -Checklists the State Regulatory Boards use for inspections -Approach to assigning beyond-use dates You could spend untold hours trying to hack through the documents and then try to figure out what sections of USP 797 apply to you. You could spend tens of thousands of dollars on consultants to help guide you. Or you can simply buy this book. This book tells you what you need to know to be compliant. Shannon's companion work, The 797 Course , supplies you with all the forms. checklists, and SOPs needed in a clean and complete manner, making you compliant while saving you time and money. All the forms, logs, and SOPs are written in plain language in a manner that you can read today and apply tomorrow. You can find that course at www.797CompliancePro.com. "We don’t mix on a counter, it’s not premixed or pre-made. Our clients can feel safe that they are getting a high quality, potent product from a sanitized area." -Amber Amaru, THE DRIPBaR Jacksonville "In our field, 797 compliance is important because it verifies [safety and sterility] of how we make our infusions. This process allows me to feel confident I am treating my patients with the best product we can give them. They come to us seeking help/looking to improve wellness and I am certain I am mixing the best possible product for them." - Tiffany Correia, Intellectual Medicine