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USP has finalized the Chapter 797 standards for sterile compounding, including standards specifically for physician in-office compounding of allergen extracts in allergy practices. The purpose of the standards is to ensure safe treatment of an allergy clinic's patients.  

The Compounding Corner has been established to prepare physicians, practice managers, and clinic staff at allergy practices to achieve and maintain compliance ahead of the updated implementation date. Ensure your practice is ready by browsing our resources and working through our training module below.

Request the Full Chapter from USP  It will be emailed to you. (Do check your Spam or Junk folders if it does not come to your inbox.)

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Frequently Asked Questions

Have a question that wasn't answered in the training module? Check our list of FAQs below. 

Q: Is a sink necessary in the same room as the dedicated Allergen Extract Compounding Area (AECA) in order to perform the hand washing procedure?
A: If a sink is present it must be at least one meter from the dedicated AECA. There is no requirement that there be a sink in the AECA.   

Q: Can a ceiling fan circulate in the room while compounding occurs, or must the room be climate controlled?
A: A ceiling fan may not be circulating in the room while compounding occurs, nor may the Dedicated Allergen Extract Compounding Area be adjacent to other environmental control challenges.  

Q: Is dilution or reconstitution of externally provided components per manufacturer’s directions considered compounding?
A: No. Dilution or reconstitution of externally provided components do not equate to compounding and are not subject to the new USP 797 guidelines.

Q: Does a physician always need to be on site during allergen extract mixing?
A: Yes, according to the current Allergen Immunotherapy Practice Parameter.

Q: Where can I access the required written test?
A: We will soon be providing a sample written test here in the Compounding Corner. You can also prepare your own. You will need to include information from updated USP standards and also from the Allergen Immunotherapy Practice Parameter.

Q: I have carpeting in my compounding area. Do I need to replace my flooring?  
Yes. Under the existing rules, no area in which compounding is being performed should have carpeting.

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