Update on USP Chapter <797>

When will the new standards be implemented?

You may be wondering when the final deadline for implementation of the new United States Pharmacopeia (USP) Chapter <797> guidelines for mixing of sterile allergy extract vials will be set. The Advocacy Council has recently explored that question, and it appears the deadline, at the earliest, will be around mid-year.

You may recall that the original implementation date of December 1, 2019 was postponed after several compounding pharmacies and professional associations filed an appeal related to, primarily, the beyond use date (BUD) provisions in the new Chapters <795> (Pharmaceutical Compounding – Nonsterile Preparations) and <797> (Pharmaceutical Compounding – Sterile Preparations). The appeal included a request for postponement of implementation. USP’s bylaws provide that the official date of a standard under appeal must be postponed while an appeal is pending. Therefore, USP postponed the official dates of the revised Chapters <795> and <797>, and the new general Chapter <825>, until further notice.

In the interim, the current USP Chapter <797> (last revised in 2008) remains official. The decisions on the appeals to Chapters <795>, <797>, and <825> do not exclude the possibility of future revisions to these chapters. For more information, please read the FAQs on the Compounding Appeals Process. The USP Appeals Panel met on January 21 and 22 to hear the final appeals to USP Chapters <795>, <797> and <825>.

What happens next?

The panel only has two choices; deny or remand the appeal. If the appeal is denied, the USP chapters may become enforceable as early as June 2020. If the appeal is remanded, enforcement may be delayed until Dec. 1, 2021 or later.  USP will update the chapters and once again open review of the changes for public comment.

What should you do?

The appeal does not include any provisions related to USP Chapter <797> Section 21, Compounding Allergenic Extracts and we do not expect any changes to be made, even if other sections are revised. Our advice is to, at a minimum, continue to follow the current guidelines but also prepare for and implement the 2019 USP Chapter <797> changes.

The Advocacy Council has you covered

 We know there are a lot of changes to implement and document. The College’s Allergen Extract Mixing Toolkit will guide you. The toolkit includes:

• Section 21 of USP Chapter 797
• An allergen extract preparation instruction guide
• Checklist for gloved fingertip-thumb sampling test
• Checklist for the media-fill test
• Initial Personnel Competency Assessment form
• Annual Personnel Competency Assessment form
• Allergen extract prescription form, complaint/adverse event documentation form, refrigerator temperature log, primary engineering control hood certification form and more.
• College EXCLUSIVE – USP compliant testing supplies, incubation and reporting analysis at a 15% discount to College members.

Our team is here to make things easier for YOUR team. We’ll keep you informed as more becomes available on USP Chapter <797>.