July 27, 2018
Updated Chapter 797 Posted for Public Comment: Separate Requirements for In-office Compounding of Allergen Extract Restored
In September 2015, the United States Pharmacopeia (USP) released a proposed updated Chapter 797 on procedures for sterile compounding. The existing chapter had provided procedures for allergen immunotherapy extracts as a separate element to processes applicable to three levels of risk for other sterile compounded products. The September 2015 draft collapsed those requirements into just two categories; treating all sterile compounds, including allergen extract, as equally and inherently dangerous. The allergy/immunology community immediately responded, sending thousands of comments expressing concern for the continuation of allergen immunotherapy, provided for more than 100 years with no data showing any infectious adverse events. The AAAAI, ACAAI and American Academy of Otolaryngic Allergy have worked collaboratively with the American Medical Association and others to influence the next iteration of the USP Chapter 797 draft.
Today we received the updated draft. Allergen extract is restored as a separate section of the proposed chapter. The allergen extract compounding requirements address compounding personnel training and evaluation, hygiene and garbing, and updated documentation requirements, plus either installation of an ISO Class 5, Primary Engineering Control (PEC), OR a Dedicated Allergenic Extracts Compounding Area (AECA), with specifications and requirements provided for either option.
With the establishment of an AECA, including requirements for the surfaces and surrounding area, a hood is NOT required.
The requirements for an AECA include no carpeting, impervious surfaces, no outside doors or openable windows, a visible perimeter, and additional reasonable expectations for sterile compounding in the physician office. Whether you use a PEC or an AECA, compounding staff will be required to be trained and regularly evaluated on aseptic and compounding technique, mostly reflecting existing requirements but with the addition of fingertip testing and thumb sampling and appropriate incubation of samples to ensure proper sterile technique is being followed. These requirements will help maintain consistent attention to the foremost importance of ensuring patient safety. Documentation requirements for compounding procedures, temperature logs for refrigeration, and prescription set documentation reflect best practices.
The AAAAI, ACAAI, and AAOA thank our many leaders and members who have been actively engaged on this issue, as well as our collaborating organizations, and most importantly the USP Compounding Committee for protecting patient safety while maintaining patient access to allergen immunotherapy through physician in-office compounding of allergenic extracts.
If you wish to view the updated proposed Chapter 797, it is available at https://www.usp.org/compounding/797-download. Comments on this updated draft are due November 30, 2018. The final version of the Chapter is expected to be posted on June 1, 2019, and to go into effect as of December 1, 2019. We will be sharing additional details over the next few weeks.
October 5, 2017
USP Issues New Timeline for Revisions to Compounding Rules, Aims to Publish Final Compounding Standards by December 2019
The United States Pharmacopeia (USP) has announced its intent to publish new draft standards for sterile compounding (Chapter 797) in the September-October 2018 issue of Pharmacopeial Forum. This announcement came on September 29 as USP stated that it would also postpone the official date of new standards on hazardous drug compounding (Chapter 800) to ensure that both chapters were aligned. This means stakeholders, including allergists, will have another opportunity, next fall, to weigh in on a revised set of compounding standards. USP states that it intends to issue final standards on sterile compounding by December 1, 2019.
The USP’s Expert Committee on Compounding met in Washington September 29 to discuss revisions to its sterile compounding proposal including the issue of physician compounding for administration to patients. AAAAI and ACAAI representatives were in attendance. At this point it is too early to say what changes will be made to the next draft set of standards, but we can tell you that the issue of physician compounding and allergy immunotherapy preparation definitely has the attention of USP. We are hopeful that the draft standards issued next fall will be substantially changed to address the concerns our organizations have been raising with USP.
February 16, 2017
Latest on Efforts to Protect In-Office Compounding
As was reported to all AAAAI and ACAAI members in a joint email, efforts taken by the specialty organizations to protect patient safety were well received by representatives of the United States Pharmacopeia (USP) and patient safety concerns during the recent USP Allergy/Immunology Stakeholder Roundtable. In particular, materials such as those available here were specifically referenced as important tools for communications with patients and other providers.
We encourage you to revisit the link in the above paragraph and review your own materials and processes on a regular basis. As always, the AAAAI continues to work with others within and beyond the specialty to protect in-office allergen immunotherapy compounding for patient safety and access.
February 7, 2017
The Latest from the USP Roundtable
This past Thursday, February 2, representatives from AAAAI and ACAAI participated in a United States Pharmacopeia (USP) roundtable on the proposed changes to USP 797 guidelines on compounding of allergen extracts in allergists' offices and clinics. Members of the USP Roundtable Steering Committee, Drs. James Sublett, Tom Casale, Mike Nelson, and Steve Kagen attended and were joined by Drs. David Bernstein, Linda Cox, Gary Gross, Stephen Imbeau, Aidan Long, Kathleen May, and Andrew Murphy along with our legal advisors. Representatives from the AAOA, AAN, AAFA, the FDA, Federation of State Medical Boards, the Allergen Extract Manufacturers Association and other stakeholders were also in attendance. The roundtable was a day long discussion with the USP staff and USP 797 Expert Panel on the potential impact of the proposed changes.
The stated objectives for the revision of USP 797 are to assure sterility and stability. Several advances by our specialty have been made since the last Chapter 797 update. Our purpose was to educate the USP staff, 797 Expert Panel Chair and Vice-Chair and other roundtable members of those accomplishments.
Following a presentation on Allergen Immunotherapy Vial Preparation, overviews of data and research and recent publications on sterility and the lack of infection risk from immunotherapy were presented. Comments related to the most recent Practice Parameter on Immunotherapy, which has been updated since the last USP 797 update, were included. There was also discussion on the importance of continued patient access to immunotherapy and its risk/benefits. One important factor that differentiates our compounding extracts is the use of phenol and glycerin in our vials. This will be considered in any decision on Beyond Use Dates.
Overall, the roundtable allowed us to fill many knowledge gaps for USP related to allergen immunotherapy. Continued dialogue will occur, and, after the revised draft of the Expert Panel is published, there will be another opportunity for public comments.
FDA Issues Update on Compounding Efforts
The Food and Drug Administration (FDA) has released a report on compounding regulations entitled “FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017)”. This document does not provide additional specific information regarding requirements for physician in-office compounding, but does provide a look at what the FDA is working to address. You can read the report here.
The AAAAI, together with the American College of Allergy, Asthma & Immunology, the American Academy of Otolaryngic Allergy and the American Medical Association, continues to vigorously advocate with the FDA, members of Congress and other interested organizations to protect patient access to care by fighting for physician in-office compounding. As always, we encourage you to have a relationship with your elected representatives. If you know any newly elected members of Congress, we would particularly like to speak to you about reaching out to educate that person. You are always welcome to contact us at firstname.lastname@example.org and indicate “compounding” in the subject line.
In other compounding news, the AAAAI and others are looking forward to a February 2 stakeholder roundtable with the United States Pharmacopeia (USP) to explore how best to protect patient access to evidence-based treatment while ensuring patient safety. We look forward to keeping you posted as we advocate for physician in-office compounding for allergen immunotherapy.
December 29, 2016
FDA 11th-Hour Guidance on Compounding
As we shared with the Trump transition team and with Congress earlier this month, the AAAAI has been watching for an 11th-hour action from the Food and Drug Administration (FDA) regarding compounding. We have been particularly concerned about any further action on the August 2016 draft guidance entitled “Insanitary Conditions in Compounding Pharmacies” that suggested that state boards of pharmacy should enforce extreme standards on physician offices by, inexplicably, applying them equally to physician offices as to commercial compounding manufacturing facilities.
The FDA issued a final guidance yesterday afternoon on compounding, focused on prescription requirements. While the final guidance does specifically include physician in-office compounding, it does not appear to reflect the overreaching approach taken in the “Insanitary Conditions” document. Yesterday’s finalized guidance on prescription requirements acknowledges that compounding in the physician’s office reflects a physician/patient relationship. It requires that the patient’s individual prescription needs to be documented, with the patient’s name, in the patient’s medical record. While we recommend that you review the document for yourself, we are pleased to tell you that we find it encouraging.
We are hopeful that this finalized guidance reflects an appreciation for the importance of our ability to provide safe and effective patient care by preparing allergen extract in our offices. Meanwhile, we will certainly continue to remain vigilant for any additional 11th-hour FDA regulations, but we are pleased to share with you what we see as an encouraging step from the FDA.
You can read the final guidance, Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act, here:
December 16, 2016
Urgent Compounding Communications
The AAAAI Board of Directors sent a letter November 25 to the Trump Transition team to share our concerns about the FDA’s recent draft guidance, “Insanitary Conditions in Compounding Facilities.” Read the letter here.
Although Republican leadership has urged federal agencies to not issue any final regulations in the waning days of 2016, there is no guarantee the FDA will not issue a final guidance. On December 2 we shared our letter with members of Congress, along with a reminder of the letter sent by Senator Casey and colleagues to the Department of Health and Human Services, expressing concern about the draft guidance.
Update on Proposed Changes to USP Chapter 797
The United States Pharmacopeia (USP) Compounding Expert Committee is meeting next week, with 90 minutes on the agenda set aside for all issues relevant to Chapter 797. The AAAAI, American College of Allergy, Asthma & Immunology and the American Academy of Otolaryngic Allergy will all be attending. It is expected there will be very little time spent on allergy/immunology concerns, although it is anticipated that USP will acknowledge the deluge of feedback received from the allergy/immunology community. We also anticipate the announcement of a stakeholder meeting to be held later in the fall that will focus on allergy/immunology concerns. The AAAAI will continue to keep you informed and work collaboratively with our members and other organizations to influence this very important issue for our specialty.
AAAAI and Others to Attend USP Compounding Expert Committee Meeting
The United States Pharmacopeia (USP) Compounding Expert Committee will meet September 20, and the AAAAI, the American College of Allergy, Asthma & Immunology and the American Academy of Otolaryngic Allergy are all planning to participate. Chapter 797 has 45 minutes on the agenda, during which the timeline, public comments, and stakeholder meetings to follow up on those comments will be discussed. Because the issues resulting from the 797 proposal impact a wide variety of specialties and concerns, we anticipate that allergy will be a fairly small part of this discussion, even though we have heard that we generated the majority of the comments.
We are currently awaiting details on a stakeholder meeting focused on allergy concerns later in the fall. The AAAAI continues to make working on behalf of the specialty in regards to access to allergen immunotherapy, and collaborating with others to do so, a top priority. We will keep you informed through Practice Matters, eNews and additional email updates.
July 21, 2016
Immunotherapy Safety and United States Pharmacopeia (USP) 797 Update
The AAAAI remains committed to advancing the practice of allergen immunotherapy and continues to fight the Chapter 797 changes proposed by the United States Pharmacopeia (USP). As communicated in June Practice Matters, AAAAI and other organizations participated in a June 3 Food and Drug Administration (FDA) listening session on compounding. Advocacy Chair Andrew W. Murphy, MD, FAAAAI, spoke with USP representatives in person at that meeting to reinforce our concerns. Executive Vice President Thomas B. Casale, MD, FAAAAI, Past President Linda Cox, MD, FAAAAI, Board member Aidan A. Long, MD, FAAAAI, and others also spoke with leaders from USP at the Eastern Allergy conference in Palm Beach, Florida on June 4.
The AAAAI recently submitted comments to the FDA in response to proposed rules about compounding in hospital and health system pharmacies. One proposed rule would allow products compounded by such a pharmacy to only be administered within one mile of the facility. We told FDA this threatens access to allergen immunotherapy for patients seen by staff physicians of healthcare systems who practice in community clinics, some of which are in economically depressed areas where pediatric patients receive allergen immunotherapy for allergic asthma. We reiterated that any proposed change to compounding rules must balance perceived safety risks with patient access to proven, safe and effective medical care. See the AAAAI's comments here.
The AAAAI received support from the American College of Physicians (ACP), which also submitted comments to the FDA in support of patient access to care and safety concerns that necessitate allergen extracts prepared via physician in-office compounding. See the ACP's letter here.
Additional postings from the FDA earlier this week will also be commented on, and outreach to members of Congress and other interested organizations continues as well. While it is difficult to estimate when the USP issue will be resolved, we are extremely confident that USP is much more aware and tuned into the concerns of the A/I community related to the proposed Chapter 797 changes.
June 16, 2016
Immunotherapy Safety and United States Pharmacopeia (USP) 797 Update: Comments Presented to FDA and Casey Letter Delivered to HHS
The AAAAI has been constantly working to advance the practice of allergen immunotherapy, especially in light of proposed changes to policies and procedures regarding sterile compounding. Several notable updates include the AAAAI's attendance at a Food and Drug Administration (FDA) listening session on compounding and the delivery of Senator Bob Casey's letter to Department of Health & Human Services (HHS) Secretary Burwell.
AAAAI Presents Comments at FDA Listening Session on Compounding
Advocacy Chair Andrew Murphy, MD, FAAAAI, attended a June 3 FDA listening session on compounding and presented comments on behalf of the AAAAI. Read the comments here.
The AAAAI was informed of the listening session by colleagues at the American College of Physicians, who the AAAAI has been working with on the compounding issue. After securing an invitation, the AAAAI requested that the American College of Allergy, Asthma and Immunology (ACAAI) and American Academy of Otolaryngic Allergy (AAOA) receive invitations as well. All three groups collaborated and coordinated to ensure a consistent message was being delivered while preserving the unique perspective of each organization. While this was strictly a listening session, the AAAAI had the opportunity to continue strategic discussions with the American Medical Association (AMA), Federation of State Medical Boards (FSMB) and USP after the meeting.
Casey Letter Delivered to HHS Secretary Burwell
At the request of the AAAAI, Senator Bob Casey (D-PA) has sent a letter to HHS Secretary Burwell expressing concern about the USP proposal and the extent to which it could "…significantly reduce access to allergen immunotherapy and increase costs, without any evidence that it would prevent infections that, to date, have not been documented in any patients." A total of 13 Senators signed the letter, and these six Democrats and seven Republicans include some very respected and high-ranking Senators. Read the final version of the letter here.
While circulating the letter, we received the attention of a number of Senators who did not sign on but indicated they planned to schedule calls with the FDA or contacts in Secretary Burwell's office to express their concern. The AAAAI's representation in Washington, DC will circle back to these offices.
Thank you to every AAAAI member who took action by calling their Senators and urging them to sign on to the Casey letter. The AAAAI will continue to keep you updated on our efforts to maintain the current USP standards for compounding allergen immunotherapy extracts.
April 29, 2016
The AAAAI is constantly working to advance the practice of allergen immunotherapy, especially in light of proposed changes to policies and procedures regarding sterile compounding.
FSMB Position Statement Will Not Advance; Further Study Likely to Follow
Jennifer Namazy, MD, FAAAAI, presented testimony on behalf of the AAAAI before the Reference Committee of the Federation of State Medical Boards (FSMB) this morning in San Diego, against a proposed position statement that called for an end to in-office physician sterile compounding. She described and distributed the recent Massachusetts General Hospital/Brigham and Women's Hospital study (in press in JACI) showing no infectious events associated with over 130,000 allergy injections provided by two allergy practices to more than 3,000 patients over 10 years. She also provided a compelling description of her patient, a young man who lives on a ranch in California, for whom immunotherapy for a hymenoptera allergy has been a life-changing therapy.
Dr. Namazy's comments were well received and referenced by others who also gave testimony as to the importance of further study so that restrictions on physician compounding would not result in limiting patient access to guideline-based medical treatment. Read Dr. Namazy's comments here.
Dr. Arthur Hengerer, the Chair-elect of the FSMB, informed the Reference Committee that the FSMB Board of Directors had discussed the issue and, after receiving and reviewing input from numerous state medical boards and input sent directly to the FSMB from many in the allergy/immunology community and a variety of other specialties, recommended withdrawing the draft position statement. The FSMB Board recommended that a study of the issue, as proposed in a resolution offered by the North Carolina Medical Board, should be undertaken to identify more appropriate policy for the FSMB regarding physician compounding. The issue will be heard again tomorrow by the FSMB House of Delegates.
The AAAAI thanks Dr. Namazy and everyone who contacted their state medical boards, and will continue to keep you informed as this process continues. Advocacy on behalf of our patients requires that all A/I physicians stand up and voice their opinions. One person alone cannot solve the myriad of challenges that we face. We believe that a stake-holder engaged, transparent process of discussing ramifications on restrictions on physician compounding for evidence-based care will not only result in a more appropriate position for the FSMB, but may also advance our ongoing advocacy with USP to maintain the current USP standards for compounding allergen immunotherapy extracts.
What's Next? Tell Your Senator to Co-Sign Casey Letter to HHS
At the request of the AAAAI, Senator Bob Casey (D-Pa) is sending a letter to U.S. Department of Health & Human Services (HHS) Secretary Burwell expressing concern about the USP proposal and the extent to which it could "…significantly reduce access to allergen immunotherapy and increase costs, without any evidence that it would prevent infections that, to date, have not been documented in any patients." Senator Casey has asked other Senators to co-sign with him. Click here to read Senator Casey's letter and request to other Senators.
Contact your Senators to ask them to co-sign Senator Casey's letter. Contact information for your two Senators can be found here. It is recommended that you call the office of each of your Senators, ask to speak to the staff person who handles health issues, and ask that the Senator co-signs Senator Casey's letter to Secretary Burwell regarding allergy immunotherapy. Talking points to make the case for signing the letter are available here. If the person has not seen Senator Casey's letter, offer to email it to him/her.
If you prefer to send a letter, it should be faxed (NOT mailed) to the Senator's office using the fax number on the Senator's website. Your letter should be faxed to the attention of the "Health Legislative Assistant."
A less effective—but easy—option is to submit your comments via the email/comment link on your Senator's website. Thank you in advance for helping the AAAAI with this next opportunity for engagement.
April 13, 2016
Immunotherapy Safety and United States Pharmacopeia (USP) 797 Update: A New Study, A Survey & Your State Board
The AAAAI is constantly working to advance the practice of allergen immunotherapy. Important updates you need to know include a new study released this week supporting the safety of immunotherapy administration; an invitation to participate in the updated adverse events survey; and an update on communications with state medical boards regarding in-office compounding.
New Study on Immunotherapy Safety
In an article published by The Journal of Allergy and Clinical Immunology (JACI), researchers from Massachusetts General Hospital have confirmed the safety of current allergen immunotherapy (AIT or allergy shots) practices. In more than 130,000 injections given to over 3,000 patients in a 10 year timeframe, no infectious events related to the allergy injections occurred. We are also sharing this new data with USP in follow up to our previous request that current standards for sterile compounding for allergen immunotherapy remain in effect. Read the article here.
Immunotherapy Adverse Events Survey Now Open
The AAAAI has collaboratively supported the Annual Anaphylaxis Survey for 7 years, and worked with David Bernstein, MD, FAAAAI, and others to update this year's survey to include both SCIT and SLIT. In addition, information will be gathered on infection risk from SCIT injections in response to concerns raised by USP. To participate, contact email@example.com for a special code and a link to the survey.
Federation of State Medical Boards Position Statement on In-Office Compounding
The Federation of State Medical Boards (FSMB) is slated to discuss a position statement at their meeting in San Diego at the end of April that discourages any sterile compounding in physicians' offices. Read the position statement here, which begins on page 7. The AAAAI initiated a multi-specialty effort to defeat this position statement, and signed on to a collaborative letter to all state medical boards. The American Medical Association (AMA) then shared information on this effort with all specialty societies seated in the House of Delegates, suggesting their state level organizations contact their state medical boards if impacted by this position statement.
You can still contact your state medical board to reinforce that this position statement interferes with your ability to provide proven effective, disease modifying SCIT to your patients. (Click here for a sample email that you can send to your state medical board.) If you personally know a member of your state medical board, reach out directly to that person. While the AAAAI and others continue to work on your behalf, nothing is as effective as individual contact.
Remember that you can invite your patients to weigh in on the importance of access to allergen immunotherapy from their perspective. Share the Change.org petition in your office, today and every day.
If you missed the AAAAI's panel discussion on USP 797 at the 2016 Annual Meeting, watch it here. It covers USP's proposed changes to the sterile compounding rules, its potential implications on the allergy/immunology specialty and what the AAAAI has done about the issue.
The AAAAI will continue to provide updates in Practice Matters and eNews; and our thanks for the many calls and emails we continue to receive on these important issues.
march 30, 2016
Watch the USP Panel Video from the 2016 AAAAI Annual Meeting.
February 1, 2016
What You Need to Know about Proposed Changes to USP 797
As previously reported to AAAAI members, the practice of allergen immunotherapy as we know it is at risk. The United States Pharmacopeia (USP) has proposed changes to be required of all sterile compounding, including allergen extract preparation.
These changes include more complicated mixing procedures, significantly shortened timeframes for how long extracts can be used, and add burden to your storage and documentation processes. You can read more about the changes in the draft update of USP Chapter 797 available here, which was open for public comment until January 31. Thank you to everyone who submitted comments to USP during this public comment period and to all who shared the AAAAI’s change.org petition to save patient access to allergen immunotherapy. The response from AAAAI members and their patients was extraordinary.
In addition, the AAAAI collaborated with the American College of Allergy, Asthma & Immunology and its Advocacy Council; the American Rhinologic Society; the American Association of Otolaryngic Allergy; the American Academy of Otolaryngology-Head and Neck Surgery; and the Allergy and Asthma Network to develop comments to send to USP.
You can read our letter here.
The AAAAI will continue to keep you updated on the situation as we learn more.
January 27, 2016
USP Update Could Significantly Change In-House Compounding and Patient Access to Immunotherapy
AAAAI Members Urged to Submit Comments to USP by January 31, 2016
As reported in the December issue of Practice Matters and a special Practice Matters alert emailed to AAAAI members yesterday, the practice of allergen immunotherapy as we know it is at risk. The United States Pharmacopeia (USP) has proposed changes to be required of all sterile compounding, including allergen extract preparation. These changes include more complicated mixing procedures, significantly shortened timeframes for how long extracts can be used, and add burden to your storage and documentation processes. These changes are included in a draft update of the USP Chapter 797, which governs sterile compounding, and which is available for public comment until January 31.
This is a critical issue that the AAAAI and ACAAI have been working together to address. If you have not already submitted comments to USP, you are urged to do so by the January 31 deadline. Keep these details in mind:
• The AAAAI's representation in Washington, DC, and a jointly retained consultant have informed us that having members submit personalized comments will be most effective in getting our voice heard. The AAAAI has compiled a variety of information here, which you can use to help put together your personalized comments to USP. The most important information is in all capital letters.
• The section of the USP document linked here that actually shows the changes USP intends to make to Chapter 797 does not have line numbers, despite the fact that USP is asking commenters to reference line numbers. Members should fill out USP's comment submission template linked here as best as they can. You can mention that the Allergen Extracts as CSPS section on pages 17-18 of the USP document is what we want restored and not deleted.
• Members should absolutely communicate with their patients about these proposed USP changes. If the changes are finalized, it will significantly impact patient access to immunotherapy. If you have patients who will personally attest to an improved quality of life thanks to allergen immunotherapy, please invite them to participate in this public comment period as well.
Click here to go directly to the USP site to read the draft update of USP Chapter 797 and download the comment submission template you must use. If you have any questions, contact the AAAAI at firstname.lastname@example.org.
The AAAAI will continue to update you on this situation.