FDA Issues Memorandum of Understanding on compounded drugs
The Food and Drug Administration (FDA) recently issued a Memorandum of Understanding (MOU) related to the interstate distribution of compounded drugs. If a sta…
A victory for allergists
The U.S. Food and Drug Administration (FDA) has issued its long-awaited final Guidance for Industry on how it intends to enforce the Insanitary Conditions prov…
USP Appeals Upheld
On March 12, USP announced that the USP Appeals Panel had issued final decisions on the appeals to revisions to General Chapters <795>&nbs…
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 …
Advocacy Council and the AMA – Part I
The United States Pharmacopeia (USP) is a scientific nonprofit organization, originally founded by physicians; it sets public standards for the identity, stren…
The latest update on USP 797 standards
The College’s Advocacy Council recently attended a call convened by the American Medical Association (AMA) with the physician community on compounding is…
Final USP standards published
New USP Chapter 797 standards on sterile compounding.
Take the updated allergenic extract preparation quiz
There’s been considerable concern regarding the changes the revision of USP Chapter 797 has brought to practices. Don’t worry – the College a…
Do you have questions about the new USP Chapter 797standards?
Many of us have questions about the new USP standards. Here are two that members have asked us for guidance on:Q. Can the allergenic extract compounding area (…
Are you ready for new USP standards?
It’s important to be compliant with the upcoming new USP 797 standards. We know you have questions and concerns. We have it covered!To start, take a look…
A look behind…and ahead
2018 was a busy year for the College’s Advocacy Council as we worked hard to provide substantive advocacy services to College members. We’ve had so…
How our Advocacy Council is working for you
AC speakers shared updates with attendees at the Annual Meeting in Seattle.
USP 797: Favorable proposed draft
Proposed standards allow for the continued compounding of allergen extract prescription sets for individual patients while including some new requirements.
Updated Chapter 797 posted for public comment
Allergen extract is restored as a separate section of the proposed chapter.
USP 797 update related to allergen extract
Update on USP 797 and FDA activities related to compounding of patient-specific allergen vials for immunotherapy
USP roundtable update
The latest from the roundtable on the potential impact of proposed changes to USP 797.
USP Chapter 797 and in-office compounding of allergen extract
We've provided comments to USP acknowledging that proposed standards for the in-office compounding of extracts are reasonable and acceptable.
Billing for venom testing and immunotherapy
As we noted in last week’s Insider, there continues to be concerns about pricing and adequate availability of venoms for testing and treatment. We also u…
Venom extract price seems stable for now
The ACAAI and American Academy of Allergy, Asthma & Immunology recognize that there are growing concerns among our members regarding venom immunotherapy re…
Venom extracts will not be interrupted/reduced
The production of venom extracts should not be interrupted due to ALK’s departure from the U.S. market.
