As we continue to monitor activity both at the FDA and USP in relation to physician compounding, we wanted to offer the latest update.
USP: To provide a unified approach to quality compounding, USP is aligning the timing and content of General Chapters <795>, <797>, and <800>. Chapter <797> Pharmaceutical Compounding – Sterile Preparations is the chapter relating to allergy immunotherapy. Below is the current proposed timeline and web links for use during the public comment periods. AAOA will continue to monitor the progress and alert you when the revised version of <797> is released for comment.
Schedule & Links for Compounding Standards
|Click the links for access where the respective information will be posted (Active after 2/28/2018)
Pharmaceutical Compounding‒ Nonsterile Preparations
Pharmaceutical Compounding ‒Sterile Preparations
|Pre-Posted on the USP Website for Public Comment**
|March 30, 2018||July 28, 2018|
|Published in the Pharmacopeial Forum
|May 1, 2018||September 4, 2018|
|Open Microphone Session
Registration will open
| April 20, 2018
March 15, 2018
|September 5, 2018
August 5, 2018
|Public Comment Period will close
| July 31, 2018
|November 30, 2018|
|Intended Publication DateUSP – NF
| June 1, 2019
|June 1, 2019|
|Anticipated Official Date
|December 1, 2019||December 1, 2019|
* The current published versions of USP-NF General Chapters <795> and <797> are official until new chapters become official.
** This pre-posting allows extra time, beyond the typical 90 day period, for stakeholders to review and provide input.
FDA: This morning the FDA held a stakeholder teleconference regarding its final guidance on compounded drug products. The links below provide the summaries. FDA recognizes that compounded drugs play an important healthcare role for certain patients for whom FDA-approved drugs are not available, as well as the increased risk associated with compounding. As such, this guidance is intended to help reduce that risk.
The final guidance documents that we will discuss are:
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
For additional information please visit FDA’s website: https://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/
FDA Approval Updates
The U.S. Food and Drug Administration (FDA) recently approved the following sublingual tablets for pollen-induced allergies:
Merck’s RAGWITEK(TM), a sublingual immunotherapy tablet for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen specific IgE antibodies for short ragweed pollen. The complete press release from Merck is available:RAGWITEK.
Greer’s ORALAIR(R), a sublingual immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen specific IgE antibodies for any of the five grass species contained in the product (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass). The complete press release from Greer is available:ORALAIR.
Merck’s GRASTEK(R), a sublingual immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen specific IgE antibodies for Timothy Grass or cross-reactive grass pollens. The complete press release from Merck is available:<a “href=”http://www.aaoallergy.org/wp-content/uploads/2017/05/GRASTEK-press-release.pdf”>GRASTEK.
A Member Benefit
The International Forum of Allergy & Rhinology (IFAR) is the official journal of the AAOA and the American Rhinologic Society (ARS). Published monthly by John Wiley & Sons, Inc., IFAR provides a forum for clinical researchers, basic scientists, clinicians, and others to publish original research and explore controversies in the medical and surgical treatment of patients with otolaryngic allergy, rhinologic, and skull base conditions.