What we’ve been fighting for – state by state

The fight for our right to provide our patients with immunotherapy continues on. And we’re still out there, battling on your behalf, no matter what. So far, we’ve been able to avert some threats and intercede in others when needed.

The Advocacy Council has found no evidence the companies from whom we purchase allergy products are behind this compounding issue; in fact, they have been supportive.  Reliable sources have indicated to us that these regulations are being promoted by the large compounding companies.  These large compounding pharmacies are the companies who were most affected by the Congressional legislation passed two years ago. 

California – The Advocacy Council recently became aware of legislation in California that would restrict a nurse’s ability to prepare allergenic extracts.  Medical Assistants licenses do not cover the preparation of allergenic extracts.  Our attorney is currently reviewing the legislation.

Colorado – The Advocacy Council, along with ACAAI and the Colorado Allergy & Asthma Society, submitted comments to the Colorado Board of Pharmacy supporting most of its proposed rule but expressed concerns about the language as it pertained to single dose antigen vials. Their final rule was recently published and we interpret the ruling to say that single dose vials should not be stored for reuse once the vial has been punctured and antigen removed. This ruling should not negatively impact the practice of allergy.

Delaware – A final rule of the Department of State, Board of Pharmacy established comprehensive requirements for nonsterile and sterile compounding in accordance with USP and became effective Jan. 11, 2016. This should not create issues for allergists that are preparing extracts in compliance with current USP 797 rules.

Florida – Within the past two weeks, the Advocacy Council became aware of the Department of Health, Board of Pharmacy’s decision to clarify and provide more comprehensive provisions regarding special sterile compounding permits. The proposal was reviewed and will not impact physicians.

Kentucky – Allergy Leaders recently became aware of the Kentucky Pharmacy Board Compounding Task Force and the possibility that they would enact legislation that could impact allergists’ ability to mix extract in their offices. After contacting the Chair of the Pharmacy Board directly, we were assured that it was not their intent to impact physician offices and were limiting their oversight to compounding pharmacies.

Nevada – The Nevada Board of Pharmacy proposed an amendment that would require an outsourcing facility engaged in the compounding of sterile drugs to obtain a license. It will not impact physician-office compounding.

North Dakota – The Advocacy Council reached out to the executive directors of each states medical association, asking for their assistance in monitoring legislation specific to compounding.  To date, the executive director from North Dakota contacted us about regulations pending there that could compromise Allergists ability to prepare extracts in their offices.  We have been successful in connecting the Allergists to the medical society executive director.  We are also preparing a letter to the North Dakota Board of Pharmacy regarding their proposed regulations.

Ohio – The Advocacy Council became aware of recent changes in Ohio law that requires every physician who compounds and dispenses drugs, to become licensed as a Terminal Distributor. Through the efforts of the AC and Ohio State Medical Association, we were able to amend the stringent regulations adopted by the Board of Pharmacy to allow an exception for allergen extracts compounded under current USP 797 requirements. We advised members to obtain their Terminal Distributors license and comply with USP 797 allergy exception rules.

And two years ago in Maryland, legislation was passed before we knew of it. It was only through the very diligent work of a few allergy leaders who gave of their time and effort, that the law was repealed. And in Michigan, we were able to secure a last-minute amendment to a bill exempting allergen extracts.

We know you understand that efforts such as these are time consuming and expensive. Many of your colleagues realize the graveness of the situation and are supporting the Advocacy Council’s efforts through their donations to DASH. We need to get all local and regional societies involved. Making a contribution is how we can show that we stand together. Support the defense – for the future of our patients and our specialty.

Advocacy Issue: 
Extracts
State-by-State Regulations