Mixing Allergen Extracts

For more than 100 years, physicians have safely prepared allergen extracts using the aseptic technique. These extracts have helped make allergen immunotherapy a proven, clinically effective treatment for patients with allergic rhinitis, allergic asthma and hypersensitivity to insect stings. To ensure our patients continue to receive the best care possible, the Advocacy Council monitors and works against rules that would affect an allergist’s ability to prepare and administer allergen extracts in the office.

Overview

The College estimates more than 4,200 allergists across the United States safely prepare and provide allergen immunotherapy extracts to their patients, administering almost 5 million immunotherapy injections annually to more than 440,000 patients.

Our Stance

The Advocacy Council works to protect the specialty from any changes to rules on sterile compounding, including the preparation of allergen extracts for in-office use with patients. The sterility record of allergen extracts prepared under these rules is well-established in both medical literature and clinical reviews.

By protecting access to allergen immunotherapy, and by preventing cost increases for such care, we will help ensure that overall patient health does not suffer.

What We’re Doing

The College continues to meet and communicate with the United States Pharmacopeia’s (USP) 797 Committee as well as the U.S. Food and Drug Administration (FDA). We are pushing for a regulatory approach that balances the potential for infectious adverse events (which the FDA acknowledges has not been identified as a problem) and the increased threat of anaphylactic reactions, should source extract products not be controlled for consistency and a patient’s status in the physician’s office. We will continue to work together and keep our members apprised as compounding rules and standards are considered and developed.

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News

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The Advocacy Council continually monitors state-proposed rules and regulations relating to allergists. The chart below provides an overview of legislation the Council is reviewing. The Advocacy Council will update this list as new details become available, so you can have the most up-to-date information on compounding regulations in your state.

State

Proposed Rule

Regulation

Impact

Status

Alabama

Practice of Pharmacy/Compounding Requirements

AAC 680-X-2-.43

No impact to allergists

Reviewed. No further action.

Alabama

Parental Sterile Therapy

AAC 690-X-2-.19

 

 

Alaska

None at this time

 

 

 

Arkansas

None at this time

SB 665/Act 815

Authorizations

Bill passed.

California

Compounding

 

 

 

Colorado

Compounding

Colo. Rev. Stat. § 12-42.5-102(31)

No impact to allergists

Reviewed. No further action.

Connecticut

None at this time

 

 

 

Delaware

Compounding

24 DEAC 2500

Boards of Pharmacy would have authority to regulate other professionals, including allergists, regarding compounding.

Monitoring

Florida

Compounding

FAC 64B16-27.797

Allergists would continue to follow USP 797.

Monitoring

Georgia

Auto-Injectable Epinephrine/Lvalbuterol Sulfate or Albuterol for Schools

 

 

Bill passed.

Hawaii

None at this time

 

 

 

Idaho

Compounding

IDAPA 27.01.01.011

No impact to allergists

Reviewed. No further action.

Illinois

None at this time

 

 

 

Indiana

None at this time

 

 

 

Iowa

Compounding

657 IAC 20.1, .2, .5, .6, .11, .15 and .16 and adoption of regulations under 657 IAC 10.12 and 41.1 through 41.6

No impact to allergists

Reviewed. No further action.

Kansas

None at this time

 

 

 

Kentucky

Compounding

201 KAR 2:076

No impact to allergists

Bill passed.

Louisiana

None at this time

 

 

 

Maine

None at this time

 

 

 

Maryland

None at this time

 

 

 

Massachusetts

Compounding

247 CMR 18.00

No impact to allergists

Reviewed. No further action.

Michigan

None at this time

 

 

 

Minnesota

Compounding

151.15

Allergists must follow specific requirements, such as USP 797.

Monitoring

Mississippi

Compounding

 

Currently no impact to allergists

Monitoring

Missouri

Asthma Education/ Home Assessments

13 MCSR 70-3.260

Allows physicians to refer Medicaid pediatric patients for in-home environmental assessments.

Bill passed.

Montana

None at this time

 

 

 

Nebraska

Compounding

175 NAC 8

No impact to allergists

Reviewed. No further action.

Nevada

Compounding

NAC 639.609, .610 and .615 and adopts regulations under NAC 639 regarding outsourcing facilities

No impact to allergists

Reviewed. No further action.

New Hampshire

Compounding

OAC 4729-5-07 through -16-04 (nonconsecutive)

No impact to allergists

Reviewed. No further action.

New Jersey

None at this time

 

 

 

New Mexico

None at this time

 

 

 

New York

None at this time

 

 

 

North Carolina

None at this time

 

 

 

North Dakota

None at this time

 

 

 

Ohio

Compounding

OAC 4729-16-07 and -10

The State of Ohio Board of Pharmacy has released a statement verifying that so long as current United States Pharmacopeia (USP) Chapter 797 rules are being followed, individualized allergen extract compounding remains fully permissible in physician offices in Ohio, with no time limited exception. This statement can be viewed here.

Reviewed. No further action.

Ohio

Terminal Distributors License

 

The State of Ohio Board of Pharmacy and Ohio State Medical Association confirm a Terminal Distributor License is needed for any site compounding prescription medications including allergen extract.

Bill passed.

Oklahoma

Compounding

OAR 535:15-10-12

No impact to allergists

Reviewed. No further action.

Oregon

None at this time

 

 

 

Pennsylvania

None at this time

 

 

 

Rhode Island

None at this time

 

 

 

South Carolina

Compounding

Chapter 99

No impact to allergists

Reviewed. No further action.

South Dakota

Compounding

Chapter 99

No impact to allergists

Reviewed. No further action.

Tennessee

 

 

 

 

Texas

Compounding

22 TAC 291.133

No impact to allergists

Reviewed. No further action.

Utah

Compounding

R156-17b-614a

No impact to allergists

Reviewed. No further action.

Vermont

None at this time

 

 

 

Virginia

None at this time

 

 

 

Washington

None at this time

 

 

 

West Virginia

None at this time

 

 

 

Wisconsin

Compounding

WAC Phar 15

No impact to allergists

Reviewed. No further action.

Wyoming

Compounding

Chapter 1, 2, 8, 15, 16 and 17 regarding pharmacy standards

No impact to allergists

Reviewed. No further action.

 

News

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