New Hampshire Board of Pharmacy

Compounding of Remicade and Similar Agents Outside of ISO 5 Conditions

On November 17, 2017, the New Hampshire Board of Pharmacy issued correspondence that prohibits the compounding of Remicade and similar agents at a physician’s office or at home or anywhere outside of a clean room effective 1/1/18. NHIA developed a response to the New Hampshire Board of Pharmacy requesting that they reconsider their decision as it conflicts with the accepted practice for preparing medications for administration as allowed by federal law and USP. NHIA states in the letter that at a minimum, the Board of Pharmacy should delay enforcement of this action until after the next revision of USP <797> is published and a new standard that may better reflect current practice regarding the preparation of drugs and biologics as part of the administration process. In the letter, NHIA also encourages the New Hampshire Board of Pharmacy to reach out to experts in sterile compounding, representatives from USP, CDC and the FDA for additional input on this matter.

Because of advocacy efforts by NHIA, the NHBOP issued a delay in the enforcement of the rule and invited representatives from stakeholder groups to a listening session to address the issue through the pharmacy rulemaking process. A stakeholder coalition that includes several associations, providers, and payers has been formed and is working continuously and collaboratively to find a solution that maintains patient access in every site of care.

This issue lead to legislation being introduced and passed in the New Hampshire state legislature. Senate Bill 581 was ultimately signed into law by the Governor on June 12, 2018. The new state law clarifies the definition of compounding for the state of New Hampshire.

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