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New Hampshire Enforcement of USP 797: An Update and Next Steps

Rheumatology Practice Management June 2018 Vol 6 No 3 - Advocacy News
Brian Nyquist, MPH

Executive Director
National Infusion Center Association
Austin, TX

 

New Hampshire Enforcement of USP 797: An Update and Next Steps

Soon after receiving a letter regarding the required compliance with the US Pharmacopeia (USP) Chapter 797 in New Hampshire (see original article in the February 2018 issue of Rheumatology Practice Management), concerned infusion providers contacted our advocacy organization, the National Infusion Center Association, to articulate their concerns to the New Hampshire Board of Pharmacy. Convinced that applying USP 797 to nonpharmacy care settings would restrict patient access to care, we joined the fight to find an alternative solution.

The imminent threat to patients’ access to quality care catalyzed a meeting between the New Hampshire Board of Pharmacy and concerned stakeholders, including healthcare providers, patients, nonprofit organizations, and coalition members. Although this meeting resulted in the delay of the implementation of USP 797, the New Hampshire Board of Pharmacy was adamant about the eventual enforcement of the proposed standards across all intravenous medication delivery channels, and expected to continue fining offices that remained out of compliance after June 2018.

New Hampshire Senate Bill 581 (SB581) was introduced into the New Hampshire Senate in January 2018. It amends the definition of “compounding” to preclude the preparation of a single dose of a nonhazardous, commercially available drug or licensed biologic for administration to an individual patient prepared in accordance with the manufacturer’s approved labeling. This bill will also establish a committee comprising 3 state representatives and 1 senator to study future rulemaking authority for reconstituting drugs. Their findings must be reported by November 1, 2018.

SB581 was passed in the New Hampshire Senate and the House of Representatives, with an amendment stipulating that administration must occur within 2 hours of preparation. Now, it waits for a signature by New Hampshire Governor Chris Sununu.

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Last modified: June 25, 2018
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