The US Pharmacopeial Convention is an independent, nonprofit organization founded by pharmacists to develop pharmacy standards. US Pharmacopeia (USP) Chapter 797 specifically relates to standards for compounding sterile products. These standards are not enforceable unless they are adopted into state law. As of December 2017, 32 states and the District of Columbia have adopted USP 797 into law, including New Hampshire. Once adopted, a state agency, which is typically the state’s Board of Pharmacy, must be appointed to oversee and enforce these standards. Because boards of medicine have jurisdiction over the practice of medicine in the physician-office setting, boards of pharmacy have not had much traction to enforce these USP 797 standards in nonpharmacy settings.
In late 2017, the National Infusion Center Association (NICA) began receiving reports that the New Hampshire Board of Pharmacy was sending inspectors into physician offices that were known or suspected to deliver in-office infusions. These inspectors wanted to observe the preparation of intravenous (IV) or injectable medications, mainly biologics, in the office setting to monitor compliance with state regulation (ie, USP 797).
In November 2017, 14 organizations were issued citations involving monetary fines and/or a letter mandating the cease and desist of compounding practices. Soon after this, the New Hampshire Board of Pharmacy issued a statement indicating the Board’s awareness “that some entities or individuals may not be complying with USP 797 standards when compounding CSPs [sterile products] such as Remicade in either clinics or in patients’ homes.” The statement closed with a directive to comply with USP 797 standards or cease and desist in-office preparations by January 1, 2018.
Examples of the cited violations include that the “compounder is not properly credentialed; medium risk sterile compounds are not prepared in satisfactory environment; the compounder does not have documented training; the finished sterile compound is not inspected for particulates; the office does not have the right equipment for sterile compounding; and there is no quality assurance program for sterile compounding.”
The New Hampshire Board of Pharmacy inspectors provided short-term recommendations for compliance, including the use of sterile gloves, full gowns, hair nets, face masks, and boot covers, and the preparation of medications on a sterile pad. Long-term recommendations for compliance included the incorporation of International Organization for Standardization 5 mixing conditions with installation of a sterile glove box or sterile compounding room (ie, a pharmacy clean room).
Are you concerned that your office cannot comply with these recommendations? Don’t worry, you are not alone. Most office-based infusion facilities across the country would not be able to comply. A sterile glove box and full gown? Maybe. A clean room? Dream on. Even if you had the space and permits to retrofit your practice with a clean room, it could be cost-prohibitive to purchase and maintain the expensive equipment. This is a moot point, however, because the preparation of an infusion treatment for a single administration event to a patient is not “compounding.”
Because the New Hampshire Board of Pharmacy interpreted New Hampshire’s statutory definition of compounding in a way that includes the preparation of biologics and other IV or injectable medications, it was enforcing standards relating to the compounding of sterile products to ensure that patient health and safety were not compromised.
The unintended consequences of this misinterpretation posed a significant threat to local and national infusion delivery channels. Termination of a cash cow line of business (infusion services) would result in fewer access points to the delivery channel (disrupted and restricted access to care), and depending on the proportion of net revenue that comes from infusion services, downsizing or even closing physician practices. In response, NICA immediately engaged with local stakeholders to address the issue. At the time of the writing of this article, the issue was nearing resolution, but had not yet been officially resolved.
If your state’s Board of Pharmacy comes to inspect your facility for compliance with USP 797, tell them that you would like to verify their jurisdiction with the state Board of Medicine, then let us (ie, NICA) know about the inspection by e-mailing firstname.lastname@example.org. Unless you have a pharmacy attached to your practice, chances are the Board of Pharmacy does not have jurisdiction. Your Board of Medicine may not know what USP 797 is, but do not worry, NICA is here to help!
NICA is a nonprofit advocacy organization that was formed to preserve and expand patient access to in-office infusions through advocacy, education, and resource development. To learn more about NICA, please visit https://infusioncenter.org.
Source: State of New Hampshire Office of Professional Licensure and Certification. November 17, 2017. www.usp.org/compounding/general-chapter-797. Accessed January 31, 2018.