03-12-2018 02:36 PM
New Hampshire State Senate is preparing to vote on a bill to distinguish drug compounding from drug preparation.
The intention of the proposed language is to protect providers and dispensers from New Hampshire Board of Pharmacy enforcement of USP 797 standards for Medium Risk compounding of preparations in office, for drugs such as Remicade. NH BOP had previously informed providers that Medium Risk CSP’s must be prepared per USP 797 standards, as required by state statue and Board adopted rules. This bill is backed heavily by insurers.
Unfortunately the language in the proposed bill is vague, and potentially eliminates standards for Medium or High Risk compounding far beyond the provider office setting, potentially eliminating the need for PECs and SECs in certain hospital settings.
“Compounding shall not include the preparation of a single dose of a non-hazardous commercially available drug or licensed biologic for immediate administration to an individual patient when done in accordance with the manufacturer’s approved labeling or instructions consistent with that labeling.”
NH BOP, NH Hospital Association, and Pharmacy Directors are trying to propose more specific language to preserve the integrity of compounding in institutional settings, but with little progress. I’ve written to my Senator expressing concern for patient safety and pharmaceutical integrity.
In other states with USP 797 enforcement, has language been carved out of the compounding definition to allow for preparation of drugs like Remicade in a doctor office, without a segregated compounding area and Primary Engineering Control?
What resources are out there to get the buy-in from our senators that this bill is a threat to patient safety?