relative to the practice of pharmacy and the dispensing of certain medications by pharmacists, authorizing the establishment of experimental treatment centers, and permitting treatment of certain severe illness under the right to try act.
What changed between versions
New RSA Chapter 126-ZZ (John Lewicke and Michael Yakubovich Experimental Treatment Centers Act) authorizes experimental treatment centers to provide investigational drugs, biologics, or devices that have completed phase one clinical trials but are not yet FDA-approved. Centers must obtain authorization from DHHS, maintain a scientific review board of at least 3 members, and allocate 2% of net annual profits to support access for qualifying NH residents.
New Section 13 allows supervised certified pharmacy technicians to administer vaccines and removes the prior requirement that vaccines be recommended by the CDC Advisory Committee on Immunization Practices before being administered by pharmacists, interns, or technicians.
Experimental treatment centers are exempt from state insurance coverage mandates, network adequacy requirements, and prior authorization procedures. They may also establish payment arrangements including direct pay, subscription models, membership fees, or digital currencies.
Experimental treatment center licensing fees set at $2,500 initial and $1,250 annually for facilities already licensed under RSA 151, and $10,000 initial and $5,000 annually for entities not otherwise licensed. Centers are also made eligible for the R&D tax credit under RSA 77-A:5, XIII.
The Right to Try Act (RSA 126-Z) is expanded from covering only terminal illness to also cover 'qualifying severe illness,' defined as an illness that is both chronic and debilitating per 21 C.F.R. 312.81(b). New definitions added for individualized investigational treatment, remote signing, and telehealth prescreening.
New liability protections: manufacturers, pharmacists, facilities, and providers are immune from suit for patient harm if the patient has a terminal or qualifying severe illness, no comparable FDA-approved treatment exists, informed consent is given, and there is no willful or reckless misconduct. A private cause of action for injunctive relief is also created against regulatory authorities that violate the chapter.
The advanced pharmacy technician examination requirement changed from a complete elimination (Senate version) to a limitation: examinations must be limited to scope of practice, and the requirement is suspended if the board cannot verify the exam complies with board requirements.
The practice of pharmacy definition (RSA 318:1, XIV(a)(6)) now includes the qualifier 'in accordance with applicable state and federal law' when describing pharmacists' authority to prescribe, order, administer, and interpret laboratory tests, controlled and noncontrolled drugs, and devices.
Effective dates are split into three tiers: Sections 14-16 (Experimental Treatment Centers) take effect January 1, 2027; Sections 1-13 (pharmacy practice changes) take effect 60 days after passage; the remainder (Right to Try amendments) takes effect immediately upon passage.
New manufacturing provisions (RSA 126-ZZ:6) allow authorized centers to manufacture drugs, biologics, or devices on-site or through contracted facilities, subject to scientific review board approval and quality standards equivalent to recognized pharmaceutical manufacturing frameworks. Batch records must be maintained for a minimum of two years.