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Understanding the regulatory landscape can maximize pharmacists' roles while ensuring legal compliance
As we approach the 2025-2026 influenza season, the public again looks to pharmacists to preserve and promote public health. In this role, pharmacists continue to rely on both state-issued standing orders and collaborative practice agreements (CPAs) to administer vaccines efficiently and in compliance with state law.1 However, the interplay between standing orders and CPAs remains complex, particularly regarding seasonal vaccinations such as influenza.
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The regulatory landscape concerning standing orders and CPAs varies from state to state.2 Pharmacists must be familiar with these evolving regulations. A thorough understanding enables legal compliance while maximizing the pharmacist’s role in public health. The primary legal distinction is whether a pharmacist may administer a vaccination pursuant to a standing order or CPA. Both are discussed below.
Standing orders are issued by state public health departments or authorized physicians and allow pharmacists to administer vaccines without individual prescriptions. These can be statewide or localized.
CPAs are formal written arrangements, typically between a pharmacist and a licensed prescriber. They may be initiated at the facility or chain level and often require annual review. Although a CPA is a private contract, both the licensed prescriber and the pharmacist are constrained by regulatory and ethical concerns. Therefore, CPAs vary significantly by state regarding permitted services, reporting responsibilities, and renewal cycles.
In some states, standing orders are limited in scope (e.g., only for adults or only for CDC-recommended vaccines),2 whereas CPAs may offer broader but more bureaucratically complex authority—requiring both that the parties agree and that the agreement fall within applicable legal limitations. Pharmacists need to know when a standing order suffices and when a CPA is required to fill gaps.
States will update standing orders, where needed, to reflect current trivalent vaccine recommendations.3 Pediatric vaccine access may continue to expand under updated laws in states such as North Carolina.4 Notably, pharmacists with immunizing status in North Carolina may now administer vaccines required or recommended by the CDC.4
The CDC Advisory Committee on Immunization Practices (ACIP) is expected to clarify recommendations on the coadministration of influenza and COVID-19 boosters, because the last update was on August 29, 2024.5
For the upcoming influenza season, pharmacists should be aware
of the following1,5,6:
• Changes in ACIP guidelines: ACIP may update age group recommendations or preferences among available influenza vaccine products.
• Standing order revisions: States often revise or renew standing orders annually, and these may contain updated patient eligibility, documentation, or reporting requirements.
• CPA renewal cycles: CPAs often have fixed renewal dates or a requirement that they be updated annually, especially when linked to seasonal protocols.
• Vaccine supply and manufacturer preference: Some CPAs may specify or limit product selection or services, whereas standing orders generally defer to availability.
Several common missteps can compromise compliance and patient safety in immunization practices. One frequent issue is the overreliance on outdated standing orders, such as using a prior year’s standing order without verifying its renewal—emphasizing the need to review standing order expiration dates.7 Another area of concern is the misinterpretation of CPA authority. CPAs must be drafted with precision, as vague language can lead pharmacists to unintentionally exceed their legal scope. Each pharmacist should be fully aware of the CPA’s parameters and ensure their actions align with state guidelines for licensed pharmacists.8
In addition, inadequate documentation or reporting can pose compliance risks. Some states mandate that immunization data be reported to registries within 24 hours, and the documentation requirements can vary between CPAs and standing orders.1 Vaccinating minors also presents potential pitfalls. Although some standing orders exclude pediatric patients, CPAs may offer broader authority if parental consent is obtained.9 For example, administering pediatric influenza vaccines under an expired CPA may place a pharmacist outside their legal authority. These scenarios highlight the critical need for vigilance in maintaining current documentation and understanding the legal frameworks governing immunization practices.
To prepare for the 2025-2026 influenza season, pharmacists can take several key steps to ensure their compliance and readiness. First, pharmacists should review their state’s standing orders to confirm they are using the most current version and are aware of any anticipated updates from the state department of health. For those practicing under a CPA, it is important to evaluate the agreement’s scope to ensure it covers influenza vaccines and all applicable age groups and aligns with the latest ACIP recommendations.5 Early coordination with prescribers—whether physicians or clinics—is also essential to address renewal timelines, revisions, and scope adjustments.
Additionally, clarify documentation responsibilities to ensure your reporting procedures align with state requirements and that the CPA language does not create unintended documentation burdens. Finally, leadership should invest time in educating staff by holding refresher training. These sessions will help reinforce proper protocols for influenza vaccine administration under both standing orders and CPAs, promoting consistency and confidence as the season begins.
Navigating the nuances of standing orders and CPAs is not just a legal compliance issue; it is an imperative for patient safety. With the 2025-2026 influenza season fast approaching, pharmacies should act now to ensure they can operate at the top of their authority while minimizing legal risk.
Properly leveraging standing orders and CPAs allows pharmacists to be agile responders in public health—precisely when their communities need them most.
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