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CLINICAL ROLE -

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Publication

Article

July 31, 2025

Supplements

July 2025 Influenza Guide for Pharmacists
Volume

Navigating State Standing Orders and Collaborative Practice Agreements: Preparing for the 2025-2026 Influenza Season

Author(s):

Kelli A. Boyden, JD, MS

Key Takeaways

  • Pharmacists must navigate state-specific regulations for standing orders and CPAs to administer vaccines effectively and legally.
  • The 2025-2026 influenza season will see updates in standing orders and CPAs, reflecting new CDC guidelines and state laws.
  • Common compliance risks include outdated standing orders, misinterpretation of CPA authority, and inadequate documentation.
  • Pharmacists should review and update standing orders and CPAs, coordinate with prescribers, and ensure staff training for the upcoming influenza season.
SHOW MORE

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.

Close-up of a doctor in gloves filling a syringe with vaccine from vials, set in a clinical lab environment. | Image Credit: Nikita Starodubtsev | stock.adobe.com

Image Credit: Nikita Starodubtsev | stock.adobe.com

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.

Understanding the Tools: Standing Orders vs CPAs

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.

What's New for the 2025-2026 Influenza Season?

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

About the Author

Kelli A. Boyden, JD, MS, completed her MS in pharmaceutical studies, specializing in regulation, at the University of Florida in Gainesville. She teaches housing law at DePaul University College of Law in Chicago, Illinois. She represents select clients with EB-5 visa, immigration, and complex regulatory and administrative law matters and appeals.

Influenza Vaccination and the 2025-2026 Season

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.

Common Pitfalls and Compliance Risks

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.

Recommendations for the 2025-2026 Season

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.

Looking Ahead

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.

REFERENCES
  1. L’Altrelli A, Miller TA, Medva R, Marini RV. Developing and implementing immunization standing orders and protocols. Pharmacy Times. September 13, 2023. Accessed May 29, 2025. https://www.pharmacytimes.com/view/developing-and-implementing-immunization-standing-orders-and-protocols
  2. Pharmacist-Administered Vaccines. American Pharmacists Association. Updated June 2020. Accessed May 29, 2025. https://aphanet.pharmacist.com/sites/default/files/files/practice/07-2020/pharmacist-administered-vaccines-june-2020.pdf
  3. Bulloch M. Understand the 2025-2026 flu vaccine composition recommendations. Pharmacy Times. April 2, 2025. Accessed May 29, 2025. https://www.pharmacytimes.com/view/understand-the-2025-2026-flu-vaccine-composition-recommendations
  4. North Carolina General Assembly. Immunizing Pharmacists. §90-85.15B. Accessed May 29, 2025. https://www.ncleg.gov/EnactedLegislation/Statutes/PDF/BySection/Chapter_90/GS_90-85.15B.pdf
  5. Grohskopf LA, Ferdinands JM, Blanton LH, Broder KR, Loehr J. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices – United States, 2024-25 influenza season. MMWR Recomm Rep. 2024;73(5):1-25. doi:10.15585/mmwr.rr7305a1
  6. Collaborative Practice Agreements and Pharmacists’ Patient Care Services: A Resource for Pharmacists. National Center for Chronic Disease Prevention and Health Promotion. October 2013. Accessed May 29, 2025. https://www.cdc.gov/high-blood-pressure/media/pdfs/2024/04/Translational_Tools_Pharmacists.pdf
  7. Using Standing Orders for Administering Vaccines: What You Should Know. Immunize.org. May 29, 2023. Accessed May 29, 2025. https://www.immunize.org/wp-content/uploads/catg.d/p3066.pdf
  8. Advancing Team-Based Care Through Collaborative Practice Agreements: A Resource and Implementation Guide for Adding Pharmacists to the Care Team. CDC. 2017. Accessed May 29, 2025. https://www.cdc.gov/high-blood-pressure/media/pdfs/2024/04/CPA-Team-Based-Care.pdf
  9. Stewart AM, Lindley MC, Cox MA. State law and standing orders for immunization services. Am J Prev Med. 2016;50(5):e133-e142. doi:10.1016/j.amepre.2015.10.003
Download Issue PDF
Articles in this issue

Close-up of a doctor in gloves filling a syringe with vaccine from vials, set in a clinical lab environment. | Image Credit: Nikita Starodubtsev | stock.adobe.com
Navigating State Standing Orders and Collaborative Practice Agreements: Preparing for the 2025-2026 Influenza Season
Smiling boy receiving vaccine at pediatrician's office. | Image Credit: Drazen | stock.adobe.com
Moving the Needle From Vaccine Hesitancy to Vaccine Acceptance
Some ampoules with covid-19 vaccine and syringe injection. Pandemic time. | Image Credit: Daniel Jędzura | stock.adobe.com
Pharmacists Can Simplify the Vaccine Schedule
Covid 19 or flu or monkeypox virus 3d | Image Credit: Feydzhet Shabanov | stock.adobe.com
Under the Weather: Unpacking the Impact of the 2024-2025 Influenza Season
Influenza Vaccine | Image Credit: Sherry Young | stock.adobe.com
Flu Vaccines Are a Go

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