Expanded Scope of Practice: The Rapid Evolution of the Pharmacist's Role in Patient Care

The role of the pharmacist is rapidly expanding from prescription drug dispenser to clinical provider, driven by critical public health needs and a focus on healthcare equity. Legislative momentum is unprecedented: in the 2025 legislative session alone, 211 bills to expand pharmacist scope and reimbursement were introduced across 44 states, with 16 already enacted in 12 states as of June 2025.¹ The currently pending federal bipartisan Ensuring Community Access to Pharmacist Services Act (ECAPS) would mandate Medicare Part B reimbursement for services like testing and treatment, permanently recognizing pharmacists as providers.² This article outlines the current models of pharmacist prescriptive authority, key regulatory safeguards, and the pressing challenge of reimbursement.

Overview of Pharmacist Scope of Practice and Prescriptive Authority

“Scope of practice” refers to the professional activities, procedures, and services that a pharmacist is legally authorized to perform within their area of competence and training. Pharmacists’ scope of practice is established by state law and regulated by State Boards of Pharmacy, creating a complex landscape where practice authority varies significantly across state jurisdictions. The traditional pharmacist's scope of practice encompasses prescription drug dispensing, drug utilization review, patient counseling, and pharmaceutical care services.

Pharmacist Scope of Practice Expansion Trends

1. Collaborative Practice Agreements (CPAs)

Collaborative Practice Agreements (CPAs) are legal frameworks allowing pharmacists to participate in collaborative drug therapy management through written protocols with prescribing practitioners. Written protocols must specify the pharmacist's scope of practice, clinical decision thresholds, referral criteria, and documentation requirements in shared health records. All 50 states and the District of Columbia authorize CPAs, enabling pharmacists to manage drug therapy under physician supervision, though scope and implementation vary significantly by jurisdiction. Recent CPA state trends are the expansion of pharmacist autonomy within CPAs (less physician oversight, more pharmacist-driven protocols).³

Common statutory requirements include periodic activity reporting, specialized continuing education or additional training/certification. Idaho, Montana, North Dakota, Oregon, Washington, and Wisconsin require periodic activity reporting of CPA activities.⁴ Montana pharmacists authorized to engage in collaborative drug therapy management must complete 10 hours of continuing education in each of the disease states of the CPA every 2 years.⁵ Several states (Alaska, California, Montana, New Mexico, North Carolina, Oregon, and Washington) require a pharmacist to have an advanced credential, certification, or formal clinical recognition before a pharmacist may enter into a CPA.⁶ CPAs and/or pharmacists engaged in CPA arrangements often require pre-implementation registration or approval by state boards of pharmacy.⁷

2. Independent Prescribing Models

Protocol/standing-order-based authority and standard-of-care models enable pharmacists to initiate, adjust, and discontinue specified drugs without direct physician oversight.

Protocol/Standing-Order-Based Authority: Under this model, jurisdictions define statewide protocols or board-developed standing orders specifying drug categories. All 50 U.S. states and the District of Columbia now permit pharmacists to prescribe or dispense medications under some form of statewide protocol/standing order for at least one clinical area.

Current protocol-based authorities for pharmacists typically include a range of clinical services. In preventive care, pharmacists are authorized to administer vaccines, furnish contraceptives, and provide PrEP or PEP for HIV prevention. For emergency and urgent care, they may dispense naloxone, emergency contraception, and smoking cessation aids. Travel health protocols allow pharmacists to furnish prophylactic medications for international travel. In chronic disease management, they can implement continuation therapy protocols and supply diabetes testing materials. Public health initiatives often involve test-and-treat protocols for common conditions such as strep throat and urinary tract infections. This authority is highly variable by state jurisdiction in scope, qualifying conditions, and which clinical areas are covered.⁸

Standard-of-Care (SOC) Model: Alaska, Idaho, Iowa, Tennessee, and Washington have adopted a "standard of care" model that allows pharmacists to exercise broad prescriptive authority, including for conditions that require a diagnosis.⁹ Additional states (e.g., California, Colorado, Utah, Virginia) are considering broad SOC adoption making this the fastest-growing model.¹⁰

Under the SOC model, state laws require pharmacists to practice in line with the professional judgment and expertise expected of a peer with comparable education and training, rather than restricting them to specific drug categories. Idaho exemplifies this approach: pharmacists may only prescribe drugs or devices for conditions for which they are educationally prepared and for which competence has been achieved and maintained, with requirements for adequate patient assessment based on the applicable standard of care and best available evidence.¹¹ To maintain accountability, statutes establish an SOC enforcement structure—typically via the state board of pharmacy—holding pharmacists liable for negligence and safety lapses against the community standard.

3. Immunization; Test and Treat

Immunization. All 50 states, DC, and Puerto Rico authorize pharmacists to prescribe, dispense, and administer immunizations to defined age populations. Under state scope-of-practice laws, pharmacists may independently administer a broad range of immunizations once they complete board-approved training — typically the CDC’s immunization curriculum plus state-specific modules—and maintain active certification in basic life support. Statutes set minimum age thresholds (often 3 years and older), define eligible vaccines (such as influenza, pneumococcal, herpes zoster, and COVID-19), and require documentation in the state immunization information system within 24 to 72 hours.¹²

Test and Treat. Point-of-care testing (POCT) services hinge on obtaining a Clinical Laboratory Improvement Amendments (CLIA) waiver, completing specialized POCT training, and establishing written policies for specimen collection, quality control, and result verification. States authorize pharmacists to perform CLIA-waived tests for conditions like influenza, Group A streptococcus, HIV, hepatitis C, and COVID-19; under collaborative practice agreements or standardized statewide test-and-treat protocols, pharmacists may then initiate or adjust therapy—such as prescribing antivirals, antibiotics, or smoking-cessation aids—based on test outcomes and predefined inclusion/exclusion criteria. Services usually require appropriate patient assessment, contraindication screening, documentation of informed consent, and establishment of referral pathways for complex cases or treatment failures. Regulatory frameworks mandate informed consent, rigorous recordkeeping (including entry into the state prescription drug monitoring program where applicable), periodic competency assessments, and renewal of testing and prescriptive privileges every 1 to 3 years in tandem with continuing education requirements. Currently, twelve states have explicit test-and-treat authority, and Arizona, Indiana, Massachusetts, Mississippi, Nevada, North Carolina, Oklahoma, South Carolina, and Texas each introduced "test and treat" or prescribing bills in 2025.^13,14

4. Controlled Substances

Very few states permit pharmacists to prescribe controlled substances under state law. Idaho represents the most comprehensive example, where pharmacists operating under the standard-of-care model may prescribe controlled substances within their scope of competence and education. New Mexico authorizes Clinical Pharmacist Practitioners (CPPs) to prescribe controlled substances under CPAs, while North Carolina permits similar authority for pharmacists with Clinical Pharmacist Practitioner certification.^15,16 Montana allows pharmacists with advanced practice authority to prescribe certain controlled substances under specific protocols.¹⁷ Colorado has a 2025 pilot for Schedule III-V under the standard-of-care model.¹⁸ Qualifying requirements include completion of board-approved controlled-substance training, mandatory prescription drug monitoring program (PDMP) reviews before each prescribing decision, adherence to strict patient inclusion/exclusion criteria, and established emergency-response protocols for adverse events.

When authorized by state law—via CPAs, advanced licenses, or board protocols—pharmacists may prescribe controlled substances but must obtain DEA registration.¹⁹ Most states limit authority to Schedule III–V drugs, with naloxone covered separately and buprenorphine requiring extra federal certification. Prescribing is subject to supply caps, dosage limits, and therapeutic category restrictions. Documentation must justify drug selection, include patient assessments, and comply with state and federal monitoring systems.²⁰

Procedural Safeguards and Compliance Requirements

States with expanded pharmacist scopes of practice implement comprehensive safeguards and compliance frameworks to ensure patient safety, professional accountability, and integration into broader public health goals.

1. Agreement and Protocol Requirements

Written collaborative practice agreements (CPAs) or prescribing protocols are universally required to define scope, eligible patient populations, and clinical procedures. Many state boards require pharmacists to submit CPAs for review or approval before services may begin. Renewal of CPAs and prescribing authority is typically required every one to three years, contingent on continuing education, competency assessments, and proof of updated professional liability coverage.²¹

2. Training, Certification, and Registration

Pharmacists must meet rigorous prerequisites to perform expanded services and maintain active registration with state boards of pharmacy. Common elements include:

• Prerequisites: Completion of board-approved didactic and clinical training tailored to the authorized service (e.g., CDC immunization training for vaccines, CLIA-waived testing certification, or controlled substance education where applicable). Basic life support (BLS) certification may be a mandatory requirement.
• Registration and Liability Coverage: Pharmacists may be required to register with their state board, maintain professional liability insurance at statutory minimums, and in some states submit CPAs for formal approval.
• Continuing Competence: States often require continuing education (e.g., Montana mandates 10 hours per disease state every two years) and periodic competency reassessment tied to renewal of prescribing authority.

3. Documentation, Monitoring, and Quality Assurance

Across all practice models, pharmacists are mandated to adhere to record-keeping protocols to ensure transparency, accountability, and continuous quality improvement. This requires that all clinical services be meticulously documented in permanent medical records or state-designated electronic systems. Specifically, vaccine administrations must be reported to state immunization information systems within a strict 24 to 72-hour window, and all prescriptions must be logged into the state's Prescription Drug Monitoring Program (PDMP) where required. Furthermore, pharmacists must comply with routine audits conducted by state boards, promptly report any adverse events, and participate in outcome monitoring.²² Together, these comprehensive measures form a critical framework for patient safety and professional oversight.

4. Common Core Requirements Across Models

Regardless of the prescribing framework, pharmacists may be required to complete standardized training, maintain certification, register with the state board, carry professional liability insurance, adhere to record-keeping rules, and participate in quality improvement monitoring. Renewal intervals vary by state but generally occur every one to three years, tying prescribing privileges to demonstrated ongoing competence and updated insurance coverage.²³

Reimbursement for Pharmacist Expanded Scope of Practice Services

Reimbursement for pharmacist-provided expanded scope services remains a complex landscape with significant variation across payers, states, and service types. Medicare Part B covers pharmacist-administered vaccines under the incident-to provision when provided in physician offices or under collaborative practice agreements, while Medicare Advantage plans may offer broader coverage for clinical services. Medicaid reimbursement varies substantially by state: some jurisdictions recognize pharmacists as healthcare providers eligible for direct billing, while others limit coverage to specific services like immunizations or require billing through supervising physicians under collaborative agreements.²⁴

Commercial insurance coverage has expanded significantly, particularly for preventive services such as vaccinations, health screenings, and chronic disease management programs. Major insurers increasingly recognize pharmacist-provided clinical services, though prior authorization requirements and coverage limitations persist. Point-of-care testing services typically receive reimbursement when performed under CLIA waiver authority, with test-and-treat protocols showing growing payer acceptance for conditions like strep throat, influenza, and COVID-19. Thirteen states have enacted legislation requiring commercial insurers to reimburse pharmacists for certain services; however, reimbursement rates often remain below physician fee schedules, and prior authorization and documentation requirements create barriers to implementation.²⁵

Conclusion: The Future of Pharmacist Practice Authority

The legislative and regulatory groundwork for a transformed pharmacy profession is in place, as the models of collaborative agreements, statewide protocols, and autonomous practice demonstrate that pharmacists are prepared to deliver safe, effective, and accessible care. Yet, these advanced scopes of practice are rendered ineffective without the final, critical component: sustainable reimbursement and national scope ofpractice alignment.To truly harness pharmacists' potential, Congress must pass federal provider status legislation to ensure Medicare reimbursement, and states must work toward harmonizing scope of practice laws.

REFERENCES

1. National Alliance of State Pharmacy Associations. Mid-year legislative update. 2025. Accessed October 12, 2025.

2. Ensuring Community Access to Pharmacist Services Act, H.R. 3164, 118th Cong (2023); Ensuring Community Access to Pharmacist Services Act, S. 2426, 118th Cong (2023. Accessed October 12, 2025.

3. American Pharmacists Association. Collaborative practice now allowed in all 50 states. Pharmacy Today. 2025;31(1):12, Accessed October 12, 2025.

4. Pharmacists' Patient Care Process: A State “Scope of Practice” Perspective, Innov Pharm. 2019 Aug 31;10(2): 10.24926/iip.v10i2.1389..Accessed October 12, 2025.

5. Montana Collaborative Practice Agreement Requirements., Mont Admin R 24.174.524 (2024). Accessed October 12, 2025.

6. Alaska, Alaska Administrative Code (AAC) 12 AAC 52.240; California, California Business and Professions Code, Section 4052; Montana, New Mexico, N.M. Admin. Code § 16.19.4.17; North Carolina, North Carolina General Statute § 90-18(c)(3a), General Statute § 90-85.3(b2), and Session Law 2025-37; Oregon, Oregon Administrative Rules 855-020-0110 and Oregon Administrative Rules (OAR) 855-041-0400, Washington, Washington Administrative Code (WAC) § 246-945-350.

7. Alaska, Georgia, Louisiana, Maine, Maryland, Massachusetts, Mississippi, Missouri, Montana Nebraska, New Mexico, North Carolina, North Dakota, Nevada, Pennsylvania, Rhode Island, South Dakota, Texas, Washington, West Virginia, Wyoming each require CPA submission or approval. National Alliance of State Pharmacy Associations, State-by-State Look at Pharmacist CPAs, Accessed October 12, 2025.

8. National Alliance of State Pharmacy Associations. Pharmacist Statewide Protocols: Key Elements for Legislative and Regulatory Authority. 2017. Accessed October 12, 2025.

9. Aucoin A. Navigating state standing orders and collaborative practice agreements: preparing for the 2025-2026 influenza season. Pharmacy Times. July 31, 2025. Accessed October 12, 2025.

10. National Alliance of State Pharmacy Associations. Mid-year legislative update. 2025. Accessed October 12, 2025.

11. Idaho Admin Code r 24.36.01.350 (2024). Accessed October 12, 2025.

12. National Alliance of State Pharmacy Associations, Pharmacist Administered Vaccines (2023).Accessed October 12, 2025.

13. National Alliance of State Pharmacy Associations, Pharmacist Prescribing – Test and Treat (2025). Accessed October 12, 2025.

14. National Alliance of State Pharmacy Associations. Mid-year legislative update. 2025. Accessed October 12, 2025.

15. N.M. Admin. Code § 16.19.4.17 - PHARMACIST CLINICIAN.Accessed October 12, 2025.

16. 21 N.C. Admin. Code 46 .3101 - CLINICAL PHARMACIST PRACTITIONER.Accessed October 12, 2025.

17. Montana Code Annotated (MCA) 37-7-106.Accessed October 12, 2025.

18. Colorado State Board of Pharmacy Statewide Protocol Medications for Opioid Use Disorder, 3 CCR 719-1, app 3 CCR 719-1-G. Accessed October 12, 2025.

19. The Controlled Substances Act requires any "practitioner" who prescribes, administers, or dispenses controlled substances to have a valid DEA number, Controlled Substances Act, 21 USC §823 (2024). Accessed October 12, 2025. 

20. Evans A., Prescribing Authority for Pharmacists: Rules and Regulations by State, GoodRx Health, July 22, 2022,Accessed October 12, 2025.

21. Alaska, Georgia, Louisiana, Maine, Maryland, Massachusetts, Mississippi, Missouri, Montana Nebraska, New Mexico, North Carolina, North Dakota, Nevada, Pennsylvania, Rhode Island, South Dakota, Texas, Washington, West Virginia, Wyoming each require CPA submission or approval. National Alliance of State Pharmacy Associations, State-by-State Look at Pharmacist CPAs, Accessed October 12, 2025.

22. American Pharmacists Association. Collaborative practice now allowed in all 50 states. Pharmacy Today. 2025;31(1):12, Accessed October 12, 2025.

23. American Pharmacists Association. Collaborative practice now allowed in all 50 states. Pharmacy Today. 2025;31(1):12, Accessed October 12, 2025.

24. Hincapie AL, Goad JA. Reimbursement for pharmacist-provided services. J Am Pharm Assoc (2003). 2021;61(1):27-32. Accessed October 12, 2025.; California Pharmacists Association. Payment for Pharmacist Services [white paper]. 2015. Accessed October 12, 2025.

25. Kirby M. State Laws Allowing Pharmacists to Bill Commercial Insurers for Certain Services. Connecticut Office of Legislative Research; 2025. Report No. 2025-R-0226. Accessed October 12, 2025.