Is Your Independent Pharmacy Ready for New Therapies and Innovations?

For decades, independent pharmacies have built their businesses around dispensing medications and providing personalized service to patients in their communities. That model remains fundamental, but the environment surrounding it is changing. Reimbursement pressures, increasingly complex payer requirements, and evolving pharmacy benefit manager practices have made reliance on traditional dispensing alone more challenging for many independent pharmacies.

At the same time, the therapies entering clinical practice are becoming increasingly diverse and, in many cases, more complex. In 2025, the FDA's Center for Drug Evaluation and Research approved 46 novel drugs addressing conditions including cancer, infectious diseases, cardiovascular and kidney conditions, endocrine and inflammatory disorders, and rare diseases.^1,2

The question is not whether a pharmacy needs to adopt every innovation. It is whether the pharmacy is prepared to recognize the right opportunities and determine what is required to deliver them safely, efficiently, and sustainably.

READ MORE: The Legislation Setting the Stage for Pharmacy’s Next Leap

Know What Is Coming

Owners can begin by reviewing the conditions most commonly treated in their practice and talking with local prescribers about emerging treatment trends. Are newer specialty medications becoming common? Are patients asking about weight-management treatments or biologics?

Keeping up with newly approved medications, clinical guidelines, therapeutic pipelines, and payer requirements can provide an early indication of where pharmacy practice is heading. This does not require tracking every drug in development. The goal is to recognize trends early enough to determine whether the pharmacy should participate.

Conduct a Pharmacy Readiness Assessment

Once a potential opportunity is identified, owners should evaluate whether the pharmacy has the infrastructure to support it. Biologics, specialty medications, and other emerging therapies may have more complex storage, distribution, administration, or monitoring requirements. Depending on the therapy, this may involve refrigeration or freezer capacity, temperature monitoring, specialized storage, or other handling requirements.

Cold-chain management deserves particular attention, not because refrigerated medications are new to community pharmacies, but because the range and complexity of temperature-sensitive therapies are expanding. Insulin, for example, has long required appropriate refrigerated storage. Newer biologics, biosimilars, and injectable therapies may have similarly specific storage requirements.³ Pharmacies handling these products should have appropriate refrigeration, temperature monitoring, documentation, and procedures for managing excursions consistent with product labeling, applicable United States Pharmacopeia standards, state requirements, and relevant payer or accreditation requirements.³ For higher-cost refrigerated medications, reliable equipment, monitoring and alarms, and contingency plans for equipment or power failure can provide additional risk management.²

Infrastructure decisions should be based on the pharmacy's anticipated needs rather than simply following the newest trend. A pharmacy may not need to make a major capital investment immediately. However, infrastructure alone does not establish readiness. Owners should also assess whether the pharmacy team has the clinical knowledge necessary to counsel patients, identify medication-related problems, recognize adverse effects, and determine when intervention or referral is warranted.

Technology deserves the same scrutiny. Owners should evaluate whether their pharmacy management and documentation systems can support relevant requirements, including product identification, inventory and lot tracking when applicable, Risk Evaluation and Mitigation Strategies (REMS) documentation, prior authorization workflows, and manufacturer assistance programs.⁴

Build the Workflow Before the Prescription Arrives

Complex therapies can introduce additional steps throughout the medication-use process, including benefits investigation, prior authorization, special medication storage, documentation, and follow-up. Establishing a defined workflow for gathering required information, communicating with prescribers, tracking authorization status, and identifying financial assistance options can reduce delays and rework while clarifying staff responsibilities. Building these processes before the first prescription arrives can improve therapy initiation and prevent administrative demands from disrupting routine pharmacy operations.

Do Not Confuse Access With Viability

The ability to obtain a medication does not necessarily mean that a pharmacy should routinely stock it. Specialty and biosimilar products often carry high acquisition costs and narrow margins, which can tie up substantial working capital and create financial risk if a prescription is delayed, denied, abandoned, or changed. Owners should understand acquisition cost, expected reimbursement, payment timing, return policies, expiration dates, and the risk of maintaining inventory that may not be dispensed. Before purchasing an expensive therapy, consider whether it should be stocked, ordered on demand, or obtained through another distribution arrangement.

Train the Entire Team

A new therapy cannot be safely managed by a single knowledgeable pharmacist. The team should understand the responsibilities relevant to their roles. Pharmacists may need education regarding indications, dosing, contraindications, interactions, adverse effects, monitoring, administration, and counseling. For injectable therapies such as glucagon-like peptide-1 receptor agonists, readiness extends beyond storage. Pharmacists should understand device-specific instructions, common adverse effects, and appropriate counseling points. Technicians may require training in ordering, receiving, storage, inventory management, benefits investigation, documentation, and refill coordination within their scope of practice.

Biosimilars provide another example. Pharmacists should understand the distinction between biosimilars and generic drugs, the FDA's interchangeable designation, how state law affects substitution, product-specific labeling, and how payer preferences may affect product selection.^5,6 Continuing education focused specifically on biosimilar science, interchangeability, and payer considerations can help close this gap.⁷ Clear communication is also important when patients or prescribers have questions about biosimilars and their reference products.

For medications subject to REMS, the challenge is maintaining an efficient workflow as needs evolve. New therapies may introduce pharmacy certification, pharmacist training, patient enrollment, laboratory monitoring, documentation, or coordination requirements that need to be integrated into existing processes.⁸ Rather than treating REMS as a separate administrative function, pharmacies should incorporate these into medication dispensing and clinical workflows. Designating responsibility for monitoring REMS and related manufacturer or specialty-program requirements can help ensure that program changes are identified promptly, staff remain appropriately trained, and patients do not experience unnecessary delays in therapy.⁴

Measure the Opportunity

New services should be evaluated not only by prescription volume but also by the resources required to deliver them. Owners can track measures such as acquisition and reimbursement costs, staff time, prescription abandonment, inventory turnover, clinical interventions, and patient satisfaction. These data can help determine whether a service is creating sustainable value and where workflow improvements are needed.

You do not need to compete by becoming everything to everyone. Your advantage may lie in doing fewer things exceptionally well. The future of independent pharmacy will likely include increasingly complex therapies, personalized treatment approaches, digital tools, and expanded pharmacist involvement in patient care.

Success will require strategic decisions about which opportunities align with the pharmacy's patients, capabilities, and business model. By selecting the right opportunities, investing in infrastructure, training staff, and measuring results, independent pharmacies can turn therapeutic complexity into an opportunity to strengthen patient care, differentiate their practice, and support sustainable growth.

READ MORE: Technology, Trust Are Reshaping the Future of Pharmacy Together

REFERENCES

1. Novel drug approvals for 2025. FDA. Updated July 8, 2026. Accessed August 10, 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025

2. Center for Drug Evaluation and Research. Advancing Health Through Innovation: New Drug Therapy Approvals 2025. FDA. January 2026. Accessed August 16, 2026. https://www.fda.gov/media/190705/download

3. USP General Chapter <1079> Good Storage and Shipping Practices. US Pharmacopeia Accessed September 14, 2026. http://ftp.uspbpep.com/v29240/usp29nf24s0_c1079.html

4. Roles of different participants in REMS. FDA. Updated May 7, 2024. Accessed August 16, 2026. https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-participants-rems

5. Biosimilars: overview for health care professionals. FDA. Updated August 1, 2024. Updated August 10, 2026. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals

6. Biosimilar and interchangeable biologics: more treatment choices. FDA. Updated August 17, 2023. Accessed August 16, 2026. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices

7. Education. National Community Pharmacists Association. Accessed August 10, 2026. https://ncpa.org/education

8. What's in a REMS? FDA. Updated January 26, 2018. Accessed August 16, 2026. https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/whats-rems