For most of pharmacy history, the therapeutic product has been relatively easy to define. A prescriber chooses a medication, a pharmacist dispenses it, and the patient uses it according to the instructions.
Software is beginning to complicate that picture.
On October 20, the FDA finalized guidance explaining how drug manufacturers can develop, distribute, and label software used alongside prescription medicines. The agency calls this category Prescription Drug Use-Related Software, or PDURS. It can include software connected to a medical device, such as an app paired with an inhaler, as well as standalone tools that provide dose reminders, symptom tracking, health coaching, or other medication-related support.
The guidance matters because FDA is no longer treating every companion app as something that simply sits beside the medication. Under certain circumstances, the software can become important enough to appear in the drug’s official prescribing information.
That creates a much bigger story for pharmacy.
The therapeutic experience is starting to expand beyond the molecule itself. A future treatment may combine the medication with software, patient-generated data, monitoring, education, and digital support.
If that happens at scale, pharmacists will need to understand more than what comes in the bottle.
FDA is defining when software becomes part of the drug story
The new guidance focuses on software distributed by or on behalf of a drug sponsor and used with one of the sponsor’s prescription products. FDA considers the software’s end-user output, meaning the information shown to a patient, caregiver, or healthcare professional, a form of prescription drug labeling.
That does not mean every app associated with a medication automatically becomes part of the drug’s official label.
FDA draws an important distinction between device-connected software and standalone software. An app connected to a medical device, such as software paired with an inhaler, generally should be described in the drug’s prescribing information because the software may play a direct role in how the medicine is used.
Standalone software faces a different test. A dose-reminder app, symptom tracker, or coaching program may appear in the prescribing information when evidence shows that the software is essential for safe and effective use or produces a meaningful improvement in a clinical outcome. Otherwise, the information shown through the app will generally fall under FDA’s rules for promotional labeling.
That is a meaningful regulatory line.
Software is not automatically part of the therapy because a manufacturer built an app. It has to earn that role through evidence.
The prescription could start carrying a digital layer
The American Telemedicine Association highlighted one example from the final guidance involving a standalone mobile app with dose reminders, health tracking, and behavioral coaching. In FDA’s example, the software showed a meaningful improvement in HbA1c when used with the medication. That type of evidence could support describing the software in the drug’s required labeling.
Think about what that means from a patient’s perspective.
A future prescription may not simply tell someone which medication to take and how often to take it. The complete treatment experience could also include an app that helps the patient remember doses, records symptoms, tracks relevant health information, provides individualized education, or communicates information back to the care team.
Another therapy might use software connected to a device. The patient could receive medication through an inhaler, injector, or other delivery system while software captures information about how the therapy is being used.
These functions already exist in different forms across healthcare. The new guidance creates a clearer path for manufacturers that want to connect them more formally to a prescription product.
FDA Deputy Commissioner for Technology Jared Seehafer said companion apps are moving beyond simple reminders toward tools that adapt to individual patients. FDA’s goal is to give manufacturers a clearer framework while making sure patients and healthcare professionals can trust the information the software provides.
The long-term implication is easy to miss.
A medication can increasingly have both a chemical component and a digital component.
This changes what we mean by medication expertise
Pharmacists have traditionally built their expertise around the drug. We study the mechanism, dose, interactions, contraindications, monitoring, adverse effects, administration, and evidence supporting its use.
Those responsibilities do not disappear when software enters the picture.
However, another layer gets added.
Imagine counseling someone on a medication that works best when paired with software that tracks symptoms and provides dosing support. The patient may ask whether the app is necessary, what information it collects, how the data affect treatment, what happens if the phone stops working, or whether the healthcare team can see the information.
A connected device may introduce different questions. Is the device syncing correctly? Does the software affect how the dose is delivered? What does a missed data point mean? Is the patient using the digital component correctly even if they understand the medication itself?
Those may not all become pharmacist responsibilities. Different products will involve different care teams, technologies, and workflows.
Still, the underlying principle matters.
If software changes how a medication is safely or effectively used, understanding the therapy may eventually require understanding the software around it.
That expands the definition of medication expertise.
The pharmacist could become the translator between the drug and the digital experience
This is where the opportunity becomes especially interesting.
Healthcare technology companies know how to build software. Drug companies know how to develop medications. Device companies understand hardware. Data teams know how to create analytics.
Patients experience all of those pieces together.
Someone still has to help translate the complete therapy into something a patient can actually use.
Pharmacists already do a version of that work. We translate pharmacology into practical instructions. We explain what to expect, what to monitor, when to call for help, and how a medication fits into the rest of a patient’s treatment.
Digital tools create new questions around that same responsibility.
A pharmacist may eventually help determine whether patients understand both the medication and the companion software. Another pharmacist may work inside a pharmaceutical company helping design the patient experience around a PDURS product. Someone else may support implementation inside a health system, specialty pharmacy, or digital health company.
Other pharmacists could work on medication adherence, remote monitoring, digital product strategy, clinical informatics, patient support, regulatory affairs, or evidence generation around the software itself.
The job title may not always say pharmacist.
The value still comes from understanding the therapy.
Evidence will determine whether the software is more than an accessory
One of the most important parts of FDA’s guidance is that it does not treat every digital feature as clinically meaningful.
A manufacturer cannot simply add an attractive app and imply that the drug works better because the software exists.
FDA expects evidence.
ATA Action emphasized that the final guidance recognizes meaningful clinical improvement as a pathway for standalone software to appear in FDA-required labeling. The organization also noted that FDA allows adequate and well-controlled studies to incorporate real-world data when appropriate.
That raises an important question for pharmacists: how do we evaluate the software component of therapy?
We already ask whether the drug improved a meaningful endpoint. We examine study design, comparator groups, patient populations, adverse events, and limitations.
Similar thinking may increasingly apply to digital components.
Did the software actually improve adherence, symptoms, glycemic control, or another meaningful outcome? Was the improvement caused by the software or simply by more patient contact? Which patients benefited? How much engagement did the software require? Would the results hold up outside a clinical trial?
A polished user interface does not create clinical value.
Evidence does.
That makes this area a natural intersection between pharmacy, clinical research, digital health, and regulatory science.
Pharma companies now have another product-development question
The guidance also changes the strategic conversation inside pharmaceutical companies.
Historically, a manufacturer developing a medication focused on the drug itself, its formulation, clinical program, manufacturing, labeling, market access, and commercial strategy.
Now a company can ask another question: could software make this therapy safer, easier to use, or more effective?
For some products, the answer will be no. A companion app would add complexity without enough value.
For others, software could address a major limitation.
A treatment with difficult adherence might benefit from digital support. A medication that requires frequent symptom monitoring could connect that information to the patient’s treatment journey. Another therapy might pair with behavioral coaching because outcomes depend partly on what happens between doses.
The manufacturer then has to decide whether the software is simply a supportive service or something important enough to generate clinical evidence around.
FDA’s final guidance gives companies a more predictable framework for making that decision. ATA Action called the policy a significant step because it confirms that standalone software does not need to be physically connected to a device to demonstrate clinical benefit.
That could encourage more drug developers to think about software earlier in development.
This also creates new career intersections for PharmDs
For pharmacists exploring nontraditional careers, PDURS is another example of why it helps to follow healthcare functions rather than familiar job titles.
A pharmaceutical company developing medication-plus-software products may need people who understand digital product development and pharmacotherapy. Regulatory teams will need professionals who can interpret FDA’s labeling framework. Medical affairs teams may need to explain how the software fits with the medication.
Clinical-development teams may help generate evidence showing whether the digital component improves outcomes. Patient-support organizations may need to integrate the software into education and adherence programs. Health systems may need to decide how these products fit into existing clinical workflows.
Specialty pharmacies could face an especially interesting challenge. Many already support complex therapies with intensive education, monitoring, access services, and follow-up. Adding validated software could make the therapy even more integrated.
Pharmacists do not need to become software engineers to participate.
They do need enough digital fluency to understand what the technology does, what evidence supports it, where it fits into the medication workflow, and what happens when the patient cannot or does not use it correctly.
That is a very different skill set from traditional dispensing, but it builds directly on pharmacy’s core expertise.
The boundaries between drug, device and software are getting less obvious
FDA’s guidance also reflects a broader shift in healthcare regulation.
The agency developed the final policy across multiple centers, including the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Oncology Center of Excellence, and Office of Combination Products.
That cross-agency involvement makes sense because modern therapies increasingly cross traditional product categories.
A drug may come with a connected delivery device. The device may communicate with software. The software may generate information for the patient or healthcare professional. Part of the software may fall under medical-device regulation while another part may fall under drug-labeling rules.
From the patient’s perspective, none of those regulatory distinctions matter very much.
They received one therapy.
That is another reason pharmacists should become comfortable working at the intersections between disciplines.
Healthcare may continue organizing expertise into separate departments, but patients experience the finished product as one connected treatment journey.
Learn one new term: PDURS
For pharmacists, there is a simple way to start exploring this area.
Learn what Prescription Drug Use-Related Software means.
Then look beyond the acronym.
Find one medication or therapeutic area where software could realistically improve how patients use treatment. Ask what the digital component would need to accomplish for it to create meaningful value.
Would it improve adherence? Help detect side effects earlier? Support dosing? Collect patient-reported outcomes? Connect with a device? Make education more personalized?
Next, ask what evidence you would require before considering that software part of the therapeutic strategy rather than an optional app.
That is the more important exercise.
The future of digital pharmacy will not depend on how many apps healthcare can create. It will depend on whether those tools measurably improve what happens to patients.
The therapeutic product is becoming a system
The October 20 guidance does not mean every prescription will soon come with an app. Nor does it mean software suddenly becomes equivalent to a drug.
FDA’s policy is more measured than that.
The agency is creating rules for a world in which software can sometimes play an important role in how prescription drugs are used. When that role becomes clinically meaningful, the software can move closer to the center of the therapeutic product.
That direction should matter to pharmacists.
For most of pharmacy history, medication expertise centered on what was inside the bottle, vial, syringe, inhaler, or device.
The next generation of therapies may ask pharmacists to understand something broader: the drug, the software, the data, the monitoring, and the patient experience connecting all of them.
That does not make pharmacy less about medications.
It expands what a medication can be.
And if software becomes part of how a therapy works safely and effectively, pharmacists should be asking where they belong in that new treatment model before the answer gets decided without them.
Resources & Citations
- U.S. Food and Drug Administration. “FDA Issues Final Guidance on Prescription Drug Apps and Software.” October 20, 2026. Primary FDA announcement describing the final PDURS framework, including device-connected and standalone software, when software may appear in prescribing information, and how FDA will treat end-user output.
- U.S. Food and Drug Administration. “Regulatory Considerations for Prescription Drug Use-Related Software.” Final Guidance for Industry, October 2026. The final guidance explains how FDA applies drug-labeling authorities to software distributed by or on behalf of prescription drug sponsors and describes when sponsors should include software functions in prescribing information or submit end-user output for FDA review.
- ATA Action. “ATA Action Applauds FDA’s Final PDURS Guidance, Recognizing Standalone Software’s Role in Improving Drug Therapy.” October 20, 2026. ATA Action’s analysis highlights FDA’s recognition of standalone software, meaningful clinical improvement as a pathway to required labeling, use of real-world evidence where appropriate, and the guidance’s standalone software example involving HbA1c improvement.
- Regulatory Affairs Professionals Society. “FDA Finalizes Guidance on Prescription Drug Apps.” October 20, 2026. Independent regulatory coverage of the final guidance, including changes from the 2023 draft, the new decision tree, labeling examples, standalone software, and FDA’s approach to app updates and promotional labeling.
