How to Start a Pharmacy Delivery Service in the United States

More than 60 million Americans are now over 65, making them 18% of the total US population. By 2040, one in five US residents will fall into this age group. The Centers for Disease Control also estimates that 129 million Americans live with at least one chronic disease. Both of these figures drive demand for prescription medications and repeat pharmacy visits. Consumers have also come to expect everything (even prescription medications) delivered directly to their doorstep. All these points lead to a promising business model: pharmacy delivery. 

US retail pharmacy sales are projected to reach $818 billion by 2032, with the online pharmacy segment more than doubling in size by 2029. Pharmacy delivery is no longer a fringe service — it’s becoming a standard revenue channel. You’ll need to follow some strict regulations, but if you’re an organized delivery company, pharmacy delivery could be your key to growth. 

This guide breaks down how to launch a pharmacy delivery service in the United States. We’ll cover what delivery model to choose, how to navigate the legal requirements, and which tools — like Shipday — can help you operate safely and scale while meeting HIPAA and DEA requirements..

Why pharmacy delivery is in demand

Three major trends are driving the growth of pharmacy delivery: an aging population, rising prevalence of chronic illnesses, and consumer demand for convenience. The US population aged 65 and up grew by 13% between 2020 and 2024. Almost 80% of Americans over 65 take at least two daily prescription medications. Nearly half of the US population— 47%-- live with at least one chronic health condition that requires daily medication. 

Technology adoption accelerated during the pandemic and never reversed. Take a look at the mail-order and online pharmacy segment: it accounts for less than 10% of prescriptions, but has gained significant traction. Convenience innovator Amazon has seen rapid growth in its Amazon Pharmacy since its launch in 2020. 

The short answer? Many Americans need daily prescription medications. And they want those medications delivered to their front door. 

Understanding the regulations

To operate a pharmacy delivery business, you’ll need to navigate multiple layers of federal and state regulations. These regulations protect patient privacy and ensure medications are delivered safely. 

These are the key laws and regulatory offices you need to know: 

• Food and Drug Administration (FDA):  The US Food and Drug Administration oversees and manages all medication distribution in the United States. Delivery services must maintain the integrity of FDA-approved labeling and packaging throughout the transportation process.
  
  
• Drug Enforcement Administration (DEA): The DEA enforces the Controlled Substances Act, which determines which drugs are “controlled substances.” If you plan to deliver prescriptions for medications that are on DEA’s controlled lists, you’ll need to adhere to strict documentation and handling requirements. 
  
  
• Health Insurance Portability and Accountability Act (HIPAA): This law protects patient privacy. In general, all patient health must be kept private; only the minimum necessary information should be disclosed for healthcare operations and payment purposes. HIPAA compliance affects how delivery services collect, store, and transmit customer information.
  
  
• State Board of Pharmacy: State Boards of Pharmacy set regulations for their respective states, and regulations can vary widely.  Even facilities without a physical presence in a state, such as mail order or internet pharmacies, may find themselves subject to licensing requirements when they dispense controlled substances in a new state. You’ll need to understand licensing requirements in any state where your delivery service operates. 

Strict rules create barriers to entry. That can work in your favor. They help keep out competitors (even major players like Uber and Doordash) that don’t want to do the work. Compliance is also no place to skimp. Spend the money to retain an attorney who specializes in healthcare regulations to advise you if your plans comply with necessary laws. 
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Building your pharmacy delivery service step-by-step

Whether you're a pharmacy adding delivery or an independent courier service entering the healthcare services market, the steps to start your business are similar. 

Step 1: Select your delivery model Find pharmacy clients

As a delivery service entering the pharmacy market, you first need to identify and secure partner pharmacies that need reliable delivery services. Building those partnerships starts with understanding what pharmacies in your location need, then showing them how your service can deliver. 

• Understand what pharmacies need: Pharmacies choose third-party delivery partners to reduce capital investment in vehicles and insurance, eliminate driver management headaches, and access compliance expertise they may lack. Some pharmacies may already operate with a hybrid delivery model, where they handle some deliveries in-house while partnering with services (like yours) for overflow capacity, extended hours, or broader coverage areas. Learn your local pharmacies’ pain points, then solve them with your delivery model.
  
  
• Target the right pharmacies: Independent pharmacies and small, local chains are your best prospects. They often lack the resources to manage their own delivery fleet but need to compete with larger chains offering delivery. Specialty pharmacies handling high-value medications also seek trusted delivery partners with proven compliance capabilities.
  
  
• Position your service strategically: Differentiate yourself from general delivery platforms like Uber or DoorDash by emphasizing HIPAA and DEA compliance expertise and any specialized training you provide for for medication handling, chain-of-custody documentation, and customer service.
  
  
• Start your outreach: Contact local pharmacy managers or owners directly. Lead with how you solve their specific challenges: reducing delivery costs, extending their reach, or handling peak demand. Consider offering exclusive partnerships to early clients or multi-pharmacy service models that benefit from route optimization.

Remember, pharmacies are betting their reputation on your service. Show them you understand the unique requirements of medication delivery and have systems in place to protect both their business and their patients.

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Step 2: Register and insure your business

Before handling any patient information or medications, you’ll need to register your business and obtain the required licenses and insurance. You’ll need to register your business with both the federal and state governments. If you are already an established business, you’ll have already done this. Both new and established businesses should also verify that their insurance coverage fully protects both general and medical delivery operations.

These are the key steps: 

• Federal registration includes obtaining an Employer Identification Number (EIN) from the Internal Revenue Service (IRS)  that you’ll use to file annual taxes. If you transmit patient health information electronically, you may also need to register for a National Provider Identifier (NPI) number. Both of these registrations are free.
  
  
• State licensing requirements depend on your service model and location. Almost every state requires that any pharmacy shipping or mailing prescription medications into their state possess a local business license. If you operate solely as a delivery service for multiple pharmacies, you may need additional permits or licenses, depending on state regulations. Each state’s Secretary of State’s Office will generally have all the information you need.
  
  
• Insurance coverage must address the unique risks of healthcare delivery. Standard commercial auto and general liability policies may not cover prescription medication transport, patient privacy breaches, or security requirements for controlled substances. Work with an insurance agent experienced in healthcare logistics to ensure you have appropriate coverage for vehicle operations, professional liability, and cybersecurity incidents.

Even existing businesses should contact their insurance agent to check that their policies cover a pharmacy delivery operation. You may need to add some form of commercial auto coverage or a policy that covers prescriptions while they are in transit. Insurance gaps are easy to overlook and expensive to fix later. 

Step 3: Define service area and policies

Successful pharmacy delivery services start with clearly defined boundaries, both geographically and operationally. You likely can’t deliver to an entire city overnight. And you likely don’t want to accept order requests 24 hours a day. Now is the time to decide on your operational policies. 

Get specific about your:

• Delivery area: If you start by delivering to a larger area than you can handle, customer service will suffer. Starting too small can reduce your profits. Set your delivery area based on major landmarks or zip codes.
  
  
• Order placement procedures: Determine when customers can place orders and how. Will you accept orders direct from patients, or only from pharmacies? Will you accept orders at all hours, or have a daily order cut-off time? Can customers request a specific delivery window, like between 9am and noon?
  
  
• Customer service format: How will customers communicate with your team? Will you have two-way SMS text messaging? Or will customers call a staffed phone number with questions or complaints? For your most frequently asked questions, an AI-enabled chatbot may be a good answer. 

Don’t worry too much about how you will do these things at this step. There are tech tools to help you roll out pretty much any policy you can think of. Right now, you’re deciding what policies you want to have; we’ll look at tools for implementing your policies in step 5. 

Step 4: Develop standard operating procedures (SOPs)

So you’ve decided on customer-facing policies, now is the time to look inward. Standard operating procedures (SOPs) keep your team on the same page throughout the delivery process. Written procedures ensure consistent service quality and compliance with regulations. Written documentation can also protect your business during audits or investigations; they demonstrate your systematic approach to compliance requirements.

These are some critical areas to develop SOPs: 

• Prescription verification procedures prevent dispensing errors and ensure proper authorization. Document how your team confirms prescription validity and handles prescription transfers from pharmacies.
  
  
• Secure handling protocols ensure the protection of medications throughout the delivery process. Different medications require different handling; some need refrigeration, others require tamper-evident packaging, and controlled substances require additional security measures. Create specific procedures for packaging, transport, and customer handoff for each medication category.
  
  
• Customer identification and delivery confirmation procedures ensure medications reach intended recipients.Your procedures must document how you will confirm patient identity and how you will log delivery confirmation. By patient signature or photo documentation? Maybe both?
  
  
• Privacy protection measures address HIPAA requirements throughout your operation. HIPAA violations include unauthorized access to patient health information, inadequate security measures, improper handling of prescriptions, and failure to train staff on HIPAA compliance. Document how your team handles patient information and disposes of any materials containing protected health information.

Step 5: Build your technology infrastructure

Now you know what your business needs to do— accept orders, route drivers, and comply with regulatory laws. It’s time to figure out exactly how you will do those things. You’ll be relieved to hear there are many software tools available to handle (and even automate) many of these tasks. 

They include: 

• Order management systems: Your operation needs to handle orders from multiple sources - phone calls, online portals, and mobile apps - while maintaining accurate information throughout the process.
  
  
• Route optimization and driver management: These tools communicate with real-time traffic maps to generate the most efficient routes for your drivers.  Advanced systems can optimize delivery routes based on medication priority, customer preferences, and driver capabilities.
  
  
• Customer communication tools:  These messaging tools send automated notifications about order confirmation, preparation status, and delivery windows help manage customer expectations. Real-time tracking matters especially for customers waiting for essential medications.
  
  
• Compliance documentation systems: These tools document chain of custody, delivery confirmations, and customer identity verification; key components of a HIPPA and DEA compliant pharmacy delivery operation. 

You may cobble together solutions for all of these individual tasks. But delivery management systems (DMSs) like Shipday provide integrated solutions to tackle all of these jobs. A DMS centralizes orders, automates route optimization, sends real-time customer notifications, and logs compliance documentation. 

Frequently asked questions (FAQs) 

Q: Can controlled substances be delivered in the United States? 

A: Yes, but with strict requirements. DEA regulations permit the transfer of controlled substance prescriptions between pharmacies and their delivery to patients, but require specific documentation, secure handling, and identity verification procedures. Many delivery services start with non-controlled medications and add controlled substances after establishing compliant operational procedures.

Q: Do delivery drivers need special licensing or training? 

A: While drivers typically don't need pharmaceutical licensing, they must receive training on patient privacy, secure handling procedures, and customer identification requirements. All pharmacy staff are required to comply with HIPAA Rules, as well as volunteers and interns that come into contact with patient health information. This training requirement applies to delivery personnel who handle patient information.

Q: Can I use standard delivery apps like Uber or DoorDash for pharmacy delivery? 

A: No. Major delivery platforms often lack the necessary compliance infrastructure for delivering prescription medications, particularly in terms of patient privacy and controlled substance security.

Q: What insurance coverage do I need? 

A: Standard commercial auto and general liability policies may not cover prescription delivery risks. You'll likely need specialized coverage for professional liability, cybersecurity incidents, controlled substance transport, and patient privacy breaches. Work with an insurance broker experienced in healthcare logistics to ensure adequate protection.

Putting it all together

Starting a pharmacy delivery service requires substantial upfront investment in compliance systems, technology, and procedures. However, operators who build proper foundations find consistent demand from an aging population that increasingly values healthcare convenience. Strict rules intimidate many potential competitors. Success requires more than just an understanding of transportation logistics. You're entering the healthcare industry. Patient safety, privacy protection, and regulatory compliance are just as important as speed. 

Shipday was built for this — healthcare delivery at scale, with the compliance features you need from day one. Start free and run your pharmacy delivery operation safely and confidently.

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