A Guide to Shipping Prescription Drugs
by Jaidyn Farar
When modern medicine meets modern logistics, the results are extraordinary: people can access life-preserving medications without leaving the comfort of their homes. And as one research paper points out, “Studies have consistently found that mail-order medications are associated with reduced healthcare costs and better health outcomes.”
Pretty amazing, right?
In our new ebook, “Medicine on the Move: A Guide for Safe and Swift Pharmaceutical Shipping,” we cover everything you need to know about shipping prescriptions:
- Package security
- The pharmaceutical cold chain
- Tips for patient-centric delivery
- And much more!
Read on to learn the basics of shipping prescription drugs, then download the ebook for free to dive even deeper.
Can you send prescription drugs through the mail?
You can send prescription drugs through the mail as long as you adhere to legal and safety guidelines. Let’s take a closer look at who’s allowed to ship prescriptions.
- Registered with the DEA. In general, only organizations registered with the Drug Enforcement Administration (DEA), such as drug manufacturers, pharmacies, and other licensed dispensers, can ship prescription drugs.
- Exempt from DEA registration. Military personnel, law enforcement officials, and those involved in civil defense are exempt from DEA registration and can ship prescriptions.
- Licensed in the state you’re sending to. Your organization needs to be licensed in the states you ship prescriptions to. (Note: While this article will focus on domestic shipping, you can find more information on international prescription shipping here.)
Before moving on, let’s quickly review the three types of drugs you may handle, as defined by the Food, Drug, and Cosmetic Act and the Controlled Substances Act:
- Prescription drugs. Prescription drugs are used to treat specific medical conditions and require a prescription from a licensed healthcare provider. While individuals cannot ship prescription drugs, licensed businesses are allowed to—as long as they follow federal laws and carrier regulations. See the section “How to send prescription drugs by mail” for more information.
- Over-the-counter (OTC) drugs. Over-the-counter drugs don’t require a prescription, so consumers can buy them without going through a healthcare provider. Pain relievers and cough syrups are common OTC drugs. Anyone can send OTC drugs in the mail as long as they follow packaging and labeling regulations.
- Controlled substances. Controlled substances are strictly regulated by the U.S. government. While some controlled substances are illegal, others have legitimate medical uses. Licensed healthcare providers are allowed to ship the latter type.
How to send prescription drugs by mail
To tap into the benefits of shipping prescription drugs, it’s essential to follow federal and state laws. Otherwise, mailing prescriptions could lead to trouble for patients and devastating consequences for your pharmacy.
When done correctly, mailing prescriptions to patients is a real time-saver. Every year, more people take advantage of this convenient way to access their medications; between 2016 and 2021, the number of people receiving prescriptions from mail-order pharmacies increased by 35%.
But when pharmacies cut corners on pharmaceutical shipping, the results can be disastrous. So how can you send prescription drugs the right way? We’ll break down the process into four steps.
Know the rules and regulations
Before you begin shipping prescription drugs, you need to thoroughly understand the rules and regulations that govern the process.
Federal Laws
Many federal laws relate, either directly or indirectly, to shipping prescription drugs. This list provides a brief overview of each one, as well as links you can follow to learn more.
- Controlled Substances Act (CSA). The CSA defines and classifies controlled substances, including prescriptions, and states which ones can be used for medical purposes.
- Food, Drug, and Cosmetic Act (FDCA). The FDCA grants the Food and Drug Administration (FDA) authority to regulate the safety, packaging, and labeling of drugs.
- Poison Prevention and Packaging Act of 1970 (PPPA). The PPPA is a federal law meant to help prevent accidental poisonings, especially among children. Under the law, prescription and OTC drugs must have child-resistant packaging.
- Drug Enforcement Administration (DEA) Regulations. Pharmacies must adhere to DEA regulations for handling and shipping controlled substances. This includes record-keeping, security, and reporting requirements.
- Ryan Haight Online Pharmacy Consumer Protection Act. This law (an amendment of the CSA) requires pharmacies to meet specific criteria when dispensing controlled substances via the internet.
- Drug Supply Chain Security Act (DSCSA). The DSCSA establishes requirements for the tracing and tracking of prescription drug products throughout the supply chain. The DSCSA was enacted in 2013, and the deadline for enforcement has been extended to November 27, 2024.
- Health Insurance Portability and Accountability Act (HIPAA). While not specific to shipping, HIPAA protects patients' privacy and the security of their medical information, including prescription details.
State Laws
Laws vary by state, and many states have specific regulations built around shipping controlled substances. Before shipping to any state, you should research their laws so you don’t unknowingly violate them.
Assemble and label packages properly
When shipping prescription drugs, it’s important to package them securely and include the right labeling and documentation. Doing so keeps the medications safe and helps patients use them correctly.
- Use secure packaging. To protect against moisture, light, and temperature, use secure, tamper-evident packaging. Make sure the material is sturdy enough to withstand rough handling.
- Include cold packs when necessary. Some prescriptions need to be kept refrigerated or they lose effectiveness. To ship these drugs, include cold packs and use insulated boxes. You should also include temperature indicators that confirm to patients that their medications arrive at the optimal temperature.
- Add required documentation. Include any necessary documentation, such as instructions for ordering a refill.
- Label packages clearly. Label packages with the recipient's name and address, as well as your business’s return address. Verify addresses to make sure the order won’t be delivered to the wrong person or get lost in the mail. If an order needs to be kept cold, add a "Keep Refrigerated" label.
USPS lays out specific guidelines for packaging different types of drugs.
- Controlled substances. When mailing a controlled substance, the inside packaging needs to be sealed and marked according to the regulations of the Controlled Substances Act. It should show the prescription number and name and address of the sender. Leave the outer packaging plain, with nothing indicating what’s inside.
- Other drugs and medicines. Packages containing non-controlled substances need to have plain outer packaging.
- Promotional samples. If you’re sending a sample of an over-the-counter drug, include the words “Sample Enclosed” on the outside.
Choose a shipping method
While the proper packaging will help protect the drugs you ship, you should also select the right shipping method. When you choose a carrier, make sure they’re reliable. Do they have a track record of delivering packages on time? Can they meet specific shipping requirements, such as cold storage or special handling?
Shipping routes and delivery times come into play here too. It’s crucial to ship temperature-controlled packages quickly (next-day or 2-day) so the coolant stays effective during transit. Keep in mind that the day you send a package can impact its delivery time. For example, if you send a temperature-controlled package on a Friday and it ends up sitting in a warehouse all weekend, the customer may find that their much-needed medication is ruined.
Communicate with recipients
Communicating with your customers helps them get their prescriptions without any issues and use them properly. Start by notifying recipients of the expected delivery date, and provide real-time tracking information so they can follow their order’s progress. Package tracking minimizes the chances packages will sit out on doorsteps for hours, potentially damaging the medications inside.
Additionally, you should include clear instructions for how the customer should store and handle the medications. Include your team’s contact information and encourage people to reach out with questions or concerns. Finally, to add an extra layer of security, consider requiring a signature when the package is delivered.
Sending drugs through USPS, UPS, FedEx, and DHL
When it comes to shipping prescription drugs, you should choose the right carrier to ensure safe and compliant delivery. The best way to learn about the rules and regulations of a specific carrier is to contact their support team, but we’ll include some general guidelines here.
USPS
The USPS provides detailed information about the types of drugs that may and may not be mailed (you can find it here). USPS notes that senders are responsible for complying with federal laws regarding mailing medications.
UPS
UPS has a dedicated healthcare logistics division specializing in pharmaceutical shipments. They offer cold chain storage, packaging, and transportation management to help your shipments reach their destination in time and intact.
FedEx
FedEx’s healthcare solutions help businesses safely transport a variety of medical supplies and devices, including pharmaceuticals. Like UPS, they offer a range of temperature-controlled packaging and transportation options. For urgent deliveries, you can send packages with FedEx SameDay® services or choose from three next-day options.
DHL
DHL Medical Express guarantees “a safe flow of time- and temperature-sensitive shipments.” They offer quick delivery options and temperature-controlled shipping options, including Smart Sensor technology that monitors the temperature of shipments.
Simplify multi-carrier pharmaceutical shipping with EasyPost Enterprise
Integrating with carriers individually takes time and resources—and you’re not always sure if you’re getting the best rates. Shipping software is a great alternative. The EasyPost Enterprise pharmacy shipping platform is an enterprise-class, multi-carrier solution that lets your business ship with an extensive library of large, regional, and local carriers. Designed for pharmaceutical shipping, EasyPost Enterprise integrates with major pharmacy systems to automate and streamline the shipping process.
Talk with a logistics expert to learn more.
Can prescription drugs be mailed to the US?
Prescription drugs can be mailed to the U.S., but importers must follow FDA regulations. Because supply chains outside of the U.S. don’t enforce the same safety, quality, and effectiveness standards, the FDA inspects drug shipments and decides whether to allow them into the country. Adulterated, misbranded, or unapproved drugs may be denied entry. Imported drugs require certain information—see this FDA flyer to learn more.
Once you have FDA approval to mail your drugs to the U.S., you need to fill out the appropriate customs documentation. This article gives detailed instructions about the forms you’ll need and how to fill them out properly.
What is the penalty for mailing prescription drugs unlawfully?
If you don’t follow the laws regarding mailing prescription drugs, you’ll face severe penalties. Not only does the federal government take prescription drugs seriously, but individual states have their own laws regarding mailing medications.
- Legal penalties. Violating laws such as the Controlled Substances Act or the Food, Drug, and Cosmetic Act can result in criminal charges and even imprisonment.
- Financial penalties. In addition to legal penalties, you can also face fines when you don’t follow the rules and regulations of shipping prescription drugs.
- Increased regulatory oversight. If you step out of line when shipping prescriptions, regulatory agencies like the DEA and FDA might conduct investigations or monitor your business more strictly.
- Loss of license. State pharmacy boards can revoke or suspend your pharmacy's license if you don’t comply with state regulations.
- Business closure. In severe cases of non-compliance, your company may be forced to close down, leading to significant financial losses and unemployment for employees.
EasyPost Enterprise can help
Shipping prescription drugs is more complicated than other types of ecommerce—patients’ health depends on whether their medication arrives on time, at the right temperature, and with the proper documentation.
With the EasyPost Enterprise pharmacy shipping solution, you can make sure every prescription shipment meets your business’s high standards of quality. Our solution provides the best rates—and prevents prescription shipping disasters—by automatically answering questions like these:
- Does the order need to be temperature-controlled?
- Is a signature or proof of delivery required?
- Is Saturday delivery needed?
Using customized business rules, you’ll easily identify the right carriers and service-level agreements.
See how EasyPost Enterprise streamlines prescription drug shipping.