Blue capsules on a conveyor

Like other forms of shipping, pharmaceutical shipping makes up a huge piece of our world’s supply chain! This industry transports a variety of items that are vital to healthcare operations and ensuring patients’ health. Some of the most common products they handle include the following.

Because of the sensitive nature of these items, this particular sector of logistics and supply chain management is highly regulated. The pharmaceutical industry relies on efficient shipping to maintain the integrity and effectiveness of medications, especially those requiring temperature control, like vaccines or biologics.

Who Regulates Pharmaceutical Shipping?

In the United States, several various entities outline industry standards and ensure compliance with all legal requirements. Here are the main regulatory authorities involved in pharmaceutical shipping.

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) leads the charge in enforcing regulations related to pharmaceutical shipping. They handle both pharmaceuticals being transported within the U.S., as well as ones that are imported into the country.

The FDA’s Drug Supply Chain Security Act (DSCSA) is responsible for tracking and tracing pharmaceuticals within the supply chain. This act outlines how to achieve interoperable, electronic tracing of products at the package level. The goal of this is to trace and identify them as they are distributed into the U.S. and therefore protect consumers.

There is also the CFR (Code of Federal Regulations) Title 21. In this document, instructions for the safe storage and handling of pharmaceuticals are extensively outlined. It is broken down into four main sections:

International Air Transport Association (IATA)

IATA handles the air transport of pharmaceuticals. They focus on setting specific regulations related to the time and temperature of items as they are shipped. This is outlined in their  Temperature Control Regulations (TCR), which handles a variety of important topics, including the following.

Transportation Security Administration (TSA)

In certain contexts and situations, TSA can also be involved. This usually occurs within the context of air transportation, where they help ensure security and safety in the supply chain.

Department of Transportation (DOT)

The Department of Transportation is responsible for any hazardous pharmaceutical products that are transported. They help ensure all materials are labeled and are shipping safely and legally.

Drug Enforcement Agency (DEA)

The DEA generally handles controlled substances, making sure they arrive at their intended destination securely. Their regulations are outlined in the Controlled Substances Act (CSA).

Pharmaceutical Companies

Pharmaceutical manufacturers themselves are also responsible for ensuring compliance with regulations. They must comply with all legal regulations and requirements, working together with a certified logistics partner to maintain product integrity.

Who Do Pharmaceutical Shipping Regulations Apply To?

Pharmaceutical shipping regulations don’t just apply to the people and organizations that are shipping them. They also apply to anyone who transports, stores, manufactures, or distributes wholesale drugs or any of their related compounds. This extends to a variety of different operations, including the following.

A Guide to Shipping Pharmaceuticals

So how do you safely ship pharmaceuticals? As you can see from the above information, it can be a highly complex process! There are many regulations and information that organizations must be aware of and adhere to. Here are some important considerations for shipping them safely.

Temperature Control

One of the largest focuses of the FDA’s pharmaceutical shipping guidelines relates to temperature control. This is because many medications and vaccines are sensitive to temperature fluctuations. These can damage or alter the effects of the medications, leading to unexpected or poor patient results when they are administered.

To accomplish stable temperature regulation, pharmaceutical shipping operations utilize what is known as cold chain logistics. These include using specialized temperature-controlled containers that maintain the required temperature throughout the entire shipping process. These can be smaller containers or entire refrigerated trucks with advanced cooling systems.

Regulatory Compliance

While the regulatory world can be tedious and frustrating sometimes, it is also non-negotiable. The FDA leads the main charge in the United States, ensuring pharmaceutical companies are always informed about and following the outlined regulations. They also conduct audits to ensure that you’re truly maintaining compliance.

Packaging and Labeling

Never neglect your pharmaceutical packages and labels! Your products must be securely packaged to prevent damage and tampering during transport and should always be clearly labeled. You should always include the following information.

Security Measures

Security should always be an important consideration as well. Pharmaceuticals can unfortunately attract theft and tampering, which can quickly become devastating to your financials and reputation. You should implement the following security measures.

Documentation and Record-Keeping

Proper record-keeping must be kept each step of the way to ensure compliance levels. Records should include key information about shipments, including the following.

Handling and Hygiene

Proper handling protocols ensure that pharmaceuticals are not contaminated or stored inappropriately as they reach their destination. People handling them must be well-trained in all parts of the shipping process, including—but not limited to—the following.

Emergency Response

There should also be robust and thorough plans outlined for how to proceed in the event of an emergency or incident. Important topics to cover include the following.

Secure Pharmaceutical Transportation with AmeriShip

Are you an organization looking for secure and fast pharmaceutical shipment options? Here at AmeriShip, we specialize in prompt medical delivery services, handling everything from overnight prescriptions to lab specimens and organ donations. We’re experienced and knowledgeable, ensuring your shipments always make it to their destination safely and quickly. Click here to request a quote!