As a shipper to some of the largest pharmaceutical brands in the US we know the ins and outs of shipping pharmaceutical products. We move all kinds of specialized freight with pharmaceuticals being one that has its own set of Government regulatory shipping standards that must be adhered to.
What is Unique About Shipping Pharmaceutical Products
The nature of the cargo itself makes a big difference in how pharmaceutical products must be treated in transit. Pharmaceuticals can either be the finished product delivered to retailers or it can be the raw materials shipped from source to manufacturer. In both instances, special care and handling is required to adhere to Federal regulations covering the treatment of pharmaceuticals throughout the entire supply chain.
This oversight is due to the sensitive nature of the raw materials and finished products. For medical practitioners and their patients who rely on pharmaceuticals, assurance that they are unadulterated by faulty transportation conditions is paramount and what the FDA strives for.
Where do Most Pharmaceutical Products Ship From and To?
Pharmaceutical products begin with raw materials. Those raw materials may come from within the US or, sometimes, from other countries. Raw materials are shipped to manufacturers who, in turn, create the final product before shipping to either a distributor, a retailer or a medical facility.
Raw materials are typically shipped to manufacturing facilities, biotechnology companies, and medical device manufacturers.
Common recipients of the final product are hospitals, pharmacies, senior living centers, and personal care facilities.
All of these facilities are required to store the raw materials and finished products in a way that provides the correct environmental conditions to maintain the efficacy of the pharmaceutical. In some cases, this means low light conditions, temperature controlled conditions, or even refrigerated conditions.
Requirements for Shipping Pharmaceutical Products and Raw Materials
Per Code of Federal Regulations § 111.455 Section C of Government’s Current Good Manufacturing Practices, manufacturers “must hold components, dietary supplements, packaging, and labels under conditions that do not lead to the mixup, contamination, or deterioration of components, dietary supplements, packaging, and labels.”
These regulations are in place to ensure that manufacturers of pharmaceuticals meet the safety guidelines for their products, including the raw materials. This also refers to the transportation of pharmaceuticals and their raw materials.
These requirements dictate standards around temperature, humidity, and light conditions so that the identity, purity, strength, and composition of the raw materials and finished products are maintained.
In order to ship pharmaceutical products and materials in accordance with Government regulations, it is best to use a shipper that has a successful track record of doing so.
Let’s dive into some of the specifics for shipping pharmaceutical products:
Pharmaceuticals Require Temperature Control
Some pharmaceuticals are very sensitive to temperature changes and must be maintained within a specific temperature range. This can be true throughout the supply chain from raw materials sourcing to manufacturer and, finally, to recipient. The transportation process in between must also adhere to temperature restrictions, so temperature controlled warehouses, trucks, and carriers are sometimes necessary.
Facility Inspections are Required
Any location that holds or ships pharmaceuticals is subject to inspection. This includes warehouses, shipping containers, and any storage facility throughout the supply chain. Inspections include temperature, light and avoidance of potential biological, chemical, or physical contaminants.
The FDA has regulations for how pharmaceutical products can be handled for packaging and shipping. In essence, packaging and handling must be done in such a way that the pharmaceutical products are not damaged or contaminated.
Administrative requirements include coding each shipment to indicate the product and status of the container and the containers used must not be reactive, additive, or absorptive. Containers must also protect against damage and contamination.
Labeling Pharmaceutical Products
Each pharmaceutical product container must be labeled according to FDA guidelines. Guidelines include:
- The name of each pharmaceutical product
- The quantity of each pharmaceutical product
- The name of the supplier
- The name of the principal manufacturer (if different than the supplier)
- The supplier’s Lot number(s)
- The Receiving Code
- The date of receipt
- The results of any test or examination of the shipment (if completed)
Delivering Pharmaceutical Products
The recipient is required to examine each container or palette to validate that the label matches the contents, that there are no missing containers or products, and that there are no signs of damage, broken seals, or contamination. This process requires the recipient to either accept or reject the shipment.
Which is Best for Shipping Pharmaceutical Products, LTL or FTL?
The initial rule of thumb is likely around the amount of pharmaceuticals to ship, the speed at which it must arrive, and its destination or destinations.
FTL shipping for pharmaceutical products
For finished products, if the total freight is enough to fill a truck and is going to one destination, FTL shipping makes the most sense. The speed at which pharmaceuticals are transported can be very important in order to adhere to Federal regulations so FTL provides the fastest way to move your cargo without stops in between.
In some instances, you may have an FTL shipment that is then parsed into several smaller shipments once it reaches a distribution center or cross-docking facility. This is commonly the case for regional shipments that are then distributed to multiple pharmacies, for instance.
LTL shipping for pharmaceutical products
If your cargo is not enough for an FTL shipment, then LTL shipping may make the most sense. Especially for short-haul shipments, LTL is a great way to save on shipping costs and move freight that may be less time sensitive.
Keep in mind that LTL shipping means that your freight will be mixed with other freight so ensuring that your carrier understands that you are shipping pharmaceuticals is important.
Learn more about the best practices for safe shipping of pharmaceuticals.
Choose On Track for Shipping Pharmaceutical Products
As a freight shipper since 1991 with vast experience shipping pharmaceutical products and materials, On Track Freight Systems is your trusted carrier.
We provided trucking services to the pharmaceutical industry along with our intermodal, logistics, and brokerage services through our robust network of premium partners. Our decades-long track record of handling sensitive freight has provided us with a unique capability that average carriers simply do not have.
We make it easy to work with us and even offer an online tool to request rate quotes, schedule pickups, and track shipments real-time and we offer same day pickups and next day delivery service within the New York/New Jersey metro area.
Contact On Track Freight Systems where we work with our clients and vendors to handle any special appointment accommodations for pharmaceutical shipments.