The Rules For Shipping Pharmaceuticals

Pharmaceutical shipping is a well-regulated process that only experienced shipping companies should take on. In the pharmaceutical industry, delivering shipments on time and in perfect condition isn’t just an expectation—it’s a necessity. Patients who rely on prescription medication to exist comfortably during their normal lives trust their pharmacies to order medication on time and the shipping company to deliver the right item, in the right quantity, when it needs to be there. The pharmaceutical industry allows no room for missteps. For medication companies, pharmacies, and industries that rely heavily on pharmaceutical shipment companies, the shipment carrier is one of the most important factors in the supply chain process. It’s important that industry leaders as well as shipping companies fully understand the rules for shipping pharmaceuticals and the complex processes the shipment goes through.

Pharmaceuticals must be temperature-controlled

One of the most important factors in shipping pharmaceutical products is temperature. Simply adjusting the temperature by a mere two degrees can make an entire shipment of pharmaceuticals unusable. This is why it’s so essential for shippers to use temperature-controlled shipping containers, trucks, and other shipping items.

Storage facilities, shipping containers, and any other holding places must be inspected

Any place in which pharmaceuticals are stored or spend time must be inspected regularly. At every step of the shipment process, an inspection must be conducted and the results of the inspection thoroughly recorded. This is done to ensure the safety and integrity of the pharmaceutical products. If any issues do arise in the testing process, the recordings of the inspections can narrow down the time and location of the confirmation or problem and prevent further issues in subsequent shipments.

Important legal regulations for pharmaceutical distribution

Shippers of pharmaceutical products must follow important legal regulations to remain legitimate operations in the eyes of the United States Food and Drug Administration. Here are some of the basic regulations to look for when you’re choosing a shipping company for your pharmaceutical distribution needs.

Employee requirements

According to FDA rules, each and every employee that comes into contact with pharmaceutical products during the distribution process must be properly trained and educated and have a reasonable amount of experience to ensure they can perform their tasks with skill and safety. They’re also required to wear clean clothing and protective apparel to avoid contaminating the product and to practice good personal sanitation and health habits. Another important thing to keep in mind is that a shipping company handling pharmaceuticals must not be understaffed, as this violates federal regulations and can put your products at risk of quarantine or rejection once they reach their destination.

Requirements for packaging and shipping

The FDA requires a few things from teams that ship and package large-freight pharmaceutical shipments. Here are the main regulations every pharmaceutical shipment must follow:

• Must keep a detailed record of procedures, including the receipt, identification, storage, handling, sampling, testing, and approval or rejection of the shipment.

• Must handle the containers in a way that minimizes risk to and prevents contamination of the shipment.

• Must give each grouping of containers or container a unique code that records the procedures and final status of the container.

• Must use containers that aren’t reactive, additive, or absorptive and which protect against damage, contamination, and other outside factors that could compromise the product.

Before the delivery address can accept a shipment

Once a shipment arrives at its final destination, the recipient must examine each container or grouping of containers. The inspector will look for proper labeling of each product and shipment container and for any damage, broken seals, or signs of contamination. If the inspector finds any of these items, they must reject the shipment. The rejected shipments remain in quarantine until someone can properly test and examine them further. The FDA sets these regulations. The recipient is responsible for providing the final inspection and for determining the shipment’s ultimate acceptance, rejection, quarantine, or destruction. They must diligently record all the procedures and findings from the examination once they receive the shipment.

Labeling requirements

Labeling is of utmost importance to shipping pharmaceuticals. Each of the containers must be properly labeled in order to fulfill the FDA’s requirements. Below you’ll find the labeling requirements you must follow to stay compliant when it comes to shipping pharmaceuticals.

Specific requirements for labeling

Labels must correctly state the identity and exact quantity of each shipment in each lot of pharmaceuticals. This means all labels on the drug containers must clearly state the name of the supplier; the supplier’s lot number (or numbers, if the supplier has multiple); the receiving code; and the precise date of receipt. In addition to this information, if the name and location of the prime manufacturer are different from those of the supplier, this should also be listed on all labeling documents.

The results of any test or examination performed on the shipment should also be clearly notated, and all conclusions should be listed. This keeps the shipment safe and protects the public by preventing contaminated drugs from making it to the shelves. Another requirement is to keep with each shipment a document containing information regarding what batch or lot of drug product the shipment containers hold.

Overall, the FDA—among other organizations—sets these many rules and regulations to keep pharmaceutical shipments safe. The pharmaceutical industry is heavily regulated to prevent contaminated or nonfunctioning products from reaching consumers, where they can have harmful effects. Patients using pharmaceutical products must be able to trust their doctors to prescribe the right items; the manufacturers to produce high-quality and potent products; the shippers to keep the item safe and free of contaminants during shipment; and the vendor to correctly care for, store, and dispense the items to them. Following all safety rules and regulations for the shipment of pharmaceuticals is extremely important to the overall well-being of the public.

If you’re looking for freight shipping in Minnesota, look no further than Freight Dynamics. Contact us today to discuss your exact needs, and let us handle all the ins and outs of regulations for your shipment.