Shipping Pharmaceuticals: Regulations & the Bulk Bag Role

March 26, 2025 | Chemicals, General

Modern pharmaceuticals are a modern miracle in today’s world. Yet the manufacturing and transportation of medicine is a logistically complicated task. Pharmaceuticals in transport are susceptible to damaging temperature changes, theft, and contamination. 

Shipping pharmaceuticals in bulk bags is an efficient, risk-mitigating alternative to the traditional shipping methods. Continue reading for more information on the shipping process and how bulk bags can play a beneficial role. 

How Are Medicines Transported?

Shipping medicine is a highly controlled process, with medicines usually shipped in insulated or refrigerated trucks to maintain the required temperature for the environment-sensitive pharmaceuticals. These trucks undergo regular inspections to maintain quality conditions and ensure the safe storage during transportation, meeting regulation and customer requirements.

Who Delivers Medication to Pharmacies?

Typically, logistics companies are responsible for shipping medication. Medications originate at the factory, moved to a wholesale distributor, then moved to different pharmacies. They move along a “cold chain” all the way, so the medications are constantly at a safe temperature. 

Pharmaceutical Transportation Regulations

Transporting pharmaceuticals is a tricky business. The medications are valuable, must be kept at temperature, and delivered promptly. Because of the high stakes, pharmaceutical transportation regulations keep everyone in the supply chain safe and maintain high-quality medication.

The Food and Drug Administration (FDA) has a set of minimum requirements (Title 21 – Food and Drugs) for food and drug storage and handling. The Title 21 requirements break down into ten aspects of shipping and handling products: facilities; security; storage; examination of materials; returned or damaged drugs; record keeping; written policies and procedures; responsible persons; compliance with federal, state, and local law; and salvaging and reprocessing.

1. Facilities

Facilities include the medicine’s manufacturing, storage, holding, offering, marketing, or display. Facilities should be easily able to facilitate cleaning, maintenance, and smooth operations and remain clean and orderly. 

They must have storage areas with adequate lighting, ventilation, and temperatures. Facilities must also have a separate quarantine area for damaged pharmaceuticals. 

2. Security

As such a valuable product that affects people’s health, facilities involved with pharmaceuticals should have adequate security. Title 21 emphasizes the restrictions of unauthorized access to facilities, generally keeping access well controlled. It also includes lighting around the perimeter – equipped alarm systems to detect after-hours entry and security systems to prevent theft.

3. Storage

Some pharmaceuticals store at room temperature, but a large amount must be kept at controlled, cooler temperatures – maintaining this throughout the manufacturing, shipping, and consumption process is called the cold chain. If there are no specific requirements for storing a drug, it is kept at a “controlled” room temperature to ensure its quality is not adversely affected. 

One less obvious factor of storage is documentation, specifically to record the temperature and humidity of the storage environment. Record keeping is crucial to ensure the proper temperature and humidity are consistent while storing pharmaceuticals. 

4. Examination of Materials

Title 21 emphasizes how pharmaceuticals should be subject to proper examination throughout its life. Basically, to make sure shippers are shipping what they should be shipping, checking the product for damage or making sure it is not out of date, and generally making sure it is in quality shape.

Once again, documentation should be used to follow up and record any examination. 

5. Returned, Damaged, and Outdated Prescription Drugs

To ensure quality and reduce risk, drugs that have been damaged, misbranded, spoiled, or are out of date are quarantined in a physically separate area and destroyed. If a drug comes back, it is destroyed unless further testing and examination can confidently assure it meets the standards of safety. 

6. Recordkeeping

Wholesale pharmaceutical distributors use recordkeeping to keep everything inventoried and accounted for, including drugs that were damaged or destroyed. Pharmaceutical record keeping includes

• The source of the drugs (name and address of seller or transporter),
• The identity and quantity of material, 
• The dates of receipt and distribution of the drugs.

All records and inventories should be available to federal, state, and local law enforcement authorities. 

7. Written Policies and Procedures

Maintain written policies and procedures, including for storage, inventory, distribution 

Some specific procedures are listed by Title 21, so any wholesale distributor should have these policies, at a minimum:

• A procedure to ensure the oldest approved stock is distributed first,
• A procedure for properly handling recalls and withdraws of prescription drugs, 
• A procedure on how the facility handles a crisis that affects the security or operation of any facility (how to react to a strike, natural disaster, etc.),
• And a procedure on how to properly dispose of damaged pharmaceuticals. 

8. Responsible Persons

Wholesale distributors should maintain lists of managers, officers, directors, and anyone else in charge of wholesale drug distribution. This list includes the individual’s respective duties and qualifications. 

9. Compliance With Federal, State, and Local Laws

Wholesale distributors should operate within Federal, State, and local law and permit authorized law enforcement to enter and inspect the premises. All controlled substances must be registered with the Drug Enforcement Administration (DEA).

10. Salvaging and Reprocessing

Wholesale distributors are subject to Federal, State, and local law regulations concerning the salvaging and reprocessing of drugs.

Packing for Shipping Pharmaceuticals

A global logistics company, pharmaceuticals are generally shipped in temperature-controlled containers – this is regulated by the FDA. Insulated containers are a big component in climate-controlled shipping, as they block significant amounts of heat, temperature, and moisture from the outside. 

Thermal pallet covers are another component of climate control. The thermal pallet covers can be pulled over the packaged pharmaceuticals to add a layer of protection against changing outside temperatures. The pharmaceuticals pack tightly together to minimize movement during shipping. 

Bulk Bags: Pharmaceuticals Shipping & Storage Solution

Palmetto’s pharmaceutical bulk bags are a potential solution for shipping large amounts of pharmaceutical products.  Palmetto’s bulk bags prevent cross-contamination, provide a sterile environment, and effectively mitigate static electricity. Consider Palmetto’s pharmaceutical bulk bags as a solution to pharmaceutical shipping.

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Pharmaceutical Shipping & the Cold Chain: What’s the Importance?

Once again, maintaining a cold chain plays an important role in shipping pharmaceuticals. The count down to expiration begins once a drug completes production. Keeping the drug at a cold temperature slows this deterioration, but it’s a logistically complicated task. 

First, pharmaceuticals come fresh off production and packed into pharmaceutical-grade containers (such as Palmetto’s pharmaceutical bulk bags). But what does pharmaceutical grade mean? Pharmaceutical grade means the shipping container the pharmaceutical arrives in does not interact with the drug itself. For instance, the type of plastic that makes up the container helps it resist a chemical reaction with the drug. Additionally, the container is clean at a microscopic level. 

Once the product is packed, it is placed in a climate-controlled shipping truck. The truck is usually refrigerated or insulated and routinely inspected to ensure the proper climate is in place. Once distributed, the pharmaceutical will go into storage, where the cold chain is still maintained with climate control, and proper storage conditions for the pharmaceuticals. 

The last step is marketing, where the pharmaceutical is sold or consumed. The cold chain is maintained throughout this process, so the drug is kept at a particular temperature throughout. 

Below is how proper storage conditions for pharmaceuticals are kept in place through the cold chain. The steps in chronological order:

• Manufacturing plant: The product is made and begins its climate-controlled trip to the consumer. It is packed into a climate-controlled truck.

• Transportation to distributor: The climate-controlled trucks are routinely inspected to ensure the child chain is maintained. 

• Storage: The product is in a climate-controlled storage facility. 

• Market: The last step of the cold chain, where the product is purchased. 

Risks for Pharmaceutical Shippers & Pharmaceutical Transportation

Pharmaceutical transportation is a tricky business. Any temperature change of more than a few degrees can alter the drug’s effectiveness, occasionally even making them deadly. Trinity Logistics identified three main risks in transportation pharmaceuticals:

• Loss of cold chain: The potential temperature changes for the drugs raise risks to the integrity of the drug’s effectiveness. Keeping the drug at a proper temperature prolongs its potency. 

• Theft: Pharmaceuticals are valuable and occasionally susceptible to theft. Opioids are especially at risk of theft.
• Overlooked specialized conditions: Modern medicine is becoming more specialized. With more specialized pharmaceuticals comes more specialized conditions for proper shipping and smaller shipment quantities, which can be overlooked by pharmaceutical shippers. Smaller portions of more specialized medicine still need to be kept at a particular temperature. 

Palmetto bulk bags can help mitigate these risks by transporting large quantities of pharmaceuticals. More effective packing can help maintain the cold chain, and larger quantities of a product may be more difficult to steal. Palmetto bulks bags are a solution to reduce the risk involved with pharmaceutical shipping. 

Shipping Refrigerated Medications: Why You Should Only Use Professionals

Use professionals for pharmaceutical transport and safely shipping refrigerated medications. Keeping products in a controlled environment over time and distance is a difficult task required in dept knowledge of shipping and pharmaceuticals. 

All manufacturers and parties involved in shipping logistics require FDA approval and meet regulations. All facilities, plants, and organizations are subject to meticulous inspection. Professionals are well versed in these regulations. 

Here are a few more benefits of using professionals:

• Keep track of your shipping products with a professional to keep you up to date along the way. 
• The product shipment uses the most up-to-date shipping practices and regulations. 
• Rest assured the products are at a safe temperature. 
• Personalize delivery time.

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Pharmaceuticals Transportation: Our Conclusion

Pharmaceuticals transportation is a complicated task best left to professionals. With so many moving parts, regulations, and specialized knowledge and skills, pharmaceuticals transportation is a major feat in the modern world of medicine and transportation. Bulk bags can play a major role in this complicated process and mitigate associated risks.