Everyone is trying to save money…especially the companies that supply medications to patients. Some insurance companies and pharmacy benefit managers encourage people to obtain their prescriptions through the mail rather than at local drugstores. But can you trust mail-order medicines that have been sitting in a hot delivery vehicle or in a mailbox for hours? We asked the FDA about this and received an unsatisfactory answer. This was all prompted by this question from a reader and an inquiry from a doctor:
Mail-Order Medicines in Texas:
Q. I am concerned about the heat damage that could be done to medicines bought through the mail and left sitting in a hot mailbox. I really don’t know what the answer is. It would seem that even if you pick your prescriptions up locally from an air-conditioned store, those items probably arrived there by way of a hot truck.
I live in the Texas Gulf Coast area and get an EXTREMELY expensive medicine shipped from Kansas. Lately, it has been packed in ice in a Styrofoam box, but in the last shipment the ice packets had melted by the time I received it.
A. We have been concerned for years about temperature and humidity during shipping of medications. It’s not just getting the medicine to the patient that worries us.
A physician asked us about how pharmaceuticals are shipped from plants in China and India to the U.S. We asked the FDA about this and the agency responded with incomplete information.
Questions for the FDA:
We specifically asked the FDA about the shipping of raw materials (APIs or active pharmaceutical ingredients) from say China to generic drug manufacturing plants in India. We wanted to know:
“how are the chemicals shipped and who has authority to oversee the process?”
Next, we asked the FDA
- When a manufacturer of finished products (say in India) ships those pills or vials to the U.S., how are they shipped? Do they travel in temperature-controlled trucks to a shipping port or airport? Once at that destination are these products shipped in temperature- and humidity-controlled containers? If not, how does the FDA verify that they are shipped according to FDA/USP specs? Are most generic drugs shipped in containers on ships? If not, how are they shipped and how does the agency monitor transport conditions?
- Once they arrive at a U.S. port, how are the containers transferred and shipped to a wholesaler or distribution location? Are these products monitored during transport?
The FDA responds:
We got a lot of technical information about applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR). What we did not get were answers to our specific questions. We did learn:
“While the regulations do not specify the logistics of how APIs [active pharmaceutical ingredients] may be transported (due to differences in the nature of each API), we review the records that are maintained by the firm to determine whether appropriate shipping conditions were preserved to ensure the integrity of the product….
“Furthermore, under Distribution Procedures, it states “APIs and intermediates should be transported in a manner that does not adversely affect their quality. Special transport or storage conditions for an API or intermediate should be stated on the label. The manufacturer should ensure that the contract acceptor (contractor) for transportation of the API or intermediate knows and follows the appropriate transport and storage conditions…
“Similar to shipping any product into the U.S., once the product is imported into the U.S., the specific transportation needs of the shipment would be determined by the firm as it is dependent upon the specifications of the particular product. The required specific storage conditions of drug products are outlined on the product’s labeling, which is intended to maintain the safety, purity, and potency of the product. It should be noted that most drug products are relatively stable at room temperature for limited periods of time, although some are temperature-sensitive…”
Making Sense of FDA Language:
Whew! It is hard to make sense of these technical answers. Does the FDA really monitor shipping conditions from China to India? How are most generic drugs shipped to the US? Do they come in the cargo hold of airplanes or on container ships? Do the companies provide the FDA with documentation about temperature and humidity? There are devices that can be included in boxes of pills to determine if conditions vary outside the standard recommendations. We still do not know if the FDA regularly reviews such documentation, even if it exists.
And what about once drugs get to the US? Do the trucks that haul generic drugs from a port in LA or New Orleans maintain temperature and humidity control? And once they get to a distribution center, how are they shipped to pharmacies? And who keeps track of mail-order medicines once they leave the packaging center?
Of course, no one is responsible for mail-order medicines once they arrive at a mail box. That becomes the customer’s problem.
What About Specs on Temperature and Humidity?
The FDA has very detailed instructions regarding storage and shipping for most medicines. Here is what we have discovered in the official prescribing information.
Guidelines for medications generally call for storage at room temperature (68 to 77 F). During shipping, temporary fluctuations are allowed between 59 and 86 F.
Does anyone believe that shipping companies and delivery trucks maintain temperatures between 59 and 86 degrees during the summer? What about during the winter?
What about during shipment from India, Thailand, Croatia, Brazil or China to the US? Do you think your $4 bottle of generic pills is constantly maintained between 59 and 86 degrees F during the time it is shipped from Mumbai to Oakland to Virginia and then to your mail box? Is anyone at the FDA following Ronald Reagan’s admonition to trust by verify?
The Bottom Line on Mail-Order Medicines:
We do not know whether anyone is actually monitoring your medicines for temperature and humidity from the point of origin abroad to the final shipping center in the U.S. We are pretty sure that most mail-order medicines that leave those distribution centers in UPS or USPS trucks are not temperature or humidity controlled. And we are quite certain that many mail boxes get quite hot in the summer.
If you would like to know how hot, you might want to check out this link. One of our readers actually monitored the temperature in his mailbox over time.
How Does Temperature Affect Mail-Order Medicines?
Share your thoughts or your story in the comment section below. If you work for a pharmaceutical company or a generic drug distributor, please let us know how pills are actually transported from manufacturing sites abroad to distribution centers in the U.S.
