Baby, it’s cold out there! Many parts of the United States are either experiencing freezing temperatures or soon will be. As I write this, it’s very cold in all the usual places: Colorado, Idaho, Montana, North Dakota, South Dakota, Minnesota, New York, Massachusetts, Utah, Vermont, Maine, New Hampshire and Wyoming, to name just a few of the usual suspects. If people in such states will be receiving mail order medication deliveries over the next few weeks, they could be in big trouble. That’s because cold weather shipping of medicines will be out of line with FDA standards!
How Are Your Medicines Transported?
Even if you don’t live in a place where it’s currently really cold, there is a good chance that your medicine will be out of spec at some point during transport. Pharmaceuticals that are delivered by the United States Postal Service, UPS and Amazon are generally not sent in vehicles with temperature-controlled cargo areas.
Even if delivery vehicles were able to maintain room-temperature standards during transport, the minute a package is left in a mailbox or on a front porch, it is subjected to outdoor conditions. That could be devastating for some products.
Cold Weather Shipping Means Violating FDA Standards:
The Food and Drug Administration has very strict guidelines for the storage and shipping of pharmaceuticals. Most medicines are supposed to be kept at room temperature (68 to 77 degrees Fahrenheit). The FDA does make allowances for short term “excursions” from 59 to 86 degrees F.
Do not take my word for this. I want you to go to DailyMed. Just click on this link. You will see a big box at the top of the page to the left of the universal signal for search (a magnifying glass). Put the name of your medicine into that box.
If you are not taking any medicine, play along anyway. Put EpiPen into the search. Scan down to # 16 on the official prescribing information:
“16 HOW SUPPLIED/STORAGE & HANDLING”
Cold Weather Shipping of EpiPen Was Out of Spec!
This reader contacted us with exactly this scenario:
Q. In early 2015, the VA Hospital sent my EpiPens via USPS. They landed in my mailbox on a day that was 34 degrees out. I was not at home when they arrived, and I got home about four hours after the mail is usually delivered.
I called the VA pharmacy to ask whether this drug would be less effective after spending hours way below the temperature threshold. He said: “I think that they should still be OK”.
My response (minus any profanities I may have used) was that if I ever need to use those EpiPens, they must work. I don’t need a pharmacist to say that he thinks they should still be OK.
The next day I drove 56 miles to the VA and turned in the ones they had sent. In exchange, they gave me new ones.
A. You were right to be concerned. The official prescribing information from the company states:
“Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Do not refrigerate.”
Most home refrigerators maintain a temperature of 36 to 37 degrees F. Consequently, the mail-order service from the VA did not treat your injectable epinephrine appropriately.
We fear that many other mail-order medicines may also be exposed to temperatures outside the FDA-mandated range. If you put your medicine into the DailyMed search box, chances are good that somewhat similar information is provided whether your drug is atorvastatin (Lipitor), lisinopril, metformin or levothyroxine.
Cold Weather Shipping Poses Special Problems for Some Drugs:
What could go wrong if liquid medicine freezes? Insulin, for example, is not supposed to be used after it has frozen. What about the very popular diabetes and weight-loss drugs such as semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro, Zepbound)?
The official prescribing information is quite clear:
“Prior to first use, OZEMPIC should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen.”
Prescribing information for the competitor, Mounjaro, states:
“Store MOUNJARO in a refrigerator at 2°C to 8°C (36°F to 46°F).
“If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30ºC (86ºF) for up to 21 days.
“Do not freeze MOUNJARO. Do not use MOUNJARO if frozen.”
When Cold Weather Shipping Leads to Freezing:
One reader from Wisconsin wrote about a medication used after eye surgery:
“I bought Lotemax gel at a local pharmacy even though the co-pay was $100. The usual mail order pharmacy sells two for a co-pay of $100. However, we were in a cold snap here in Wisconsin and I didn’t want to use frozen and thawed Lotemax. This is a real problem in cold winters.”
According to the official prescribing information for Lotemax:
“Store upright at 59 degrees F to 77 degrees F.”
Wisconsin in mid-winter is often well below 59 degrees F. How can any shipping company guarantee that the package will be maintained in an “upright” position throughout the shipping process?
An Insider Spills the Beans on Hot or Cold Weather Shipping:
We heard from this insider:
“I have worked in the pharmaceutical industry for over 20 years in clinical research. When drugs are being tested, strict guidelines are utilized to assure that the drug under investigation is shipped and maintained at the acceptable temperature range for that drug. If not, they are discarded, with strict documentation.
“Many drugs may become unstable or ineffective outside of the designated temperature. I’ve always worried that such strict guidelines are followed during clinical trials in which the effectiveness and safety of the drug are determined, but not when it is shipped to the consumer.”
The FDA and “Excursions”
The asthma drug Advair (fluticasone and salmeterol) comes with this recommendation about storage and handling:
“Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C).”
“Excursions” are not well defined by the FDA. The agency often uses the phrase:
“short-term excursions outside the label storage conditions (such as might occur during shipping)”
We find that woefully inadequate. Does the FDA define short-term as hours or days? What about drugs made in China, India or Slovakia and shipped to the U.S.? Would weeks be considered short-term? We do not have a clue.
Medicines Delivered in Northern States:
Anyone who gets Advair delivered in Colorado, Idaho, North or South Dakota, Illinois, New Hampshire or Maine (to name just a few cold spots these days), is not likely get medicines delivered above 59 degrees F. That means they are out of the recommended range. And remember, many medicines are shipped to mail-order distribution centers in trucks that are also not temperature controlled.
The FDA has been very clear about storage and handling for most medications. Sadly, it claims to have no authority over how your medicines are shipped or delivered. In fact, we have been disappointed in the way the FDA monitors storage and delivery from drugs manufactured abroad. Are such products shipped in temperature- and humidity-controlled containers? The FDA has not been clear about that fundamental question either. And who is supposed to enforce the rules?
There’s No Sheriff at the FDA Enforcing Cold Weather Shipping Rules:
Imagine a town anywhere in the United States that sets the speed limit on its streets. It might, for example, put up signs around schools that limits the speed to 25 mph.
At the same time, though, the town would state that it has no authority to enforce that speed limit. If people choose to drive at 60 mph, the police department in that town could not arrest them. We would consider such a system totally ludicrous.
Why bother to provide specific guidelines if no one cares if your medicines are delivered out of the recommended range? We think it’s past time for the FDA, drug companies and boards of pharmacy to ensure that medications are shipped and stored properly.
Please share your thoughts in the comment section below. Perhaps a new FDA Commissioner will do something about this mess. When that person is appointed we will ask for your help in lobbying the FDA and all other relevant organizations to improve this hot and cold weather shipping mess.
If you think this article is worthy, please share it with family and friends. No matter how often we discuss this problem, no one at the FDA, at boards of pharmacy or in the medical world seems to care. That’s why we need your help. Thanks for your support.
