Question: My compounded prescription always showed an expiration date of one year. The new one says 3 months. Why is the pharmacist making my script last for a shorter time? I suspect the reason is for profit. If he charges me the same price for a script that is good for a shorter period of time, I’ll have to buy it again in three months. As compounded prescriptions are not covered by insurance this is costly for me. As far as I’m concerned I can see no other reason except they are getting as greedy as the big drug companies.

Answer from Larry: Until recently compounding pharmacists were allowed to use different science-based techniques to establish Beyond Use Dates (BUDs). Most used a combination of published literature, in-house testing, and testing with outside laboratories. Since around 2015 those techniques have been under attack by several regulatory organizations, from FDA to other more local groups. While I have evidence that a compound is potent (and sterile when necessary) for up to 12 months, the FDA now insists we put much shorter dating on the preparations. Currently, date changes are dropping of BUDsfrom a year to less than 90 days – and more cuts are expected in 2020. Our scientific evidence for a one-year dating is being replaced with the opinions of “the suits” from behind their desks.

Keep in mind that your prescription doesn’t KNOW when it is supposed to expire. If it’s being made the same way it always was, the only thing that changed was the date printed on the label. If it was okay before, chances are good it’s still good, regardless of the date. Ask at your pharmacy before concluding that they’re doing something nefarious.

While nothing has changed on in the preparation and testing of compounded items, regulators are deciding that shorter dates are in order. We may soon be forced to apply a 28-day BUD on everything. There aren’t objective criteria for these changes but they must be followed or the pharmacy runs the risk of forfeiting their 503a exemption (losing the ability to do compounding all together).

These changes are not coming from the compounding pharmacists, but from bureaucrats and regulators in places far from the pharmacy. The pharmacist is not the enemy, but another victim, and it appears many are tossing in the towel every year. The dating thing is a big issue, but it’s only one of many threatening the future of pharmacy compounding. I suspect it won’t be long before there won’t be a compounding pharmacy anywhere.

The regulators, manufacturers, and third-party payers aren’t concerned with costs. They have no problem compelling a small pharmacy to spend thousands of dollars to maintain compliance. The pharmacy isn’t taking advantage of their customers. In the eyes of the regulators, you, your doctor, and your pharmacist are irrelevant. Pharmacies being forced to raise prices or drop out. I actually met with a pharmacist today who tells me she’s seriously thinking about closing the doors this year – after decades serving her community.

Finally, it costs money to fill a prescription. It is best to get something filled once or twice a year. Twelve times is a burden on everyone, including the pharmacist. In fact, our insurance carrier charges extra because we fill more prescriptions – even when we don’t make more money. If I fill a prescription twice a year and then start refilling it 12 times per year, my number of prescriptions goes up – and my insurance premium climbs. Who pays my insurance? My customers.

I suggest you talk to your local compounding pharmacist to verify what I’ve written here. You will certainly discover that the pharmacist isn’t the greedy person you might believe. Most often, higher prices are not associated with more profit, but an effort to stay in business despite rising costs from more regulations. The sad part is that they will probably win their battle and the compounding pharmacies will fade into obscurity. Who benefits when that happens?