FDA Might Create A "Behind-The-Counter" Drug Category

Next Month, the FDA will hold a public meeting to discuss whether or not they should allow certain drugs to be sold “behind-the-counter”—that is, after consultation with a pharmacist, but without the need for a prescription. If they move ahead with the plan, a new BTC category will be created, although what drugs will fall under it have not been determined.

Several trade and professional groups support the idea, including the National Community Pharmacists Association and the National Association of Chain Drug Stores. The FDA points out that pharmacists have the necessary training to educate consumers about how to use certain drugs, and that a BTC category would help people without health insurance gain access to certain medications.

The one huge down-side we can see to this: big pharma will start targeting pharmacists with freebies and samples to pass out to customers—we can imagine going to get a BTC drug in 2009 and being met by a pharmacist wearing more pieces of “Ask Me About [Drug Name]” flair than Jennifer Aniston’s nemesis at Chotchkie’s.

“FDA explores behind-the-counter drug sales” [Reuters]

“US FDA Considering ‘Behind-The-Counter’ Drug Status” [CNN Money]
(Photo: Getty)


Edit Your Comment

  1. trickonion says:

    I already can’t get sudafed when the stupid pharmacy is closed.

    I’m not cooking meth, I just have a stuffed up head. Throw me a bone :(

  2. emona says:

    I’m curious what medication they’d deem a pharmacist worthy enough to ‘prescribe’. Valtrex? The morning after pill?

  3. HungryGrrl says:

    nah, I think they’re going to make prescription things “BTC”… I think they’ll put a bunch of current “OTC” stuff “BTC,” stuff like Benedryl, Delsym, Coracidin and Sudaphed… stuff that either can be used to make meth or abused by the poor teenagers who can’t get pot anymore because of the war on drugs.

  4. amoeba says:

    I hope they put “behind the counter” those children’s syrup cough remedies. I am tired to see my brother giving one of those to my nephew when they come to visit me. Oh well, I don’t mind asking my pharmacist, he is kind of a hot guy (blush).

  5. swalve says:

    What happens when the pharm. doesn’t want to give you what you’re asking for? Like thhe morning after pill?

    I like the idea, but it will have to be pretty specific.

  6. bohemian says:

    It depends on what they are going to put there. More OTC items? Move some prescription items there instead? Somehow I don’t trust this to benefit consumers.

  7. serreca says:

    @quarterly: Morning after pill is already available “Behind the Counter”.

  8. kellyhelene says:

    Canada already has a system like that. You can get codine without a script, just ask the pharmacist. And we pretty much have this now in the US, with things like allergy/cold meds and the morning after pill.

  9. cds2 says:

    I hate to sound like a conspiracy theorist but this sounds like a veiled attempt by social conservatives to restrict certain OTC drugs and possibly even ‘accessories’ they would otherwise deem socially unacceptable. I recall there being a huge debate within the Bush administration regarding the FDA approval of Plan B and one of the proposals floated was to require the consumer to contact the pharmacist and request it from ‘behind the counter’. The rationale was that it would ensure the woman’s safety even though the FDA had scientific study results that showed it just as ‘dangerous’ as aspirin (iow _anything_ taken in high doses can cause damage). I also don’t buy the ‘opens access to uninsured’ argument as this would open a _huge_ liability issue for the pharmacists themselves if they are quasi-prescribing BTC drugs to essentially unknown walkin ‘patients’ with no drug interaction, allergy, etc. history.

  10. EtherealStrife says:

    Great. More stuff that’s up to the Abrahamic or Scientologist to ration out to me. Somebody needs to start a website listing secular pharmacies.

  11. muddgirl says:

    This is already done in the UK. Certain decongestants and pain-killers are available from the pharmacist. Frankly, I don’t see the problem with this – I doubt that they’re going to put many drugs that are OVER-the-counter BEHIND-the-counter. Hopefully, the FDA will be smart and make drugs more available, rather than less. I guess I’m just an optimist.

  12. formergr says:

    Ugh, great, another opportunity for a pharmacist to “judge” whether or not I am worthy of a medication, be it birth control or morning after pills if he’s a conservative Christian, or anti-depressants if he’s a Scientologist. I’d only be for this if rules were tightened that prevent denials on “philosophical” grounds.

  13. erratapage says:

    Maybe I’ll be able to get antibiotics for a UTI without having to wait to see a doctor who will tell me that the anesthetic I took to kill the pain muddied the lab test? Or maybe I can get birth control without seeing a doctor? Or how about that steroid cream that my husband takes for his skin allergies? I mean… I understand that you have to see a doctor regularly, but there are some things we just don’t need doctors to prescribe for us…. (and I am NOT suggesting that antibiotics be generally available for every sniffle… but women KNOW when it’s a UTI, fer cryin’ out loud!)

    If it’s about making simple health care more accessible to me, I’m all for it. If it’s about hiding the benedryl, I’m against it.

  14. teh says:

    So the articles state that they are accepting electronic comments until Nov. 28th. Can anyone find the correct docket? The FDA page is: [www.fda.gov]

  15. ElizabethD says:


    Gawd, I’m with you on the UTI thing. Not so much nowadays, but when I was a young woman I pretty much had a constant UTI. The urologist loved doing those excruciating “scope” exams up my urethra into my bladder, and sending me for kidney X-rays, etc., none of which showed anything helpful… The only thing that helped was the antibiotic and that pain-killing stuff (which back then was Rx only). Finally in my mid 30s I had a wonderful smalltown doctor who gave me a *standing prescription* for the most effective antibiotic, and had me use them prophylactically to prevent the infections in the first place. I loved that guy. He was the same way about Tranxene for air travel. It was so nice to be trusted and treated as a partner in my health care. (Dr. McDonald, I miss you!)

  16. @quarterly: In the UK, it’s like super-strength decongestants and stuff. When I studied abroad there I came down with a horrible sinusy cold trying to turn into a sinus infection, and I was able to mosey down to Boots, talk to the chemist, and get this stuff that was like Sudafedx10 + painkiller + sleep aid. It was so convenient to be able to get something STRONGER than Sudafed without having to go to the doctor, since I wasn’t actually at the “need antibiotics” phase yet.

  17. lyndyn29 says:

    If I believed for a second this would make some now-prescription meds more available, I would be all for it. As new categories of regulation are only ever created to make currently accessible goods and services less accessible, I think it stinks.

    I recently had my first experience with buying BTC Sudaphed (I switched to Claritin when it went OTC, but now Walmart has Claritin behind the counter too, and when I saw the Sudaphed behind the pharmacist’s shoulder, I went, “No, give me that!” The procedure is insanely intrusive. No thanks.

  18. The FDA is probably worried about drugs that are safe when used properly, but have a high rate of accidental misuse.

    For example, a group of pharmacists and doctors asked for OTC vaginal yeast infection treatments to be classified “behind the counter” a few years ago, because they were seeing women misuse the treatments for other vaginal problems, like menstrual cramps and STDs.

    I hate to say it, but the morning-after pill probably belongs BTC, because so many people confuse it with RU486 — you probably don’t want confused & scared teenagers taking that pill when they’re already a month pregnant.

    (By the way, have I mentioned lately how badly health education sucks in this country?)

    @amoeba: Those infant cough syrups might be a good candidate, actually. Buying the wrong box of that stuff can kill a kid.

  19. Jesse in Japan says:

    Anything that can be used to make methamphetamines is already pretty much “behind the counter.”

  20. Her Grace says:

    This is done in Australia. A lot of random things are BTC–notably, any treatment for a yeast infection/thrush. As if it’s not embarassing enough to purchase, I now get the run-down on any potential drug interactions. All the higher strength headache meds are also BTC and anything for coughs/colds.

    I don’t really mind it, as it does add a layer of protection to the consumer (they have to talk to someone before they buy it), but that’s here in Australia. No pharmacist here would deny birth control or the morning after pill. I’m not sure how great this will be back in the States.

  21. Maybe I’m being naive, but I’m cautiously optimistic. For one thing, I think big pharma would want this opportunity to sell more product. The CNN article linked under “Related” cites a couple of cholesterol meds as examples of what would likely be classified as behind-the-counter:

    In 2005, an FDA panel of outside medical experts turned down a bid by Merck & Co. (MRK) and Johnson & Johnson (JNJ) to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a “behind-the-counter” system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck’s Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

    (Wow, I can’t believe “blockquote” works in the comments.)

  22. Mr. Gunn says:

    Well, using the same antibiotic chronically isn’t exactly the best idea, but being able to get codeine from the pharmacy would be great.

    I have to agree with the pessimists, though. This will more likely end up making things harder to get rather than easier.

  23. Consumerist Moderator - ACAMBRAS says:

    @Michael Bauser:

    I’m not a doctor, but I am female, and I’ve never heard of taking a yeast infection remedy to alleviate menstrual cramps.

  24. @Chris Walters: “For one thing, I think big pharma would want this opportunity to sell more product.”

    I agree. This is one instance where big pharma could work in our favor as consumers. They fight tooth and nail to keep OTC drugs from going BTC, and they’ll fight and lobby and spend LOTS of money to get some current Rx drugs made BTC when OTC is clearly off the table.

  25. Raanne says:

    OMG – totally with you guys on the UTI thing – right now all i have to do is call my doctors office, talk to a nurse, have an embarrassing conversation over the phone, and then they call in an Rx which is good – and if it isn’t gone in 3 days you have to come in. if they could make it so you could just go to the pharmacist, that would be awesome.

    plus, but the cough syrup behind there. its not a bad idea – especially with all the studies showing that they have absolutely no effect on kids under the age of 6.

    I trust a pharmacist to be able to accurately dispense drugs – they know the interactions – they went through school for it – its not an easy program by any means. besides, a PA or a nurse practitioner can prescribe drugs, and they only have a masters also…

  26. Veeber says:

    Those of you with concerns about being denied your medications (morning after pill …) You can still go to your doctor to get a prescription. There are plenty of medications now that are OTC but you can get a prescription for and have filled by your pharmacist.

    Allowing the pharmacist to dispense certain medications without a prescription would seem to only help consumers out. Most of them know these drugs better than the doctors do, especially stuff that’s less common. This does mean that it would be best for you to stick to one pharmacy so that they have your current list of prescriptions to avoid counter-indications.

    The hesitation comes from what is allowed to go BTC. In a lot of asian countries all sorts of “health professionals” hand out antibiotics for anything that ails you. That could get out of hand.

  27. kelmeister says:

    As much as I hate the bi-monthly pat down and ID check for Sudafed, this news actually makes me happy, if pain killers are part of this (although I doubt it). I know my husband and I probably aren’t the only ones who horde pain pills. You know: you have a tooth worked on and you’re lucky enough to get a prescription for 10 codeine, which you hang onto like gold for those times when your headache can’t be touched by four Tylenol, or you strain your back in the yard, or menstrual cramps leave you writhing in bed.

    I’ve always thought it would be awesome if during the yearly physical, your doctor could give you six pills, specifically for those times when you’re left incapacitated but not so bad off that you need to get in with the doctor. But now I’ll probably be labeled a dealer or abuser, so I should probably shut up.

  28. Consumerist Moderator - ACAMBRAS says:


    Uristat FTW. It doesn’t clear up any underlying infection, but it will make you feel SOOOO much better.

  29. One of the few things that I miss about the UK is being about to buy a Canistan Duo (diflucan plus a cream) and Nurofen Plus (ibuprofen + codeine) without a prescription. Those two things made my life so much easier.

  30. pkrieger says:

    @ElizabethD: Your comment about a “standing” antibiotic scrip keeps those of us in the public health field up at night. If you are constantly taking the same antibiotic for the same bacteria, then you are already making a low level of antibacterial resistance worse. This is why we have MRSA.

  31. Indecision says:

    @kelmeister: “You know: you have a tooth worked on and you’re lucky enough to get a prescription for 10 codeine, which you hang onto like gold…”

    I knew I couldn’t be the only one. I’ve got about 8 vicodin hanging out in my medicine cabinet from my surgery two months ago. :)

  32. I also don’t buy the ‘opens access to uninsured’ argument as this would open a _huge_ liability issue for the pharmacists themselves if they are quasi-prescribing BTC drugs to essentially unknown walkin ‘patients’ with no drug interaction, allergy, etc. history.

    @cds2: Don’t doctors face the same thing with new patients? Do they end up with malpractice lawsuits due to the medications they prescribe? If so, you’re right and this won’t help them since you still need to see a doctor. If not, I don’t see why a pharmacist should be more liable than a doctor.

  33. OnceWasCool says:

    This might allow them to deregulate some drugs to keep you from having to go to the doctor.

    Example: Viagra

    See, there is an UP side to this.

  34. synergy says:

    Oh great. I get to stand in line behind the mentally and physically slow to get a medication that already has all the warnings and whatnot on the damn box! I just want to get what I need and go without having to talk to anyone about it!

  35. infinitysnake says:

    I don’t think this is necessarily a bad idea. We used to put a lot more trust in pharmacits, and they tend to be better educated on medicines than many (or most) doctors. To be successful, I think it would be best to restrict certain types of marketing, but as most phramacists are conscientious, I don’t see much issue.

  36. kc1200 says:

    This is such a great idea and I am all for it. It will only be beneficial for patients and the health care industry. In fact, it is a wo=in-win for patients. Americans are not idiots and i do not understand why other countries have this kind of system and Americans who are largely very educated are treated like fools by the doctors. We know when we have allergies, UTI, cough, and even sexually impotent. This system will help us get these medications without wiating for over two hours for a doctor, pay him or her $100 then heading to the pharmacy to get a drug that only cost $5.00. We as citizens must push hard to make this system a reality because it will save us money and needless visits. This doesn’t mean that we would stop seeing our doctors, but not all things need seeing a doctor. Mind you, pharmacists also have doctorate degrees and are highly trained to administer this service. Pharmacists have been pretty loyal to their patients and very respected, it is a shame they do not have this power sooner.