# How does a perscription-only drug get over-the-counter status from the FDA? **URL:** \ **Category:** Factual Questions\ **Created:** [March 22, 2012, 2:39am UTC](https://boards.straightdope.com/t/how-does-a-perscription-only-drug-get-over-the-counter-status-from-the-fda/616464 "2012-03-22T02:39:00Z")\ **Posts on this page:** 4\ **Page:** 1
**Author:** ![Duke](https://avatars.discourse-cdn.com/v4/letter/d/e8c25b/32.png) [@Duke](https://boards.straightdope.com/u/Duke)\ **Post date:** [March 22, 2012, 2:39am UTC](https://boards.straightdope.com/t/how-does-a-perscription-only-drug-get-over-the-counter-status-from-the-fda/616464/1 "2012-03-22T02:39:00Z")
Some time ago my neurologist was discussing a nasal spray medication for migraine relief. The doctor remarked, “I don’t know why this med is still prescription only…it was developed in the fifties and has very little incidence of side effects. A lot more people would use it if it were over the counter.” That got me thinking: exactly what is the process through which a drug goes from prescription only to OTC? I understand that the FDA must declare the drug “generally recognized as safe and effective,” but how is that process initiated? Must the manufacturer petition the FDA for a ruling? What is the practical definition for “safe and effective” with regards to OTC? (I vaguely remember Cecil once saying it meant “has been around a long time and hasn’t killed many people yet”…) ---
**Author:** ![mnemosyne](https://avatars.discourse-cdn.com/v4/letter/m/c4cdca/32.png) [@mnemosyne](https://boards.straightdope.com/u/mnemosyne)\ **Post date:** [March 22, 2012, 3:21pm UTC](https://boards.straightdope.com/t/how-does-a-perscription-only-drug-get-over-the-counter-status-from-the-fda/616464/2 "2012-03-22T15:21:18Z")
I believe (from vague memories from a place I worked at 6+ years ago) that it’s a combination of the manufacturer collecting the data on a medication and filing a request for a change of status of the drug - possibly through an abbreviated new drug approval process (ANDA) but I’m not 100% sure. I’m looking through [this section](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm) of the FDA’s website and I’ll come back if I find something clearer, but it might interest you to have a look. I know we have a few other people involved in the industry on these boards but offhand I think most of us are (or were, in my case) on the technical side rather than the paperwork side. Was the spray medication Civamide? Just curious 😉 ---
**Author:** ![mnemosyne](https://avatars.discourse-cdn.com/v4/letter/m/c4cdca/32.png) [@mnemosyne](https://boards.straightdope.com/u/mnemosyne)\ **Post date:** [March 22, 2012, 3:38pm UTC](https://boards.straightdope.com/t/how-does-a-perscription-only-drug-get-over-the-counter-status-from-the-fda/616464/3 "2012-03-22T15:38:45Z")
Well that was quick. Here is the FDA’s page on how drugs are developed and approved. [Good read straight from the horse’s mouth, so to speak.](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm) [Here is how drugs](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm209647.htm) are developed through the NDA process…an Abbreviated NDA would be filed for an existing drug to change it’s status if it’s already available as a prescription. Getting into some of the applicable laws: The FDA is guided by the Code of Federal Regulation, specifically CFR 21. [Part 314](http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=2a88f275a8609a20ed3f25adbeb7205f&rgn=div5&view=text&node=21:5.0.1.1.4&idno=21#21:5.0.1.1.4.4.3.2) is the relevant section for New Drug Approvals (and Abbreviated ones), and so far I’ve found the following: (Bolding mine) > [@](#): > > **Efficacy supplement means a supplement to an approved application proposing to make one or more related changes from among the following changes to product labeling** : > > (1) Add or modify an indication or claim; > > (2) Revise the dose or dose regimen; > > (3) Provide for a new route of administration; > > (4) Make a comparative efficacy claim naming another drug product; > > (5) Significantly alter the intended patient population; > > (6) **Change the marketing status from prescription to over-the-counter use** ; > > (7) Provide for, or provide evidence of effectiveness necessary for, the traditional approval of a product originally approved under subpart H of part 314; or > > (8) Incorporate other information based on at least one adequate and well-controlled clinical study. 314.5: > [@](#): > > (a) Application form. The applicant shall submit a completed and signed application form that contains the following: > > (1) The name and address of the applicant; the date of the application; the application number if previously issued (for example, if the application is a resubmission, an amendment, or a supplement); the name of the drug product, including its established, proprietary, code, and chemical names; the dosage form and strength; the route of administration; the identification numbers of all investigational new drug applications that are referenced in the application; the identification numbers of all drug master files and other applications under this part that are referenced in the application; and the drug product’s proposed indications for use. > > (2) A statement whether the submission is an original submission, a 505(b)(2) application, a resubmission, or a supplement to an application under §314.70. > > (3) **A statement whether the applicant proposes to market the drug product as a prescription or an over-the-counter product.** The applicant - the manufacturer/patent holder - will have, at this point, clinical trial information supporting OTC safety (to get info on the paperwork involved for investigating new drugs, read [CFR 21 Part 312!](http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=2a88f275a8609a20ed3f25adbeb7205f&rgn=div5&view=text&node=21:5.0.1.1.3&idno=21)) This whole thing is a HUGE part of a company’s time and staffing - Regulatory Affairs departments tend to be some of the largest ones in the company (at least the two places I’ve worked at!) because there is just so much paperwork and evidence to gather, condense and manage. It’s probably as much work to manage drugs that are already on the market as it is to develop new ones! ---
**Author:** ![anson2995](https://avatars.discourse-cdn.com/v4/letter/a/c77e96/32.png) [@anson2995](https://boards.straightdope.com/u/anson2995)\ **Post date:** [March 22, 2012, 3:55pm UTC](https://boards.straightdope.com/t/how-does-a-perscription-only-drug-get-over-the-counter-status-from-the-fda/616464/4 "2012-03-22T15:55:47Z")
[Found this](http://www.institute-shot.com/switching%20from%20prescription%20to%20OTC.htm): > [@](#): > > A section, (503 (b) (3)), of the Durham-Humphrey Amendment grants the FDA authority to switch prescription drugs to OTC status by regulation. Such a switch may take place when one of the following occurs: > > [ul] > [li]The drug manufacturer requests the switch by submitting a supplemental application to its approved NDA.[/li][li]The drug manufacturer petitions the FDA.[/li][li]The drug may be switched through the OTC drug review process.[/li][/ul] > > The primary mechanism of switching drugs to OTC status is the third–the OTC drug review process. Also, [this news story from the Boston Globe earlier this month](http://www.boston.com/Boston/dailydose/2012/03/fda-considers-putting-more-drugs-over-the-counter-while-curtailing-antibiotic-use/pMhYsyerDfs5jVcmPx4OhK/index.html) which says the FDA is considering changes to the prescription/OTC system to make some maintenance drugs more easily available w/o prescription and to curtail the overuse of others, like antibiotics.