Are you good at internet searches?

I am trying to find the US regulations that specifically relate to injectable B12 being by prescription only. The trouble is that I can't find them. No form of cobalamin is listed on the DEA's schedule of controlled substances, so it's clearly not limited that way.

It's probably limited based on the fact that it is administered with a syringe, so that is the angle I'm currently trying to focus on. But what I'm looking for is the regulation that states that any injectable compound requires a prescription. So far I haven't found that either. Anyone want to help me look? I'm poking around at the FDA website (http://www.fda.gov/default.htm) to try to locate it. If I want to submit a citizen petition to get a law changed, I have to reference the law I want changed (which is awfully hard to do if I can't find the actual law).

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  • found this

    nabp.net/news/fda-actions-a...

    There's a link on the main site to controlled substances

    nabp.net/news/tagged/federa...

    though it does look as if it is really all news bulletins but may be there is something more specific on the site (National Association of Board of Pharmacy)

    It might also be worth contacting B12 Awareness in the US as they might be able to help eg with publicising a petition - but you may already be aware of them :)

  • Thanks Gambit. I have also come across this site: usp.org/

    for the US Pharmacopeia, which is supposed to be the official list of drugs for the US. So far I haven't been able to make heads or tails of the site though. There doesn't seem to be an actual list...

    Before I can enlist any help with a petition, I need to figure out what, exactly, to ask for. I haven't found anything so far to even indicate that it's really a prescription only drug except that the label on the American Regent vial does say "Rx only" on it. And that makes me wonder if it's really all down to a labeling law somewhere. There's a image on this page of the label: americanregent.com/AllProdu...

    Trying to trace backwards through the law to how we got to this point is enough to make my head spin.

  • shouldn't think that interaction between state and federal law helps much either :)

    Have you tried talking to a pharmacist at all just to see if they can give you an answer - it's legislation that is professionally relevant to them so they should have some idea where the rule originates?

  • I did actually talk to a pharmacist yesterday. She told me to try looking up the term 'injectable compounds' on the FDA site (but that didn't yield anything) and she also described what a 'legend drug' is. She said that all the medications that are sold from behind the counter are legend drugs (meaning a prescription is required) but I think that can't be right since, with the explosion of meth production in the US, most pharmacies keep all the over the counter cold medicine behind the counter now too. I also asked about the flu shots that all pharmacies sell nowadays and she told me that the way they get around needing a doctor's prescription for those is that pharmacies have been given prescribing authority. Again, I'm thinking I need to take this one conversation with a grain of salt. I probably need to talk to multiple pharmacists to get a clearer picture.

  • good luck. hope you get the answers you need soon

  • Hi,

    Do you have this? Gray/White box very bottom of site:

    drugs.com/pro/cyanocobalami...

    Might be of help. Of interest, as sure you know, it can be bought online without prescription. This is an example, not a recommendation, I haven't dealt with this site.

    buy-otc.com/more.aspx?Z=25273&

    Good luck,

    Leilani

  • Galaxie...It appears that the USP does not handle legal issues related to drug dispensing.

    "For more than a century, the United States Pharmacopeial Convention (USP) and the U.S. Food and Drug Administration (FDA) have worked together to protect the public health and promote the quality and safety of drugs, dietary supplements, and foods."

    "Enforcement of USP standards is the responsibility of FDA and other governmental authorities, in the United States and elsewhere. USP has no role in enforcement."

    I don't think this would be helpful source for your purposes.

    Leilani

  • Yes that American Regent info you linked to is the same product that I get when my prescription is filled.

    I know the US Pharmacopeia isn't the enforcing authority. I'm hoping that I can find something, somewhere, that can point me in the direction of the FDA regulation that relates to injectable B12 being prescription only. So far I have figured out that it isn't based on the ingredients in the medication itself (because it isn't a drug listed on the DEA's schedule of controlled substances), so there might be a law related to how a drug is administered or something? There has to have been some criteria used to establish that it is a prescription only medication. Ideally, I'm looking for the law itself that applies and also, if possible, the backup documentation that was used to support the passage of whatever the law actually is.

    If I can find the law and understand why it was passed, I can formulate a petition to get it changed. But without knowing the actual law that applies, I can't even get started.

  • Galaxie, I'll try to keep working on this as I am an experienced website researcher and this really has me going!

    I sent message on FDA site (see bottom of following) but answer isn't real promising...I'm copying to you JIC there is a contact you don't yet have.

    ~~~~~~~~~

    Entered on 04/17/2015 at 09:00:08 EDT (GMT-0400) by Pat M:

    The Regulations.gov Web site was created as a way for the public to review and comment on proposed federal rules and regulations. We are unable to answer questions about current federal rules and regulations.

    Please contact FDA's Division of Drug Information directly at (855) 543-3784 or druginfo@fda.hhs.gov

    If you need any help using the Regulations.gov Web site to review or comment on proposed federal rules or regulations, please contact us again.

    Thank you,

    Regulations.gov Help Desk

    Entered on 04/17/2015 at 09:00:08 EDT (GMT-0400) by Pat M:

    Hello,

    I am attempting to learn whether or not the FDA determines the requirement of a prescription for injectable non-controlled drugs/vitamins, e.g., cyanocobalamin (B12). If not, could you please tell me who makes this decision and possibly where I might find more information? If it helps, I live in California.

    Thank you,

  • Thank you! I could certainly use all the help I can get since I am really not that good at internet research. Did you end up emailing that question to the druginfo@fda.hhs.gov email address?

    I am happy to report that I did just get a really helpful response to an email I sent inquiring how to go about asking for injectable B12 to be made OTC. It's long, but I will paste it below:

    OTC drug products are legally marketed in the United States as a result of two types of reviews by the FDA.

    In general, to market an OTC product, the product must meet the standards of the OTC monograph. OTC drug monograph regulations are described in 21 CFR Part 330, which is available at: accessdata.fda.gov/scripts/...

    Provided is a link to the list of OTC monographs: fda.gov/Drugs/DevelopmentAp...

    Otherwise, a new drug application (NDA) must be submitted. NDA regulations are described in 21 CFR Part 314, which is available at: accessdata.fda.gov/scripts/... Cyanocobalamin products are legally marketed under a new drug application or abbreviated new drug application.

    Prescription (Rx) to OTC drug product switch approval occurs when a prescription product is demonstrated to be safe and effective for self-care. A complete switch means that the OTC product has the same indication, strength, dose, duration of use, dosage form, target population, and route of administration as the prior prescription product. However, more commonly, a prescription drug is approved for self-care at a different dose and duration of treatment. For all prescription to OTC switches, the labeling is revised to provide consumers with easy-to-read, important self-care information.

    Drugs are commonly switched one of two ways, either under an OTC drug review, or by a manufacturer's submission of additional information to the original drug application. When considering a prescription to OTC switch, the key question that must be answered is whether the drug can benefit consumers without endangering their safety. An efficacy supplement should be submitted to an approved NDA for a prescription product if the sponsor plans to switch the drug product covered under the NDA to OTC marketing status in its entirety without a change in the previously approved dosage form or route of administration. An NDA 505(b)(1) should be submitted if the sponsor is proposing to convert some but not all of the approved prescription indications to OTC marketing status. An original NDA (505)(b)(1) or 505(b)(2) needs to be submitted if the sponsor plans to market either a new product OTC whose active substance, indication, or dosage form has never previously been marketed OTC.

    For additional information about OTC drugs, please visit fda.gov/Drugs/DevelopmentAp... and fda.gov/Drugs/DevelopmentAp...

    FDA regulations (21 CFR 10.30) permit an individual to submit a citizen petition regarding the following, which includes requesting a RX to OTC switch for a drug product:

    (1) If the petition requests the Commissioner to issue, amend, or revoke a regulation, the exact wording of the existing regulation (if any) and the proposed regulation or amendment requested.

    (2) If the petition requests the Commissioner to issue, amend, or revoke an order, a copy of the exact wording of the citation to the existing order (if any) and the exact wording requested for the proposed order.

    (3) If the petition requests the Commissioner to take or refrain from taking any other form of administrative action, the specific action or relief requested.

    Instructions for submitting citizens petitions (CPs) are available at: fda.gov/RegulatoryInformati... If you plan to submit a citizen petition, we recommend that you retain the services of a lawyer experienced in drug law to provide you with the guidance that you need to request a RX to OTC switch.

  • Galaxie,

    Yes I did. This portion of the information I posted above is the "Answer."

    ~~~~~~~

    "Entered on 04/17/2015 at 09:00:08 EDT (GMT-0400) by Pat M:

    The Regulations.gov Web site was created as a way for the public to review and comment on proposed federal rules and regulations. We are unable to answer questions about current federal rules and regulations.

    Please contact FDA's Division of Drug Information directly at (855) 543-3784 or druginfo@fda.hhs.gov

    If you need any help using the Regulations.gov Web site to review or comment on proposed federal rules or regulations, please contact us again.

    Thank you,

    Regulations.gov Help Desk

    Entered on 04/17/2015 at 09:00:08 EDT (GMT-0400) by Pat M:"

    ~~~~~~~~~~~~~~

    Linda

  • Just a long shot, but could Sally Pacholok who wrote 'Could it Be B12?' not help you? I don't suppose it would be in the book itself, but she must know the subject inside out by now - perhaps you could email her from her website?

  • Based on her website, which lists the goals they have to raise awareness, legislation to get rid of the prescription requirement isn't even on their radar. I'd be willing to ask her, but I'm kind of paranoid about giving out my phone number and their 'contact us' page lists it as a requirement. :(

  • Ah well, just a thought...

  • It looks to me as if it is the Drug Enforcement Administration which is in charge of it all. Being a UK citizen, I have little knowledge of USA government, but as the DEA define the five schedules, who else could it be?

  • No form of cobalamin is listed on any of the five schedules. That means it isn't a controlled substance. The FDA and DEA sort of work together. It is FDA regulations that DEA enforce. There is a section in the FDA regulations that lists specific exemptions to the DEA's schedule of controlled substances. (It's here if you're interested: accessdata.fda.gov/scripts/... )

    At first I thought I could maybe ask for cobalamin to be added to the list of exemptions - until I realized they aren't a controlled substance so there is nothing to exempt. ::sigh::

    I suspect that the real issue is going to be with the words "methods of administration" which I found in the regulation regarding medical devices (which includes syringes) here: accessdata.fda.gov/scripts/...

    I bet there is wording somewhere (although I haven't yet found it) that limits any medication to prescription only depending on the route of administration (specifically parenteral). I need to find that piece of the puzzle.

    But if that is the case, it ends up being a much bigger mess than just getting the status of injectable B12 changed. It would either mean fighting to change the syringe law in it's entirety, or fighting to get medications evaluated separately from the route they would be administered. I have a feeling I would need a whole lot more support to go after either of those (though the latter seems more possible than the former).

  • I would guess it is because it is an injection like the UK law so maybe try searching laws regarding injectables?

  • Based on the info I've gathered so far, it sounds like I need to submit something called an efficacy supplement, which - I think - is different from a citizen petition. I was able to find a definition of an efficacy supplement in section 314.3:

    "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."

    #6 is the important one in this list.

    Now I have to find samples or templates of how to submit an efficacy supplement.

  • So good to learn someone is working on changing things here in the US. I'm envious of the ease our fellow PA sufferers on the other side of the Atlantic have in acquiring their needed medications.

    My question is about syringes, whether they can be obtained without a prescription as I think it depends on the state. In my state (Calif) I believe up to 10 syringes can legally be purchased at a time without a prescription, though not all pharmacies will necessarily allow a customer to buy them. Recall there some states require a prescription though don't remember exactly which ones. Some information was quite dated and may have since changed.

  • Yes, it varies quite a bit among states. On the federal level I believe all syringes require a prescription, but most states have laws that allow the purchase of some insulin syringes without a prescription. Most states still require a prescription for anything other than an insulin syringes (such as those used for IM injections). And a few states don't allow any syringes to be sold without a prescription. It's really a hodgepodge. In Washington state we're legally allowed to buy any kind of syringe without a prescription, but the pharmacies get to use their own discretion on whether or not they will sell syringes without a prescription. I've even seen one local (large chain) pharmacy take it to the extreme that they not only require a prescription, but also require that the prescription for the injectable that the syringe is needed for also be filled through them. Thankfully they aren't the only pharmacy in town.

    In trying to figure out how to change the status of injectable B12 (and I have yet to come across an example of an efficacy supplement to use as a template) I have decided to avoid the issue of syringes largely because the states seem to have taken on syringe issues independently. For example, the Washington state syringe law was passed in order to cut down on HIV and other disease infections that occur from sharing needles (basically the exact problem that Indiana has been facing lately).

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