Mon, Nov 23, 2015 12:11 am
RE: Annual limit on decongestants
From: DRUGINFO@fda.hhs.govhide details
Dear Johnna Stahl,
Thank you for writing the Division of Drug Information, in the FDA’s Center for Drug Evaluation and Research (CDER), regarding the legal limit for pseudoephedrine-containing products.
As you may already be aware, the sale of products containing pseudoephedrine is subject to limitation under the Combat Methamphetamine Epidemic Act of 2005 (CMEA). This Act was passed to control the distribution and sale of drug products that may be used to illicitly produce methamphetamine.
These legal requirements restrict over-the-counter sales of products containing ephedrine, pseudoephedrine, and phenylpropanolamine (PPA) and are enforced by the Drug Enforcement Administration (DEA), not the FDA. For further information regarding CMEA, please visit http://www.deadiversion.usdoj.gov/meth/index.html. For information on registration, enforcement, and policy, please visit DEA’s website at http://www.dea.gov.
The law limits the amount of pseudoephedrine that may be purchased per transaction and per month; no more than 9 grams of pseudoephedrine per month, and no more than 3.6 grams per transaction may be purchased. The table below describes how much pseudoephedrine may be purchased based upon the strength of the drug.
The CMEA, as well as numerous state and local laws, require retailers of products containing pseudoephedrine and ephedrine to capture customer data at the point of sale. In order to help track the purchases of pseudoephedrine, most states utilizes the National Precursor Log Exchange (NPLEx). NPLEx offers a real-time electronic tracking service, free of charge, to law enforcement and state governments. Please be advised that only pharmacies and law enforcement have access to NPLEx. During the application process for access to the system, the registrant is asked to provide verification of either pharmacy or law enforcement status.
The pharmacy scans a government identification or enters the data into the secure MethCheck portal. The information is transmitted instantly to the database where it is available for review by law enforcement. The NPLEx tool, MethCheck, is entirely web-based, with no servers, software, or hardware. The data is housed at the Appriss data center, subject to annual FBI audit, and under tight security policies that include independent security testing and HIPAA compliance. Appriss is also the disaster recovery site for the National Law Enforcement Recovery System (NLETS).
I assume this database is run by the DEA, through state and local law enforcement?
FDA does not have or maintain a database of purchase history. However, you may use the NPLEx website (via https://www.nplexanswers.com/NPLExAnswers/content/startForm.go) to get a summary of the purchase history tied to your identification. You will need to enter the transaction ID from the denied sale and your last name. Please be advised that the FDA does not endorse any of the information contained on non-government websites.
Why would there be a transaction ID from the denied sale? Was the Walmart pharmacy employee supposed to give me a receipt that said I was denied?
Please note that some states do not participate in the above NPLEX system. Please contact your state Board of Pharmacy to determine if they participate in the NPLEX system or for assistance with your purchase denial if your state does not participate in the NPLEX system. Please be aware that some states already have regulations controlling the sale of products containing these ingredients. In instances in which state and federal guidelines conflict, stores are to follow the more stringent of the two. To learn your state requirements, please contact your state board of pharmacy, available through the National Association of Boards of Pharmacy at http://www.nabp.net/.
I can’t find specific information on decongestants on the NABP website, and I’m still waiting to hear back from the New Mexico Board of Pharmacy. (Actually, I’m not really waiting, as I don’t think I’ll ever hear from them again.)
Lastly, although the Combat Methamphetamine Epidemic Act of 2005 (CMEA) restricts the over-the-counter (OTC) sales of products containing pseudoephedrine, your physician can still write a prescription for pseudoephedrine that will allow you to obtain greater amounts than the maximum OTC amounts allowed by the CMEA. The pharmacist would enter the prescription into the computer as if it were a prescription drug (meeting the regulation for logging/signing a record book), and the product would be purchased at the register, like paying for any prescription medication. Please note that this action would fall under the practice of medicine and is not regulated by the DEA or FDA.
Sure, pay for a doctor appointment and a prescription. Perhaps you can understand why I choose to just pay for over-the-counter allergy medicine? Of course, with all these regulations, Claritin-D is not really an OTC medicine anymore, is it?
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: http://twitter.com/fda_drug_info
This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
Who would have thought that it would be this hard to buy allergy medicine? And when the beginning of the year rolls around, will I cave in and buy more Claritin-D? (Achoooooooo!)