- Issuing Office:
- Center for Drug Evaluation and Research | CDER
FROM: The United States Food and Drug Administration
RE: Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
DATE: May 4, 2022
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.inhousepharmacy.vu and has observed that your website introduces into interstate commerce domperidone drug products that are unapproved new drugs in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§331(d) and 355(a)].
As discussed below, FDA has observed that www.inhousepharmacy.vu introduces into interstate commerce unapproved domperidone drug products. Domperidone is not currently a legally marketed human drug and it is not approved for sale in the U.S. There are serious risks associated with domperidone including cardiac arrhythmias, cardiac arrest, and sudden death. These risks are related to the blood level of domperidone, and higher levels in the blood are associated with higher risks of these events. Concurrent use of certain commonly used drugs, such as erythromycin, could raise blood levels of domperidone and further increase the risk of serious adverse cardiac outcomes. The easy availability of domperidone via the Internet poses significant risks to U.S. consumers.
There are inherent risks to consumers who purchase unapproved new drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.inhousepharmacy.vu cease offering any unapproved drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.inhousepharmacy.vu are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.
For example, among other domperidone drug products offered on your website, www.inhousepharmacy.vu offers domperidone marketed as “Vomistop (Domperidone 10mg) 500 Tablets/Pack” manufactured by Acme Generics LLP (marketed by Cipla Ltd). Your website states, “Vomistop tablets 10mg contain domperidone, an antiemetic that prevents nausea and vomiting as well as relieving bloating and gastric discomfort, by blocking dopamine receptors in the brain and upper intestine.” There are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Vomistop (Domperidone 10mg) 500 Tablets/Pack” manufactured by Acme Generics LLP (marketed by Cipla Ltd) and offered by www.inhousepharmacy.vu.
FDA is sending this Warning Letter to www.inhousepharmacy.vu because of the inherent risks to consumers who purchase unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.
If you are not located in the U.S., please note that products that appear to be unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
S. Leigh Verbois, Ph.D.
Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research