- Issuing Office:
FROM: The United States Food and Drug Administration
RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
DATE: December 27, 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.globalpharmacyplus.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), and 355(a)].
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.1 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.2 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As discussed below, FDA has observed that www.globalpharmacyplus.com offers drug products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.
FDA has also observed that www.globalpharmacyplus.com introduces into interstate commerce unapproved and misbranded drugs for which the FDA-approved version is subject to a Risk Evaluation and Mitigation Strategy (REMS) program. A REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
In addition, FDA has observed that www.globalpharmacyplus.com introduces into interstate commerce unapproved and misbranded drugs that have a narrow therapeutic index (NTI). NTI drugs are drugs where small differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in persistent or significant disability or incapacity. Substituting an NTI drug without the U.S. prescriber’s direction poses significant health risks to patients. Given the serious safety concerns with these products, the easy availability of these products via the Internet poses significant risks to U.S. consumers.
There are inherent risks to consumers who purchase unapproved new drugs and misbranded 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.globalpharmacyplus.com cease offering any unapproved or misbranded 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.globalpharmacyplus.com 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, www.globalpharmacyplus.com offers molnupiravir marketed as “Molnunat 200.” Your website states, “Molnupiravir is an oral medication, that is authorized by the FDA to treat Covid-19. Molnupiravir is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Early treatment with the drug reduces the risk of hospitalization or death in at-risk patients that have or have not been vaccinated.” There are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Molnunat 200” offered by www.globalpharmacyplus.com. Moreover, while there is an FDA-authorized version of molnupiravir currently available in the U.S. under an emergency use authorization (EUA) pursuant to section 564 of the FD&C Act (21 U.S.C. 21 U.S.C. §360bbb-3), FDA has not authorized for emergency use the “Molnunat 200” offered by www.globalpharmacyplus.com.3 FDA-authorized molnupiravir is an unapproved drug for which FDA has issued an EUA for emergency use for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
Your website also offers mycophenolate mofetil marketed as “CellCept 500mg” tablets. Your website states, “CellCept, brand name product by Roche is used to prevent your body from rejecting a kidney, liver, or heart transplant. CellCept (mycophenolate mofetil) lowers your body’s immune system.” While there are FDA-approved versions of mycophenolate mofetil tablets, including CellCept, on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “CellCept 500mg” tablets offered by www.globalpharmacyplus.com. FDA-approved mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. FDA-approved mycophenolate mofetil products, including mycophenolate mofetil tablets, are subject to a REMS program that requires healthcare providers to report pregnancies to a registry and includes an educational component regarding fetal toxicity. FDA-approved mycophenolate mofetil also bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the increased risk of first trimester pregnancy loss and congenital malformations, increased risk of developing lymphoma and other malignancies, and the increased susceptibility to infection.
Additionally, www.globalpharmacyplus.com offers tacrolimus pictured as “Tacrolimus Capsules Tacrograf – 0.5”. Your website states, “Prograf (Tacrolimus) is used to lower the body’s immune system to help fight infections. Tacrolimus is most widely used on organ transplant recipients to have a better chance of the organ to be accepted in their body.” Your website also states, “Generic Prograf is used together with other medications to prevent your body from rejecting organs such as heart, liver, or kidney transplant.” While there are FDA-approved versions of tacrolimus on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Tacrolimus Capsules Tacrograf – 0.5” offered by www.globalpharmacyplus.com. Capsules of tacrolimus administered orally are NTI drugs. FDA-approved tacrolimus capsules are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving certain transplants, in combination with other immunosuppressants. FDA-approved tacrolimus bears a boxed warning addressing an increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death.
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for the intended uses. Consequently, the labeling for these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because the drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.globalpharmacyplus.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
These drugs are also misbranded under section 502(f)(2) of the FD&C Act [21 U.S.C. § 352(f)(2)] because they fail to bear “adequate warnings against use…where [their] use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application....” This is particularly concerning because, as noted above, FDA-approved mycophenolate mofetil products, including CellCept, are subject to a REMS program to mitigate the risk of embryofetal toxicity associated with use of mycophenolate during pregnancy. Your website www.globalpharmacyplus.com is causing important safety measures that are put in place for the FDA-approved versions of this drug to be bypassed.
FDA is sending this Warning Letter to www.globalpharmacyplus.com because of the inherent risks to consumers who purchase misbranded and 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 misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your website, 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 and that you are not distributing misbranded products in violation of the FD&C Act.
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 misbranded or 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 and misbranded 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 and COVID-19-Task-Force-CDER@fda.hhs.gov.Sincerely,
Jill P. Furman
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
1 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
2 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak. Mar. 13, 2020, 85 FR 15337, available at https://www.federalregister.gov/documents/2020/03/18/2020-05794/declaring-a-national-emergency-concerning-the-novel-coronavirus-disease-covid-19-outbreak.
3 The molnupiravir EUA was initially issued by FDA on December 23, 2021 and has been subsequently reissued. Information on FDA-authorized molnupiravir available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain.