WARNING LETTER
www.directpharmashop.net
MARCS-CMS 668345 —
November 08, 2023
Product:
Drugs
Recipient:
www.directpharmashop.net
Netherlands
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
FROM: The United States Food and Drug Administration
DATE: November 8, 2023
WARNING LETTER
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.directpharmashop.net and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].
As discussed below, FDA has observed that www.directpharmashop.net introduces into interstate commerce unapproved and misbranded aripiprazole drug products. In addition, FDA has observed that your website introduces into interstate commerce misbranded quetiapine drug products. 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.directpharmashop.net cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.directpharmashop.net 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.directpharmashop.net offers aripiprazole marketed as “Abilify 15mg” tablets manufactured by Bristol-Myers Squibb. Your website describes the product as “an antipsychotic drug” and states, “Ability[sic] treats mental and mood disease. It is used for the therapy of schizophrenia, Tourette’s or autistic disorder in children, bipolar malady and irritations cased[sic] by depression.” While there are FDA-approved versions of aripiprazole, including Abilify tablets, 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 “Abilify 15mg” tablets manufactured by Bristol-Myers Squibb and offered by www.directpharmashop.net. FDA-approved aripiprazole is an atypical antipsychotic indicated for schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder, and treatment of Tourette’s disorder and is only available pursuant to a prescription from a licensed practitioner. FDA-approved aripiprazole 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 risk of increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors with antidepressant drugs.
Misbranded Drugs:
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 drug is a prescription drug 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 product safely for its intended use. Consequently, the labeling for this drug fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because the drug is not approved in the U.S., it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.directpharmashop.net 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)].
FDA has also observed that www.directpharmashop.net offers prescription drugs for sale without a prescription. in addition to the drug listed above, www.directpharmashop.net offers quetiapine marketed as “Seroquel 200mg” tablets. Your website states, “This is an antipsychotic drug. This medication affects the chemicals in the brain and changes their activity.” FDA‐approved quetiapine is indicated for schizophrenia and bipolar disorder and is only available pursuant to a prescription from a licensed practitioner. FDA‐approved quetiapine bears a boxed warning addressing the risk of increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors.
Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.directpharmashop.net jeopardizes patient safety and misbrands the drug under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
FDA is sending this warning letter to www.directpharmashop.net 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 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 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.
Sincerely,
/S/
S. Leigh Verbois, Ph.D.
Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
11/21/2023
Regulated Product(s)
Drugs