WARNING LETTER

Ketamine Troche Store / www.ketaminetrochestore.com MARCS-CMS 722122 — June 23, 2026

Delivery Method:: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
Product:: Drugs

Recipient:: Ketamine Troche Store / www.ketaminetrochestore.com; United States; contact@ketaminetrochestore.com

Issuing Office:: Center for Drug Evaluation and Research (CDER); United States

June 23, 2026

WARNING LETTER
Reference Number: MARCS-CMS 722122

To Ketamine Troche Store:

This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.ketaminetrochestore.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

As discussed below, FDA has observed that www.ketaminetrochestore.com introduces into interstate commerce unapproved and misbranded ketamine drug products, including certain drugs for which the FDA-approved version is an injectable or subject to a Risk Evaluation and Mitigation Strategy (REMS).¹ FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.

There are also 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.ketaminetrochestore.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.

FDA Review

Violations were identified and documented during a review of your website www.ketaminetrochestore.com, FDA Establishment Identifier (FEI) 3042658413, from January 9 to January 16, 2026.

Violations of the Federal Food, Drug, and Cosmetic Act

On your website at internet address www.ketaminetrochestore.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)).

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

Unapproved New Drug Violations

Drugs Introduced or Delivered for Introduction into Interstate Commerce Without an Approved Application in Violation of Sections 505(a) and 301(d) of the FD&C Act

Certain products offered for sale by www.ketaminetrochestore.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.

You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.

An example of an unapproved ketamine drug product you offer for sale on www.ketaminetrochestore.com is ketamine marketed as "Ketamine Liquid." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Ketamine liquid is revolutionizing the way we treat mental health conditions and manage pain. Whether it's used for anesthesia, depression treatment, or chronic pain relief, ketamine liquid offers rapid and effective results."

A second example of an unapproved ketamine drug product you offer for sale on www.ketaminetrochestore.com is ketamine marketed as "Ketamine Suppository." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Ketamine suppository which is a rectally administered form of ketamine is emerging as a promising alternative for individuals seeking to find relief in chronic pain, treatment-resistant depression (TRD) and other medical conditions."

A third example of an unapproved ketamine drug product you offer for sale on www.ketaminetrochestore.com is esketamine marketed as "Ketamine Nasal Spray." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims "Ketamine is a breakthrough in modern medicine offering a fast and effective solution for treating various mental health conditions, particulary [sic] depression and anxiety" and "can also be used to treat anxiety problems that don't respond to traditional therapy."

While there are FDA-approved versions of ketamine drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Ketamine Liquid," "Ketamine Suppository," and "Ketamine Nasal Spray" offered by www.ketaminetrochestore.com.

FDA-approved ketamine, including products marketed under the brand name KETALAR, is a Schedule III controlled substance. It is an intravenous or intramuscular injection indicated as a general anesthetic, including as a sole agent or as an adjunct to other anesthetic agents, for the induction of anesthesia and for diagnostic and surgical procedures. Ketamine is a racemic mixture consisting of two mirror image molecules, R- and S-ketamine (arketamine and esketamine, respectively). This product is only available pursuant to a prescription from a licensed practitioner. Ketamine is not FDA-approved for the treatment of any psychiatric disorder.

FDA-approved esketamine, a ketamine derivative, is a Schedule III controlled substance marketed under the brand name SPRAVATO. It is a nasal spray indicated for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant. Furthermore, FDA-approved SPRAVATO 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 for sedation, dissociation, and respiratory depression after administration; the potential for abuse and misuse; the increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants; and the requirement that SPRAVATO be available only through a restricted program, the SPRAVATO REMS, because of the risks of serious adverse outcomes from sedation, dissociation, respiratory depression, abuse, and misuse. The SPRAVATO REMS requires SPRAVATO to be dispensed and administered in medically supervised health care settings that are certified in the REMS and monitor patients for a minimum of two hours following administration. In addition, pharmacies must be certified in the REMS and must only dispense SPRAVATO to health care settings that are certified in the program.

Compounded Drug Products Not Eligible for the Exemptions Under Sections 503A and 503B of the FD&C Act and Therefore Also in Violation of Sections 505(a) and 301(d) of the FD&C Act

Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions under which human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FD&C Act: compliance with current good manufacturing practice of section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)); labeling with adequate directions for use of section 502(f)(1); and FDA approval prior to marketing of section 505.²

Section 503B of the FD&C Act (21 U.S.C. 353b) describes the conditions under which human drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from three sections of the FD&C Act: labeling with adequate directions for use of section 502(f)(1); FDA approval prior to marketing of section 505; and the Drug Supply Chain Security Act requirements in section 582 (21 U.S.C. 360eee-1).³
You failed to meet the conditions of sections 503A and 503B of the FD&C Act.

An example of an unapproved compounded ketamine drug product you offer for sale on www.ketaminetrochestore.com is ketamine marketed as "Ketamine 100 mg Troche." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim "Ketamine Troches 100mg is a carefully formulated drug used to treat a wide range of diseases, including chronic pain, depression, anxiety, and other mental health issues."

Your operation permits the purchase of "Ketamine 100 mg Troche" that has not been compounded pursuant to a prescription. Receipt of prescriptions for individually identified patients for drug products compounded by licensed pharmacists in State-licensed pharmacies and Federal facilities, or by licensed physicians is a condition necessary to qualify for the exemptions under section 503A of the FD&C Act. In addition, your operation is not a registered outsourcing facility, and therefore, any drug products produced by your operation do not qualify for the exemptions under section 503B of the FD&C Act. Further, section 503B of the FD&C Act includes a condition that states a drug compounded by an outsourcing facility "will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug."⁴ Because your “Ketamine 100 mg Troche” does not meet the conditions of either section 503A or section 503B of the FD&C Act, it is not eligible for the exemptions of those sections, including FDA approval requirements of section 505 of the FD&C Act.

There are no FDA-approved applications in effect for your “Ketamine 100 mg Troche.” Under sections 505(a) and 301(d) of the FD&C Act a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FD&C Act.

Misbranded Drug Violations

A drug is misbranded under section 502(f)(1) of the FD&C Act 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 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)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.

You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. 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 their intended use. Consequently, the labeling for these drug products fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. In addition, because your compounded drug products do not meet the conditions of sections 503A or 503B of the FD&C Act, they are also not exempt from section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.ketaminetrochestore.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.

Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug products without requiring a prescription, www.ketaminetrochestore.com jeopardizes patient safety and misbrands the drug products 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.

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 722122” in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

If you are not located in the United States, 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 United States.

Please note FDA posts warning letters on www.fda.gov.

Sincerely,
/S/
Sangeeta Vaswani Chatterjee, PharmD
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

/S/
Matthew J. Lash, JD
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

________________________

1 REMS refers to a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. See the Risk Evaluation and Mitigation Strategies website at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.

2 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FD&C Act.

3 We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FD&C Act.

4 Section 503B(a)(8) of the FD&C Act (21 U.S.C. 353b(a)(8)) does not prohibit administration of the drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 503(b)(1) of the FD&C Act.