FROM: The United States Food and Drug Administration
RE: Notice of Unlawful Sale of Unapproved and Misbranded Drug Products to United States Consumers over the Internet
DATE: September 19, 2017
The United States (U.S.) Food and Drug Administration (FDA) recently reviewed your websites (listed at the bottom of this letter) and determined that they offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved new drugs and misbranded drugs for sale in U.S. commerce in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)]. FDA requests that you immediately cease marketing violative drug products to U.S. consumers.
Unapproved New Drugs
As labeled, certain products offered for sale through your websites 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 products, as marketed through your websites, 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. New drugs may not be 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 [21 U.S.C. § 355] are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].
An example of an unapproved new drug on your websites is “Generic Chloromycetin (chloramphenicol).” Your websites claim “Generic Chloromycetin” is “an antibiotic that is clinically useful for serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated” and is “an effective remedy in some forms of meningitis caused by H.influenza, as well as diseases caused by typhoid and some other bacteria.” There are currently no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for oral chloramphenicol. On September 21, 2016, it was announced in the Federal Register that FDA would not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 50 mg, 100 mg, 250 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL because FDA determined that previously approved versions of these chloramphenicol products were withdrawn from sale in the U.S. for reasons of safety or effectiveness. (81 FR 64914)
Prior to their removal from the market, the approved labeling for these products contained a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating the drug carries a significant risk of serious or life-threatening adverse effects. The boxed warning for chloramphenicol indicated that serious and sometimes fatal blood disorders [e.g., hypoplastic or aplastic anemia (very few or no blood cells in bone marrow), thrombocytopenia (low blood platelet counts), and granulocytopenia (low white blood cell counts)] are known to occur after administration of chloramphenicol. The boxed warning further described aplastic anemia attributed to chloramphenicol that later resulted in leukemia. In determining that these products were withdrawn from the market for reasons of safety or effectiveness, FDA relied on the fact that additional therapies with less severe adverse drug effects have been approved, and that the risks associated with these chloramphenicol products as labeled therefore outweighed the benefits.
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drugs are prescription drugs intended for condition(s) 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(s). Consequently, the labeling for these products fails to bear adequate directions for their intended use(s), causing them to be misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, your websites are 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)].
Your websites also offer prescription drugs for sale without a prescription. Prescription products, as defined in the FD&C Act § 503(b)(1) include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/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. For example, both chloramphenicol and Levaquin (levofloxacin) are prescription drugs as defined by FD&C Act § 503(b)(1) offered for sale on your websites without a prescription. Chloramphenicol is associated with serious risks including, but not limited to, fatal aplastic anemia and the approved labeling for this product, before it was withdrawn from sale, the formerly FDA-approved chloramphenicol labeling recommended extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days.
Levaquin is the brand name of a prescription drug approved by FDA to treat certain bacterial infections. The labeling for the FDA-approved drug Levaquin contains a boxed warning that addresses serious adverse reactions including tendinitis (tendon rupture or swelling of the tendon), peripheral neuropathy (changes in sensation and possible nerve damage), central nervous system effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure), and exacerbation of myasthenia gravis (a chronic disease that causes muscle weakness).
Under U.S. law, prescription drug products can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. Your offering prescription drug products without requiring a prescription jeopardizes patient safety and misbrands the drug products under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Dispensing a prescription drug without a valid 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)].
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FDA is taking this action against Rx-Partners because of the inherent risk to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
This letter is not intended to identify all the ways in which your activities might be in violation of law. It is your responsibility to ensure that all products you market are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to correct the violations noted above as well as any other violations of the FD&C Act (which would include the offer for sale of all unapproved and/or misbranded drug products by your websites, not just the products noted above). Failure to correct violations may result in FDA regulatory action, including seizure or injunction, without further notice.
Please notify this office in writing within 10 working days of receipt of this letter of any steps you have taken or will take to correct the violations set forth above and to prevent their recurrence.