Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rxcashbiz-05292018
Timestamp: 2019-07-21 12:10:15
Document Index: 528793122

Matched Legal Cases: ['§ 331', '§ 321', '§ 321', '§ 355', '§ 331', '§ 352', '§ 353', '§ 331']

RxCash.Biz - 05/29/2018 | FDA
RxCash.Biz - 05/29/2018
RxCash.Biz May 29, 2018
TO: RxCash.Biz
The United States (U.S.) Food and Drug Administration (FDA) has determined that RxCash.Biz offers products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, your network introduces into interstate commerce, opioids that are misbranded and unapproved new drugs, in violation of sections 301(a), 301(d), 503{b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331{a), 331(d), 353(b), and 355(a)].
As labeled, certain products offered for sale by RxCash.Biz 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. 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, RxCash.Biz offers tramadol that is described as being "used to relieve moderate to moderately severe pain." While there are FDA-approved versions of tramadol 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 tramadol product offered by RxCash.Biz. FDAapproved tramadol 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 risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when taken in conjunction with other central nervous system depressants, including alcohol, use may result in coma or death.
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)(l) of the FD&C Act 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. 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 drug is a prescription drug intended for a condition(s) that is 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(s). Consequently, the labeling for this drug fails to bear adequate directions for its intended use(s), causing it to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because this drug is not approved in the U.S. it is also not exempt under 21 CFR 201.115 from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, RxCash.Biz is causing the introduction of a misbranded drug into U.S. interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
FDA is taking this action against RxCash.Biz because of the inherent risk to consumers who purchase misbranded and 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.
This letter is not intended to identify all the ways in which your activities might be in violation of law. Furthermore, included below is a list of websites identified as part of your network (this is not intended to be all-inclusive). It is RxCash.Biz's 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 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 misbranded and/or unapproved new drugs, not just the drugs noted above). Failure to correct these violations may result in FDA regulatory action, including seizure or injunction, without further notice.
http://www.medsusa.club
http://www.canada meds.site
http://www.vip-clients.biz
http://www.rx-checkout.net
http://www.norxmedi.com
http://www.medecine4u.net
http://www.pharmacy-24x7.com
http://www.24x7medpharm.com
http://www.shop-medicines.com
http://www.medzxpress.com
http://www.best4ph.com
http://www.greatmedz.com
http://www.pro-medz.com
http://www.pharmaonlinepro.com
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