WhoIs Rxmexicoonline.com

Drug Enforcement Agency

United States of America


The Ryan Haight Act Known as
Online Pharmacy Consumer Protection Act of 2008
Sec. 2. Requirement of a valid prescription for
controlled substances dispensed by means of the Internet.

SUMMARY: The Ryan Haight Online Pharmacy Consumer Protection Act,
which was enacted on October 15, 2008,amended the Controlled Substances Act and Controlled Substances Import and Export Act by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet.


DEA Warning–Buying drugs online may be illegal and dangerous!

Federal law prohibits buying controlled substances such as narcotic pain relievers (e.g., OxyContin®, Vicodin®), sedatives (e.g., Valium®, Xanax®, Ambien®), stimulants (e.g., phentermine, phendimetrazine, Adderall®, Ritalin®) and anabolic steroids (e.g., Winstrol®, Equipoise®) without a valid prescription from your doctor.

This means there must be a real doctor-patient relationship, which by most state laws requires a physical examination. Prescriptions written by “cyber doctors” relying on online questionnaires are not legitimate under the law.



Address lookup
canonical name rxmexicoonline.com

aliases
addresses 64.234.227.115
Domain Whois record
Queried whois.internic.net with “dom rxmexicoonline.com

Domain Name: RXMEXICOONLINE.COM
Registrar: INTERNET.BS CORP.
Whois Server: whois.internet.bs
Referral URL: http://www.internet.bs
Name Server: NS1.RXMEXICOONLINE.COM
Name Server: NS2.RXMEXICOONLINE.COM
Name Server: NS3.RXMEXICOONLINE.COM
Status: clientTransferProhibited
Updated Date: 02-dec-2011
Creation Date: 14-jul-2010
Expiration Date: 14-jul-2013

Last update of whois database: Mon, 25 Jun 2012 00:06:35 UTC
Queried whois.internet.bs with http://www.rxmexicoonline.com

Domain rxmexicoonline.com

Date Registered: 2010-7-14
Date Modified: 2011-12-2
Expiry Date: 2013-7-14

DNS1: ns1.rxmexicoonline.com
DNS2: ns2.rxmexicoonline.com
DNS3: ns3.rxmexicoonline.com

Registrant
Medicina Mexico, S.A. de C.V.
Lic. Gerardo Suarez, Esq.
Email:sales@meds.com.mx
Mediciana Mexico, S.A. de C.V. is the owner of this domain
Our pharmacies are licensed, regulated and located in Baja
California, Mexico. We own 43 pharmacies & several web sites.
22010 Tijuana, B.C.
Mexico
Tel: +52.526641381600

Administrative Contact
Medicina Mexico, S.A. de C.V.
Lic. Gerardo Suarez, Esq.
Email:sales@meds.com.mx
Mediciana Mexico, S.A. de C.V. is the owner of this domain
Our pharmacies are licensed, regulated and located in Baja
California, Mexico. We own 43 pharmacies & several web sites.
22010 Tijuana, B.C.
Mexico
Tel: +52.526641381600

Technical Contact
Medicina Mexico, S.A. de C.V.
Lic. Gerardo Suarez, Esq.
Email:sales@meds.com.mx
Mediciana Mexico, S.A. de C.V. is the owner of this domain
Our pharmacies are licensed, regulated and located in Baja
California, Mexico. We own 43 pharmacies & several web sites.
22010 Tijuana, B.C.
Mexico
Tel: +52.526641381600

Registrar: Internet.bs Corp.
Registrar’s Website : Internetbs.net

Network Whois record
Queried whois.arin.net with “n ! NET-64-234-224-0-2

NetRange: 64.234.224.0 – 64.234.231.255
CIDR: 64.234.224.0/21
OriginAS: AS53318
NetName: MEDIADEFENDER
NetHandle: NET-64-234-224-0-2
Parent: NET-64-234-224-0-1
NetType: Reassigned
Comment: For information on this assignment please contact
Comment: network-operations@critical.net
RegDate: 2011-02-04
Updated: 2011-02-04
Ref: http://whois.arin.net/rest/net/NET-64-234-224-0-2

CustName: Media Defender, Inc. – mediadefender.com
Address: 2461 Santa Monica Blvd
Address: D-520
City: Santa Monica
StateProv: CA
PostalCode: 90404
Country: US
RegDate: 2011-02-04
Updated: 2011-03-19
Ref: http://whois.arin.net/rest/customer/C02689973

OrgAbuseHandle: NETWO3256-ARIN
OrgAbuseName: Network Operations
OrgAbusePhone: +1-619-923-2167
OrgAbuseEmail: network-operations@critical.net
OrgAbuseRef: http://whois.arin.net/rest/poc/NETWO3256-ARIN

OrgNOCHandle: NETWO3256-ARIN
OrgNOCName: Network Operations
OrgNOCPhone: +1-619-923-2167
OrgNOCEmail: network-operations@critical.net
OrgNOCRef: http://whois.arin.net/rest/poc/NETWO3256-ARIN

OrgTechHandle: NETWO3256-ARIN
OrgTechName: Network Operations
OrgTechPhone: +1-619-923-2167
OrgTechEmail: network-operations@critical.net
OrgTechRef: http://whois.arin.net/rest/poc/NETWO3256-ARIN

RTechHandle: NETWO3256-ARIN
RTechName: Network Operations
RTechPhone: +1-619-923-2167
RTechEmail: network-operations@critical.net
RTechRef: http://whois.arin.net/rest/poc/NETWO3256-ARIN

RNOCHandle: NETWO3256-ARIN
RNOCName: Network Operations
RNOCPhone: +1-619-923-2167
RNOCEmail: network-operations@critical.net
RNOCRef: http://whois.arin.net/rest/poc/NETWO3256-ARIN

RAbuseHandle: NETWO3256-ARIN
RAbuseName: Network Operations
RAbusePhone: +1-619-923-2167
RAbuseEmail: network-operations@critical.net
RAbuseRef: http://whois.arin.net/rest/poc/NETWO3256-ARIN

DNS records

DNS query for 115.227.234.64.in-addr.arpa returned an error from the server: NameError
name class type data time to live
rxmexicoonline.com IN SOA
server: server162
email: domains@bajadatacenter.com.mx
serial: 1319050321
refresh: 10800
retry: 3600
expire: 604800
minimum ttl: 38400
38400s (10:40:00)
rxmexicoonline.com IN NS ns3.rxmexicoonline.com 38400s (10:40:00)
rxmexicoonline.com IN NS ns1.rxmexicoonline.com 38400s (10:40:00)
rxmexicoonline.com IN NS ns2.rxmexicoonline.com 38400s (10:40:00)
rxmexicoonline.com IN A 64.234.227.115 38400s (10:40:00)
rxmexicoonline.com IN MX
preference: 10
exchange: mail.rxmexicoonline.com
38400s (10:40:00)

— end –< hr />

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Medicina Mexico, S.A. de C.V.
Blvd. Sanchez Taboada #10488
Zona Rio
Tijuana, B.C. Mexico CP22010

E-Mail: sales@rxmexicoonline.com

Our Telephone Numbers
Tel: +52 664 138-1600
Tel: 1-800-464-6009 Toll Free

FAX Numbers:
1619 309-1174 U.S. Fax
+52 664 138-1441 Mexico Fax

20 thoughts on “WhoIs Rxmexicoonline.com

  1. Laura Gonzales Silva says:

    Medicina Mexico is a licensed and regulated pharmacy in Mexico. If you have a problem with Medicina Mexico contact the Mexican Regulatory Body that is present at each of their pharmacies twice a week.

    Mexican licensed Pharmacies are only allowed to purchase medication from approved labs and pharmaceutical suppliers and wholesalers

    http://rxmexicoonline.com

    • THEReporter says:

      Thanks for bringing this to our attention. May we suggest that the Medicina pharmacy get licensed in the US or some federal waiver to prevent site like ours for putting them in the category of unapproved. The internet is a jungle and consumers deserve protection.

      • Laura Gonzales Silva says:

        Your statement about getting licensed in the United States is outrageous! How would you feel if I told you to get your website approved by the Mexican Government, or the Russian Government because consumers deserve protection?

        We are Mexicans, our business is in Mexico and we are bound by Mexican law. We are not bound by laws of the United States, China, Russia or any other country.

        The real issue should be:
        1) Are you licensed and regulated by a governmental agency? The answer is YES!
        2) Does Mexico require license pharmacies to only purchase medications from approved labs and pharmaceutical companies? The answer is YES
        3) Does Mexico have law regarding scheduled medications? The answer is YES

        What does it mean Regulated?

        Each license pharmacy in Mexico is visited by Mexican Government’s Secretaria de Salud which is our Federal Health department. They check all invoices, medications, prescriptions and inventory. They have the power to arrest, close a pharmacy and detain anyone that violates the Mexican laws. These regulators take their job very serious as they should in order to protect the health of every citizen.

      • THEReporter says:

        Well, all we can say here is that US Laws is what governs our website. In the US, your online pharmacy must be approved in order to avoid negative publication. What else can I say.

    • THEReporter says:

      Just one last point. I feel your pain and understand your frustration but believe me, it’s worth the headache to get your site certified or accredited by some US organization to avoid being place in the unapproved category as many online pharmacy websites are.

      Get rid of all appearance of “distrust” and conduct your business in transparency.

      What we at SFA is advocating is “consumers protection.” That consumers must be able to make purchases from online pharmacies with the assurance that the product is “SAFE” and there is some recourse if the opposite is true.

      Until owners of websites, resellers, affiliates and others that are engaged in the sale of pharmacy via websites online put in place measures that protect consumers, we at SFA will continue on with this “mission.”

  2. Laura Gonzales Silva says:

    We are REGULATED and LICENSE BY A GOVERMENTAL AGENCY. Your referral to a US organization is inane. Since when does a so called U.S. Organization, (non-governmental) have more authority than a GOVERNMENTAL AGENCY?

    Maybe your U.S. congress needs to be certified by a U.S. (non-governmental) Organization? Sound crazy, it is as crazy as your statement is.

    I know that this may come as a shock, but the world is not based in the United States. The Americans always think they are the world leaders. I wouldn’t tell that to the citizens of Russia, China, United Kingdon and many other countries. One could construe that as grounds for world war 3. (smile)

    There is a real need for verification of pharmacies since so many engage in illegal activities. Worse, many people die from fraudulent medications. See: http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Pharmaceutical-crime

    There are so many so called verification sites on the interest that are just worthless. Some have hidden agendas; some are into collecting money only and some report information that is untruthful. Yet they all claim they are the best. It has become a joke to anyone that has a brain.

    If you really want to be an asset to the world, then report information that is truthful and accurate.

    The way you are doing it is completely wrong!

    Instead, you should be asking the correct questions like:

    If you are real, then please send us your governmental proof. Please give us the name, address and telephone number of your governmental license or regulatory body. Also, send us proof that you are purchasing medications from a real wholesaler. Real pharmacies never have a problem with producing copies of their licenses, paperwork and, or distributors.

    We have not updated our web sites, but we are now operating 49 pharmacies in Mexico and we are currently in construction for an additional 22 in Baja California. Our long range plans are to have over 1000 pharmacies in Mexico within the next 48 months.

    We are nowhere close to being the biggest pharmacy group in Mexico since our main competition (Farmacias Similares) has over 5000 pharmacies.

    • THEReporter says:

      Look, we could go back and forth with arguments. It’s like the law, both sides have credible arguments and the ultimate decision rest on one person the judge or a jury…. This is a situation where the buyers need to beware. That’s exactly what we are doing.

      What would be best for websites that want to sell pharmacy online is to create a system like“visa or mastercard” that provide some kind of consumer protection. The days and risks of creating websites and selling prescription drugs online without validation of sites have since gone.

      If your site is accredited by the Mexican authorities, then they should only sell in Mexico and avoid the international market.

      What we do at SFA is somehow unfair but it’s the best way based on what we have researched over the years. If you do not want to be branded as unapproved, then get the US firms to buy into your accreditation that if you plan on selling across borders.

      Best of luck………..

  3. THEReporter says:

    The truth is that you should provide this sort of information to some third party entity designated ensuring public safety that have the public trust not us at SFA. We are just a consumer advocate group that bring public awareness to issues of importance.

    If you are real, then please send us your governmental proof. Please give us the name, address and telephone number of your governmental license or regulatory body. Also, send us proof that you are purchasing medications from a real wholesaler.

    Real pharmacies never have a problem with producing copies of their licenses, paperwork and, or distributors.

  4. Laura Gonzales Silva says:

    We do not need US firms to buy into our accreditations. Our pharmacy licenses speak for themselves.

    Out of curiosity what US firms do accreditation? Please list them!

    I am glad you admit that what you do is unfair.

    I know of no organization that has the public’s trust other than real governmental agencies.

    • THEReporter says:

      Try the *National Association of Board of Pharmacy [NABP] *……. they do accreditation. Their VIPPS program. Another is the partnership for safe medicine.

      You guys are well funded to come up with a system that protect consumers. So far, not one of you want to do that but longing to continue to sell prescription drugs without doctor’s approval or accreditation. This is a flaw business model period. It put people health at risks.

      This practice is more dangerous than WHAT we at SFA are doing. Alternatively, you could PLACE ON YOUR SITE……”WE DO NOT SELL TO THE US.” That too should work or we do not sell to countries that required country accreditation.

      It’s up to you guys.. Come up with a system that protect consumers and we at SFA will let go. You guys have the resources, the technology, and the ability to make this happen. Quit fooling around and get REAL.

  5. THEReporter says:

    Here is my final point. Whoever come up a system of providing affordable prescription drugs via the internet that ensures public safety and consumer protection, would have the market to themselves.

    • Laura Gonzales Silva says:

      Your statement is 100% correct!

      Very few pharmacies in Mexico are allowed to sell controlled medications and those pharmacies are normally part of a hospital.

      We do not have the license to dispense or purchase controlled substances at any of our pharmacies.

  6. Laura Gonzales Silva says:

    In Mexico, it is against the law for any pharmacy or its employees to mix, or open any medication. In fact, it is a Federal Felony to violate this law. The only exception is a Mexican licensed Medical Doctor.

    All employees of pharmacies in Mexico that sell medications are nothing more than clerks.

    First Problem: We as all countries in Latin America do not have pharmacists. There is no such person or license.

    Second Problem: Both of these associations will not approve any pharmacies outside of Canada, U.K., U.S. or New Zealand. So if your pharmacy is located outside of these countries than these organizations are worthless.

    Third problem: These associations will only approve pharmacies that have pharmacists which Mexico has none.

    I read a story of a pharmacist that killed several people by mixing medications in the US. He is still a member of these organizations and he still has his license. He is being sued and he is now working for the American Government at their VA hospital. This guy worked at Doc’s pharmacy and he was regarded by his peers. He was named pharmacist of the year in 1997 by Professional Compounding Centers of America, the 62-year-old Walnut Creek resident was also on the board of one of the industry’s powerful lobbying organizations. (National Association of Board of Pharmacy [NABP]
    See: http://www.sfgate.com/health/article/CHRONICLE-INVESTIGATION-Who-s-Mixing-Your-2827215.php#page-2

    A licensed pharmacists in the United States does not have to be a member of these organizations to be licensed however, it is a good idea for them to join since they are very heavy into education.

    With a medical Doctor, he knows you; he knows your body where a pharmacist only knows the medications.

    If I need medications that needed to be mixed, then I would want my medical doctor to mix them. Not sure that I would trust a pharmacist. We like the states have different medical doctors that specialize in different areas of medicine and I trust them more than a person that learned only medications.

    You need to change your web site to reflect that you only rate pharmacies that are located in the US, Canada, UK or New Zeeland if you base your information on these two organizations.

  7. THEReporter says:

    Mexico’s laws governing medicines are similar to those in the United States. Any drug classified as a controlled medicine cannot be purchased in Mexico without a Mexican prescription. This prescription must be written by a Mexican federally registered physician. Purchasing a controlled medicine without a valid prescription in Mexico is a serious crime for both the purchaser and the seller. Purchasing a controlled medicine with a U.S. prescription is not sufficient and is illegal, regardless of what the Mexican pharmacy may be willing to sell to the purchaser. By law, Mexican pharmacies cannot honor foreign prescriptions.

    In Mexico, medications such as Valium, Vicodin, Placidyl, Ambien, codeine, pseudoefedrine, Demerol, morphine, and Ativan are not legally sold over-the-counter without a valid prescription from a Mexican physician. If the purchaser succeeds in purchasing controlled medicines without a prescription, Mexican police can arrest the purchaser and vendor and charge them with possession/sale of a controlled substance. The sentence for possession of a controlled substance runs from ten months to fifteen years in a Mexican prison. Making such an illegal purchase also puts the buyer at risk for various extortion scams perpetuated by police officials (who sometimes work in league with the very pharmacy that sold the medication).

    There are a number of medications considered controlled substances in Mexico which are not controlled in the United States. To find out if a medication is considered controlled in Mexico, purchasers should ask their Mexican physician or pharmacist. Purchasers may also refer to the following Mexican government website (in Spanish, listing generic and brand names) for information on controlled substances in Mexico: http://www.cofepris.gob.mx/Paginas/Inicio.aspx.

    To bring the medications into the United States, travelers will need to show a valid U.S. prescription to the inspector at the Port of Entry. The U.S. prescription is in addition to the Mexican prescription used to purchase the medications in Mexico. For more information on bringing medications into the United States, purchasers may refer to the U.S. Customs and Border Protection website: http://www.cbp.gov.

    Over the last few years, there have been several highly publicized arrests of Americans purchasing controlled medications without a Mexican prescription. We hope to reduce the numbers of Americans arrested in Mexico for possession of controlled items by disseminating this information.

  8. Laura Gonzales Silva says:

    I should have added that several pharmacies in the past that had this license to sell controlled medications that violated Mexican Law were immediately shut down, all employees were arrested including their owners. Each received a mandatory 10 years.

    Just making a simple mistake regarding a controlled medication is a automatic 10 year sentence and that is why our owners refused to accept this license after it was offered.

  9. THEReporter says:

    I’ve heard this argument before. I was told years ago that posting fraudulent jobs online was the norms. That there wasn’t anything anyone could do to STOP SUCH PRACTICE. Well in retrospect, it still exists but the overwhelming risks is far less than it used to be.

    Crime is part of our society. If you get unlucky or by association, you get to deal with crime. The idea that one can put up a website to sell prescription drugs online without regards to public safety or consumer protection is beyond comprehension. Such entity or individuals are either gutless or don’t give a damn. We would not be in business if what we are doing did not serve public interest.

    I am going to repeat this. Whoever come up with a way to sell prescription drugs online at affordable prices that guarantee public safety and protect consumers will have the market to themselves.

    The current business model of creating websites to dispense prescription drugs are long gone. It was the days of the wild wild west and those days are behind us.

    We are committed to identifying as much of these websites and warn the public about such danger.

    If you want to sell prescription drugs from Mexico to the US, come up with a system that works and put to rest ALL public safety issues. You are wasting your time trying to convince us. We do not see where public safety is paramount on these websites.

    Approximately 98% of the sites we identify are either hosted overseas and the site owner is privately protected. If the site owner is just a reseller of prescription drugs via websites, then form a lobby group to pursue Congress to make such practice legal guys. Damn it, you guys have the ability and resources to do things the RIGHT WAY.

    MyWot have done an extensive researched into your operations and as it turns out, it’s the same groups of entities and individuals responsible about 95% of most bogus pharmacy websites. http://www.mywot.com/en/forum/24070-medicina-mexico

    Below are some sites they’ve identified.

    bajafarmacia.com
    docmorrismexicopharmacy.com
    familypharmacymexico.com
    mexicanchemist.com
    pharmacyonlinegroup.com
    tijuanadrugcompany.com
    bajameds.com
    bestrxmexico.com
    costcomeds.com
    pharmastatmexico.com
    paylessmexicanpharmacy.com

    It appears that the guys at Mywot have put to rest the owner identity by identifying that this operation is associated with one

      Stephen Cohen of San Diego, CA.

    All of the name servers points back to his operations.

    IP ADDRESSES and OTHER BUSINESSES

    66.11.127.146
    66.11.127.150
    66.11.127.151
    66.11.127.153

    californiainvestigationagency.com
    coheninvestigationagency.com
    meredithasociados.com
    stephencoheninvestigationagency.com

    more “pharmacy” domains:

    66.11.127.147
    66.11.127.148

    paylessmexicandrugstore.com
    realmedsmexico.com

    ns1.fnb.com.mx
    ns2.fnb.com.mx
    ns3.fnb.com.mx
    mail.fnb.com.mx

    Go to mywot and see their researched.

    Good luck and thank you for this exchanged. Sure hope it helps and make this a public debate and safety issue.

  10. SFA Reporter says:
    TO:        Medicina Mexico
    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
    WARNING LETTER
    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 chloranfenicol (also known as chloramphenicol) offered for sale under the brand name, Lebrocetin. Your websites claim that chloranfenicol is an “antibiotic indicated for typhoid, paratyphoid, rickettsial, brucellosis, meningitis, endocarditis, osteomyelitis, bacteremia and infections caused by anaerobic 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 previously approved versions of these chloramphenicol products were determined to have been withdrawn from sale in the U.S. for reasons of safety or effectiveness. (81 FR 64914)
    Prior to being removed 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 had been withdrawn for reasons of safety and effectiveness, FDA relied on the fact that additional therapies with less severe adverse drug effects have been approved, and that, therefore, the risks associated with these chloramphenicol products as labeled outweighed the benefits.
    Misbranded Drugs
    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 products 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 drug products as defined in the FD&C Act § 503(b)(1) that are 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, 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 Levaquin product 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)].
    * * *
    FDA is taking this action against Medicina Mexico 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.
    If the corrective action(s) cannot be completed within 10 working days, state the reason for the delay and the time within which the correction(s) will be completed.  Your response and any other inquiries concerning this letter should be sent to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
     
    Table of Websites:
    Connecting URL
     
    americanonlinepharmacy.com
    buymeds4less.com
    buymedsonlinenow.net
    buyrxmedsnow.com
    meds4sale.com
    orderyourmedsonline.com
    rxmexicoonline.com
    rxonline.com.mx
    Sincerely,
    /s/
    Thomas Christ
    Director
    Office of Drug Security, Integrity, and Response
    Office of Compliance
    Center for Drug Evaluation and Research
    Food and Drug Administration

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