FDA Warning Letter – Worldwide Drug Store

TO:       Worldwide Drug Store
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 oral chloramphenicol. Your websites claim that chloramphenicol “is used for treating serious infections caused by certain 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.
Another example of an unapproved new drug product offered on your websites is roxithromycin, which your websites claim “is used for treating several different infections, including some STDs, upper and lower respiratory tract infections and asthma, gum infections like gingivitis, and bacterial infections associated with stomach and intestinal ulcers.”  There are currently no (and have never been) approved applications pursuant to section 505 of the FD&C Act
[21 U.S.C. § 355] in effect for roxithromycin in the U.S.
Misbranded Drugs
Your websites also offer prescription drugs for sale without a prescription.  Prescription products, as defined in 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 of the drugs identified above (chloramphenicol and roxithromycin) 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, recommended extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days.
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)].
A drug is also 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)].
* * *
FDA is taking this action against Worldwide Drug Store 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.
 
 
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Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

2017

Page Last Updated: 09/19/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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FDA Warning Letter – Rx-Partners

TO:        Rx-Partners
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 “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.
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 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)].
* * *
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.
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.
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Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

2017

Page Last Updated: 09/19/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی 

FDA Warning Letter – Pharmempire

TO:        Pharmempire
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 oral chloramphenicol. Your websites claim that chloramphenicol “is used for treating serious infections caused by certain 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.
Another example of an unapproved new drug product offered on your websites is roxithromycin, which your websites claim is “used for treating several different infections, including some STDs, upper and lower respiratory tract infections and asthma, gum infections like gingivitis, and bacterial infections associated with stomach and intestinal ulcers.”  There are currently no (and have never been) approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for roxithromycin in the U.S.
Misbranded Drugs
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 of the drugs identified above (chloramphenicol and roxithromycin) are prescription drugs under FD&C Act § 503(b)(1) and are offered on your websites without a prescription. Chloramphenicol is associated with serious risks including, but not limited to, fatal aplastic anemia. Additionally, the formerly FDA-approved chloramphenicol labeling recommended extensive safety monitoring, including baseline blood studies followed by periodic blood studies approximately every 2 days.
Another example of a misbranded drug offered on your websites is Keflex (cephalexin). Keflex is the brand name of a prescription drug approved by FDA to treat certain bacterial infections. The labeling for the FDA-approved product Keflex includes significant risks, including but not limited to, warnings concerning serious allergic reactions, severe watery or bloody diarrhea, anemia, and seizures.
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)].
A drug is also 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)].
* * *
FDA is taking this action against Pharmempire 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.
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Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

2017

Page Last Updated: 09/19/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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FDA Warning Letter – PharmCash

TO:        PharmCash
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 oral chloramphenicol offered for sale under the brand name, Chloromycetin. Your websites claim “[Chloramphenicol] is used to treat serious infectious diseases such as meningitis, rickettsial disease, salmonellosis and anaerobic infections.” 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.
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 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 in the FD&C Act §503(b)(1) and 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 PharmCash 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.
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2017

Page Last Updated: 09/19/2017
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Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی |English

FDA Warning Letter – MyRXCash

TO:         MyRXCash
 

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), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 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)].
For example, your websites offer tramadol, marketed as “tramadol 50 mg/ml,” described as an “immediate-release oral formulation” that is “used to treat pain and discomfort ranging from mild to severe cases….” While there are FDA-approved versions of tramadol in tablet and capsule form on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for the “tramadol 50 mg/ml” oral solution product marketed on your websites. FDA-approved 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.
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 drug is a prescription product 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 this product safely for its intended use(s). Consequently, the labeling for this product 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 [21 U.S.C. § 352(f)(1)].  Because “tramadol 50 mg/ml” 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, 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)].
Offering tramadol for sale on your websites is particularly concerning given its potential for abuse and dependency, especially amid the growing epidemic of opioid abuse in the U.S.  The Centers for Disease Control and Prevention found that opioid overdose deaths involving prescription opioids have quadrupled since 1999, and in 2015, opioids were involved in the deaths of 33,091 people in the U.S.[1] In addition, deaths by drug overdose, including overdose from prescription opioids, are now the leading cause of injury death in the U.S.\
* * *
FDA is taking this action against MyRXCash 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 that 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.
  
 
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Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

 


[1] Drug Overdose Death Data, Centers for Disease Control and Prevention, athttps://www.cdc.gov/drugoverdose/data/statedeaths.html [Accessed August 28, 2017].

FDA Warning Letter – MediPK

TO: MediPK

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), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 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)].

For example, your websites offer unapproved new drugs such as tramadol, marketed as “Tonoflex SR” and described as “a medication used to treat pain that is moderate to severe.” 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 [21 U.S.C. § 355] in effect for the “Tonoflex SR” product marketed on your websites. FDA-approved 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.

Your websites also offer for sale unapproved codeine products such as “Brufen Plus+” which is described on the image of the label on your websites as containing codeine and ibuprofen and “Powerful Double Action for Pain Relief.” While there are FDA-approved codeine products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for the “Brufen Plus+” product marketed on your websites. There are also no approved drug applications in the U.S. for products that contain the combination of codeine and ibuprofen. FDA-approved codeine bears a boxed warning that addresses risks including addiction, abuse, misuse, life-threatening respiratory depression, and neonatal opioid withdrawal syndrome. In addition, when taken in conjunction with other central nervous system depressants, including alcohol, use may result in coma or death.

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 these 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)].

Offering these drugs for sale on your websites is particularly concerning given their potential for abuse and dependency, especially amid the the growing epidemic of opioid abuse in the U.S. The Centers for Disease Control and Prevention found that opioid overdose deaths involving prescription opioids have quadrupled since 1999, and in 2015, opioids were involved in the deaths of 33,091 people in the U.S.[1] In addition, deaths by drug overdose, including overdose from prescription opioids, are now the leading cause of injury death in the U.S.

* * *
FDA is taking this action against MediPK 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 that 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:
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Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

[1] Drug Overdose Death Data, Centers for Disease Control and Prevention, at https://www.cdc.gov/drugoverdose/data/statedeaths.html [Accessed August 28, 2017].
2017
Page Last Updated: 09/19/2017

FDA Warning Letter – Medicina Mexico

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

FDA Warning Letter – GlavMed

TO:       GlavMed
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 oral chloramphenicol. Your websites claim that chloramphenicol “is used for treating serious infections caused by certain 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 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 reasoned that the risks associated with these chloramphenicol products as labeled therefore outweighed the benefits.
Another example of an unapproved new drug product offered on your websites is roxithromycin, which your websites claim is “used for treating several different infections, including some STDs, upper and lower respiratory tract infections and asthma, gum infections like gingivitis, and bacterial infections associated with stomach and intestinal ulcers.”  There are currently no (and have never been) approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for roxithromycin in the U.S.
Misbranded Drugs
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 of the drugs identified above (chloramphenicol and roxithromycin) are prescription drugs as defined in the FD&C Act § 503(b)(1) and are offered on your websites for sale 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.
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)].
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 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)].
* * *
FDA is taking this action against GlavMed 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
reynoldsdrug.com
cipropharmacy.com
rxmedscanada.com
internationalpharm.net
official-drugstore.com
med-shop365.com
meds-247.com
topmedsonline24-7.com
trustmdeal.com
vipmdline.com
soikin.com
canadianqualitydrugs.net
med-shop24.net
secureonline-shop.com
buy-azithromycin.top
online-ph.com
drugsforhealth.org
rx-canadian-store.com
amoxil-news.net
mypills24x7.com
buyamoxicillinnorx.com
buyazithromycinnorx.com
buymetronidazolenorx.com
medcareonline.net
canadianmed.net
pharmacygen.com
topdrugstore24.com
yourcanadianmeds.com
world-medstore.com

Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

FDA Warning Letter – American Pharmacy Group

TO:         American Pharmacy Group
 
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), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 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)].
For example, your websites offer unapproved new drugs including, hydrocodone and acetaminophen 10/500 mg, marketed as “combined to achieve pain relief.” While there are FDA-approved versions of hydrocodone and acetaminophen on the market in the U.S., there are currently no approved drug applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for the hydrocodone products that contain 500 mg of acetaminophen offered for sale on your websites. In January 2011, due to the risk of severe liver injury, FDA issued a Drug Safety Communication and asked drug manufacturers to voluntarily limit the strength of acetaminophen in prescription drugs to 325 mg per tablet or capsule to make these products safer for patients.  Also in January 2011, FDA announced via a Federal Register notice its intention to intitiate withdrawal proceedings pursuant to section 505(e)(2) of the FD&C Act for any prescription acetaminophen combination products with acetaminophen strengths greater than 325 mg still on the market as of January 2014.[1] In March 2014, FDA announced the withdrawal of 108 abbreviated new drug applications (ANDA) for prescription pain drug products containing more than 325 mg of acetaminophen.[2] In addition, FDA-approved hydrocodone and acetaminophen also 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), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and hepatotoxicity (liver failure).
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 drug is a prescription product 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 this product safely for its intended use(s). Consequently, the labeling for this product 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 [21 U.S.C. § 352(f)(1)]. Because hydrocodone and acetaminophen 10/500 mg 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, 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)].
Offering hydrocodone products for sale on your websites is particularly concerning given the potential for abuse and dependency, especially amid the growing epidemic of opioid abuse in the U.S. The Centers for Disease Control and Prevention found that opioid overdose deaths involving prescription opioids have quadrupled since 1999, and in 2015, opioids were involved in the deaths of 33,091 people in the U.S.[3]  In addition, deaths by drug overdose, including overdose from prescription opioids, are now the leading cause of injury death in the U.S.
* * *
FDA is taking this action against American Pharmacy Group 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 that 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
 
rxgreenovernight247.net
discreetdelivery.net
mrpharmacy.net
rxclick1.com
rxforever.com
rxplaces.com
rxclick1.net
rxforever.net
rxplaces.net
hi2rx.com
rx3go.com
sky2med.com
usabigstores.com
hi2rx.net
rx3go.net
safeshopping1.net
sky2med.net
storerx.net
rxcoinshealthcare247.net
blueovernight.com
safeshopping1.com
Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration


[1] Prescription Drug Products Containing Acetaminophen: Actions to Reduce Liver Injury from Unintentional Overdose, FDA-2011-N-0021, January 14, 2011.
[2]Actavis Totowa LLC, et al.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen, FDA-2011-N-0021,https://www.federalregister.gov/documents/2014/03/27/2014-06801/actavis-totowa-llc-et-al-withdrawal-of-approval-of-abbreviated-new-drug-applications-for, March 27, 2014. 
[3] Drug Overdose Death Data, Centers for Disease Control and Prevention, athttps://www.cdc.gov/drugoverdose/data/statedeaths.html [Accessed August 31, 2017].

FDA Warning Letter – Global Drug Supply

TO: Global Drug Supply
FROM: The United States Food and Drug Administration
RE: Shipment of Unapproved New Drugs and Misbranded Drugs to the United
States
DATE: December 6th, 2016
WARNING LETTER
The United States Food and Drug Administration (FDA) has determined that your firm
causes the introduction of unapproved new drugs and misbranded drugs into the United
States (U.S.) by shipping to U.S. consumers in violation of sections 301(a), 301(d), and
505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a),
331(d), and 355(a)]. FDA requests that Global Drug Supply immediately cease shipping
violative drug products to U.S. consumers.
UNAPPROVED NEW DRUGS
Global Drug Supply dispenses and ships unapproved new drugs directly to individual
U.S. consumers on behalf of Canadadrugs.com, an internet pharmacy from which U.S.
consumers purchase violative drug products.1
The drug products shipped by Global Drug
Supply are represented as being equivalent to U.S. approved drug products that are
indicated to treat serious conditions including (but not limited to) seizures, Parkinson’s,
hypertension, depression, and asthma. Because these products are intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect
the structure or function of the body, these products are drugs within the meaning of
section 201(g) of the FD&C Act [21 U.S.C. § 321(g)]. These products 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 [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)].

1
Canadadrugs.com and Global Drug Supply are both under criminal indictment in the U.S. District Court
for the District of Montana for engaging in the illegal importation of unapproved new drugs, misbranded
drugs, and counterfeit drugs for sale and distribution to physicians and physician office practices in the U.S.
(The charges contained in the Indictments are merely accusations and the defendants are presumed
innocent unless and until proven guilty.)
Canadadrugs.com received an FDA Warning Letter in 2012 for causing the introduction of misbranded and
unapproved drugs into the U.S. See
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm321068.htm.
Page 2
FDA physically examined packages imported to the U.S. by Global Drug Supply that
were determined, based on shipping labels, prescription order forms, and product labeling
to contain unapproved new drugs.
One example of an unapproved new drug shipped by Global Drug Supply to a U.S.
consumer is Pristiq. While Pristiq is the name of an FDA-approved prescription drug, the
product labeling for the drug shipped to the U.S. from Global Drug Supply is intended for
Australia. For example, the product labeling states, “Pfizer Australia Pty Ltd” and refers
to medical information available at “Australia 1800 675 229” and
“medicalaffairs.anzpfizer.com.” In the U.S., Pristiq is approved for the treatment of
depression. Shipping an unapproved version of this drug to U.S. consumers is particularly
concerning given that FDA-approved Pristiq 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 suicidal thoughts or actions. There have also been reports of
several serious adverse reactions associated with the use of Pristiq such as a potentially
life-threatening condition called serotonin syndrome that can happen when Pristiq is
taken with certain other medicines. Serotonin syndrome can cause serious changes in
how the brain, muscles, heart and blood vessels, and digestive system work. In addition,
Pristiq can cause other serious side effects such as new or worsened high blood pressure,
abnormal bleeding or bruising, and visual problems.
Another example of an unapproved new drug shipped by Global Drug Supply to a U.S.
consumer is Exforge. While Exforge is the name of an FDA-approved prescription drug
indicated for the treatment of high blood pressure, the product labeling for the drug
shipped to the U.S. from Global Drug Supply states that it is distributed in Australia.
Shipping an unapproved version of Exforge to U.S. consumers is especially concerning
given that FDA-approved Exforge bears a boxed warning regarding harm or death to an
unborn baby. Exforge product shipped to the U.S. by Global Drug Supply contains no
such boxed warning. In addition, the FDA-approved product labeling for Exforge
includes warnings and precautions regarding low blood pressure, risk of heart attack or
worsening chest pain, decreased kidney function, and increased potassium levels in the
blood. There have been reports of several adverse reactions associated with the use of
Exforge including, but not limited to, swelling of the hands, ankles, or feet, nasal
congestion or sore throat, head or chest cold, and dizziness.
MISBRANDED DRUGS:
Because drugs shipped by Global Drug Supply appear to be manufactured and marketed
for countries other than the U.S., they are unapproved new drugs under the FD&C Act, as
described above. A drug is misbranded under section 502(f)(1) of the FD&C Act [21
U.S.C. § 352(f)(1)] if the drug 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). The drug products
shipped by Global Drug Supply purport to treat conditions that are not amenable to selfdiagnosis
and treatment by persons who are not medical practitioners. Therefore,
adequate directions for use cannot be written for these drug products, and they must
qualify for one of the exemptions to 502(f)(1) to avoid being misbranded The exemption
Page 3
to 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] found at 21 CFR § 201.100 does
not apply to unapproved new drugs because that exemption requires that such drugs bear
“the labeling authorized by the approved new drug application.” Furthermore,
unapproved new prescription drugs also do not qualify for the exemption set forth at 21
CFR 201.115, which also requires an approved new drug application (NDA) or active
investigational new drug application (IND). Consequently, a prescription drug that is a
new drug and has not been approved by FDA or is not subject to an exemption from the
premarketing approval requirements under the FD&C Act cannot qualify for the
exemptions to 502(f)(1). Because none of the exemptions to 502(f)(1) apply, the labeling
for the drug products shipped by Global Drug Supply fails to bear adequate directions for
the intended uses, and the products are therefore misbranded under section 502(f)(1) of
the FD&C Act [21 U.S.C. § 352(f)(1)]. By shipping these products to U.S. consumers,
Global Drug Supply 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)].
Additional examples of misbranded and unapproved new drugs that have been shipped by
Global Drug Supply to U.S. consumers are noted in the table below.* This list may not be
all-inclusive.
Generic Name Brand Name
Budesonide/formoterol    Vannair
Bupropion Zyban
Celecoxib Celebrex
Conjugated Estrogen Premarin
Estrogens, Conjugated/Medroxyprogesterone Premia
Duloxetine Cymbalta
Escitalopram Lexapro
Estradiol Estradot
Estradiol/Norethindrone Estalis
Ezetimibe Ezetrol
Fexofenadine Telfast
Finasteride Regen
Fluticasone Flixotide
Fluticasone/Salmeterol Seretide
Hydroxychloroquine Plaquenil
Metoprolol CR Betaloc CR
Pentosan Elmiron
Phenytoin Dilantin
Pramipexole Sifrol
Rosuvastatin Crestor
Salbutamol/Ipratropium Duolin
Sildenafil Viagra
Tazarotene Zorac
Telmisartan/Hydrochlrothiazide Micardis Plus
Tretinoin Retrieve
Valsartan/Hydrochlorothiazide Co-Diovan
*Several of the accompanying labels purport that the shipped drug is equivalent to an FDA-approved drug.
Page 4
CONCLUSION:
FDA is taking this action against Global Drug Supply because of the risks posed by its
conduct in causing the importation of drugs that are unapproved and misbranded into the
U.S. FDA’s regulation and oversight of the drug approval process protects consumers by
requiring rigorous scientific standards for new drug approval, labeling review for
accuracy and completeness, and manufacturing procedures and testing performed under
closely controlled conditions at FDA-registered and inspected facilities.
Unapproved foreign versions of FDA-approved drugs often have different trade names or
manufacturers and may have substantially different risk profiles due to changes in drug
formulations, drug delivery methods, directions for use, or contraindications and
warnings. Any and all of these factors may harm consumers who are unaware that they
are not receiving the same medications prescribed by their healthcare practitioners.
Taking an unapproved drug in place of the FDA-approved product can negatively affect
patient outcomes because the health care practitioner may unknowingly make subsequent
treatment decisions based on the patient’s response to the unapproved drug, rather than to
the approved drug that was prescribed. This can also cause potentially dangerous drug
interactions with the patient’s other medications.
This letter is not intended to identify all the ways in which your activities might be in
violation of law. You should promptly cease shipping misbranded and unapproved new
drug products to U.S. consumers and correct any other violations of the FD&C Act.
Failure to do so immediately may result in further 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 FDAInternetPharmacyTaskForceCDER@fda.hhs.gov.

Sincerely,
/s/
Thomas Christl
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration