Source: https://unapprovedpharmacy.com/2017/09/
Timestamp: 2019-04-24 04:40:22+00:00

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

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