Source: https://unapprovedpharmacy.com/2017/09/30/fda-warning-letter-bulk2usa/
Timestamp: 2020-05-31 09:29:54
Document Index: 524997377

Matched Legal Cases: ['§ 355', '§ 355', '§ 503', '§ 353', '§ 331', '§ 352', '§ 353']

FDA Warning Letter – Bulk2USA – scamFRAUDalert®Pharmacies Checker
TO: Bulk2USA
For example, your websites offer unapproved new drugs, including hydrocodone and acetaminophen 10/500 mg, which is described as a “combination of narcotic drug (Hydrocodone) and non narcotic drug (Acetaminophen)…. used to treat Moderate to severe pain.” 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. 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]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). 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,”
Your websites also offer for sale tramadol, marketed as “Tramal SR,” and described as an “opioid pain medication… to treat moderate to moderately severe pain.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] in effect for the “Tramal SR” product marketed on your website. FDA-approved tramadol bears a boxed warning addressing 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.
Your websites also offer for sale prescription drugs 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. Prescription drugs offered for sale on your website include opioids such as tramadol and hydrocodone drug products. Offering these drugs for sale on your websites is particularly concerning given 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.
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 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)].
In addition, 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.
FDA is taking this action against Bulk2USA 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.
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[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 28, 2017].
Posted in: unapproved
FDA Warning Letter – American Pharmacy Group