Source: https://unapprovedpharmacy.com/2017/09/30/fda-warning-letter-bulk2usa/
Timestamp: 2019-04-20 04:15:02+00:00

Document:
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. 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.
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)].
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.
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.
 Prescription Drug Products Containing Acetaminophen: Actions to Reduce Liver Injury from Unintentional Overdose, FDA-2011—N-0021, January 14, 2011.
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.
 Drug Overdose Death Data, Centers for Disease Control and Prevention, athttps://www.cdc.gov/drugoverdose/data/statedeaths.html [Accessed August 28, 2017].

References: § 355
 § 503
 § 353
 § 331
 § 352
 § 353
 § 352
 § 331