Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm576576.htm
Timestamp: 2019-04-21 22:47:29+00:00

Document:
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 In determining that these products had been withdrawn for reasons of safety and effectiveness, FDA relied on the fact that additional therapies with less severe adverse drug effects have been approved, and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.
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.
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.

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