FDA Moves Against Internet Drug Retailers

The FDA has cracked down on a host of operators peddling prescription drugs online, claiming the vendors are selling the drugs without a prescription, or marketing the drugs in a way that is not approved by the agency, or both.

The FDA cited 13 marketers in a batch of warning letters dated Sept. 19, in each case basing the action on a review of numerous web sites advertising the products. No physical addresses for the operators were included in the letters.

The letters, with the alleged violations, were sent to:

• GlavMed, Medicina Mexico, MediPK, PharmCash, Pharmempire, Rx-Partners and Worldwide Drug Store, all for selling prescription drugs without requiring prescriptions and for selling the unapproved medication oral chloramphenicol. In 2016, the FDA announced that it would not accept applications for approval of oral chloramphenicol because previously approved oral chloramphenicol products had been withdrawn from sale due to safety or effectiveness concerns. GlavMed, Pharmempire and Worldwide also offered for sale the unapproved drug roxithromycin, while MediPK advertised an unapproved combination of codeine and ibuprofen, the letters said.
• 247Med, Bulk2USA and MyRXCash, all for selling unapproved versions of the opioid tramadol. Versions of tramadol are approved for sale by the FDA, but not under the names used by the three operators. Bulk2USA also sold prescription drugs without a prescription, its letter said.
• American Pharmacy Group, for selling an unapproved formulation of acetaminophen and the opioid hydrocodone. There are such formulations approved for sale by the FDA, but not at the 500mg level for acetaminophen of the American Pharmacy Group product, which exceeds the allowable maximum of 325mg per tablet.
• CanAmerica Global, for selling injectable epinephrine under the unapproved name Allerject. Injectable epinephrine is approved for sale as EpiPen. Allerject was recalled from sale in Canada in 2015 due to concerns of injection-device malfunctions, the letter said.
• HA Stores, for selling the opioid roxicodone in an unapproved version called Roxicontin, and for selling the obesity treatment Slimall (sibutramine). Roxicodone is approved in some versions by the FDA, but not as HA Stores markets it. There are no current approvals for Slimall: It was voluntarily withdrawn from sale in the U.S. in 2010 due to clinical indications of increased risk of heart attack and stroke, and it was the subject of a 2011 FDA recommendation to physicians to cease prescribing it.