FDA Sweeps Websites with Warning Letters

September 21, 2017
Pharmaceutical Technology Editors
PTSM: Pharmaceutical Technology Sourcing and Management

Volume 12, Issue 10

The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.

On Sept. 19, 2017, FDA sent warning letters to 13 companies with websites selling unapproved and misbranded drug products on the Internet, including versions of tramadol and epinephrine. The companies each run several websites selling these unapproved products.

In one of the letters, the agency stated, “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.”

FDA found that one of the companies, PharmCash, was selling unapproved drugs such as Chloromycetin, an oral chloramphenicol. In the letter, the agency stated, “On September 21, 2016, it was announced in the Federal Register that FDA would not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 50 mg, 100 mg, 250 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL because FDA determined that previously approved versions of these chloramphenicol products were withdrawn from sale in the US for reasons of safety or effectiveness. (81 FR 64914).”  

A variety of companies were also found to be selling versions of oral chloramphenicol, among other unapproved and misbranded drugs. These companies include GlavMed, Worldwide Drug Store, Medicina Mexico, Rx-Partners, and Pharmempire.

Bulk2USA and American Pharmacy Group were cited for selling unapproved painkillers such as hydrocodone and acetaminophen 10/500 mg and Tramal SR, an unapproved version of tramadol. FDA also cited 247Med, MediPK, and MyRXCash with selling unapproved versions of tramadol that lacked black box warnings about the drug’s risks.  HA Stores, Ltd was cited for selling an unapproved narcotic pain reliever.

A product called Allerject was found on websites run by CanAmerica Global. Allerject claims to be an injectable epinephrine. FDA points out that the only FDA-approved injectable epinephrine available on the market is the EpiPen. “…particularly concerning is that all Allerject devices in Canada were the subject of a nationwide recall in 2015 due to a drug delivery concern associated with a device malfunction. FDA-approved ‘EpiPen’ is a prescription drug used to treat allergic emergencies (anaphylaxis) due to stinging or biting insects, foods, drugs, exercise, or unknown causes.  Offering this unapproved new drug on your websites is particularly concerning given that even FDA-approved epinephrine products are associated with significant risks including warnings regarding serious infections at the injection site and use in patients with heart disease,” the agency stated in the warning letter. 

FDA has given the companies 10 working days upon receipt of the warning letters to respond to the agency. A list of websites operated by these companies is enumerated in FDA’s warning letters.

Source: FDA