Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, May 24, 2013
FDA warns of infections tied to Tennessee pharmacy By MATTHEW PERRONE AP Health Writer / May 24, 2013
WASHINGTON (AP) — Government health officials are investigating several complications reported with potentially contaminated medications made by a Tennessee specialty pharmacy.
The Food and Drug Administration said Friday that the investigation involves seven reports from patients who received steroid injections from Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.
The injections contain methylprednisolone acetate, the same drug at the center of last year’s deadly outbreak of fungal meningitis. More than 55 people have died and over 740 others have been sickened after receiving contaminated injections from a Massachusetts compounding pharmacy. The steroids are usually used to treat pain.
The FDA says at least one of the seven cases appears to be a fungal infection. The government recommends doctors stop using any sterile drugs distributed by the pharmacy.
Main Street Family Pharmacy is a compounding pharmacy, which means it mixes custom formulations of drugs based on doctors’ specifications. Compounding pharmacies have long operated in a legal gray area between state and federal regulations. Since last year’s outbreak, the FDA has stepped up inspections of compounding pharmacies across the country, triggering several national recalls of potentially contaminated medications.
A woman reached at Main Street Family Pharmacy on Friday afternoon could not immediately provide comment.
In a separate announcement, the North Carolina Department of Health said it is investigating two cases of complications reported with patients who received the injections at a clinic in Greenville, N.C. State officials say the problems reported to date involve skin infections. There have been no reports of meningitis, stroke or death, according to a state release.