In response to the nationwide fungal meningitis outbreak last year, the Tennessee Board of Pharmacy has finally implemented new rules on the governing of compounding pharmacies in the state. The regulations, which went into effect in late January—nearly 6 months after they were first approved—were passed by the state attorney general, but not without a few compromises.
Absent from the final version of the new restrictions are provisions that would have given the board or the state health commissioner the power to immediately shut down a pharmacy suspected of defective drug manufacturing without first convening a hearing.
Reginald Dillard, executive director of the pharmacy board, told The Tennessean: “There is no provision for an immediate cease-and-desist order. We can’t just shut someone down.”
However, the rules have brought about several new restrictions and requirements on pharmacies that compound drugs. Drug compounders must now:
- Disclose to state regulators what sterile drugs they are compounding;
- Keep accurate records of where the drugs were shipped—both to patients and healthcare facilities;
- Submit quarterly reports to the state board;
- Establish quality assurance programs and mandatory training for individuals who will actually be compounding the drugs; and
- Comply with federal sterility standards.
Additional requirements include labeling all compounded drugs, specifically warnings labels on the possible side effects.
The push to expand much-needed regulation on compounding pharmaceutical companies began last year, after hundreds of patients contracted fungal meningitis due to contaminated vials from the New England Compounding Center in Massachusetts. In all, 64 people died and 751 were hospitalized. Tennessee was one of the hardest hit states, with 153 reported cases.
While this most recent outbreak has gotten most of the publicity and media attention, there is a lesser known chronic reliability problem with compounding pharmacies in general. The Food and Drug Administration has found that there is a significant error rate in filling compounded prescriptions for at various pharmacies around the country. As a result, many people have become seriously or fatally ill because of defective drugs or taking the wrong type of medicine.
If you are a victim of pharmaceutical error or a contaminated drug from a compounding pharmacy, talk to a defective drug liability attorney after you receive medical attention to see what your legal rights are to fair compensation. Contact Gilreath & Associates of Tennessee for a free consultation today.