BRISTOL, Tenn. - Tennessee state lawmakers are having their say in new federal regulations aimed at compounding pharmacies. They will be held to a higher standard under the bill that's headed to President Obama's desk.
When you get sick you rely on pharmacies and compounding companies to get you the medication you need, but after an outbreak that killed dozens some people are concerned. "When you come to the drugstore to get your medicine you want to make sure they're right," says patient Gary Hinton.
Now Congress has passed a bill that would keep a closer eye on compounding pharmacies and that helps some patients feel better. "Patients should feel more secure in medicines they get at their doctor's office and they get from the just the general public," says compounding pharmacist Mark Flanary.
Flanary is the lab director at Anderson's Compounding Pharmacy. He tells us the new regulations will not affect traditional pharmacies like theirs, but it'll impact 'outsourcing facilities' -- "Those compounders who compound in bulk for in-office use of physicians and doctors, and do not have specific patent prescriptions," explains Flanary.
Flanary says the new regulations will stop a regular compounding pharmacy from making bulk medication and not being overseen by the Food & Drug Administration. "They will be overseen by the FDA where we're still overseen by our state boards," says Flanary.
The changes come after more than 750 people were sickened by last year's outbreak of deadly fungal meningitis. It was traced back to the now-closed New England Compounding Center. That outbreak killed 16 Tennesseans.
The changes make patients like Hinton feel more confident. "You come to get your medicines [and know] that it's correct and the right dosage if they're being more regulated to get that done," adds Hinton.
Drug makers will also be required to add serial numbers to all drug packages within four years to catch a counterfeit or stolen drug that was also a part of the new bill.