President Obama Signs Drug Compounding Pharmacy Regulatory Bill into Law
The bill passed the House and the Senate without opposition on Monday, November 18th, and has now officially been signed into law by the president the following week.
The outbreak of fungal meningitis was tied directly to the NECC, which, like many compounding pharmacies, had been skirting the law by making large, unregulated batches of drugs. The Centers for Disease Control found that injectable steroids at the compounding pharmacy were visibly tainted – investigations found that the Massachusetts-based company was not leaving enough time for proper sterilization of their products – the investigators found “dirty mats and hoods, a leaky boiler, dark debris floating in vials of medicine.” The steroids, made to be injected into the spine, caused non-contagious fungal meningitis that sickened 751 people across the US, and eventually killed 64 patients.
Originally, compounding pharmacies were subject to state regulations, but federal agencies like the FDA, CDC, and USDA had almost no control over them. They were not subject to requirements to report problems with illnesses, unlike other pharmaceutical manufacturers.
The new bill – the Drug Quality and Security Act – would require compounding pharmacies that wished to produce large batches of drugs for mass consumption to register with the FDA, like other pharmaceutical manufacturers, so they would be subject to the same sort of inspections and oversight. Compounding pharmacies that did not wish to make this change would be unable to make large batches of drugs, and would be required to stick to the original definition of “compounding,” meaning they would tailor-make drugs for specific prescriptions. Although these compounding pharmacies would not be required to meet traditional FDA drug regulations, they would be required to open their books to the FDA when the agency received complaints.
Critics of the law question how the FDA will be able to identify “rogue” pharmacies, since some have allowances for individually-compounded drugs and still do not have to report such activity to the FDA. However, proponents of the bill say that, if doctors and hospitals remain conscious of working with good-faith compounders, then the fraudsters will be driven out of business.
Within 4 years, drugmakers and compounders will be required to put serial numbers on all drug packages, and in 10 years, the industry must upgrade to electronic codes. These measures will make it easier for the FDA to regulate drug compounding pharmacies, and track problems that occur in the substances.
The Strom Law Firm Can Help with Personal Injury Claims from Dangerous Drug Recalls
If you or a loved one have been injured, harmed, or killed by a medical product such as a drug or device, from medical device manufacturers or compounding pharmacies, you may be entitled to file a personal injury lawsuit. Defective medical devices and dangerous drugs can hurt you to such a great extent that you are unable to work, with mounting medical bills The attorneys at the Strom Law Firm can help get you the compensation you deserve, to get you through these tough times. We are licensed to practice across South Carolina, Georgia, and New York. To help you with your case, we offer free, confidential consultations. Do not hesitate to contact us. 803.252.4800