A court action brought by the US Food and Drug Administration against a drug compounding and outsourcing facility puts the spotlight on this specialized area that only started being heavily overseen recently, in 2013.
A federal judge in early June entered a consent decree of permanent injunction against Delta Pharma, Inc, of Ripley, Mississippi, and two of its executives. The company was alleged to have made drugs without following current Good Manufacturing Practices (CGMPs) and distributed drugs without adequate directions for use.
The drugs they made were supposed to have been sterile and included injectable corticosteroids and antihistamines. The company agreed to cease operations until it “completes corrective actions, including hiring a qualified independent expert” to inspect the facility and confirm compliance, and then gets FDA authorization to reopen.
Many important changes in Food and Drug Law are inspired by tragedies. For example, serious birth defects from thalidomide in the 1950s led to tougher new drug approval requirements first put in place in the 1960s, and injuries associated with some intrauterine devices led to tougher regulation of medical devices in the 1970s.
Add drug compounding to that list, as a change in the law was made in 2013 following deaths and infections across the country associated with injectable drug products made at a compounder.
Compounders combine, mix or alter ingredients to make a customized or specialized version of a drug or drugs, for example for patients with allergies to the regular medication or with other special needs.
This can help medical providers meet patients’ needs on a more individualized basis, but not if the compounders don’t do it correctly. Nevertheless, until about 5 years ago, FDA’s regulatory oversight of compounding was rather limited.
Before 2013, drug compounding, even though it resulted in new products that are not FDA-approved, wasn’t regulated by FDA as was ordinary drug manufacturing. As you may know, FDA regulates drug manufacturing and sale but not the practice of medicine – the old cliché is that FDA’s jurisdiction stops at the doctor’s office door.
What then to make of compounding facilities mixing and matching and customizing drug products manufactured by others? These operations were not quite a drug manufacturer, which FDA could regulate, but also not quite a medical doctor or pharmacist, which FDA couldn’t.
The 2013 law, the Drug Quality and Security Act, changed that, and required compounders to comply with CGMPs, subjected them to FDA inspection, and required the facilities to make adverse event and other reports. Drug compounders now have to receive patient-specific prescriptions before they compound a specific product, but some facilities are qualified as “outsourcing facilities” and can prepare products in response to a health care provider’s order rather than a patient-specific order.
This particular outsourcing facility is alleged by FDA to have not followed these new, additional requirements, and is being required to shape up before they can again ship out. No one likes getting into trouble with FDA, but at least this company’s fate isn’t permanent: It has a path forward that tells them what they need to do, and if they do it, will allow them to re-start.
Information only. Not legal advice.