Earlier this month, FDA announced it will provide states one more year to decide whether to sign its compounding memorandum of understanding (MOU) before the agency begins enforcing the statutory 5% limit on out-of-state distribution of compounded human drug products. This comes after many states asked for more time to wrangle with the legal and logistical ramifications of signing. The new enforcement date is October 27, 2022, and only applies to pharmacies in states that do not sign the MOU.
The extension will also allow for more time to dispel misinformation that has circulated about the MOU, misconceptions that could impede the enactment of this vital measure to protect patient safety. We’ve outlined the most common misconceptions below.
Misconception #1: States can negotiate their own versions of the MOU.
Only one MOU exists, and all who sign it have the same obligations. Understandably, the standard MOU is meant to avoid a patchwork of agreements that FDA and pharmacies located in multiple states would need to track and comply with.
Misconception #2: The MOU forces states to scrutinize every compounded prescription.
“Our Information Sharing Network helps states easily share compounding data.”
States do not need to evaluate and verify every compounded drug order to determine whether a pharmacy has met the inordinate amount threshold. To help states more easily determine and report this information, we created the Information Sharing Network. Using it is optional, but the boards can rely exclusively on the comprehensive data that pharmacies report through the network and transmit it to FDA electronically. States may also utilize the Information Sharing Network to report complaints of serious adverse drug experiences and product quality issues for compounded human drug products shipped out of state by pharmacies.
Misconception #3: States must inspect and investigate compounding physicians’ offices.
The MOU does not require boards to enter physicians’ offices to inspect or investigate compounding activities. It only requires states to report complaints of adverse drug events or product quality issues for compounded human drug products compounded by physicians’ offices and shipped out of state if they become aware of such complaints. In addition, the MOU requires states to report if they become aware that a physician’s office is shipping any amount of compounded products interstate.
So, What Do You Have to Lose?
Signing the MOU is a win-win for regulators and patients. Greater compounding oversight means less chance of a state dealing with the fallout from something similar to the 2012 NECC tragedy. But most importantly, patients can rest knowing that regulators are closely watching the pharmacies that produce the drugs that improve and save their lives. And isn’t the protection of patient health what we all strive for?
You can learn more information about the FDA MOU from these FAQs and also from this blog. Our State Government Affairs department is also available to answer questions at email@example.com.