Regulatory Focus™ > News Articles > Quality & Compliance: FDA’s Acetaminophen Notice: A Snapshot of the Current Regulatory Environment

Quality & Compliance: FDA’s Acetaminophen Notice: A Snapshot of the Current Regulatory Environment

Posted 01 June 2011 | By Kevin D. Healy, PhD, RAC

As part of an ongoing safety initiative, the US Food and Drug Administration (FDA) recently announced that it is asking manufacturers to limit the maximum amount of acetaminophen allowed in prescription products to 325 mg/unit.1Acetaminophen is an active ingredient found in many common over-the-counter (OTC) products (e.g., Tylenol, Excedrin, Nyquil) and prescribed combination products (e.g., Percocet, Vicodin). FDA's action will directly impact several highly prescribed drug products in the US, and it is possible that future FDA actions will impact the substantial OTC acetaminophen market. The regulatory activity surrounding acetaminophen illustrates FDA's continued focus on drug safety and exemplifies the tools and tactics being utilized in the wake of Food and Drug Administration Amendments Act (FDAAA)of 2007.

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