FDA lays out new rules to measure impurities in medications

fda logo FDA lays out new rules to measure impurities in medications The Food and Drug Administration (FDA) has laid down new rules for drug companies that detail acceptable levels of impurities – such as arsenic –allowed in medications as well as the processes for detecting them. The 81-page guidance outlines five different classifications for various elements including potentially dangerous ones like lead to relatively safe ones like zinc.

The FDA created the guidance along with drug regulators in Europe and Japan as part of the International Conference on Harmonisation, an effort to establish “permitted daily exposure” (PDE) standards for potentially dangerous elements.

The guidance details whether elements should be included in a formal risk assessment based on their toxicity and whether the element was intended to be used. For example, silver and thallium are often intentionally used in drug products for various reasons. Some elements such as arsenic are not but, the agency noted, are “ubiquitous in the environment and present in food, soil, drinking water and in air.”

However, higher levels of these materials can lead to serious health consequences. The guidelines determine acceptable exposure levels in drug products, which varies depending on whether the drug is swallowed, inhaled or injected.

The guidance explains that there are countless ways in which unwanted ingredients can wind up in a finished drug product, such as through contaminated water used during processing, and containers that leach chemicals into pharmaceutical components. Establishing a permitted daily exposure for these elements can reduce the risk of toxicity.

Source: Law 360