FDA Clarifies Rules|for Mixed Products

WASHINGTON (CN) - The Food and Drug Administration has clarified good manufacturing practice requirements for combination products, in a new regulation. Combination products are those that include any mix of drugs, devices, or biological products.

Previously, each type of product had good manufacturing practice requirements, but there were no rules to clarify and explain the requirements when the products were combined, according to the regulation.

The absence of clear requirements for combination products could result in inconsistent or differing application of the various good manufacturing requirements applicable to the constituent parts, which could affect product safety and the public health, according to the FDA.

The new regulation spells out requirements for combination products that are packaged together and those that are packaged separately, as well as those that are produced as a single entity.

A manufacturer has two options for demonstrating compliance with the good manufacturing requirements applicable to a co-packaged or single-entity combination product, under the new regulations: 1) Demonstrate compliance with the specifics of all current good manufacturing practice regulations applicable to each of the parts included in the combination product; or 2) Demonstrate compliance with the specifics of either the drug current good manufacturing practice regulations or the quality system regulation for a device, rather than both, when the combination contains both a drug and a device, and also comply with certain provisions from the other of these two sets of current good manufacturing practice requirements. Certain provisions would be added for a combination product that included a biological product, and certain provisions would be added for a combination product that included any human cell, tissue, and cellular and tissue-based products.

The regulation goes into effect July 22.

To learn more click the document icon for this regulation and others.

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