FDA Summarizes Good Manufacturing Practices for Holding and Distribution

This week, the US Food and Drug Administration published on its website a list of questions and answers about good manufacturing practices for the holding and distribution of drug products. The online document provides information about human-drug recalls, including details about the agency’s authority and manufacturers’ responsibilities.

FDA defines recalls as measures that manufacturers take to remove from the market drug products that violate laws administered by the agency. Recalls are undertaken on a pharmaceutical company’s initiative or upon FDA request. Regulations for finished pharmaceuticals require manufacturers to establish and follow written procedures to facilitate recalls, according to the website. Over-the-counter (OTC) drugs are subject to the same recall provisions as are prescription drugs.

The document notes that FDA does not have the authority to order a recall, but that the agency can initiate legal actions such as seizures and injunctions against manufacturers that continue to market defective products. The agency may take these actions against companies that refuse to initiate recalls, and manufacturers typically initiate recalls voluntarily to avoid them, according to the website.

H.R. 5740, which US Representative Edolphus Towns (D-NY) introduced on July 14, 2010, and S. 3690, which Senator Michael Bennet (D-CO) introduced on August 3, 2010, would grant FDA the authority to order mandatory drug recalls. Both bills currently are in committee.

Manufacturers of OTC drugs approved in new drug applications must report quality defects to FDA, but manufacturers of OTC monograph drugs (i.e., drugs that were not approved in product-specific applications) are exempt from this requirement. Instead, the manufacturer, packer, or distributor identified on an OTC monograph drug’s label must alert FDA about serious adverse events associated with that drug.

FDA expects companies to investigate released and rejected lots alike for potential recalls, according to the document. Manufacturers periodically must review complaints, recalls, returned or salvaged drug products, and investigations of product discrepancies. Firms must also review an appropriate number of batches and records associated with the batches to ensure that all potentially affected product has been investigated thoroughly and that appropriate follow-up action has been taken.

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FDA Needs More Muscle and Money (blog post)

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