FDA Proposes Electronic Registration for All Manufacturers and Drugs

A new system would enhance enforcement, promote access to drug information, and help identify illegal drug manufacturing.
Oct 02, 2006
Volume 30, Issue 10

Jill Wechsler
The US Food and Drug Administration needs an effective system for registering and tracking pharmaceutical manufacturers and their products to identify the facilities it needs to inspect, select products for testing and sampling, levy user fees, monitor adverse events, and uncover alternative sources of needed medicines. FDA has long maintained a list of all drug products distributed in the United States, including the names of their manufacturers, product formulations, and national drug code (NDC) numbers. The system, however, is rife with errors and omissions. Many manufacturers fail to register new products accurately, to report changes, and to remove discontinued drugs from the list. And, many listed products have incomplete or inaccurate information and erroneous NDC codes.

OIG finds NDC errors

A recent analysis by the Office of the Inspector General (OIG) of the US Department of Health and Human Services found that some 34,000 of the 120,000 drugs listed in FDA's National Drug Code Directory no longer exist and that 9000 marketed drugs are not on the list. The OIG urged FDA to fix the system, and FDA responded that it had plans to do so. Developing an accurate and complete electronic drug-registation and listing process "has been a high priority for several years," an FDA official explained to Pharmaceutical Technology.

In Washington This Month
In fact, a few days after the OIG published its critical report in August 2006, FDA unveiled a proposed regulation that requires manufacturers, repackagers, relabelers, and drug-product salvagers to submit information about facility locations and marketed drug products to a new electronic drug registration and listing system. Knowing where drugs are made and who is making them will "help stop illicit and substandard manufacturers" that do not comply with good manufacturing practices (GMPs), FDA notes. This information also can facilitate efforts to implement product recalls, monitor adverse events, provide bar codes on all drug products, and identify sources of drugs to counter bioterrorism attacks and address emergencies. Conversion to an electronic system, moreover, supports broader efforts to ensure drug safety and quality, commented FDA Deputy Commissioner Janet Woodcock.

Registration requirements

This lengthy proposed rule calls for manufacturers to register their establishments within five days of beginning operations. All foreign manufacturers would have to register and provide information about their US agents and about importers for each drug made for the US market. Producers of excipients and other inactive ingredients would not have to register, but contract manufacturers and laboratories would. The proposed rule applies to human and animal drugs and biologics, including vaccines and therapeutics. It does not apply to blood banks, medical-device makers, or private-label distributors unless they perform manufacturing or relabeling activities. All registrants would have either to update their registration information whenever changes occur or confirm their information twice a year.

Major benefits also would come from integrating the data with the DailyMed electronic labeling system. This linkage not only would help detect errors and omissions in FDA's list, but also would expand public access to drug information and support electronic prescribing initiatives. By scanning a product's bar code, patients and providers would be able to retrieve the latest drug-labeling and safety information, thereby avoiding prescribing and dispensing errors in the process. FDA says the benefits of the new system ultimately justify implementation costs, which it estimates will be about $5.6–5.8 million per year.

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