Jill Wechsler
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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
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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.
