Regulatory Focus™ > News Articles > FDA Will Continue to Allow Unapproved Drugs to Receive National Drug Code Numbers

FDA Will Continue to Allow Unapproved Drugs to Receive National Drug Code Numbers

Posted 05 March 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) will continue to grant national drug code (NDC) numbers to pharmaceutical and other drug products not explicitly approved by FDA for a given indication after rejecting a Citizen Petition from Susan Alpert, RAC.


NDCs were created in 1969 as a response to the difficulties of processing claims in the absence of a standardized product identification system for drug products. The NDCs were intended to provide "an identification system in computer language to permit automated processing of drug data by Government agencies, drug manufacturers and distributors, hospitals and insurance companies." The system also benefited others in the drug distribution ecosystem, such as re-packagers and wholesalers.

The code itself is made up of 10 digits, with three possible configurations allowing for the identification of the labeler, the product and the package form or size.

While FDA phased in the NDC between 1969 and 1971, the 1972 Drug Listing Act required all manufacturers to list their products, regardless of whether or not it had received FDA approval. NDCs, then, are applied to three classes of products: FDA-approved products, products without FDA approval for a particular claim, and products that were grandfathered in under the 1962 Kefauver-Harris Amendments or the Federal Food, Drug and Cosmetic Act of 1938.

Alpert's Petition

It is the second of these two categories that motivated Alpert-former director of FDA's Office of Device Evaluation and senior VP of regulatory at Medtronic before retiring in 2012-to request that FDA stop issuing NDCs.

 In her petition, Alpert notes that these drugs are unusually dangerous to public health, with one Vitamin E product, E-Ferol, being responsible for the death of 40 infants in 1984, and a carbinoxamine-containing drug product responsible for the deaths of 21 infants in 2006.

Both of these products had a NDC, as do-per FDA's own estimates, Alpert said-"several thousand drug products," which she argued should be removed from the marketplace. But even as Alpert said FDA had done a commendable job in trying to remove unapproved drug products from the market, "It is now time to take a different approach and limit the financial potential and investives for health insurance reimbursement for violative pharmaceutical firms that market unapproved drug products."

It is time, there, "to stop issuing NDCs for unapproved drug products," Alpert argued, noting that she believed that the Code of Federal Regulations doesn't require FDA to issue those codes. Just the presence of these codes allows many of them to obtain insurance reimbursement, thereby facilitating their market entry and maintenance.

Petition Denied

But FDA denied her petition, saying that while it "appreciates the safety concerns that motivate [Alpert's] request … we nevertheless deny your requests."

Its denial is predicated in part upon that third segment of drug products, those marketed legally while never having received approval from the agency. "For these drugs, the lack of an NDA or ANDA does not suggest unacceptable risk, as there are processes other than the review of an individual application by which a drug may be established to meet the applicable standards for safety."

While there are many drugs that don't meet this standard-and FDA said it is just as concerned as Alpert is about these drug products-making her recommended changes to the system "would not immunize the public against illegal and potentially harmful unapproved drugs."

"In fact," FDA continued, "the changes you propose to the NDC system would make it more difficult for FDA to protect the public."

FDA argued that, regardless of their approval situation, having these products receive and use NDC codes makes it considerably easier for them to identify noncompliant drugs and subject them to enforcement actions when necessary, including recalls.

FDA also rejected Alpert's argument regarding NDCs facilitating market access. "[W]hile you assert that issuance of an NDC 'opens the door to allow firms to market,' in fact, assignment of an NDC does not confer any such permission," the agency explained. "FDA's regulations make very clear that 'registration of a drug establishment or drug wholesaler, or assignment of a registration number, or assignment of a NDC number does not in any way denote approval of the firm or its products.'"

"Thus, possession of an NDC does not absolve a drug manufacturer or marketer from its responsibility to obtain an approved NDA or ANDA, if one is required by law," FDA concluded.

FDA said it is currently working to implement "other initiatives to address" those same concerns, but did not specify those particular actions.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.