July 27, 2022
On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to minimize the impact of FDA running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs. The NDC is the FDA standard for uniquely identifying drugs marketed in the United States. FDA is proposing to change the NDC to 12 digits in length with three distinct and consistent segments and one uniform format. Additionally, FDA is proposing to revise the drug product barcode label requirements.
NDCs are currently used across the healthcare system. Changes to the NDC would impact human and animal drug manufacturers, insurers/payors, wholesale distributors, drug databanks, pharmacies, hospitals, small clinics and healthcare practitioners, dentist offices, prisons, nursing care facilities, importers, federal agencies using the NDC, state and local governments, and other supply chain stakeholders that use FDA-assigned NDCs.
Because the Agency is running out of 10-digit NDCs, this rule, if finalized, would provide certainty and predictability to stakeholders by selecting a prespecified date for an NDC change. The COVID-19 pandemic significantly increased the rate at which NDC codes were issued.
In light of the nature of the drug supply chain, FDA recognizes that it would be difficult for firms to immediately transition from a 10-digit NDC to a 12-digit NDC without a transition period and FDA is proposing a delayed effective date of the final rule. FDA anticipates that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) standards and other code sets that currently require 10-digit native NDCs to be converted to 11-digit NDCs, will likely need to be updated in some manner.
One expected benefit of the proposed rule, if finalized, is that the proposed standardized format would facilitate the adoption of a single NDC format by all stakeholders. Such an adoption would eliminate the need to convert NDCs from one of FDA’s prescribed formats to a different standardized format used by other sectors of the healthcare industry (e.g., healthcare providers and payors).
FDA is proposing to amend our regulations on foreign and domestic establishment registration and listing for drugs, including biological products and animal drugs. This proposed rule will affect drug products that are required to be listed under section 510 of the FD&C Act and 21 CFR part 207. Once effective, existing 10-digit NDCs will be required to convert to the new uniform 12-digit NDC format, and new NDCs will be assigned in the 12-digit format.
To create the proposed rule, FDA considered various stakeholders’ input. In 2016, FDA published the final rule: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs and Listing. In 2018, FDA held a public hearing about several proposed formatting options FDA could adopt. Comments were in favor of FDA’s adoption of a single standardized format that could be used by all stakeholders. The majority of the commenters were in favor of FDA establishing a certain date when stakeholders would be required to have systems capable of handling the new format.
April 18, 2016
On December 23, 2015, the FDA announced a proposed rule regarding the regulation of fixed-combination drugs. In its announcement, FDA proposed that its requirements for prescription fixed-combination...
June 14, 2016
On Thursday, June 2nd the FDA issued a final guidance, entitled “Charging for Investigational Drugs Under an IND — Questions and Answers.” The guidance provides information concerning the...
September 18, 2015
FDA is implementing its authority to destroy a drug valued at $2,500 or less after being denied admission into the United States. The final rule was announced on the Federal Register on Tuesday,...