Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with FDA. In addition, the FD&C Act requires that all foreign establishments must identify a U.S. agent and importer(s) at the time of registration. The establishment registration is a 1962 statutory obligation.

The Drug Listing Act of 1972, which is a statutory obligation (Section 510 of the FD&C Act), requires that a registered establishment list with FDA all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution. Drug products are identified using a unique, three-segment ten-digit number, called the National Drug Code (NDC). The NDC number consists of a labeler code (i.e., establishment number), a product code that identifies the formulation, dosage form, physical form, and a package code that identifies the size and type of package. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory.

FDA relies on the establishment information and the drug listing information for: post-marketing surveillance; monitoring drug safety and integrity; providing consumers with access to drug information; monitoring of drug shortages and availability; and determining the commercial distribution and sale of misbranded drugs. Additionally, drug product listing information is used for drug billing and reimbursement purposes by The Centers for Medicare and Medicaid Services (CMS), which uses listing information to determine drug eligibility for reimbursement and rebate programs.

This establishment registration and drug listing requirements are codified in 21 CFR part 207 and were amended in August 2016 to update the regulations with recent statutory amendments and current practice. The revisions in 21 CFR 207 include mandatory electronic submission of the establishment registration and drug listing using the Structured Product Labeling (SPL) and clarifies the following:

  • the registration and listing obligations are with the those who physically manufacture, repack, or relabel drugs;
  • all establishments must be registered annually from 1 October to 31 December;
  • drug listing information (NDC) must be reviewed and updated for all commercial drug products, if necessary, every June and December;
  • if no changes to the product listing information have occurred since the last update the registrant must certify that no changes have occurred; and inactive ingredients must be identified in a listed drug.

The amendment also emphasizes that National Drug Codes (NDCs) should not appear on labels of non-drug products.

If your responses to the following questions are “yes”, you must both electronically register your establishment and electronically list your drug product with the FDA:

  1. Is the drug product for humans?
  2. Does your firm participate in the manufacture or processing of the drug?
  3. Does the drug enter into commercial distribution after being manufactured or processed?

If you responded “yes” to the three questions, your establishment registration must be completed within 5 days of beginning to manufacture a drug for commercial distribution.  And, once registered, you must: renew your registration and listing annually between 1 October and 31 December; de-register if the firm is going out of business or ceases to engage in the manufacture or processing of a drug; or de-list if a previously listed product is discontinued in the U.S.

Pearl Pathways is experienced in establishment registrations and drug listing and can provide these services for your company. Contact us today for a consultation with our team of experts.