Drug Registration and Listing

Owners or operators of all U.S. and non-U.S. drug establishments that engage in the manufacture, preparation, propagation, compounding, processing of drugs or that are offered for import into the U.S., are required to register and submit a list of every drug in commercial distribution by way of U.S. FDA's new Electronic Drug Registration and Listing System (eDRLS).

These domestic or foreign firms must at the time of registration list all drugs manufactured, prepared, propagated, compounded or processed for commercial distribution in the U.S.

Foreign establishments must identify a U.S. agent at the time of their registration. Registration information must be renewed annually.

Two regulatory pathways exist for the legal marketing of such products:

  • marketing in compliance with an Over the Counter (OTC) drug monograph
  • marketing under the authority of an approved product-specific new drug application (NDA), or an abbreviated new drug application (ANDA)

Bringing Nonprescription Drug Products to the market under an OTC Monograph

OTC drugs can be brought to the market following the NDA process or under an OTC monograph. Each OTC drug monograph is a kind of "recipe book" covering acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters. OTC drug monographs are continually updated to add additional ingredients and labeling as needed.

Products conforming to a monograph may be marketed without FDA pre-approval. The NDA and monograph processes can be used to introduce new ingredients into the OTC marketplace. For example, OTC drug products previously available only by prescription are first approved through the NDA process and their "switch" to OTC status is approved via the NDA process. OTC ingredients marketed overseas can be introduced into the U.S. market via a monograph under a Time and Extent Application (TEA) as described in 21 CFR 330.14.

Contact us to find out more about how our Drug Regulatory Consulting Services can help you register your product or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.