9-14-2023 – FDA is updating the marketing category and application number fields for over-the-counter (OTC) monograph drugs in eDRLS. Companies who list OTC monograph drugs should update their drug listings accordingly as part of the annual establishment registration renewal and drug listing certification period that begins on October 1, 2023.
- For the marketing category field, FDA is replacing “OTC monograph final” and “OTC monograph not final” with the single term “OTC monograph drug” for nonprescription drug products marketed without an approved new drug application under section 505G of the FD&C Act.
- For the application number field, provide an OTC monograph reference in the drug listing, use the number of the applicable OTC monograph found on the OTC Monographs@FDA portal. For example, include “M014” as the application number for an otic drug product marketed under OTC Monograph M014: Topical Otic Drug Products for OTC Human Use.) In the case of a drug currently marketed under 505G(a)(3), include the term “505G(a)(3)” in the application number field.
Owners or operators of drug manufacturing establishments are required to register their establishments with FDA. Registrants are also required to list each drug manufactured at their establishment(s) intended for commercial distribution and submit updated drug listing information to FDA twice each year, in June and December, notifying FDA if this information has changed.
- Registration renewal occurs between October 1 and December 31 each year
- Listing updates may occur at any time in the calendar year
Establishment registration and drug listing data are submitted electronically using structured product labeling (SPL) format. This provides the agency with a list of all drug manufacturers currently producing drugs for sale in the U.S. and a current inventory of all drugs in the U.S. supply chain. Parts of the data are published in the FDA National Drug Code Directory, FDA label repository, FDA drug establishment current registration site and NIH’s DailyMed. See eDRLS instructions for information and instructions on the electronic submission process.
Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote patient safety. FDA relies on establishment registration and drug listing information for several key programs, including:
- Drug establishment inspections
- Post market surveillance
- Drug quality reports
- Adverse event reports
- Monitoring of drug shortages and availability
- Supply chain security
- Drug import and export
- Identification of products that are marketed without an approved application
Drug registration and listing information is also widely used outside FDA for several purposes, such as electronic prescribing and electronic health records, reimbursement and patient education. This is why correct and up-to-date information in FDA’s NDC Directory and other public drug listing databases is essential to protect public health.
See section 510 of the Federal Food, Drug, and Cosmetic Act and part 207 of Title 21 of the Code of Federal Regulations (CFR) for more information on the requirements for establishment registration and drug listing.
CARES Act requirements for OTC drug manufacturers
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) was signed into law on March 27, 2020. The CARES Act added section 505G to the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Section 505G reforms and modernizes the over-the-counter (OTC) drug review process.
As part of these reforms, under section 505G(b)(8) of the FD&C Act, a final monograph or tentative final monograph (TFM) that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act and that represents the most recently issued version of the conditions of use, including as modified, in whole or in part, by any proposed or final rule, is deemed to be a final order (deemed final order).
FDA has made available all such deemed final orders. The current OTC monographs are posted in the OTC Monographs@FDA portal. FDA also intends to issue a notice to withdraw the pre-CARES regulations establishing final OTC monographs in title 21 of the Code of Federal Regulations (CFR), which no longer govern the marketing of OTC monograph drugs. A drug that complies with the OTC monograph conditions embodied by a final order and other applicable requirements, including general requirements for OTC drugs, can be legally marketed without an approved new drug application.
In addition to drugs that are subject to final orders, currently, an OTC drug that was categorized in category III for safety or effectiveness in the preamble of a tentative final monograph (TFM) that is the most recently applicable proposal or determination for such drug issued under 21 CFR part 330 (prior to enactment of the CARES Act) and that was not deemed to be a new drug under section 505G(a)(4) of the FD&C Act, may be legally marketed without an approved new drug application if the drug conforms to the provisions of section 505G(a)(3)(A) of the FD&C Act, even though a determination of whether there are conditions under which the drug is generally recognized as safe and effective (GRASE) has not yet been made. When a final order issued by FDA under section 505G(b)(1)(A) regarding such a drug takes effect, that order will govern subsequent marketing.
- Electronic Registration and Listing Compliance Program
- Drug Registration and Listing Workshop Webinar (10/13/2021)
- FDA reminds manufacturers and repackagers to update their drug listings with product identifiers (10/3/2018)
- Human drug compounding registration and product reporting procedures
- Human drug establishment registration and drug listing compliance course
- NDC Directory
- FDA drug establishment current registration site