The CARES Act, signed into law on March 27, 2020, brought significant changes to the regulatory framework governing Over-the-Counter (OTC) drugs in the U.S. Section 505G, which was added to the Federal Food, Drug, and Cosmetic (FD&C) Act, specifically addresses OTC monograph drugs and aims to modernize their regulation. The new rules are intended to streamline and update how OTC drugs are brought to market, offering clearer pathways for both manufacturers and regulators.
- Drug Application Process: This involves a more traditional route where a drug is subject to FDA review and approval before being marketed.
- OTC Drug Monograph Process: This is the streamlined process under which drugs that meet certain pre-established conditions (set out in an OTC drug monograph) can be marketed without needing FDA approval. The monograph details the conditions for the drug’s safety and effectiveness.
The CARES Act introduces Section 505G, which provides updates and new provisions to the OTC monograph process. This includes the ability for the FDA to issue administrative orders that can add, remove, or modify the conditions under which a drug is considered Generally Recognized as Safe and Effective (GRASE).
- OTC Monographs: These are established for therapeutic categories (e.g., sunscreen, antacid). They include details on acceptable active ingredients, intended uses, dosages, routes of administration, labeling, and testing that a product must meet to be considered GRASE.
- FDA’s Authority: Section 505G gives the FDA the authority to issue both proposed and final administrative orders to update, remove, or change the conditions under which an OTC drug can be marketed. This gives the FDA more flexibility to respond to evolving scientific data and public health needs.
- Initiation of the Administrative Order Process: The process can be initiated either by the FDA or by a requestor (typically a manufacturer or other interested party).
- Administrative Orders: These orders are part of the mechanism for modifying or creating new OTC monographs. The orders can cover the addition of new ingredients, new uses, or new standards for an existing OTC drug category.
This reform modernizes and simplifies the process for updating OTC monographs, allowing more agility in responding to changes in scientific evidence and public health concerns. It also creates a clearer path for manufacturers to bring their OTC products to market without needing full approval through the traditional New Drug Application (NDA) process.
Masuu is a regulatory consulting firm that provides a range of services to assist businesses with Over-the-Counter (OTC) drug submissions. They likely help companies navigate the complexities of regulatory processes, including the FDA’s OTC monograph system and the drug application process. Masuu also supports in Preparing and submitting necessary documentation to the FDA for OTC drugs, including requests for changes or updates to OTC drug monographs.
Guideline for OTC: OTC MONOGRAPHS @ FDA | FDA