Author

Marco Theobold

Director of Medical Device and Drug Services

FDA Issues First OTC Monograph Final Orders; Includes Updates to Sunscreen Drug Product Requirements

Oct 20, 2021

On September 20, 2021, the U.S. Food and Drug Administration (FDA) released an initial batch of final administrative orders for Over-The-Counter (OTC) drug monographs, the first to emerge from the OTC Monograph Reform. FDA established the reform on March 7, 2020, under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

FDA released the first final administrative orders for the following:

  • Nighttime Sleep-Aid Drug Products for OTC Human Use
  • Antiflatulent Drug Products for OTC Human Use
  • Topical Otic Drug Products for OTC Human Use
  • Corn and Callus Remover Drug Products for OTC Human Use

FDA has continued to release several more final administrative orders since the initial batch, which the portal reflects. Recent additions include a final order for Sunscreen Drug Products for Over-the-Counter Human Use.

The Sunscreen Drug Product Final Order

FDA had regulated Sunscreen products under enforcement discretion for more than 20 years, maintaining a stay on a 1999 final monograph. FDA had previously established several proposed rules for Sunscreen products that would lift the stay. In 2011, FDA published a final rule that codified the labeling of OTC sunscreen drug products, including dramatic changes to the content of the Drug Facts panel. In 2019, FDA issued a tentative final monograph in the form of a proposed rule that deemed all of the active ingredients non GRASE with the exception of titanium dioxide and zinc oxide, and included changes to the labeling requirements.

FDA has released the deemed final order for Sunscreen Drug Products for Over-the-Counter Human Use. At the same time, FDA issued a proposed order to amend the final order that included significant changes, mimicking much of what had been in the 2019 tentative final monograph. FDA is currently taking public comments on the proposed order.

Notable comparisons and contrasts between the final order and the most recent proposed order include:

  • The final order maintains the same GRASE active ingredients that  were covered under the original 1999 final monograph. Titanium dioxide and zinc oxide remain classified as generally recognized as safe and effective (GRASE) for use in sunscreens at concentrations of up to 25 percent, per the proposal. However, the proposed order would exclude several other ingredients from GRASE, citing insufficient data.
  • A maximum labeled Sun Protection Factor (“SPF”) value of 60+ and limits on the maximum formulated SPF value of the product.
  • Powder as a dosage form is included in the final order but deemed not GRASE in the proposed order.

How FDA is Handling OTC Monographs Moving Forward

FDA has stated it will release the remaining orders in phased batches. The Agency will also post all orders on its new web portal, OTC Monographs@FDA. FDA has stated that, as final administrative orders add, remove or change conditions for an existing OTC monograph, the portal will reflect such changes. Final administrative orders will not be announced on the Federal Register, which was common practice for publishing proposed and final rules prior to OTC Monograph reform.

Before the OTC Monograph Reform, the Administrative Procedure Act determined the process for establishing, revising, and amending a monograph. If FDA determined that a drug was generally recognized as safe and effective (GRASE) for a therapeutic category, FDA would place the drug in a proposed rulemaking stage, and the final monograph was tentative. Rulemaking is a lengthy process that requires a proposal, periods of public comment, and finalization.

The OTC Monograph Reform replaced the extensive rulemaking stage for monographs with a more streamlined administrative order process. This process indicates that a drug that meets certain requirements is GRASE, not a new drug, and not subject to certain requirements. Administrative orders may apply to drugs that, among other things, meet specified requirements for conformity to current tentative or final monographs and represent the most recently issued version of the drug’s conditions of use.

Questions about FDA Regulations?

Registrar Corp is a private company that assists businesses in complying with FDA regulations. We can help you navigate the most recent advances in the OTC Monograph Reform. For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

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Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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