The U.S. Food and Drug Administration released its annual forecast of planned over-the-counter monograph activities for the next 3 years. The forecast focused on public health priorities and potential changes to conditions generally recognized as safe and effective for over-the-counter drugs.

The FDA described the over-the-counter (OTC) monograph Annual Forecast as a nonbinding list of planned monograph activities intended to be initiated. These activities are expected to include FDA-initiated proposed administrative orders to add, remove, or change generally recognized as safe and effective (GRASE) conditions for OTC drug monographs.

The agency noted that public health priorities generally guide its decision-making process regarding which activities to initiate. Information from various sources, including literature, the FDA Adverse Event Reporting System, and submitted data and information, was considered in determining which activities to initiate.

Proposed priorities include:

Codeine-Containing Cough Medicines (OTC Monograph M012)

The FDA plans to address the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients. This action was part of the agency's ongoing evaluation of pediatric cough and cold drug products.

Pediatric Acetaminophen Dosing (OTC Monograph M013)

A proposed order is to address dosage strengths of oral, single-ingredient pediatric acetaminophen products. The FDA intends to propose the addition of weight- and age-based dosing for children under 12 years of age.

Propylhexedrine Abuse and Misuse (OTC Monograph M012)

The agency plans to propose a warning for propylhexedrine-containing drug products to inform consumers of serious health risks associated with abuse and misuse.

NSAID Pregnancy Labeling (OTC Monograph M013)

Updated pregnancy labeling for NSAID-containing drugs is proposed to address the risk of oligohydramnios.

Oral Health Care in Infants and Children (OTC Monograph M022)

The FDA intends to address the GRASE status of OTC oral health care drug products containing benzocaine or phenol preparations labeled for anesthetic and analgesic indications.

Ipecac Syrup for Poison Treatment (OTC Monograph M023)

A reassessment of the GRASE status of OTC ipecac labeled for poison treatment is planned.

Pediatric Cough and Cold Dosing (OTC Monograph M012)

The FDA intends to reassess the risks and benefits of cough and cold drugs in children under 6 years of age.

Oral Phenylephrine Effectiveness (OTC Monograph M012)

The agency plans to address the GRASE status of OTC phenylephrine as an oral decongestant ingredient.

The FDA is seeking data to support the inclusion of the pH cycling test as an acceptable anticaries test method (OTC Monograph M021). The agency recommended that sponsors or requestors seek a formal meeting to obtain FDA feedback on the acceptability of data and adequacy of OTC monograph order development programs to support potential new test methods.

The FDA said it would announce a request to submit data and information on this topic to the public. When announced, complete details on the request for data will be available on the OTC Monographs@FDA portal at https://dps.fda.gov/omuf.