On October 1, 2021, the FDA published the first list of monograph activities that will be prioritized to address areas of concern and the GRAS status of certain products under the new monograph system.  The plan is currently to address these issues over the next few years; however, the Agency does not commit to assessing all of the issues, so it is more of an aspirational list.  Activities to be addressed include:

  • Risks associated with codeine-containing cough medicine
  • Pediatric acetaminophen dosing
  • Risks associated with propylhexedrine abuse and misuse
  • Nonsteroidal anti-inflammatory drugs and oligohydramnios
  • Oral healthcare in infants and children
  • Serious skin reactions associated with acetaminophen
  • Anticaries test methods

All of the activities are based on public health priories and now, without the need for comment and rule making, FDA will have a better chance of advancing these issue in a timely manner.  To see the list and the relevant regulatory citations please click here .