In a pre-publication Federal Register Notice (FRN) (here) on FDA’s webpage on Over-The-Counter Monograph Drug User Fee Program (OMUFA) (here), the FDA announced the OTC Monograph User Fees for FY 2027. The Notice explains how the fees were set and the change where “beginning with FY 2027, FDA is consolidating the separate facility fee notices […]
Today, the FDA approved a combination of acetaminophen and naproxen sodium tablets, 325 mg/110 mg for minor pain as an over-the-counter product for 12-hour pain relief. FDA says in a press release (here): “This nonprescription product is indicated for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual […]
In today’s prepublication of the Federal Register, the FDA, in response to an over-the-counter (OTC) monograph order request (OMOR), announced the availability of an amended final administrative order (OTC000039) for sunscreen ingredients permitting the over-the counter (OTC) use of the ingredient bemotrizinol, considering it to be generally recognized as safe and effective (GRASE) for its […]
In a pre-publication notice in the Federal Register today, the FDA published OTC manufacturing facility fees for Fiscal Year 2026. The fees are due on June 1, 2026. There are two types of OTC manufacturing facilities outlined in the statute: First is the OTC Manufacturing Drug Facility (MDF), which is described as “a foreign or domestic […]
In a prepublication Federal Register notice here, the FDA announced its FY 2026 OTC monograph order requests (OMOR). The Agency has indicated that it will publish the FY 2026 OMUFA facility fee rates (i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates) in a subsequent Federal Register notice. There are two tiers of […]
New MaPP 5200.11 (here) provides an outline of internal FDA policy applied when an NDA product makes a full OTC switch. A partial OTC switch means there is a “leave behind” indication in the NDA product that still requires a prescription. This can be a use, a dose, or a related disease state. This MaPP […]
The FDA has made clear that it is interested in hearing your thoughts on the OTC drugs approved through the NDA process and wants your feedback on a number of topics. In a pre-publication notice in the Federal Register yesterday (here), the FDA noted that it would like interested parties to “share their perspectives with […]
As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on […]
Almost everywhere you go, whether at a gas station, health store, supermarket, or on the internet, there are advertisements and/or an opportunity to purchase CBD (cannabidiol), a byproduct of hemp that is a non-psychoactive cannabinoid. According to the FDA, cannabidiol occurs in relatively high levels in hemp. Ever since the passage of the Agricultural Improvement […]
On July 21, 2025, the FDA published its updated Over-The-Counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists. The updated versions can be found here for the facility arrears list and here for a download of the paid list. If your facility is still engaged in the manufacture of OTC products and […]
